Haifa, Israel -- (SBWIRE) -- 09/14/2017 -- Pluristem Therapeutics Inc., a leading developer of placenta-based cell therapy products, announced today that the company has been issued two new patents by Hong Kong Patents Registry for its cell therapy products relating to two of the company's leading indications, Critical Limb Ischemia (CLI) and muscle regeneration.

The first patent addresses the use of mesenchymal stem cells for the treatment of skeletal muscle damage or injury. The second is for the use of adherent cells to treat ischemia and for connective tissue regeneration and repair.

Pluristem holds over 100 patents globally, including 19 approved patents in China and Hong Kong, that cover various innovations, including the application of Pluristem's proprietary PLacental eXpanded (PLX) cells, to a wide variety of medical indications like Intermittent Claudication (IC), CLI, hematological disorders such as Acute Radiation Syndrome (ARS), and recovery and repair of injured skeletal muscle.

The approval for the patents follows a recent "Smart Money" grant from Israel's Ministry of Economy and Industry to support marketing activities in Hong Kong and China. Pluristem's progress in these markets reflects the company's goal of offering accessible cell therapy treatments to Asia's growing healthcare market.

"Receiving approval for these patents strengthens our position in Asia, where we believe our PLX cells can have a lasting and beneficial impact on the way millions of patients are treated for prevalent medical conditions," noted Yaky Yanay, President and Co-CEO of Pluristem. "We view these patent approvals as a vote of confidence in our innovative treatments and intellectual property, as our cell therapies move closer to commercialization."

About Pluristem Therapeutics
Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapy products. The Company has reported robust clinical trial data in multiple indications for its patented PLX (PLacental eXpanded) cells, and is entering late-stage trials in several indications. PLX cell products release a range of therapeutic proteins in response to inflammation, ischemia, muscle trauma, hematological disorders, and radiation damage. The cells are grown using the Company's proprietary three-dimensional expansion technology and can be administered to patients off-the-shelf, without tissue matching.

Pluristem has a strong intellectual property position; Company-owned and operated, GMP-certified manufacturing and research facilities; strategic relationships with major research institutions; and a seasoned management team.

Safe Harbor Statement
This press release contains express or implied forward-looking statements within the Private Securities Litigation Reform Act of 1995 and other U.S. Federal securities laws. For example, Pluristem is using forward-looking statements when its discusses that its strategy is to penetrate Asian markets and offer accessible cell therapy treatments to patients, its belief that the Asian continent's aging populations and growing healthcare market make it ripe for cell therapy treatments and its belief that PLX cells can have a lasting and beneficial impact on the way millions of patients are treated for prevalent medical conditions. These forward-looking statements and their implications are based on the current expectations of the management of Pluristem only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; Pluristem may encounter delays or obstacles in launching and/or successfully completing its clinical trials; Pluristem's products may not be approved by regulatory agencies, Pluristem's technology may not be validated as it progresses further and its methods may not be accepted by the scientific community; Pluristem may be unable to retain or attract key employees whose knowledge is essential to the development of its products; unforeseen scientific difficulties may develop with Pluristem's process; Pluristem's products may wind up being more expensive than it anticipates; results in the laboratory may not translate to equally good results in real clinical settings; results of preclinical studies may not correlate with the results of human clinical trials; Pluristem's patents may not be sufficient; Pluristem's products may harm recipients; changes in legislation may adversely impact Pluristem; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem's reports filed from time to time with the Securities and Exchange Commission.

For more information on this press release visit: http://www.releasewire.com/press-releases/release-3.htm

Yaky Yanay appointed Co-Chief Executive Officer to serve together with Co-Chief Executive Officer Zami Aberman Erez Egozi appointed as Chief Financial Officer

Haifa, Israel -- (SBWIRE) -- 03/31/2017 -- Pluristem Therapeutics Inc., a leading developer of placenta-based cell therapy products, announced today two senior executive appointments to support the company's growth and ensure continued success as it enters advanced stages of clinical development for its PLX products.

Yaky Yanay, President of Pluristem and formerly Chief Operating Officer, will join current Chairman and Chief Executive Officer Zami Aberman as Co-Chief Executive Officer and retain his title of President of the company. Mr. Yanay will no longer serve as the company's Chief Financial Officer and Chief Operating Officer. Mr. Yanay joined Pluristem in 2006 as Chief Financial Officer and Secretary, before being promoted to Executive Vice President in 2013 and then to President and Chief Operating Officer in 2014. Previously, Mr. Yanay was the Chief Financial Officer of Elbit Vision Systems, Ltd. He is also Co-Chairman of Israel Advanced Technology Industries, the largest umbrella organization representing Israel's hi-tech and life science industries and has served on its Board of Directors for three years.

In addition, Erez Egozi has been appointed to the position of Chief Financial Officer of the company. Previously, Mr. Egozi served as the company's Vice President of Finance and Secretary. Prior to joining Pluristem, Mr. Egozi held several senior financial positions at Verint Systems Inc. including senior director of finance-worldwide finance controller of Verint's Communications and Cyber Intelligence Solutions division. From 2003 to 2007, Mr. Egozi held several financial positions at Intel Corporation. From 2000 to 2003, Mr. Egozi served as an auditor in the hi-tech technology sector at Deloitte & Touche.

"It's a very exciting time for Pluristem, as we move forward in our mission to deliver PLX cell therapies to patients suffering from severe conditions," said Mr. Yanay. "I look forward to continue working with Zami to shape Pluristem's strategic direction and leverage our vast wealth of intellectual property and innovation to bring the company closer to global marketing for our products to provide much-needed treatments."

"As we near the critical juncture of pivotal-stage clinical trials for our cell therapy products, broadening our expertise and experience at the senior-most level will enable us to deliver even better results and opportunities for the company, investors, and potentially many patients who can benefit from our therapies," noted Mr. Aberman.

About Pluristem Therapeutics
Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapy products. The company has reported robust clinical trial data in multiple indications for its patented PLX (PLacental eXpanded) cells and is entering late-stage trials in several indications. The cell products release a range of therapeutic proteins in response to inflammation, ischemia, hematological disorders, and radiation damage. PLX cell products are grown using the company's proprietary three-dimensional expansion technology. They are off-the-shelf, requiring no tissue matching prior to administration.

Pluristem has a strong intellectual property position; company-owned and operated, GMP-certified manufacturing and research facilities; strategic relationships with major research institutions; and a seasoned management team.

Safe Harbor Statement
This press release contains express or implied forward-looking statements within the Private Securities Litigation Reform Act of 1995 and other U.S. Federal securities laws. For example, the company is using forward-looking statements when we discuss Pluristem entering advanced stages of clinical development for its PLX products, leveraging Pluristem's wealth of intellectual property and innovation to bring Pluristem closer to global marketing for its products and that broadening Pluristem's expertise and experience at the senior-most level will enable Pluristem to deliver even better results and opportunities for the company, investors and the potentially many patients who can benefit from the company's therapies.

These forward-looking statements and their implications are based on the current expectations of the management of Pluristem only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; the company may encounter delays or obstacles in launching and/or successfully completing its clinical trials; the company's products may not be approved by regulatory agencies, the company's technology may not be validated as it progresses further and its methods may not be accepted by the scientific community; the company may be unable to retain or attract key employees whose knowledge is essential to the development of its products; unforeseen scientific difficulties may develop with the company's process; the company's products may wind up being more expensive than the company anticipates; results in the laboratory may not translate to equally good results in real clinical settings; results of preclinical studies may not correlate with the results of human clinical trials; the company's patents may not be sufficient; the company's products may harm recipients; changes in legislation; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem's reports filed from time to time with the Securities and Exchange Commission.

For more information on this press release visit: http://www.releasewire.com/press-releases/release-3.htm

PLX-PAD cells could potentially obtain early conditional marketing approval in Europe via the Adaptive Pathways pilot project based on positive interim efficacy data from first 125 patients.

Haifa, Israel -- (SBWIRE) -- 01/20/2017 -- Pluristem Therapeutics Inc., a leading developer of placenta-based cell therapy products, today announced that Germany's health regulatory agency, the Paul Ehrlich Institute (PEI), has cleared Pluristem to begin enrollment in Germany for its pivotal Phase III trial of PLX-PAD cells to treat Critical Limb Ischemia (CLI) in patients who are unsuitable for revascularization. The trial was recently cleared by the United States' Food and Drug Administration (FDA) and the United Kingdom's Medicines & Healthcare products Regulatory Agency (MHRA).

PLX-PAD cells have been selected by the European Medicines Agency (EMA) to be developed for CLI via the Adaptive Pathways pilot project. Under this regulatory pathway, the multinational Phase III trial may potentially lead to early marketing approval of PLX-PAD for CLI in Europe, based on interim efficacy data from the first 125 patients that have completed a follow-up of 12 months. Data from the entire 250 patients will be submitted to the U.S. FDA for a Biologics License Application (BLA) targeting commercialization, and to the EMA to apply for full marketing approval.

"The potential for early marketing approval is an important achievement for us, and we are glad that we may help bring hope to CLI patients with no good treatment options. It is gratifying to see that regulatory authorities around the world are working to accelerate patient access to innovative treatments for medical conditions, such as CLI, that are unmet medical needs," stated Pluristem Chairman and CEO, Zami Aberman.

The global Phase III trial will evaluate PLX-PAD cells in the treatment of CLI in a double-blind, randomized, placebo-controlled trial. An estimated 250 patients with CLI Rutherford Category 5, who are unsuitable candidates for revascularization, will be enrolled. Patients will be treated with 300 million cells or placebo, injected twice intramuscularly (IM) two months apart. The primary endpoint will be time to amputation or death, allowing for a survival analysis which enables collection of more data during the trial thereby significantly reducing the number of patients needed, to allow statistically significant results from a trial of this size.

About Critical Limb Ischemia
In CLI, fatty deposits block arteries in the leg, leading to greatly reduced blood flow. This causes leg pain at rest, non-healing ulcers and gangrene. Patients with CLI are at high risk for limb amputation and death within a year of diagnosis. While some conservative treatments exist to relieve pain, and provide localized ulcer care, most patients will ultimately need a revascularization procedure. CLI patients who cannot undergo revascularization procedures are left with poor treatment options, and have a severe unmet medical need. With over 700,000 citizens suffering from critical limb ischemia, Germany represents the single largest Western European market, as per the Sage group (2010). This reflects the fact that Germany has the highest regional prevalence of diabetes, as well as the greatest number of elderly citizens, which are major risk factors for CLI.

About The Adaptive Pathways Pilot Project
The purpose of EMA's Adaptive Pathways pilot project is to shorten the time it takes for innovative medicines to reach patients with serious conditions that lack adequate treatment options. The pathway is open to clinical programs in early stages of development only. After a therapy is selected for the program, the Adaptive Pathways group conducts high level discussions and provides guidance to the applicant regarding the formal regulatory processes that precede a trial, targeting early approval and further expansion of the indications.

About Pluristem Therapeutics
Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapy products. The Company has reported robust clinical trial data in multiple indications for its patented PLX (PLacental eXpanded) cells. The cell products release a range of therapeutic proteins in response to inflammation, ischemia, hematological disorders, and radiation damage. PLX cell products are grown using the Company's proprietary three-dimensional expansion technology. They are off-the-shelf, requiring no tissue matching prior to administration.

Pluristem has a strong intellectual property position; Company-owned and operated, GMP-certified manufacturing and research facilities; strategic relationships with major research institutions; and a seasoned management team.

Safe Harbor Statement
This press release contains express or implied forward-looking statements within the Private Securities Litigation Reform Act of 1995 and other U.S. Federal securities laws. For example, we are using forward-looking statements when we discuss the timing of patient enrollment in our Phase III CLI trial, the potential for expedited approval of PLX-PAD cells for the treatment of CLI in Europe by the EMA, the review of patient data from the Phase III CLI study by the EMA, the potential for the efficacy data as a result of the Phase III CLI trial to support Pluristem's Biologics License Application and when we discuss the potential for PLX-PAD cells to treat CLI. These forward-looking statements and their implications are based on the current expectations of the management of Pluristem only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; we may encounter delays or obstacles in launching and/or successfully completing our clinical trials; our products may not be approved by regulatory agencies, our technology may not be validated as we progress further and our methods may not be accepted by the scientific community; we may be unable to retain or attract key employees whose knowledge is essential to the development of our products; unforeseen scientific difficulties may develop with our process; our products may wind up being more expensive than we anticipate; results in the laboratory may not translate to equally good results in real clinical settings; results of preclinical studies may not correlate with the results of human clinical trials; our patents may not be sufficient; our products may harm recipients; changes in legislation; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem's reports filed from time to time with the Securities and Exchange Commission.

For more information on this press release visit: http://www.releasewire.com/press-releases/release-3.htm

Haifa, Israel -- (SBWIRE) -- 01/12/2017 -- Pluristem Therapeutics Inc., a leading developer of placenta-based cell therapy products, today announced that the Company's Phase III study of its PLX-PAD cells in the treatment of critical limb ischemia (CLI) was cleared by the U.S. Food and Drug Administration (FDA). Pluristem's strategy is to use this single multinational Phase III study to support the submission of a biologics license application (BLA) to the FDA for marketing approval. Pluristem expects to begin enrolling patients in its Phase III study in both the U.S. and Europe during the first half of 2017.

"We are excited to have received FDA clearance to initiate our Phase III study for this very important indication. Our PLX-PAD product candidate provides hope for a new, effective treatment and a better quality of life for millions of CLI patients. Pluristem is committed to advancing its peripheral artery disease programs in CLI and intermittent claudication (IC) worldwide," stated Pluristem Chairman and CEO Zami Aberman.

"The use of a time-to-event endpoint in our CLI trial, as is employed in many advanced clinical trials, will allow us to gather more data during the trial thereby significantly reducing the number of patients needed. Data from previous clinical studies have shown that, by increasing tissue perfusion, PLX-PAD may improve the healing of wounds in CLI patients, and could allow for significant delays in events of amputation or death in the treated group," Mr. Aberman concluded.

In CLI, fatty deposits block arteries in the leg, leading to greatly reduced blood flow, pain at rest, non-healing ulcers, and gangrene. Patients with CLI are at an immediate risk for limb amputation and death. With poor treatment options, CLI patients who cannot undergo revascularization procedures have a severe unmet medical need.

Pluristem's Phase III CLI study will be a double blind, randomized, placebo controlled trial of about 250 patients with CLI Rutherford Category 5 who are unsuitable for revascularization. At an estimated 40 clinical sites in the U.S. and Europe, patients will be treated with 300 million PLX-PAD cells or placebo, injected twice intramuscularly (IM), with the second injection administered two months after the first. The primary endpoint is time to amputation or death. The European Medicines Agency (EMA) previously selected the PLX-PAD program in CLI for its Adaptive Pathways pilot project, which may allow for conditional marketing approval after a single pivotal study.

About Pluristem Therapeutics
Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapy products. The Company has reported robust clinical trial data in multiple indications for its patented PLX (PLacental eXpanded) cells. The different cell products each release their own range of therapeutic proteins in response to inflammation, ischemia, hematological disorders, and radiation damage. PLX cell products are grown using the Company's proprietary three-dimensional expansion technology. No tissue matching is required to administration of PLX cell products.

Pluristem has a strong intellectual property position; Company-owned and operated, GMP-certified manufacturing and research facilities; strategic relationships with major research institutions; and a seasoned management team.

Safe Harbor Statement
This press release contains express or implied forward-looking statements within the Private Securities Litigation Reform Act of 1995 and other U.S. Federal securities laws. For example, we are using forward-looking statements when we discuss our multinational Phase III study in CLI, the timing of patient enrollment for the trial, how this trial can support our BLA for marketing approval and when we discuss the potential for PLX-PAD cells to treat CLI and the potential impact such treatment could have in improving patient healing and quality of life. These forward-looking statements and their implications are based on the current expectations of the management of Pluristem only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; we may encounter delays or obstacles in launching and/or successfully completing our clinical trials; our products may not be approved by regulatory agencies, our technology may not be validated as we progress further and our methods may not be accepted by the scientific community; we may be unable to retain or attract key employees whose knowledge is essential to the development of our products; unforeseen scientific difficulties may develop with our process; our products may wind up being more expensive than we anticipate; results in the laboratory may not translate to equally good results in real clinical settings; results of preclinical studies may not correlate with the results of human clinical trials; our patents may not be sufficient; our products may harm recipients; changes in legislation; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem's reports filed from time to time with the Securities and Exchange Commission.

For more information on this press release visit: http://www.releasewire.com/press-releases/release-3.htm

Patent addresses methods of treating Ischemic conditions such as CLI using placental cells

Haifa, Israel -- (SBWIRE) -- 11/08/2016 -- Pluristem Therapeutics Inc, a leading developer of placenta-based cell therapy products, today announced that the State Intellectual Property Office of the People's Republic of China has issued an allowance to Pluristem for its patent application titled, "Adherent Cells From Adipose or Placenta Tissues and Use Thereof In Therapy". The patent addresses methods of treating Ischemic conditions such as CLI using placental cells. Additional patents of Pluristem in China cover methods of expending placental cells in a 3D apparatus, various therapeutic uses of placental cells and devices for a 3D culture of placental cells.

"This most recent patent strengthens our intellectual property position globally, and specifically in the Chinese market. With our recent announcement of potential strategic partnership with Innovative Medical, we believe that PLX cell therapy products may have an important role in addressing the needs of China's rapidly growing healthcare market and aging population," stated Pluristem Chairman and CEO, Zami Aberman.

About Pluristem Therapeutics
Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapy products. The Company has reported robust clinical trial data in multiple indications for its patented PLX (PLacental eXpanded) cells. The cell products release a range of therapeutic proteins in response to inflammation, ischemia, hematological disorders, and radiation damage. PLX cell products are grown using the Company's proprietary three-dimensional expansion technology. They are off-the-shelf, requiring no tissue matching prior to administration.

Pluristem has a strong intellectual property position; Company-owned and operated, GMP-certified manufacturing and research facilities; strategic relationships with major research institutions; and a seasoned management team.

Safe Harbor Statement
This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995 and federal securities laws. For example, we are using forward-looking statements when we discuss that our products may have an important role in addressing the needs of China's rapidly growing healthcare market and aging population. These forward-looking statements and their implications are based on the current expectations of the management of Pluristem only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; we may encounter delays or obstacles in launching and/or successfully completing our clinical trials; our products may not be approved by regulatory agencies, our technology may not be validated as we progress further and our methods may not be accepted by the scientific community; we may be unable to retain or attract key employees whose knowledge is essential to the development of our products; unforeseen scientific difficulties may develop with our process; our products may wind up being more expensive than we anticipate; results in the laboratory may not translate to equally good results in real clinical settings; results of preclinical studies may not correlate with the results of human clinical trials; our patents may not be sufficient; our products may harm recipients; changes in legislation; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem's reports filed from time to time with the Securities and Exchange Commission.

For more information on this press release visit: http://www.releasewire.com/press-releases/release-3.htm

Pluristem expects to begin patient enrollment in the UK in first half of 2017 The trial will recruit in the U.S. and EU

Haifa, Israel -- (SBWIRE) -- 11/02/2016 -- Pluristem Therapeutics Inc. (PSTI) (PSTI), a leading developer of placenta-based cell therapy products, today announced that the United Kingdom's Medicines & Healthcare Products Regulatory Agency (MHRA) has cleared Pluristem's application to begin the pivotal Phase III trial of PLX-PAD cells in the treatment of Critical Limb Ischemia (CLI) for patients who are unsuitable for revascularization. Pluristem's CLI program was previously selected by the European Medicines Agency (EMA) for its Adaptive Pathways pilot project, which may allow for conditional marketing approval after a single pivotal Phase III trial.

The multinational Phase III trial will be conducted in the U.S. as well as Europe. The U.S. Food and Drug Administration (FDA) has previously given positive feedback on the trial protocol in a pre-Phase III interaction. Pluristem's intention is to file a request for marketing authorization in the U.S. and in Europe following a successful completion of this 250-patient trial.

"Pluristem is very pleased to receive clearance to commence our pivotal Phase III CLI trial in the United Kingdom. We are eager to move forward to confirm efficacy of PLX-PAD cells in CLI, and anticipate receiving similar authorizations from additional regulators in Europe and the United States. Executing on an accelerated clinical development timeline, we anticipate commencing patient enrollment in the first half of 2017," stated Pluristem Chairman and CEO, Zami Aberman. "We believe cell therapy holds great promise for patients with difficult to treat, life threatening conditions, such as CLI, and hope to play an important role in improving their health outcomes."

The Phase III trial will evaluate PLX-PAD cells in the treatment of CLI in a double blind, randomized, placebo controlled trial. An estimated 250 patients with CLI Rutherford Category 5, who are unsuitable candidates for revascularization, will be enrolled. Patients will be treated with 300 million cells or placebo, injected twice intramuscularly (IM) two months apart. The primary endpoint will be time to amputation or death, allowing for a survival analysis that is well powered to deliver statistically significant results from a trial of this size.

About Critical Limb Ischemia
In CLI, fatty deposits block arteries in the leg, leading to greatly reduced blood flow. This causes leg pain at rest, non-healing ulcers and gangrene. Patients with CLI are at high risk for limb amputation and death within a year of diagnosis. While some conservative treatments exist to relieve pain and provide local ulcer care, most patients will ultimately need a revascularization procedure. Many, however, are not suitable candidates for revascularization, and have high rates of major amputations (up to 40% at six months from diagnosis).

About the Adaptive Pathways Pilot Project
The purpose of EMA's Adaptive Pathways pilot project is to shorten the time it takes for innovative medicines to reach patients with serious conditions that lack adequate treatment options. The pathway is open to clinical programs in early stages of development only. After a therapy is selected for the program, the Adaptive Pathways group conducts high level discussions and provides guidance to the applicant regarding the formal regulatory processes that precede a trial, targeting early approval and further expansion of the indications.

About Pluristem Therapeutics
Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapy products. The Company has reported robust clinical trial data in multiple indications for its patented PLX (PLacental eXpanded) cells. The cell products release a range of therapeutic proteins in response to inflammation, ischemia, hematological disorders, and radiation damage. PLX cell products are grown using the Company's proprietary three-dimensional expansion technology. They are off-the-shelf, requiring no tissue matching prior to administration.

Pluristem has a strong intellectual property position; Company-owned and operated, GMP-certified manufacturing and research facilities; strategic relationships with major research institutions; and a seasoned management team.

Safe Harbor Statement
This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995 and federal securities laws. For example, we are using forward-looking statements when we discuss the design and endpoints of our Phase III trial of PLX-PAD cells in the treatment of CLI, the expected timing for commencing enrollment, and our plan to conduct the trial in the U.S. and in Europe; when we discuss our intention to file a request for marketing authorization in the U.S. and in Europe following a successful completion of the trial; when we discuss our anticipation to receive similar authorizations from additional regulators in Europe and the U.S.; and when we discuss the potential of cell therapy to treat life threatening conditions and improve health outcomes. These forward-looking statements and their implications are based on the current expectations of the management of Pluristem only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; we may encounter delays or obstacles in launching and/or successfully completing our clinical trials; our products may not be approved by regulatory agencies, our technology may not be validated as we progress further and our methods may not be accepted by the scientific community; we may be unable to retain or attract key employees whose knowledge is essential to the development of our products; unforeseen scientific difficulties may develop with our process; our products may wind up being more expensive than we anticipate; results in the laboratory may not translate to equally good results in real clinical settings; results of preclinical studies may not correlate with the results of human clinical trials; our patents may not be sufficient; our products may harm recipients; changes in legislation; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem's reports filed from time to time with the Securities and Exchange Commission.

For more information on this press release visit: http://www.releasewire.com/press-releases/release-3.htm

Haifa, Israel -- (SBWIRE) -- 10/14/2016 -- Pluristem Therapeutics Inc., a leading developer of placenta-based cell therapy products, today announced its Chairman and CEO, Zami Aberman, has been re-elected as Member of the Board of Directors of the Alliance for Regenerative Medicine (ARM). This is Mr. Aberman's second year serving on the Board of the Washington, D.C.-based, international organization that represents the gene therapy, cell therapy and tissue engineering sector. Pluristem has been a member of ARM for 4 years and has actively supported the organization's goals.

Mr. Aberman will work with fellow board members, officers and executive committee members of ARM who come from the leading companies and institutions in regenerative medicine, to set the overall vision and direction of ARM.

"I am honored to be re-elected to the Board of ARM. Over the past year, Pluristem has made a meaningful contribution to this very important organization, which advances the regenerative medicine industry for the benefit of patients and healthcare systems around the globe," stated Pluristem CEO Zami Aberman.

About The Alliance for Regenerative Medicine
The Alliance for Regenerative Medicine (ARM) is an international multi-stakeholder advocacy organization that promotes legislative, regulatory and reimbursement initiatives necessary to facilitate access to life-giving advances in regenerative medicine worldwide. ARM also works to increase public understanding of the field and its potential to transform human healthcare, providing business development and investor outreach services to support the growth of its member companies and research organizations. Prior to the formation of ARM in 2009, there was no advocacy organization operating in Washington, D.C. to specifically represent the interests of the companies, research institutions, investors and patient groups that comprise the entire regenerative medicine community. Today, ARM has more than 225 members and is the leading global advocacy organization in this field.

To learn more about ARM or to become a member, visit http://www.alliancerm.org.

About Pluristem Therapeutics
Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapy products. The Company has reported robust clinical trial data in multiple indications for its patented PLX (PLacental eXpanded) cells. The cell products release a range of therapeutic proteins in response to inflammation, ischemia, hematological disorders, and radiation damage. PLX cell products are grown using the Company's proprietary three-dimensional expansion technology. They are off-the-shelf, requiring no tissue matching prior to administration.

Pluristem has a strong intellectual property position; Company-owned and operated, GMP-certified manufacturing and research facilities; strategic relationships with major research institutions; and a seasoned management team.

For more information on this press release visit: http://www.releasewire.com/press-releases/release-3.htm

- Dr. Hillard Lazarus of Case Western Reserve University will be the Principal Investigator of the trial - The trial protocol was cleared by the U.S. FDA - Incomplete engraftment after HCT is one of several hematologic indications to be targeted by PLX-R18

Haifa, Israel -- (SBWIRE) -- 09/15/2016 -- Pluristem Therapeutics Inc., a leading developer of placenta-based cell therapy products, today announced the appointment of Dr. Hillard Lazarus of Case Western Reserve University as the Principal Investigator of the Company's Phase I trial of its PLacental eXpanded (PLX)-R18 cells to treat incomplete hematopoietic recovery following hematopoietic cell transplantation (HCT).

Enrollment for the Phase I trial, which was recently cleared by the U.S. Food and Drug Administration, is expected to begin in the coming months at multiple clinical sites in the U.S. The open label, dose escalating study will evaluate the safety of intramuscular injections of PLX-R18 in 30 patients with incomplete hematopoietic recovery following HCT. Additional endpoints will include changes in platelet and hemoglobin levels, transfusion frequency, frequency of shift from transfusion dependence to transfusion independence, quality of life, and various immunological parameters in the blood.

Dr. Lazarus is a Professor of Medicine at Case Western Reserve University and doctor of Hematology-Oncology at University Hospitals Case Medical Center. He is the George & Edith Richman Professor and Distinguished Scientist in Cancer Research and Director of Novel Cell Therapy. He was Director of the Blood and Marrow Transplant Program for over 25 years. For the past decade, he has been the Principal Investigator of the Case Consortium of the Blood & Marrow Transplant Clinical Trials Network. Having developed many new anti-cancer therapies and sophisticated supportive care technologies, Dr. Lazarus is internationally recognized for his contributions in several areas, including mesenchymal stem cell transplantation and allogeneic blood and marrow transplantation for malignancies. Dr. Lazarus has over 600 publications to his name and is the Editor-in-Chief of both Bone Marrow Transplantation and Blood Reviews. He is a member of Pluristem's clinical advisory board for the development of PLX-R18 in hematology, and was actively involved in both the selection of the indication and the study design.

"We are pleased and honored that Dr. Lazarus will lead our Phase I trial as Principal Investigator. His extensive experience in the field of hematologic-oncology is an asset to our PLX-R18 development program," stated Pluristem Chairman and CEO Zami Aberman.

"Having previously studied the potential of PLX-R18 in pre-clinical settings to improve outcomes for umbilical cord blood stem cell transplantation, I am eager to lead a clinical trial to explore PLX-R18's benefits in hematologic recovery following HCT," commented Dr. Lazarus. "Positive clinical data could support further development of PLX-R18 to increase the success rates of transplants used to treat a broad range of indications."

About PLX-R18
PLX-R18 is Pluristem's second cell therapy product cleared for clinical studies by the U.S. FDA. It has already been studied in preclinical models of acute radiation syndrome, support of hematopoietic cell transplants, and side effects of radiotherapy and chemotherapies used to treat cancers. Preclinical data from trials conducted by the U.S. National Institutes of Health, Hadassah Medical Center, and other prominent research institutions have shown that PLX-R18 cells secrete a range of specific proteins that trigger the regeneration of bone marrow hematopoietic cells, thereby supporting the recovery of blood cell production. By this mechanism of action, PLX-R18 could potentially treat a broad range of hematologic indications.

Incomplete Recovery Following HCT
Hematopoietic cell transplantation (HCT) is a standard treatment for a range of conditions, including malignant diseases such as multiple myeloma, non-Hodgkin's lymphoma, Hodgkin's disease, and acute myeloid leukemia, as well as non-malignant diseases and autoimmune disorders such as aplastic anemia and thalassemia. The hematopoietic cells for HCT can come from a donor (allogeneic) or from the patient (autologous), and can be harvested from peripheral blood, bone marrow or umbilical cord blood.

In a number of cases, complete hematopoietic recovery following HCT is not reached, and patients are at increased risk of bleeding, infection, anemia, and poor general function. Current treatments include administration of factors stimulating growth of specific blood cell types, such as granulocyte-colony stimulating factor (G-CSF), granulocyte-macrophage colony-stimulating factor (GM-CSF), and erythropoietin. However, a significant number of patients do not respond to growth factors and may require frequent transfusions, which expose them to transfusion-related risks such as allo-sensitization and infections, without providing a curative solution. These are also associated with significant costs.

About Pluristem Therapeutics
Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapy products. The Company has reported robust clinical trial data in multiple indications for its patented PLX (PLacental eXpanded) cells. The cells release a range of therapeutic proteins in response to inflammation, ischemia, hematological disorders, and radiation damage. PLX cell products are grown using the Company's proprietary three-dimensional expansion technology. They are off-the-shelf, requiring no tissue matching prior to administration.

Pluristem has a strong intellectual property position; Company-owned and operated, GMP-certified manufacturing and research facilities; strategic relationships with major research institutions; and a seasoned management team.

Safe Harbor Statement
This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995 and federal securities laws. For example, we are using forward-looking statements when we discuss the expected timing for enrollment for the Phase I trial, when we discuss the planned trial design and its endpoints, when we discuss the potential of positive clinical data to support further development of PLX-R18 to increase the success rates of transplants, and when we discuss the potential of PLX-R18 to treat a broad range of hematologic indications. These forward-looking statements and their implications are based on the current expectations of the management of Pluristem only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; we may encounter delays or obstacles in launching and/or successfully completing our clinical trials; our products may not be approved by regulatory agencies, our technology may not be validated as we progress further and our methods may not be accepted by the scientific community; we may be unable to retain or attract key employees whose knowledge is essential to the development of our products; unforeseen scientific difficulties may develop with our process; our products may wind up being more expensive than we anticipate; results in the laboratory may not translate to equally good results in real clinical settings; results of preclinical studies may not correlate with the results of human clinical trials; our patents may not be sufficient; our products may harm recipients; changes in legislation; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem's reports filed from time to time with the Securities and Exchange Commission.

For more information on this press release visit: http://www.releasewire.com/press-releases/release-3.htm

- The study will enroll about 250 patients in Europe and the U.S. - The grant will cover a significant portion of the study expenses - PLX-PAD was previously selected by the EMA to be developed via the Adaptive Pathways project

Haifa, Israel -- (SBWIRE) -- 08/12/2016 -- Pluristem Therapeutics Inc., a leading developer of placenta-based cell therapy products, today announced that its critical limb ischemia (CLI) program in the European Union has been awarded an $8 million grant. The grant is part of the European Union's Horizon 2020 program, which is its largest Research and Innovation program. The Phase III study of PLX-PAD in CLI will be a collaborative project carried out by an international consortium led by the Berlin-Brandenburg Center for Regenerative Therapies (BCRT) under the leadership of Prof. Hans-Dieter Volk and Prof. Petra Reinke together with Pluristem.

The consortium, which will include leading European research institutes and clinical sites, will undertake an extensive scientific program in parallel to the trial, using in-depth immunological, endocrine, and molecular analyses to better understand the mechanism of action of PLX-PAD in CLI.

As previously announced, Pluristem's PLX-PAD development program has been selected for the EU's Adaptive Pathways project, whose goal is to shorten the time it takes for innovative medicines to reach patients with serious conditions that lack adequate treatment options.

"We are honored to have been awarded this Horizon 2020 grant designed to support the manufacturing and development of our cell products for potential commercialization. This grant is a vote of confidence and an expression of hope by the European Union that we may be able to provide a regenerative therapy for millions of CLI patients around the world. Pluristem is committed to developing PLX-PAD for patients with peripheral artery disease, and this grant will help us move towards our goal of rapid entry into the European and U.S. markets, given positive results," stated Pluristem Chairman and CEO Zami Aberman.

The pivotal study for Pluristem's PLacental eXpanded (PLX) PAD cells in the treatment of CLI is a double blind, randomized, placebo controlled trial in an estimated 250 patients with CLI Rutherford Category 5 who are unsuitable candidates for revascularization. Patients will be treated with 300 million cells or placebo, injected twice intramuscularly (IM), with the second dose administered two months after the first. The primary endpoint will be time to amputation and death.

Patients will be enrolled in clinical sites located throughout Europe and the U.S. Pluristem's intention is to utilize this study as a single pivotal trial for regulatory approval in both regions. PLX-PAD cells are designed to address the $12 billion global CLI market.

About The Berlin-Brandenburg Center for Regenerative Therapies
The Berlin-Brandenburg Center for Regenerative Therapies (BCRT) was founded as a cooperative research institution of the Charite University Hospital in Berlin, which is one of the largest university hospitals in Europe, and Germany's largest research association, the Helmholtz Association. The goal of the BCRT is to enhance endogenous regeneration by cells, biomaterials, and factors which can be used to develop and implement innovative therapies and products. The primary focus of the BCRT is on diseases of the immune system, the musculoskeletal system and the cardiovascular system for which currently only unsatisfactory treatment options are available.

About The Adaptive Pathways
The purpose of Europe's Adaptive Pathways is to shorten the time it takes for innovative medicines to reach patients with serious conditions that lack adequate treatment options. The pathway is open to clinical programs in early stages of development only. After a therapy is selected for the program, the Adaptive Pathways group conducts high level discussions and provides guidance to the applicant regarding the formal regulatory processes that precede a trial targeting early approval and further expansion of the indications.

About Pluristem Therapeutics
Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapy products. The company has reported robust clinical trial data in multiple indications for its patented PLX (PLacental eXpanded) cells. The cells release a range of therapeutic proteins in response to inflammation, ischemia, hematological disorders, and radiation damage. PLX cell products are grown using the Company's proprietary three-dimensional expansion technology. They are off-the-shelf, requiring no tissue matching prior to administration.

Pluristem has a strong intellectual property position; company-owned and operated, GMP-certified manufacturing and research facilities; strategic relationships with major research institutions; and a seasoned management team.

Safe Harbor Statement
This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995 and federal securities laws. For example, forward-looking statements are used in this press release when we discuss obtaining the $8 million grant as a part of the EU's Horizon 2020 program, the estimated use of the grant, the potential for obtaining conditional marketing approval in Europe in the event of positive results of our pivotal CLI trial and Pluristem's intention to utilize the results of the CLI trial in applying for regulatory approval in both the Europe and the U.S. These forward-looking statements and their implications are based on the current expectations of the management of Pluristem only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; we may encounter delays or obstacles in launching and/or successfully completing our clinical trials; our products may not be approved by regulatory agencies, our technology may not be validated as we progress further and our methods may not be accepted by the scientific community; we may be unable to retain or attract key employees whose knowledge is essential to the development of our products; unforeseen scientific difficulties may develop with our process; our products may wind up being more expensive than we anticipate; results in the laboratory may not translate to equally good results in real clinical settings; results of preclinical studies may not correlate with the results of human clinical trials; our patents may not be sufficient; our products may harm recipients; changes in legislation; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem's reports filed from time to time with the Securities and Exchange Commission. Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem's reports filed from time to time with the Securities and Exchange Commission.

For more information on this press release visit: http://www.releasewire.com/press-releases/release-3.htm

Phase II data showed PLX-PAD’s strong muscle regeneration capacity following total hip replacement surgery

Haifa, Israel -- (SBWIRE) -- 08/02/2016 -- Pluristem Therapeutics Inc., a leading developer of placenta-based cell therapy products, today announced recently that it intends to conduct a Phase III trial assessing its PLX-PAD cells in recovery following surgery for femoral neck fracture, which is the most common form of hip fracture. The trial protocol is now being designed by Pluristem and its Clinical Advisory Board (CAB), which is comprised of world-leading orthopedic surgeons, and experts in rehabilitation. Pluristem is planning to meet with the FDA later this year to discuss the Phase III protocol. The Company has already submitted this protocol to the European Medicines Agency (EMA) following consultation with the Adaptive Pathways Project Group. Pluristem's program in critical limb ischemia is already being developed via the Adaptive Pathways Project.

The Phase III study design builds upon positive data from a Phase II trial which showed that PLX-PAD cells induced significant muscle regeneration in patients who had undergone total hip replacement surgery. Patients treated with PLX-PAD at the time of surgery showed a 500% improvement in muscle force and a 300% improvement in muscle volume six months after surgery, as compared to the placebo group.

Muscle injury related to surgery, or to immobilization following surgery, may impact effective rehabilitation, and can lead to the loss of the ability to live independently, severe morbidity, and increased mortality. In the U.S., according to different sources, the lifetime prevalence of a hip fracture is 20% for women and 10% for men. Annual treatment costs in the U.S. are estimated to be between $10 to $15 billion, and are expected to rise because of the aging population.

"PLX-PAD's proven ability to regenerate muscles could play a critical role in improving the outcomes of the growing number of surgeries for femoral neck fracture," stated Pluristem Chairman and CEO Zami Aberman. "We are eager to move into Phase III trial in the U.S. and Europe in this important orthopedic indication. We look forward to working with the FDA and EMA to receive clearance to commence the trials."

Experts present at the meeting:
- Dr. Tobias Winkler. Charite - Universitaetsmedizin Berlin, Germany
- Prof. Mohit Bhandari - McMaster University, Hamilton, Canada
- Dr. Kenneth Koval - Orlando Health Orthopedic Institute
- Prof. Laurie Burke - LORA Group, Maryland
- Prof. Jack Guralnik - University of Maryland
- Prof. Jay Magaziner - University of Maryland
- Prof. Thomas Einhorn - New York University

About Hip Fracture
Fractures of the hip are relatively common in adults and are associated with substantial morbidity and mortality. Most hip fractures occur in elderly individuals as a result of minimal trauma, such as a fall from the standing position. One-year mortality rates have been reported to range from 12 to 37 percent, and approximately half of patients are unable to regain their ability to live independently. In 2003, there were 310,000 individuals hospitalized with hip fractures in the U.S., according to data from the United States Agency for Healthcare Research and Quality (AHRQ), accounting for 30 percent of all hospitalized patients. As the U.S. population ages, the annual number of hip fractures is expected to increase significantly. The estimated cost for treatment of hip fracture is approximately $10 to $15 billion per year in the United States.

About Pluristem Therapeutics
Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapy products. The Company has reported robust clinical trial data in multiple indications for its patented PLX (PLacental eXpanded) cells. The cells release a range of therapeutic proteins in response to inflammation, ischemia, hematological disorders, and radiation damage. PLX cell products are grown using the Company's proprietary three-dimensional expansion technology. They are off-the-shelf, requiring no tissue matching prior to administration.

Pluristem has a strong intellectual property position; Company-owned and operated, GMP-certified manufacturing and research facilities; strategic relationships with major research institutions; and a seasoned management team.

For more information on this press release visit: http://www.releasewire.com/press-releases/release-3.htm

Haifa, Israel -- (SBWIRE) -- 07/11/2016 -- Pluristem Therapeutics Inc., a leading developer of placenta-based cell therapy products, reported positive data from preclinical studies of its PLX-PAD cells in the treatment of Duchenne muscular dystrophy. The studies were conducted in conjunction with ADI, the Association Duchenne Israel, whose members are parents of children with Duchenne. They are committed to helping to find a cure for Duchenne muscular dystrophy through research, clinical trials, and advocacy.

Duchenne muscular dystrophy is the most common neuromuscular disorder, and affects roughly one in 3,500 boys. The disease causes progressive muscle weakness, and leads to severe disability and death. There is currently no cure.

Following Pluristem's announcement of positive results from a Phase II clinical trial of PLX-PAD as a treatment for muscle injury, the Association Duchenne Israel approached Pluristem with a request to study PLX-PAD cells in Duchenne muscular dystrophy. Pluristem donated PLX-PAD cells for the preclinical studies, and the association supported the research in cooperation with Science in Action Ltd.

The studies demonstrated that, in a mouse model of muscular dystrophy, PLX-PAD cells reduced creatine phosphokinase (CPK), a marker of muscle degeneration or injury, by approximately 50% as compared to placebo. CPK levels were measured via a blood sample taken 5 days after each intramuscular PLX-PAD injection made at day 15 and day 29 of the study. Histological analyses of quadriceps and diaphragm muscles show PLX-PAD reduced levels of inflammation and necrosis, a type of cell death, and induced regeneration of muscle tissue.

Hila Krupsky, CEO of ADI, the Association Duchenne Israel, stated, "These preclinical data suggest that PLX-PAD cells could possibly be a breakthrough therapy to help treat symptoms of Duchenne muscular dystrophy. We are thankful for Pluristem's donation of PLX-PAD and are eager to continue studying the cells since new therapeutic approaches are needed to manage this disease, save children's lives, and give them hope and a chance for the future."

"Because PLX-PAD cells have already displayed efficacy in muscle regeneration in a Phase II muscle injury study, we believe our cell therapy may potentially be beneficial in Duchenne muscular dystrophy in human clinical trials," said Pluristem Chairman and CEO Zami Aberman. "We admire the commitment of the Association Duchenne Israel to find a cure for Duchenne muscular dystrophy, and we will work closely with them in an effort to develop a treatment for the children around the world who suffer from this disease."

Related Quotes

About Duchenne Muscular Dystrophy
Duchenne muscular dystrophy (DMD) is a genetic disorder characterized by progressive muscle degeneration and weakness. It is caused by a shortage of dystrophin, a protein that helps keep muscle fibers intact as they contract and relax. This shortage is due to a mutation in the gene that controls the production of dystrophin. Muscle weakness can begin as early as age 3, and by the early teens the heart and respiratory muscles also are affected. Average life expectancy for people with DMD is 27 years, though there is significant individual variability. Although girls can be carriers and mildly affected, the disease typically affects boys, and there is currently no cure.

About Pluristem Therapeutics
Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapy products. The Company has reported robust clinical trial data in multiple indications for its patented PLX (PLacental eXpanded) cells. The cells release a cocktail of therapeutic proteins in response to inflammation, ischemia, hematological disorders, and radiation damage. PLX cell products are grown using the Company's proprietary three-dimensional expansion technology. They are off-the-shelf, requiring no tissue matching prior to administration.

Pluristem has a strong intellectual property position; Company-owned and operated, GMP-certified manufacturing and research facilities; strategic relationships with major research institutions; and a seasoned management team.

Safe Harbor Statement
This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995 and federal securities laws. For example, we are using forward-looking statements when we discuss the findings of the study of our cell therapy and its potential to treat symptoms of, or be part of a possible cure for, DMD and that we will work closely with the Association Duchenne Israel in an effort to develop a treatment to this disease. These forward-looking statements and their implications are based on the current expectations of the management of Pluristem only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; we may encounter delays or obstacles in launching and/or successfully completing our clinical trials; our products may not be approved by regulatory agencies, our technology may not be validated as we progress further and our methods may not be accepted by the scientific community; we may be unable to retain or attract key employees whose knowledge is essential to the development of our products; unforeseen scientific difficulties may develop with our process; our products may wind up being more expensive than we anticipate; results in the laboratory may not translate to equally good results in real clinical settings; results of preclinical studies may not correlate with the results of human clinical trials; our patents may not be sufficient; our products may harm recipients; changes in legislation; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem's reports filed from time to time with the Securities and Exchange Commission. Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem's reports filed from time to time with the Securities and Exchange Commission.

For more information on this press release visit: http://www.releasewire.com/press-releases/release-3.htm

- Trial expands to randomize 20 more patients to receive two injections per patient - Data release on track for 2017

Haifa, Israel -- (SBWIRE) -- 05/20/2016 -- Pluristem Therapeutics Inc., a leading developer of placenta-based cell therapy products, today announced it has completed the planned enrollment of 150 patients in a global Phase II trial of its PLacental eXpanded (PLX)-PAD cells for the treatment of intermittent claudication (IC), a peripheral artery disease (PAD). The double blind, randomized, placebo controlled trial enrolled 50 patients since October 2015 in the U.S., Germany, Israel, and South Korea.

Pluristem has expanded the trial to enroll 20 additional patients to be randomized in order to preserve the study's original design to administer two injections to each of 150 patients. Twenty of the 150 patients originally enrolled did not complete the trial with two injections. Previous findings in clinical and preclinical studies of PLX cells demonstrated the superior efficacy of two injections vs. a single injection in certain indications.

"We have seen a significant increase in the enrollment rate in the last six months, and I eagerly anticipate the final results of this study. As there is significant suffering of patients with peripheral artery disease, the medical field must advance in offering treatment strategies in addition to revascularization or supervised exercise training, which is not suitable for all patients," stated the study's Principal Investigator, Prof. Dr. Norbert Weiss, of the Dresden Division of Angiology, Center for Vascular Medicine and Department of Internal Medicine, University Hospital Carl Gustav Carus, Technische Universitaet Dresden in Germany.

"In the last two years we significantly advanced our understanding of the mechanisms of action of PLX cells, and established the importance of repeat injections to stimulate tissue regeneration in certain acute and chronic indications. Based on our recruitment rate in the last half year, we anticipate quickly completing enrollment of the additional patients," said Pluristem Chairman and CEO Zami Aberman.

About Intermittent Claudication
IC is a subset of peripheral artery disease, caused by atherosclerosis of the lower extremity arteries. IC is characterized by muscle pain, cramping, numbness or a sense of fatigue, classically in the calf muscle, which occurs during walking or similar exercise and is relieved by a period of rest. The prevalence of IC in the United States alone is approximately 14 million patients, representing a cost of approximately $2.5 billion annually to the national health care system.

About the Study
Pluristem's Phase II trial is evaluating the safety and efficacy of two doses of PLX-PAD cells versus placebo, administered via intramuscular injections. The study protocol is now comprised of approximately 170 patients with IC, Fontaine class IIb, Rutherford category 2-3. In addition to the primary efficacy endpoint of change in the maximal walking distance from baseline during an exercise treadmill test, secondary endpoints of the study are hemodynamic and quality of life measurements. Safety parameters are also being assessed.

About Pluristem Therapeutics
Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapy products. The Company has reported robust clinical trial data in multiple indications for its patented PLX (PLacental eXpanded) cells. The cells release a range of therapeutic proteins in response to inflammation, ischemia, hematological disorders, and radiation damage. PLX cell products are grown using the Company's proprietary three-dimensional expansion technology. They are off-the-shelf, requiring no tissue matching prior to administration.

Pluristem has a strong intellectual property position; Company-owned and operated, GMP-certified manufacturing and research facilities; strategic relationships with major research institutions; and a seasoned management team.

Safe Harbor Statement
This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995 and federal securities laws. For example, we are using forward-looking statements when we discuss our plan to enroll 20 additional patients to our Phase II trial of our PLX-PAD cells for the treatment of IC, the expected enrollment rate and timing of completion of the enrollment. These forward-looking statements and their implications are based on the current expectations of the management of Pluristem only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; we may encounter delays or obstacles in launching and/or successfully completing our clinical trials; our products may not be approved by regulatory agencies, our technology may not be validated as we progress further and our methods may not be accepted by the scientific community; we may be unable to retain or attract key employees whose knowledge is essential to the development of our products; unforeseen scientific difficulties may develop with our process; our products may wind up being more expensive than we anticipate; results in the laboratory may not translate to equally good results in real clinical settings; results of preclinical studies may not correlate with the results of human clinical trials; our patents may not be sufficient; our products may harm recipients; changes in legislation; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem's reports filed from time to time with the Securities and Exchange Commission.

For more information on this press release visit: http://www.releasewire.com/press-releases/release-3.htm

Pluristem Enters into Licensing Agreement with TES Holdings Co., Ltd., a venture company derived from the University of Tokyo, to Acquire Rights for Placental Cell Therapy Patent for Variety of Ischemic Conditions including Heart Disease and Stroke

Haifa, Israel -- (SBWIRE) -- 04/22/2016 -- Pluristem Therapeutics Inc, a leading developer of placenta-derived cell therapy products, today announced that it has entered into a licensing agreement with TES Holdings Co., Ltd., a venture company derived from the University of Tokyo, to obtain a key patent in Japan to cover the treatment of ischemic diseases with placental cell therapy rounding out the Company's IP coverage. This license follows Pluristem's recent announcement that the Japan Patent Office granted the Company two key patents addressing three-dimensional methods for expanding placental and adipose cells, and specified cell therapies produced from placental tissue using these methods.

The Japanese Patent No. 4554940 is titled "Drug containing human placenta-derived mesenchymal cells and process for producing VEGF employing said cells". The patent covers use of all placenta-derived mesenchymal cells that are able to produce VEGF, a signaling protein that promotes the growth of new blood vessels, which the body needs to address the damage in ischemic tissue in the heart, brain, skeletal muscle, or elsewhere in the body. The listed inventors of the patent are Dr. Naohide Yamashita, Professor at the Department of Advanced Medical Science, University of Tokyo, Dr. Takashi Nakaoka, and Dr. Toshihide Nishishita. The patent is valid through 2023 and may be eligible for up to five years of patent term extension. Ischemic indications covered by the patent include the two leading causes of death worldwide - ischemic heart disease and stroke - as ranked by the World Health Organization, in addition to peripheral artery disease. Pluristem recently received clearance of its protocol for a Japanese pre-marketing trial in critical limb ischemia, a type of peripheral artery disease.

Akio Hayashi, President of TES Holdings, which manages the commercialization of this IP, commented, "Placenta-derived cell therapies may significantly improve the health and wellbeing of millions of people who suffer from ischemic disease. We are pleased that Pluristem, which is a leading player in the world's regenerative medicine space, has licensed this patent because their unique experience with placental cell therapies make them optimally positioned to use knowledge developed at the University of Tokyo which demonstrates Japan's strong capabilities in this space. We hope that this cooperation will advance the regenerative medicine industry and benefit the people with unmet medical needs."

"The University of Tokyo is well known in for its cutting edge research in the field of cell therapy, and we are happy to expand our cooperation with this world class academic institution. As we prepare to initiate a clinical trial in critical limb ischemia targeting conditional marketing approval via Japan's new accelerated regulatory pathway for regenerative medicine, our patents addressing placental cell therapies remain a core asset and important to our current negotiations with large pharmaceutical companies regarding potential partnerships in Japan," stated Pluristem Chairman and CEO Zami Aberman.

"This latest Japanese patent covers the use of placental treatments in any ischemic indication, including heart disease and stroke, which are multi-billion dollar markets. We are securing the IP landscape for placental cell therapies in Japan, which is particularly important because Japan is a large potential market for our cell products, together with the U.S. and Europe, and the world's leader in facilitating the commercialization of regenerative medicines," Aberman concluded.

About Ischemic Diseases
Ischemia is an insufficient supply of blood to an organ or tissue, usually due to a blocked artery. Myocardial ischemia can lead to a heart attack, which is the leading cause of death in the United states and Japan. Cerebral ischemia occurs when arteries are blocked in the brain, and can lead to a stroke, brain damage and death. About 80-85% of all strokes are ischemic. When cholesterol blocks the arteries in the leg, patients develop peripheral artery disease, which includes intermittent claudication and critical limb ischemia. The latter condition often leads to severe illness, amputation and death, and over a million patients suffer from it in the U.S. alone.

About Pluristem Therapeutics
Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapy products. The Company has reported robust clinical trial data in multiple indications for its patented PLX (PLacental eXpanded) cells. The cells release a cocktail of therapeutic proteins in response to inflammation, ischemia, hematological disorders, and radiation damage. PLX cell products are grown using the Company's proprietary three-dimensional expansion technology. They are off-the-shelf, requiring no tissue matching prior to administration.

Pluristem has a strong intellectual property position; Company-owned and operated, GMP-certified manufacturing and research facilities; strategic relationships with major research institutions; and a seasoned management team.

Safe Harbor Statement
This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995 and federal securities laws. For example, forward-looking statements are used in this press release when we discuss the duration of the IP protection provided by the Japanese patent, when we discuss potential partnerships for the development and commercialization of our PLX cells in Japan, when we discuss our plan to obtain marketing approval in Japan via Japan's accelerated regulatory pathway for regenerative medicines and when we discuss the market size with respect to heart disease and stroke. These forward-looking statements and their implications are based on the current expectations of the management of Pluristem only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; we may encounter delays or obstacles in launching and/or successfully completing our clinical trials; our products may not be approved by regulatory agencies, our technology may not be validated as we progress further and our methods may not be accepted by the scientific community; we may be unable to retain or attract key employees whose knowledge is essential to the development of our products; unforeseen scientific difficulties may develop with our process; our products may wind up being more expensive than we anticipate; results in the laboratory may not translate to equally good results in real surgical settings; results of preclinical studies may not correlate with the results of human clinical trials; our patents may not be sufficient; our products may harm recipients; changes in legislation; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem's reports filed from time to time with the Securities and Exchange Commission.

For more information on this press release visit: http://www.releasewire.com/press-releases/release-3.htm

IP addresses both 3D growth of placental and fat cells and the use of placental cells grown with 3D technology for the treatment of hematopoietic disorders

Haifa, Israel -- (SBWIRE) -- 04/14/2016 -- Pluristem Therapeutics Inc., a leading developer of placenta-based cell therapy products, today announced that the Japan Patent Office has granted the Company two key patents addressing: 1) Pluristem's core technology of three-dimensional expansion methods for producing therapeutic cell products derived from placental or fat cells; 2) the use of placenta-derived cells grown with this 3D technology to treat disorders of the hematopoietic system, such as disorders caused by exposure to radiation or chemotherapy, and failed engraftment of hematopoietic stem cell transplants. Pluristem continues to strengthen its IP position in order to support the current negotiations with pharmaceutical companies in Japan regarding potential partnerships for the development and commercialization of its PLacental eXpanded (PLX) cells. Pluristem recently received clearance for its protocol for a Phase 2 trial in critical limb ischemia targeting marketing approval in Japan, via Japan's accelerated regulatory pathway for regenerative medicines.

Patent No. 5733894, titled "Methods for Cell Expansion and Uses of Cells and Conditioned Media Produced Thereby for Therapy", covers three-dimensional methods of growing adherent placental or adipose cells, and the cells produced by the claimed methods.

Patent No. 5766041, titled "Pharmaceutical Composition for Enhancing Subject Hematopoietic System", addresses pharmaceutical compositions containing placental stromal cells grown using 3D culturing methods for supporting engraftment of hematopoietic progenitor cells, thus enabling treatment of disorders of the hematopoietic system by promoting the recovery of the immune system and bone marrow function.

"These latest patent grants in Japan fortify our intellectual property position globally, and specifically in the Japanese market, where we are in active negotiations with potential pharmaceutical partners," stated Pluristem Chairman and CEO Zami Aberman. "Our proprietary process and technology for growing placenta-derived cells within a 3D microenvironment make large scale, cost effective cell therapy production a reality, and IP protection of these methods in Japan is a key asset. The use of these cells to treat disorders of the hematopoietic system is an important indication for PLX cells that is now protected in Japan."

About Pluristem Therapeutics
Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapy products. The Company has reported robust clinical trial data in multiple indications for its patented PLX (PLacental eXpanded) cells. The cells release a cocktail of therapeutic proteins in response to inflammation, ischemia, hematological disorders, and radiation damage. PLX cell products are grown using the Company's proprietary three-dimensional expansion technology. They are off-the-shelf, requiring no tissue matching prior to administration.

Pluristem has a strong intellectual property position; Company-owned and operated, GMP-certified manufacturing and research facilities; strategic relationships with major research institutions; and a seasoned management team.

Safe Harbor Statement
This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995 and federal securities laws. For example, forward-looking statements are used in this press release when we discuss potential partnerships for the development and commercialization of our PLX cells in Japan, when we discuss our plan to obtain marketing approval in Japan via Japan's accelerated regulatory pathway for regenerative medicines and the statement that our proprietary process and technology for growing placenta-derived cells within a 3D microenvironment make large scale, cost effective cell therapy production a reality. These forward-looking statements and their implications are based on the current expectations of the management of Pluristem only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; we may encounter delays or obstacles in launching and/or successfully completing our clinical trials; our products may not be approved by regulatory agencies, our technology may not be validated as we progress further and our methods may not be accepted by the scientific community; we may be unable to retain or attract key employees whose knowledge is essential to the development of our products; unforeseen scientific difficulties may develop with our process; our products may wind up being more expensive than we anticipate; results in the laboratory may not translate to equally good results in real surgical settings; results of preclinical studies may not correlate with the results of human clinical trials; our patents may not be sufficient; our products may harm recipients; changes in legislation; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem's reports filed from time to time with the Securities and Exchange Commission.

For more information on this press release visit: http://www.releasewire.com/press-releases/release-3.htm

• Phase I, open-label trial will allow for interim data analysis • PLX-R18 could potentially treat a broad range of hematologic indications • Pluristem will pursue early market access for PLX-R18 in the U.S.

Edwards, CO -- (SBWIRE) -- 01/13/2016 -- Pluristem Therapeutics Inc., a leading developer of placenta-based cell therapy products, announced today that the U.S. Food and Drug Administration (FDA) cleared the Company's Investigational New Drug (IND) application to begin its Phase I trial of PLX-R18 cells to treat incomplete hematopoietic recovery following Hematopoietic Cell Transplantation (HCT). The clinical trial is expected to begin in the first half of 2016.

PLX-R18 is Pluristem's second cell therapy product cleared for clinical studies by the U.S. FDA. It has already been studied in preclinical models of acute radiation syndrome, support of hematopoietic cell transplants, and side effects of radiotherapy and chemotherapies used to treat cancers. Preclinical data from trials conducted by the U.S. National Institutes of Health, Hadassah Medical Center, and other prominent research institutions have shown that PLX-R18 cells secrete a range of specific proteins that trigger the resurgence of progenitor cells, supporting the recovery of blood cell counts. By this mechanism of action, PLX-R18 could potentially treat a broad range of hematologic indications.

"The PLX-R18 product is designed to be an entirely new and innovative treatment approach for a wide variety of hematopoietic disorders, and might save the lives of severely ill patients with no alternative treatment options. We are encouraged by the strong pre-clinical data, and intend to pursue early market access in the U.S. for this important clinical indication," stated Pluristem Chairman and CEO, Zami Aberman.

Phase 1 Study Design
The planned study is a Phase 1, multi-center, open-label, dose-escalating study to evaluate the safety of intramuscular injections of PLX-R18 cells in subjects with incomplete hematopoietic recovery following hematopoietic cell transplantation (HCT). This study will be conducted in 30 subjects with incomplete hematopoietic recovery persistent for 6 months or more after HCT. There will be three cohorts: 1) 3 subjects receiving two administrations of 1 million PLX-R18 cells/kg each, separated by a 1-week interval; 2) 12 subjects receiving two administrations of 2 million cells/kg each, separated by a 1-week interval; and 3) 15 subjects receiving two administrations of 4 million cells/kg each, separated by a 1-week interval. The follow up period will be 12 months. The primary endpoints will be safety endpoints and will include adverse events, laboratory values and vital signs. Exploratory endpoints will include changes in platelet and hemoglobin levels, changes in transfusion frequency, a shift from transfusion dependence to transfusion independence, quality of life and changes in the serum immunological parameters.

Bone Marrow Failure and HCT

Bone marrow failure is the inability of bone marrow to produce sufficient numbers of platelets, white or red blood cells. This inability may result in serious illness or death, because these cells are necessary to prevent hemorrhage, infection or severe anemia. Bone marrow failure can be caused either by medical conditions such as aplastic anemia, myelodysplastic syndrome, hematologic malignancies, or as a side effect of radiation or chemotherapy cancer treatment. The incidence of bone marrow failure resulting from these conditions varies widely, but is increasing.

The only cure for bone marrow failure is HCT, although supportive therapies and treatments can reduce symptoms and prolong life for some patients. The hematopoietic cells for HCT can come from a donor or from the patient, and can be harvested from peripheral blood, bone marrow or umbilical cord blood. Transplant patients require extensive care and monitoring, and sometimes need intensive treatment for complications. In cases of incomplete engraftment, blood cell counts are insufficient causing the patient to be at high risk of severe or lethal complications. In severe cases the patient may need to undergo the arduous and dangerous process of a second transplant.

About Pluristem Therapeutics
Pluristem Therapeutics is a leading developer of placenta-based cell therapy products. In 2016, the Company expects to initiate pivotal trials with PLX-PAD cells aimed at conditional marketing approval for the treatment of critical limb ischemia in Europe and Japan. A global Phase 2 trial is currently being conducted with PLX-PAD cells for the treatment of intermittent claudication. PLX cell products release product-specific cocktails of therapeutic proteins in response to conditions such as inflammation, ischemia or hematological disorders. The Company's proprietary, three-dimensional expansion technology can grow mass quantities of commercial-grade cells with batch-to-batch consistency at Pluristem's FDA and EMA-approved, state-of-the-art manufacturing facility. The cells are off-the-shelf, requiring no tissue matching prior to administration, making the treatment cost effective and readily available in virtually any medical setting. Pluristem has a strong intellectual property position and strategic relationships with major research institutions.

Safe Harbor Statement
This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995 and federal securities laws. For example, we are using forward-looking statements when we discuss our expected Phase 1 trial of PLX-R18 cells to treat incomplete hematopoietic recovery following HCT, including the recruitment process and its timing; when we discuss the possibility of PLX-R18, if successful, to be used to support the recovery of the hematological system and restore production of normal levels of blood cells by the transplanted hematopoietic cells; when we discuss PLX-R18's potential to become novel innovative product with the ability to support the recovery of all three blood lines; when we discuss PLX-R18's potential to treat a broad range of indications related to abnormal bone marrow function; when we discuss the possibility of PLX-R18 cells to be an entirely new and innovative treatment for incomplete engraftment of HCT, and to save the lives of severely ill patients with no remaining treatment options; when we discuss our intention to pursue early market access in the U.S. for PLX-R18; and when we discuss our plan to initiate pivotal trials with PLX-PAD cells aimed at conditional marketing approval for the treatment of critical limb ischemia in Europe and Japan in 2016. These forward-looking statements and their implications are based on the current expectations of the management of Pluristem only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; we may encounter delays or obstacles in launching and/or successfully completing our clinical trials; our products may not be approved by regulatory agencies, our technology may not be validated as we progress further and our methods may not be accepted by the scientific community; we may be unable to retain or attract key employees whose knowledge is essential to the development of our products; unforeseen scientific difficulties may develop with our process; our products may wind up being more expensive than we anticipate; results in the laboratory may not translate to equally good results in real clinical settings; results of preclinical studies may not correlate with the results of human clinical trials; our patents may not be sufficient; our products may harm recipients; changes in legislation; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem's reports filed from time to time with the Securities and Exchange Commission. Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem's reports filed from time to time with the Securities and Exchange Commission.

For more information on this press release visit: http://www.releasewire.com/press-releases/release-3.htm

- First published study comparing therapeutic outcome of placenta-derived cells as compared to cells derived from bone marrow or fat tissue - Data describes the mechanism of action of PLX-PAD cells in preeclampsia - Study independently conducted by scientists at Texas A&M Health Science Center - PLX-PAD Cells recently received Orphan Drug Designation for Severe Preeclampsia

Haifa, Israel -- (SBWIRE) -- 01/13/2016 -- Pluristem Therapeutics Inc., a leading developer of placenta-based cell therapy products, today announced the publication of a scientific study of PLacental eXpanded (PLX) cells in the prominent peer-reviewed journal Clinical Science. The paper, titled "Human Placenta-Derived Stromal Cells Decrease Inflammation, Placental Injury, and Blood Pressure in Hypertensive Pregnant Mice," describes the positive findings of a recent preclinical study of PLX-PAD cells for the treatment of preeclampsia. This marks the first published study indicating the superiority of placenta-derived mesenchymal cells in a therapeutic outcome as compared to cells derived from bone marrow or fat tissue, thus having implications beyond preeclampsia. Scientists also described the potential mechanism of action by which PLX-PAD cells treated symptoms of preeclampsia. Conducted by independent scientists at the Texas A&M Health Science Center/Baylor Scott & White Health, the paper was co-authored by scientists from the Health Science Center and Pluristem Therapeutics.

Preeclampsia occurs in approximately 6-8% of pregnancies worldwide, and greatly increases the risks of serious illness and death for a pregnant woman and her baby. There is no cure other than delivery, which may be necessary even if the baby will be born prematurely, in some cases even before a viable gestational age is reached. Pluristem's PLX-PAD cells recently received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for the treatment of severe preeclampsia.

"This study is extremely important at this time because it provides data which demonstrate two critical outcomes. First, study findings indicated the potential mechanism of action to explain the effectiveness of PLX-PAD cells in the treatment of symptoms of preeclampsia following intramuscular injection. Second, the data have implications beyond preeclampsia by suggesting the superiority of placenta-derived cells over those sourced from fat tissue and bone marrow," stated Pluristem Chairman and CEO Zami Aberman. "The study confirms the power of placental cells to address complex diseases without harming the patient, through a clear mechanism of action and multifactorial response. Specific to preeclampsia, with the support of the FDA's Orphan Drug Designation, we look forward to advancing into clinical studies in this severe unmet need that causes so many serious consequences for pregnant women and their babies."

Data from the study showed that PLX-PAD cells, which are derived from placental cells, were able to normalize or significantly lower all the key symptoms of preeclampsia in two mouse models of the disease with only one intramuscular dose. PLX-PAD cells normalized blood pressure, marker levels of kidney function, and blood vessel function, all of which are considered to be key physiologic features contributing to preeclampsia. PLX-PAD also reduced levels of markers of inflammation and placental injury, thought to be central to the disease process as well.

Another important finding was that PLX-PAD cells did not affect healthy pregnant mice or their fetuses, consistent with prior independent studies conducted at Charles River. The trial data provide further evidence that administration of PLX cells into muscle generates a systemic effect, without any cell migration or engraftment into the mother, the placenta or her fetus. The article cites an earlier animal study, in which PLX-PAD cells were shown to stay in the muscle in which they were injected, and that they were no longer detectable after several weeks, i.e., there was no migration or engraftment of PLX cells.

The study also compared PLX-PAD cells, which are placenta derived, to cells derived from bone marrow and human adipose (fat) tissue, which were found to have no therapeutic effect. Data showed that PLX-PAD cells successfully treated symptoms that are present in diseases beyond preeclampsia, including immune system disturbances, excessive inflammation, and vascular dysfunction. Cells from bone marrow and fat tissue administered in these studies did not improve outcomes.

Additional Information about the Study
There were three study arms. On gestational days 13, 15 and 17, pregnant C57BL/6J mice were given intraperitoneal injections of a control (saline), TLR3 agonist or TLR7 agonist. Administration of TLR3 or TLR7 agonists generated two parallel animal models of preeclampsia. On gestational day 14, mice within each group received an intramuscular injection of either a control (PlasmaLyte) or PLX-PAD cells. Selected groups of TLR3 and TLR7 agonist-exposed mice received either adipose cells or bone marrow cells on day 14, administered intramuscularly as well.

Mice exposed to either TLR3 or TLR7 agonists developed preeclampsia-like symptoms; these included hypertension, signs of kidney dysfunction (abnormal urinary protein/creatinine ratio), and signs of vascular dysfunction (abnormal endothelium-dependent relaxation responses). Those treated with intramuscular injection of PLX-PAD cells on day 14 of gestation exhibited significantly decreased systolic blood pressure by day 17. In both mouse models of preeclampsia, each decrease was statistically significant (p<0.05) for PLX-PAD treated mice as compared to control. By day 17, PLX-PAD treatment normalized the elevated levels of urinary protein/creatinine ratio in both models, and both decreases were statistically significant (p<.05) as compared to control. On gestational day 17, aortic endothelium-dependent relaxation responses improved significantly in PLX-PAD treated mice both in the TLR3 and the TLR7 models of preeclampsia, and the improvements were statistically significant for both (p<.05) as compared to control. Treatment with PLX-PAD cells also reduced the levels of markers of systemic inflammation and placental injury in these models.

In both mouse models of preeclampsia, single doses of PLX-PAD cells were able to reduce all of the measured preeclampsia symptoms in these mice. In contrast, human adipose or bone marrow cells were not able to reduce the inflammation, hypertension, or proteinuria in these preeclamptic mice.

The cells were shown to secrete multiple chemical factors thought to address pathological processes central to the disease, including hMMP-1, hMMP-2, hMMP-3, and hTIMP-1. Also observed in treated mice were increased levels of mEGF and mVEGF. These findings suggest that PLX-PAD cells exert multifactorial therapeutic mechanism to address various features of a complex disease process.

About Preeclampsia
Preeclampsia is one of the most common medical complications of pregnancy, and one of the leading known causes of premature births, stillbirths and early neonatal and maternal deaths. The disease occurs after the 20th week of pregnancy, and is characterized by high blood pressure and significant amounts of protein in the urine or end-organ dysfunction. The disease may lead to liver and renal failure, central nervous system (CNS) abnormalities including seizures, and disseminated intravascular coagulopathy. The only definitive treatment for preeclampsia is delivery. Severe preeclampsia, which occurs in 1% of pregnancies in the U.S., is defined by the presence of at least one additional symptom in a patient meeting the criteria for preeclampsia; these additional symptoms include severe high blood pressure, signs of severe kidney malfunction, low platelets, persistent headaches, and pulmonary edema.

About Pluristem Therapeutics
Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapy products. The Company has reported robust clinical trial data in multiple indications for its patented PLX (PLacental eXpanded) cells. The cells release a cocktail of therapeutic proteins in response to inflammation, ischemia, hematological disorders, and radiation damage. PLX cell products are grown using the Company's proprietary three-dimensional expansion technology. They are off-the-shelf, requiring no tissue matching prior to administration.

Pluristem has a strong intellectual property position; Company-owned and operated, GMP-certified manufacturing and research facilities; strategic relationships with major research institutions; and a seasoned management team.

Safe Harbor Statement
This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995 and federal securities laws. For example, we are using forward-looking statements when we discuss the findings of the study, the evidence they provide and their potential implications, such as the superiority of placenta-derived cells over those sourced from fat tissue and bone marrow and the potential power of placental cells to address complex diseases without harming the patient, and when we discuss our plans to advance into clinical studies of PLX-PAD cells in treating preeclampsia. These forward-looking statements and their implications are based on the current expectations of the management of Pluristem only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; we may encounter delays or obstacles in launching and/or successfully completing our clinical trials; our products may not be approved by regulatory agencies, our technology may not be validated as we progress further and our methods may not be accepted by the scientific community; we may be unable to retain or attract key employees whose knowledge is essential to the development of our products; unforeseen scientific difficulties may develop with our process; our products may wind up being more expensive than we anticipate; results in the laboratory may not translate to equally good results in real clinical settings; results of preclinical studies may not correlate with the results of human clinical trials; our patents may not be sufficient; our products may harm recipients; changes in legislation; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem's reports filed from time to time with the Securities and Exchange Commission. Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem's reports filed from time to time with the Securities and Exchange Commission.

For more information on this press release visit: http://www.releasewire.com/press-releases/release-3.htm

PLX Cells Were Demonstrated to be Safe for Both the Mother and Fetus and Improved Several Parameters of Preeclampsia in Several Animal Studies

Haifa, Israel -- (SBWIRE) -- 01/04/2016 -- Pluristem Therapeutics Inc., a leading developer of placenta-based cell therapy products, today announced that the U.S. Food and Drug Administration has granted the Company's PLX-PAD cells Orphan Drug Designation in the treatment of severe preeclampsia. Preeclampsia is among the most common medical complications of pregnancy and a leading cause of premature births, stillbirths and neonatal and maternal deaths. There is no cure except delivery. Due to high risks to the mother, women diagnosed with severe preeclampsia are usually delivered promptly, even if the baby will be born prematurely and may suffer permanent disabilities as a result. Severe preeclampsia occurs in approximately 1% of pregnancies in Western countries.

Benefits of Orphan Drug Designation for PLX-PAD cells include close guidance that may accelerate time to marketing approval, orphan drug grants, tax credits, and a 7-year market exclusivity upon marketing approval. It is estimated by different sources that preeclampsia costs the global health care system about $3 billion annually.

"Attainment of Orphan Drug Designation for our cells in severe preeclampsia exemplifies our global strategy of bringing cell therapies to patients through accelerated approval pathways," stated Pluristem Chairman and CEO Zami Aberman. "We are encouraged by the US FDA designation that demonstrates Pluristem's commitment to the program and the potential promise it holds to address a serious, unmet medical need faced by pregnant women every year."

PLX-PAD cells improved several parameters of preeclampsia in animal models in a study conducted in collaboration with Brett Mitchel PhD, Associate Professor of Internal Medicine at the Cardiovascular Research Institute (CVRI) of the Texas A&M College of Medicine. In a different animal study conducted by Charles River Laboratories, PLX-PAD cells were demonstrated to be safe for both the mother and fetus. As previously requested by the FDA, study in additional animal model (over expression of sFLT-1) to confirm the efficacy of PLX-PAD is on-going to test the efficacy of PLX-PAD in an additional therapeutic pathway. Data is expected in H1 of 2016.

About Preeclampsia
Preeclampsia is one of the most common medical complications of pregnancy, and one of the leading known causes of premature births, stillbirths and early neonatal and maternal deaths. The disease occurs after the 20th week of pregnancy, and is characterized by high blood pressure and significant amounts of protein in the urine or end-organ dysfunction. The disease may lead to liver and renal failure, central nervous system (CNS) abnormalities including seizures, and disseminated intravascular coagulopathy. The only definitive treatment for preeclampsia is delivery. Severe preeclampsia, which occurs in 1% of pregnancies in the U.S., is defined by the presence of at least one additional symptom in a patient meeting the criteria for preeclampsia; these additional symptoms include severe high blood pressure, signs of severe kidney malfunction, low platelets, persistent headaches, and pulmonary edema.

About Pluristem Therapeutics
Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapy products. The Company has reported robust clinical trial data in multiple indications for its patented PLX (PLacental eXpanded) cells. The cells release a cocktail of therapeutic proteins in response to inflammation, ischemia, hematological disorders, and radiation damage. PLX cell products are grown using the Company's proprietary three-dimensional expansion technology. They are off-the-shelf, requiring no tissue matching prior to administration.

Pluristem has a strong intellectual property position; Company-owned, GMP-certified manufacturing and research facilities; strategic relationships with major research institutions; and a seasoned management team.

Safe Harbor Statement
This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995 and federal securities laws. For example, we are using forward-looking statements when we discuss benefits of Orphan Drug Designation for PLX cells, or when we discuss our global strategy of bringing cell therapies to patients through accelerated approval pathways, or when we discuss our commitment to the severe preeclampsia program and the potential promise it holds to address a serious, unmet medical need faced by pregnant women every year. These forward-looking statements and their implications are based on the current expectations of the management of Pluristem only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; we may encounter delays or obstacles in launching and/or successfully completing our clinical trials; our products may not be approved by regulatory agencies, our technology may not be validated as we progress further and our methods may not be accepted by the scientific community; we may be unable to retain or attract key employees whose knowledge is essential to the development of our products; unforeseen scientific difficulties may develop with our process; our products may wind up being more expensive than we anticipate; results in the laboratory may not translate to equally good results in real clinical settings; results of preclinical studies may not correlate with the results of human clinical trials; our patents may not be sufficient; our products may harm recipients; changes in legislation; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem's reports filed from time to time with the Securities and Exchange Commission. Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem's reports filed from time to time with the Securities and Exchange Commission

For more information on this press release visit: http://www.releasewire.com/press-releases/release-3.htm

Haifa, Israel -- (SBWIRE) -- 10/13/2015 -- Pluristem Therapeutics Inc., a leading developer of placenta-based cell therapy products, today announced it has expanded its five-year Collaborative Research Agreement with the Berlin-Brandenburg Center for Regenerative Therapy at Charite - University Medicine Berlin. The expanded agreement, which was executed on October 11th at the Berlin-Tel Aviv Business Forum in Tel Aviv, broadens the parties' cooperation to include identification of orthopedic indications that may be eligible for development under Europe's Adaptive Pathways and conditional marketing approval in the European Union. Pluristem's program to develop PLX cells in critical limb ischemia is already under discussion with the EMA and other European Stakeholders under the Adaptive Pathways.

Under the five-year Collaborative Research Agreement, Pluristem and Charite have jointly completed a successful orthopedic Phase I/II study using PLacental eXpanded (PLX) cells in muscle injury. The parties have also collaborated on a variety of other indications, including kidney diseases such as acute kidney injury, cardiovascular indications such as inflammatory cardiomyopathy, and comprehensive immunological research for Pluristem's Peripheral Artery Disease clinical programs.

Dr. Tobias Winkler of the Center for Musculoskeletal Surgery & Julius Wolff Institute Berlin, Charite, who served as Senior Scientist on the completed Phase I/II orthopedic study, commented, "In our studies PLX cells demonstrated the potential to improve overall muscle functionality, with an impressive magnitude of effect. An additional orthopedic PLX indication has a promising potential."

"Pluristem has enjoyed a very productive relationship with European regulators and our PLX cells have already been selected for the Adaptive Pathways in critical limb ischemia. Working with the prestigious Charite, we look forward to advancing an orthopedic indication through Adaptive Pathways as well," stated Pluristem Chairman and CEO, Zami Aberman.

About BCRT
The Berlin-Brandenburg Center for Regenerative Therapies was founded as a cooperative research institution of the Charite University Hospital in Berlin and Germany's largest research association, the Helmholtz Association. The mission of the BCRT is to develop a translational platform for Regenerative Therapies from bench-to-bedside. The five clinical platforms–Immune, musculoskeletal, hepatic, neuronal, and cardiovascular system–are cross-linked by technology platforms (basic science, bio-engineering, translational technologies.

About Adaptive Pathways
The purpose of Europe's Adaptive Pathways is to shorten the time it takes for innovative medicines to reach patients with serious conditions that lack adequate treatment options. The pathway is open to clinical programs in early stages of development only. After a therapy is selected for the program, the Adaptive Pathways Discussion Group provides detailed guidance to the applicant previous to the formal regulatory processes that precede a trial targeting early or conditional approval and further expansion of the indications.

About Pluristem Therapeutics
Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapy products. The Company has reported robust clinical trial data in multiple indications for its patented PLX (PLacental eXpanded) cells. The cells release a cocktail of therapeutic proteins in response to inflammation, ischemia, hematological disorders, and radiation damage. PLX cell products are grown using the Company's proprietary three-dimensional expansion technology. They are off-the-shelf, requiring no tissue matching prior to administration. Pluristem has a strong intellectual property position; Company-owned, GMP-certified manufacturing and research facilities; strategic relationships with major research institutions; and a seasoned management team.

Safe Harbor Statement
This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995 and federal securities laws. For example, we are using forward-looking statements when we discuss PLX cells' potential to improve overall muscle functionality with an impressive magnitude of effect, when we discuss the potential of the orthopedic PLX indication to be a promising clinical program and when we discuss our plans to continue to work with Charite to advance an orthopedic indication through Adaptive Pathways as well. For example. we are using forward-looking statements when we discuss the findings of the scientific study and the evidence they provide, that the research may lead to a new understanding of how PLX cells influence and potentially heal the immune system through paracrine and endocrine effects, and opens the window for the use of PLX cells for new indications, or that the data from the study suggest the potential for PLX cells to treat a range of severe conditions related to immune function, or that PLX cells could potentially help treat diseases of the immune system such as aplastic anemia, and autoimmune diseases such as multiple sclerosis, lupus and graft versus host disease (GVHD). These forward-looking statements and their implications are based on the current expectations of the management of Pluristem only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; we may encounter delays or obstacles in launching and/or successfully completing our clinical trials; our products may not be approved by regulatory agencies, our technology may not be validated as we progress further and our methods may not be accepted by the scientific community; we may be unable to retain or attract key employees whose knowledge is essential to the development of our products; unforeseen scientific difficulties may develop with our process; our products may wind up being more expensive than we anticipate; results in the laboratory may not translate to equally good results in real clinical settings; our patents may not be sufficient; our products may harm recipients; changes in legislation; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem's reports filed from time to time with the Securities and Exchange Commission.

For more information on this press release visit: http://www.releasewire.com/press-releases/release-3.htm

ARM is the Preeminent Global Advocate for the Advancement of Regenerative Medicine

Haifa, Israel -- (SBWIRE) -- 10/09/2015 -- Pluristem Therapeutics Inc., a leading developer of placenta-based cell therapy products, today announced that Pluristem's Chairman and CEO, Zami Aberman, has been elected to serve on the Board of Directors of the Alliance for Regenerative Medicine (ARM). Based in Washington, D.C., ARM promotes research, development, investment and commercialization of regenerative medicine technologies. Pluristem has been a member of ARM for 3 years and has actively supported the organization's goals. Mr. Aberman joins other prominent leaders in the field of regenerative medicine who are currently serving on the board.

Dr. Karine Kleinhaus, Divisional Vice President, North America, presented a company overview on October 7 at the Stem Cell Meeting on the Mesa in La Jolla, California. Co-hosted by ARM, the California Institute for Regenerative Medicine (CIRM) and the Sanford Consortium for Regenerative Medicine, the 2015 Stem Cell Meeting on the Mesa was attended by leading cell therapy, gene therapy and tissue engineering companies, large pharma and biotech, industry investors and major academic research institutions. A webcast of the presentation will be available on ARM's website shortly after the conference.

About Pluristem Therapeutics
Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapy products. The Company has reported robust clinical trial data in multiple indications for its patented PLX (PLacental eXpanded) cells. The cells release a cocktail of therapeutic proteins in response to inflammation, ischemia, hematological disorders, and radiation damage. PLX cell products are grown using the Company's proprietary three-dimensional expansion technology. They are off-the-shelf, requiring no tissue matching prior to administration.

Pluristem has a strong intellectual property position; Company-owned, GMP-certified manufacturing and research facilities; strategic relationships with major research institutions; and a seasoned management team.

For more information on this press release visit: http://www.releasewire.com/press-releases/release-3.htm

Safety Clearance is Another Step Towards the Start of Phase II CLI Trial Via Japan's Accelerated Approval Pathway

Haifa, Israel -- (SBWIRE) -- 08/21/2015 -- Pluristem Therapeutics Inc, a leading developer of placenta-based cell therapy products, announced that Japan's Pharmaceuticals and Medical Devices Agency (PMDA) has cleared the Company's PLX-PAD cells for use in clinical trials in Japan. This clearance is required in order to apply for approval to conduct a Phase II study of PLX-PAD in critical limb ischemia (CLI) through Japan's accelerated regulatory pathway for regenerative medicine. This regulatory pathway generally allows for conditional, time-limited marketing approval after a single successful Phase II trial.

"We are very pleased to receive this important safety clearance to administer PLX-PAD to Japanese patients during our anticipated clinical trial in Japan. Our next step is to conclude the discussion of the clinical protocol with the PDMA for our proposed Phase II CLI study. We expect to talk with the PDMA during the last quarter of 2015, and are anticipating that we will receive permission to begin the trial by the end of 2015," stated Pluristem CEO Zami Aberman. "This approval would enable us to potentially start a trial in early 2016."

Safety clearance is the second of three authorizations required by the PMDA prior to commencement of a Phase II trial. Pluristem announced that it received the first of these in May 2015, when the Agency accepted PLX-PAD cells' quality standards and large-scale manufacturing methods. The third and final step, yet to be achieved, is approval of the clinical study design.

About Japan's Conditional time-limited Approval for Regenerative Medicine
Japan's Act on the Safety of Regenerative Medicines went into effect in November 2014. It effectively fast-tracks the approval of cellular therapies and other regenerative medicine treatments for marketing. According to the law, these therapies can receive conditional, time-limited approval for marketing, and be eligible for reimbursement, upon proof of safety and a signal of effectiveness but prior to verification of efficacy. Safety and efficacy need to be confirmed via collection of observational data after the conditional approval. No formal Phase III trial is expected to be required.

About Pluristem Therapeutics
Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapy products. The Company has reported robust clinical trial data in multiple indications for its patented PLX (PLacental eXpanded) cells. The cells release a cocktail of therapeutic proteins in response to inflammation, ischemia, hematological disorders, and radiation damage. PLX cell products are grown using the Company's proprietary three-dimensional expansion technology. They are off-the-shelf, requiring no tissue matching prior to administration.

Pluristem has a strong intellectual property position; Company-owned, GMP-certified manufacturing and research facilities; strategic relationships with major research institutions; and a seasoned management team.

Safe Harbor Statement
This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995 and federal securities laws. For example, we are using forward-looking statements when we discuss whether the PDMA will allow us to conduct a Phase II clinical study of PLX-PAD in CLI, the expected timing for the approval of our Phase II protocol for CLI by the PDMA, the expected timing for starting a Phase II trial for CLI and whether a Phase III clinical trial will be required. These forward-looking statements and their implications are based on the current expectations of the management of Pluristem only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements.

The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; we may encounter delays or obstacles in launching and/or successfully completing our clinical trials; our products may not be approved by regulatory agencies; changes in legislation, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements.

Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem's reports filed from time to time with the Securities and Exchange Commission.

For more information on this press release visit: http://www.releasewire.com/press-releases/release-3.htm

She will be discussing adult placenta cell therapy and its treatment for inflammation, ischemia, hematological disorders, and radiation damage, as well as treating bone marrow transplant failure in order to return a patient’s white cell, red cell and platelet levels to normal.

Westchester, NY -- (ReleaseWire) -- 05/29/2015 -- Scarsdale resident, Karine Kleinhaus, M.D., M.P.H., VP, North America, for Pluristem Therapeutics (NASDAQ: PSTI), will be an hour long live radio guest on Peter Moses's radio show on WVOX 1460 AM in Westchester, NY and streaming live at http://www.wvox.com, this Monday, June 1, 2015 from 3-4 pm E.

She will be discussing adult placenta cell therapy and its treatment for inflammation, ischemia, hematological disorders, and radiation damage, as well as treating bone marrow transplant failure in order to return a patient's white cell, red cell and platelet levels to normal.

About Karine Kleinhaus, M.D., M.P.H.
Karine Kleinhaus, M.D., M.P.H., is Divisional Vice President, North America at Pluristem Therapeutics. She has worked with multiple public and private biotechnology companies on both public and investor relations. Prior to that, she was an Assistant Professor in the Departments of Obstetrics and Gynecology and Psychiatry at the NYU School of Medicine. At NYU, Dr. Kleinhaus conducted medical research funded under a multi-year NIH grant. She published more than 25 papers in leading peer-reviewed journals such as the Annals of the New York Academy of Science, American Journal of Medical Genetics, and the American Journal of Epidemiology. Before that Dr. Kleinhaus practiced obstetrics and then completed two fellowships at Columbia University.?Dr. Kleinhaus received her medical degree from Tel Aviv University, earned a Master of Public Health from Columbia's Mailman School of Public Health, and a bachelor's degree, cum laude, from Princeton University.

About Pluristem Therapeutics Inc.
Pluristem Therapeutics Inc. (NASDAQ: PSTI), is a leading developer of placenta-based cell therapy products. The Company's patented PLX (PLacental eXpanded) cells release a cocktail of therapeutic proteins in response to inflammation, ischemia, hematological disorders, and radiation damage. PLX cells are grown using the Company's proprietary three-dimensional expansion technology and are an "off-the-shelf" product that requires no tissue matching prior to administration. The Company has a strong intellectual property position, Company-owned, GMP-certified manufacturing and research facilities, strategic relationships with major research institutions. Pluristem's PLX-R18 cells can address crucial recovery stages in treating bone marrow failure and/or blood disorders including returning a patient's white cell, red cell and platelet levels to normal. http://www.pluristem.com/

For more information on this press release visit: http://www.releasewire.com/press-releases/release-3.htm

Pluristem completes successful meeting with PMDA and satisfies critical prerequisite for initiation of clinical study targeting fast-track approval in Japan

Haifa, Israel -- (SBWIRE) -- 05/15/2015 -- Pluristem Therapeutics Inc., a leading developer of placenta-based cell therapy products, today announced that Japan's Pharmaceuticals and Medical Devices Agency (PMDA) agreed with the proposed quality and large-scale manufacturing methods for PLX-PAD cells for use in clinical trials. This agreement is an important milestone for initiation of a Phase I/II study in critical limb ischemia through Japan's Accelerated Pathway for Regenerative Medicine. The new regulatory pathway could potentially significantly reduce time to market for cell therapies such as PLX cells.

"Pluristem is emerging as an early leader in the industry's push to enter Japan's newly established accelerated regulatory pathway. It is our hope that the PDMA will approve our application for a Phase I/II clinical study of PLX cells in critical limb ischemia via the Accelerated Pathway," stated Pluristem CEO Zami Aberman.

Japan's Accelerated Pathway for Regenerative Medicine went into effect in November 2014. According to the law, regenerative medicine therapies can receive conditional, time-limited approval for marketing, and be eligible for reimbursement, upon proof of safety and initial proof of efficacy. Safety and effectiveness need to be confirmed within 7 years after the conditional approval.

About Pluristem Therapeutics
Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapy products. The Company's patented PLX (PLacental eXpanded) cells release a cocktail of therapeutic proteins in response to inflammation, ischemia, hematological disorders, and radiation damage. PLX cells are grown using the Company's proprietary three-dimensional expansion technology and are an "off-the-shelf" product that requires no tissue matching prior to administration.

Pluristem has a strong intellectual property position, Company-owned, GMP-certified manufacturing and research facilities, strategic relationships with major research institutions, and a seasoned management team. For more information visit http://www.pluristem.com, the content of which is not part of this press release.

Safe Harbor Statement
This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995 and federal securities laws. For example, forward-looking statements are used in this press release when we discuss the potential of Japan's Accelerated Pathway for Regenerative Medicine to significantly reduce time to market cell therapies such as PLX cells, and when we discuss our hope that the PDMA will approve our application for a Phase I/II clinical study of PLX cells in critical limb ischemia via the Accelerated Pathway. These forward-looking statements and their implications are based on the current expectations of the management of Pluristem only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; we may encounter delays or obstacles in launching and/or successfully completing our clinical trials; our products may not be approved by regulatory agencies, our technology may not be validated as we progress further and our methods may not be accepted by the scientific community; we may be unable to retain or attract key employees whose knowledge is essential to the development of our products; unforeseen scientific difficulties may develop with our process; our products may wind up being more expensive than we anticipate; results in the laboratory may not translate to equally good results in real surgical settings; results of preclinical studies may not correlate with the results of human clinical trials; our patents may not be sufficient; our products may harm recipients; changes in legislation; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem's reports filed from time to time with the Securities and Exchange Commission.

For more information on this press release visit: http://www.releasewire.com/press-releases/release-3.htm

In parallel Pluristem and Case Western University announce early data on PLX-R18 in umbilical cord blood transplantation

Haifa, Israel -- (SBWIRE) -- 03/04/2015 -- Pluristem Therapeutics Inc., a leading developer of placenta-based cell therapy products, announced today strong positive data from a preclinical study of PLX-R18 cells to improve outcomes of bone marrow transplantation. In the study, conducted in conjunction with Hadassah Medical Center's Department of Bone Marrow Transplantation and Cancer Immunotherapy, mice with damaged bone marrow who received intramuscular injections of PLX-R18 cells together with a bone marrow transplant had significantly faster recovery of blood cell production compared to those who received a placebo with the bone marrow transplant. A rapid return to normal blood cell counts is critical for people who require a transplant to replace dysfunctional bone marrow because of diseases such as leukemia or other blood cancers. PLX-R18, Pluristem's second product, is being developed to treat a range of hematologic indications including bone marrow deficiency and complications of bone marrow and umbilical cord blood transplantation.

The objective of the Hadassah trial was to compare the production of blood cells after intramuscular injection with PLX-R18 cells or placebo in the context of transplantation of hematopoietic stem cells obtained from bone marrow. Mice received lethal doses of radiation followed by either a low dose or a high dose of bone marrow cells and either PLX-R18 cells or placebo. Evidence of more rapid recovery was found at the two earliest data collection time points of the study. Nine days after transplantation with a low dose of bone marrow cells and concurrent administration of either PLX-R18 or placebo, those treated with PLX-R18 had statistically significant increases in numbers of platelets and granulocytes as compared to controls; they also had more lymphocytes and total white blood cells, though these increases were not statistically significant.

Nine days after transplantation with a high dose of bone marrow cells and concurrent administration of either PLX-R18 or placebo, those treated with PLX-R18 also had statistically significant increases in platelet levels. One week later, at 16 days after a low dose transplantation, those treated with PLX-R18 cells had more platelets than controls, and those treated with PLX-R18 and a high dose of bone marrow had statistically significant increases in platelets, granulocytes and total white blood cells. After a bone marrow transplant patients cannot fight infections or prevent hemorrhage until white blood cell and platelet levels return to normal. The accelerated recovery of platelet and white blood cell levels demonstrated in this study could potentially have important clinical implications.

Alongside the study at Hadassah, a preliminary study was conducted by Hillard M. Lazarus, MD, a Professor of Medicine in the Department of Hematology and Oncology at Case Western Reserve University. The study was part of ongoing research there to test PLX-R18 for use in umbilical cord blood stem cell transplantation. Data in eight mice showed that six weeks after exposure to high doses of radiation, followed by transplantation with human umbilical cord blood cells, three out of four mice who received PLX-R18 cells survived compared to only one out of the four who received a placebo after transplant. At eight weeks after irradiation and transplantation the mice who received PLX-R18 each had a higher percent of hematopoietic cells (CD45+) in their peripheral blood than the surviving control subject. This early finding is encouraging as research continues at Case Western University to study the effects of PLX-R18 on the speed and success of engraftment of umbilical cord blood cells.

"A statistically significant increase in blood counts soon after bone marrow transplant is very meaningful. For the transplant patient, the most critical period for hematopoietic recovery is in the days following the transplant. We were particularly encouraged to see that the administration of PLX-R18 cells resulted in the greatest early improvement when using a lower dose of bone marrow cells. This means we could one day potentially achieve success with lower bone marrow transplant doses, thus addressing both treatment costs and donor availability," stated Professor Reuven Or, Director of the Department of Bone Marrow Transplantation and Cancer Immunotherapy at Hadassah Medical Center and the study's Principal Investigator.

Zami Aberman, Chairman and CEO of Pluristem, added, "Improving the outcomes of bone marrow and umbilical cord blood transplantation can have a significant impact on the treatment of a range of diseases, from blood cancers to immune and genetic disorders. We are happy with the data from preclinical studies of PLX-R18 in the context of transplantation and look forward to continuing our work in these indications with both Hadassah Medical Center and Case Western University."

Additional Information about the Bone Marrow Transplant Study

Seventy-eight irradiated mice were put into four groups receiving: 1) a transplant of four million bone marrow cells, plus an intra-muscular (IM) injection of 1 million PLX-R18 cells on day one and day ten; 2) a bone marrow transplant of eight million cells, plus an IM injection of one million PLX-R18 cells on day one and day ten; 3) a transplant of four million bone marrow cells, plus an IM injection of placebo on days one and ten; 4) a transplant of eight million bone marrow cells, plus an IM injection of placebo on days one and ten. Complete blood counts (CBC) were measured on day nine following the bone marrow transplant and first dose of PLX-R18 or placebo, on day sixteen following the second dose of PLX-R18 or placebo, and on day twenty-three.

Data showed that on day 9, after only one PLX-R18 injection, subjects treated with PLX-R18 plus the lower dose of 4 million bone marrow cells had more platelets and granulocytes than controls (all controls received a transplant), and these differences were statistically significant (p=.0059 and p=.0267 respectively). The subjects injected with PLX-R18 cells also had higher levels of granulocytes and white blood cells overall, although the differences were not statistically significant. The group which received PLX-R18 plus 8 million bone marrow cells also showed significantly higher platelet counts than controls (p=.0015). One week later, those who received a low dose of bone marrow cells together with PLX-R18 had more platelets than controls, although the difference wasn't significant. Those who received the higher dose of bone marrow cells had significant increases in their levels of platelets, granulocytes and total white blood cells (p=.0053, p=.0122 and p=.0262 respectively). There were no significant differences in numbers of cells between the groups on day 23. Thus, PLX-R18 cells significantly accelerated recovery of several components of normal blood counts.

About Pluristem Therapeutics
Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapy products. The Company's patented PLX (PLacental eXpanded) cells release a cocktail of therapeutic proteins in response to inflammation, ischemia, hematological disorders, and radiation damage. PLX cells are grown using the Company's proprietary three-dimensional expansion technology and are an "off-the-shelf" product that requires no tissue matching prior to administration.

Pluristem has a strong intellectual property position, Company-owned, GMP-certified manufacturing and research facilities, strategic relationships with major research institutions, and a seasoned management team. For more information visit http://www.pluristem.com. Follow us on Twitter: https://twitter.com/pluristem

Safe Harbor Statement
This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995 and federal securities laws. For example, forward-looking statements are used in this press release when we discuss that PLX-R18, is being developed to treat a range of hematologic indications, when we discuss the potential clinical implications of the accelerated recovery of platelet and white blood cell levels demonstrated in the study; the potential future achievement of success with lower bone marrow transplant doses to address both treatment costs and donor availability; the potential significant impact that improving the outcomes of bone marrow and umbilical cord blood transplantation can have on the treatment of a range of diseases, and our continuous work with both Hadassah Medical Center and Case Western University. These forward-looking statements and their implications are based on the current expectations of the management of Pluristem only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; we may encounter delays or obstacles in launching and/or successfully completing our clinical trials; our products may not be approved by regulatory agencies, our technology may not be validated as we progress further and our methods may not be accepted by the scientific community; we may be unable to retain or attract key employees whose knowledge is essential to the development of our products; unforeseen scientific difficulties may develop with our process; our products may wind up being more expensive than we anticipate; results in the laboratory may not translate to equally good results in real surgical settings; results of preclinical studies may not correlate with the results of human clinical trials; our patents may not be sufficient; our products may harm recipients; changes in legislation; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem's reports filed from time to time with the Securities and Exchange Commission.

For more information on this press release visit: http://www.releasewire.com/press-releases/release-3.htm

Haifa, Israel -- (ReleaseWire) -- 02/19/2015 -- Pluristem Therapeutics Inc., a leading developer of placenta-based cell therapy products, announced today the positive results of a recently completed trial conducted by the U.S. National Institutes of Health (NIH) to evaluate PLX-R18 cells to treat bone marrow damaged by exposure to high levels of radiation, such as can occur after a nuclear disaster. Injection of PLX-R18 cells into muscle, as compared to a placebo, resulted in a statistically significant improvement in the recovery of white blood cell, red blood cell, and platelet levels in animals exposed to high levels of radiation. The data also suggested that the treatment may potentially be able to shorten time to recovery. High levels of radiation can destroy the body's ability to produce these three blood lineages, and rapidly regaining that capacity is a key factor in surviving the hematologic component of acute radiation syndrome (ARS), a condition caused by high-dose irradiation that can involve severe, sometimes lethal damage to the bone marrow as well as other physiologic systems and organs.

The objective of this latest trial was to investigate the mechanism of action behind the significant improvement in survival in irradiated mice treated with PLX-R18 that was demonstrated in the NIH's first efficacy study. The results of the current study indicate that intramuscular administration exerts a systemic healing effect on bone marrow, lending further support to the concept that Pluristem's cells work systemically via secretion of therapeutic proteins, although the cells themselves remain in the muscle into which they were initially injected. While additional animal trials are needed prior to U.S. Food and Drug Administration (FDA) approval of PLX-R18 for use in ARS, no human trials would be required because product development is conducted under the FDA's Animal Rule.

"Our PLX-R18 cell product was developed and targeted to become a strong candidate for government procurement programs designed to protect the population in the case of exposure to dangerous levels of radiation. PLX-R18 cells are an off-the-shelf cell therapy product with a long shelf life. They do not require matching before use and can be administered through intramuscular injection. These features are important to facilitate rapid initiation of treatment on a large scale. The study results also support Pluristem's unique approach of injecting cells intramuscularly to enable the cells to remain in the body long enough to respond to signals from damaged tissues and adapt their therapeutic secretion profiles accordingly," stated Zami Aberman, Chairman and CEO of Pluristem.

"We have had a productive working relationship with the NIH's National Institute of Allergy and Infectious Diseases (NIAID), which has independently conducted its studies with PLX-R18 cells provided by Pluristem," Aberman added.

Pluristem is developing PLX-R18 cells for other potential indications including enhancement of engraftment of transplanted hematopoietic stem cells for the treatment of bone marrow deficiency. Trials for this indication are ongoing at Case Western University and Hadassah Medical Center. Data from the NIH studies in ARS are expected to benefit Pluristem's development of its hematology program.

Data from Mechanism of Action Study conducted by NIH

The objective of this study, performed at the Indiana University School of Medicine and funded by the Product Development Support Services Contract HHSN277201000046C from NIAID, was to investigate the mechanism of action behind the results of the NIH's first study of the efficacy of PLX-R18 in ARS. That first study showed a significantly increased 30-day survival and overall survival time of mice treated with PLX-R18 compared to controls.

In the current study, 256 mice were randomized to be injected intramuscularly with PLX-R18 or placebo after total body irradiation, or PLX-R18 or placebo after sham irradiation. Mice were dosed intramuscularly with PLX-R18 cells or a placebo on day 1 and day 5 post-irradiation. Complete blood count parameters and body weight were measured at 8 post-irradiation time points (days 2, 4, 6, 9, 13, 15, 17, and 23), and bone marrow and spleen cellularity and hematopoietic progenitor cells (HPC) were measured at 6 time points (days 2, 4, 6, 9, 13, and 23). Treatment with PLX-R18 cells significantly increased recovery of white blood cells (p=.0024), neutrophils (p=.0026), monocytes (p=.0272), red blood cells (p<.0001), platelets (p=.0005), hemoglobin (p<.0001), and hematocrit (p<.0001) at day 23 post-irradiation compared with vehicle-treated control mice. Increases in lymphocytes and percent of neutrophils were also observed, but were not statistically significant. The increase in bone marrow progenitor cells was accelerated in mice treated with PLX-R18 cells as compared to the control group, but this was not statistically significant. The population of bone marrow cells responsible for the earlier stages of new red cell, white cell, and platelet production began to increase before those involved in later stages of production; this is consistent with normal physiology in which the progenitor cells proliferate and replenish the more mature cell populations and eventually the peripheral blood cells.

Published data for ARS study conducted earlier by Pluristem

Previous studies of PLX-R18 cells for ARS were conducted by Prof. Raphael Gorodetsky, head of the Biotechnology and Radiobiology Laboratory at the Sharett Institute of Oncology at the Hadassah Hebrew University Medical Center. Those studies showed an up to four-fold increase in the survival rate of irradiated animals treated with PLX cells versus those treated with a control, as well as improvements in additional parameters. The findings have been published in the peer-reviewed journal PLOS ONE.

About Acute Radiation Syndrome (ARS)
Acute radiation syndrome (ARS) is an acute illness caused by irradiation of the whole body (or a significant portion of it). It follows a somewhat predictable course and is characterized by signs and symptoms that reflect cellular deficiencies and the reactions of various cells, tissues, and organ systems to ionizing radiation. The hematologic component of ARS results from damage to the bone marrow and is characterized by acute decreases in red and white blood cell and platelet counts, which can lead to infection, hemorrhage and death. The gastrointestinal component is characterized by loss of cells lining the intestines, resulting in fluid and electrolyte loss, sepsis, and damage to the intestinal microcirculation, all of which can lead to death. Other components of ARS include potentially lethal damage to the central nervous system and the lungs.

About Pluristem Therapeutics
Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapy products. The Company's patented PLX (PLacental eXpanded) cells release a cocktail of therapeutic proteins in response to inflammation, ischemia, hematological disorders, and radiation damage. PLX cells are grown using the Company's proprietary three-dimensional expansion technology and are an "off-the-shelf" product that requires no tissue matching prior to administration.

Pluristem has a strong intellectual property position, Company-owned, GMP-certified manufacturing and research facilities, strategic relationships with major research institutions, and a seasoned management team. For more information visit http://www.pluristem.com, which is not part of this press release.

Safe Harbor Statement
This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995 and federal securities laws. For example, forward-looking statements are used in this press release when we discuss that our PLX-R18 cell product is a strong candidate for government procurement programs designed to protect the population in the case of exposure to dangerous levels of radiation or when we discuss our unique approach of injecting cells intramuscularly in order to enable the cells to remain in the body long enough to respond to signals from damaged tissues and adapt their therapeutic secretion profiles accordingly. These forward-looking statements and their implications are based on the current expectations of the management of Pluristem only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; we may encounter delays or obstacles in launching and/or successfully completing our clinical trials; our products may not be approved by regulatory agencies, our technology may not be validated as we progress further and our methods may not be accepted by the scientific community; we may be unable to retain or attract key employees whose knowledge is essential to the development of our products; unforeseen scientific difficulties may develop with our process; our products may wind up being more expensive than we anticipate; results in the laboratory may not translate to equally good results in real surgical settings; results of preclinical studies may not correlate with the results of human clinical trials; our patents may not be sufficient; our products may harm recipients; changes in legislation; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem's reports filed from time to time with the Securities and Exchange Commission.

For more information on this press release visit: http://www.releasewire.com/press-releases/release-3.htm

Haifa, Israel -- (SBWIRE) -- 02/11/2015 -- Pluristem Therapeutics Inc., a leading developer of placenta-based cell therapies, announced an important new finding from its Phase I/II clinical trial of PLacental eXpanded (PLX-PAD) cells in the treatment of muscle injury after total hip arthroplasty (THA). Data showed that six months after surgery the magnitude of improvement in muscle force of the contralateral (non-operated) gluteal muscle was approximately 40 times larger in patients treated with 150 million PLX-PAD cells than in those who received placebo, and the difference was statistically significant (19.4 vs 0.5 Nm, p=0.0114). Patients treated with 300 million PLX-PAD cells also showed a larger increase in muscle force than patients injected with placebo (9.48 vs 0.46 Nm, p=0.227).

Pluristem further announced positive twelve-month safety data from the trial. These findings follow the January 21, 2014 announcement that the study had met its primary efficacy and safety endpoints. The primary efficacy finding was the change in maximal voluntary isometric contraction force of the gluteal muscle in the operated leg at six months after total hip replacement. There was a large and statistically significant improvement in patients who were injected with 150 million cells versus those who received placebo (31.1 vs 5.4 Nm, p=0.0067).

The study's Senior Scientist, Dr. Tobias Winkler of the Center for Musculoskeletal Surgery & Julius Wolff Institute Berlin, Charite – Universitaetsmedizin Berlin, Germany, commented "I am impressed with the magnitude of the effect seen in the treated and contralateral legs. PLX cells demonstrated good safety and these newest findings suggest that intramuscular injection of PLX cells might potentially improve overall muscle functionality."

Zami Aberman, Chairman and CEO, stated "It is very encouraging to have a large and statistically significant effect of PLX-PAD cells on our primary efficacy endpoint and also the unexpected finding of increased muscle strength in the non-operated leg. Although additional confirmatory studies are needed, these findings support our previous studies in which we showed that injection of PLX-PAD cells into muscle generates a systemic effect. The findings also open up new possibilities for the potential use of PLX-PAD cells. Based on these results, we intend to continue to develop PLX-PAD in orthopedic indications including sports injuries and muscle trauma, as well as muscle wasting and rehabilitation."

The Phase I/II trial was a randomized, double blind, placebo controlled study conducted at the Orthopedic Clinic of the Charite – Universitaetsmedizin Berlin jointly with the Berlin-Brandenburg Center for Regenerative Therapies under the auspices of the Paul-Ehrlich-Institute (PEI), Germany's health authority. The injured muscle studied was the gluteus medius muscle, which is intentionally cut during total hip arthroplasty using the transgluteal approach. Post-operative healing is crucial for joint stability and function. The 20 patients in the study were randomized into three treatment groups. Each patient received injections in the gluteal muscle that had been traumatized during surgery. One group was treated with 150 million PLX-PAD cells (n=7), the second was administered 300 million PLX-PAD cells (n=6), and the third received placebo (n=7). The primary efficacy endpoint was clearly met and the safety profile at 12 months was excellent.

About Pluristem Therapeutics
Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapy products. The Company's patented PLX (PLacental eXpanded) cells release a cocktail of therapeutic proteins in response to inflammation, ischemia, hematological disorders, and radiation damage. PLX cells are grown using the Company's proprietary three-dimensional expansion technology and are an "off-the-shelf" product that requires no tissue matching prior to administration.

Pluristem has a strong intellectual property position, Company-owned, GMP-certified manufacturing and research facilities, strategic relationships with major research institutions, and a seasoned management team.

For more information visit http://www.pluristem.com or follow us on Twitter: https://twitter.com/Pluristem

Safe Harbor Statement
This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995 and federal securities laws. For example, forward-looking statements are used in this press release when we discuss the follow up results of our muscle injury clinical trial and the potential of PLX cells to improve overall muscle functionality, when we discuss how the new findings open new possibilities for the potential use of PLX-PAD cells and our intention to continue to develop PLX-PAD in orthopedic indications. These forward-looking statements and their implications are based on the current expectations of the management of Pluristem only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; we may encounter delays or obstacles in launching and/or successfully completing our clinical trials; our products may not be approved by regulatory agencies, our technology may not be validated as we progress further and our methods may not be accepted by the scientific community; we may be unable to retain or attract key employees whose knowledge is essential to the development of our products; unforeseen scientific difficulties may develop with our process; our products may wind up being more expensive than we anticipate; results in the laboratory may not translate to equally good results in real surgical settings; results of preclinical studies may not correlate with the results of human clinical trials; our patents may not be sufficient; our products may harm recipients; changes in legislation; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem's reports filed from time to time with the Securities and Exchange Commission.

For more information on this press release visit: http://www.releasewire.com/press-releases/release-3.htm