London, ON -- (SBWIRE) -- 12/14/2017 -- Sernova Corp., a clinical stage company developing regenerative medicine technologies for the long-term treatment of diseases including diabetes and hemophilia, is pleased to announce it has received US Food and Drug Administration (FDA) notice of allowance for its IND for a new human clinical trial with the Cell Pouch System (TM) (CPS) in the United States.

Sernova plans to initiate the new clinical trial under this US IND to investigate the Cell Pouch for treatment of type 1 diabetes (T1D) in individuals with hypoglycemia unawareness. The trial is a Phase I/II prospective single arm study of islets transplanted into the subcutaneously implanted Cell Pouch. The primary objective of the study is to demonstrate safety and tolerability of islet transplantation into the Cell Pouch and the secondary objective is to assess efficacy through a series of defined measures.

JDRF has previously committed to provide Sernova up to $2.45 million USD to support the clinical trial.

"Hypoglycemia unawareness is a serious consequence of type 1 diabetes," said Derek Rapp, President & CEO, JDRF International. "We are excited to see progress in this and other potentially life-saving JDRF-funded research, which could help prevent people with hypoglycemia unawareness from experiencing dangerous lows, as we strive to achieve our vision of a world without T1D."

"We are extremely enthusiastic about the promise of Sernova's regenerative medicine platform to provide a new therapeutic option for diabetes patients with hypoglycemia unawareness. We believe Sernova's multiple advancing cell based therapies have the potential to deliver significant improvement in the quality of life of patients suffering from diabetes and other debilitating diseases," said Dr. Philip Toleikis, Sernova's president & CEO.

About The Trial
The study is a Phase I/II single site, single arm, Company sponsored trial. Following approval by the Institutional Review Board, patients with hypoglycemia unawareness will be enrolled into the study under informed consent. Patients will then be implanted with the Cell Pouch including sentinel devices. Following vascularized tissue development, a dose of purified islets under strict release criteria will be transplanted into the Cell Pouch and patients followed for safety and efficacy measures for approximately six months. At this point a decision will be made whether to transplant a second islet dose with subsequent safety and efficacy follow up. Patients will then be further followed for one year.

"Sernova's FDA clearance to commence human clinical trials in the United States is an exciting step forward in diabetes research, initially focused to reduce the risk of hypoglycemia unawareness, a complication in which a patient is unaware of a deep drop in blood sugar that can have life threatening consequences," said Dave Prowten, President and CEO of JDRF Canada. "This is also an example of the international collaboration fostered by JDRF-funded projects to accelerate transformative research to benefit the T1D community," added Mr. Prowten.

About Sernova's Cell Pouch
The Cell Pouch is a novel, proprietary, scalable, implantable macroencapsulation device for the long-term survival and function of therapeutic cells (donor, stem cell derived cells and xenogeneic cells) which then release proteins and/or hormones as required to treat disease. The device is designed upon implantation to incorporate with tissue, forming highly vascularized tissue chambers for the transplantation and function of therapeutic cells. The device with therapeutic cells has been shown to provide long term safety and efficacy in small and large animal models of diabetes and has been proven to provide a biologically compatible environment for insulin producing cells in humans.

About Diabetes
T1D is a life-threatening disease in which the body's immune system mistakenly attacks and kills the pancreatic cells that produce insulin—a hormone that is essential for life because of its role to help the body use glucose. The existing standard of care for patients with TID is suboptimal. To date, there is no cure for T1D, and people living with the disease are dependent on exogenous insulin therapy to help keep their blood-sugar levels from spiking too high, which can lead to long-term complications such as kidney and heart diseases or an acute, potentially deadly health crisis. Present-day insulin therapy is, however, an imperfect treatment method that requires people with T1D to carefully monitor their blood sugar throughout the day and take multiple, calculated doses of insulin based on food intake, exercise, stress, illness and other factors. A miscalculation or unexpected variable leading to high or low blood sugar episodes are daily threats, and only a third of people with T1D achieve their long-term blood glucose targets, placing them at risk for T1D-related health complications.

About Sernova Corp
Sernova Corp is developing disruptive regenerative medical technologies using a medical device and immune protected therapeutic cells to improve the treatment and quality of life of people with chronic metabolic diseases such as insulin-dependent diabetes, blood disorders including hemophilia, and other diseases treated through replacement of proteins or hormones missing or in short supply within the body. For more information, please visit http://www.sernova.com.

About JDRF
JDRF is the leading global organization funding type 1 diabetes (T1D) research. Our mission is to accelerate life-changing breakthroughs to cure, prevent and treat T1D and its complications. To accomplish this, JDRF has invested nearly $2 billion in research funding since our inception. We are an organization built on a grassroots model of people connecting in their local communities, collaborating regionally for efficiency and broader fundraising impact, and uniting on a national stage to pool resources, passion, and energy. We collaborate with academic institutions, policymakers, and corporate and industry partners to develop and deliver a pipeline of innovative therapies to people living with T1D. Our staff and volunteers throughout the United States and our six international affiliates are dedicated to advocacy, community engagement and our vision of a world without T1D. For more information, please visit jdrf.org or follow us on Twitter: @JDRF.

Forward Looking Information
This release may contain forward-looking statements. Forward-looking statements are statements that are not historical facts and are generally, but not always, identified by the words "expects", "plans", "anticipates", "believes", "intends", "estimates", "projects", "potential" and similar expressions, or that events or conditions "will", "would", "may", "could" or "should" occur. Although Sernova believes the expectations expressed in such forward-looking statements are based on reasonable assumptions, such statements are not guarantees of future performance and actual results may differ materially from those in forward looking statements. Forward-looking statements, are based on the beliefs, estimates and opinions of Sernova's management on the date such statements were made, which include our belief about the conduct and outcome of clinical trials and that Sernova will be able to raise additional capital to fund its clinical programs including its planned US FDA clinical trial. Sernova expressly disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information, future events or otherwise.

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Sernova reports on active pharma collaboration, upcoming clinical trial and fertile BD pipeline to advance scale of diabetes and hemophilia programs

London, ON -- (SBWIRE) -- 06/06/2017 -- Sernova Corp., a clinical stage company developing medical technologies for the long-term treatment of chronic metabolic diseases including diabetes, blood disorders such as hemophilia and other diseases, today provided a brief company outlook on corporate and clinical developments.

"During the first half of 2017, we have achieved significant progress in advancing our diabetes and hemophilia programs and have continued to build our intellectual property portfolio reaching new milestones in the development of our global patent portfolio, including coverage of leading indications in major markets," stated President and CEO, Dr. Philip Toleikis. "We look forward to advancing our ongoing collaboration with a leading, global pharmaceutical company and are confident in our ability to execute on multiple fronts including our upcoming U.S. clinical study earmarked for the second half of 2017, and additional notable collaborations to bring the most innovative and effective regenerative medicine combination products to the forefront," he added.

Our product development program plans for 2017 includes the following:

- Commence a Phase I/II clinical study of our Cell Pouch™ in the United States to support our positive results in diabetic patients with hypoglycemia unawareness using human donor islets to further develop the safety and efficacy of our regenerative medicine combination product;

- As a member of the HemAcure Consortium who will continue development of IND-enabling cell production and preclinical studies for personalized medicine treatment of hemophilia A consisting of factor VIII releasing therapeutic cells transplanted within Sernova's implanted prevascularized Cell Pouch. (The HemAcure Consortium is the name of the consortium developing a product for hemophilia A);

- Conduct IND-enabling preclinical studies for treatment of hypo-thyroid disease consisting of thyroid hormone releasing tissue transplanted within Sernova's Cell Pouch;

- Production of human stem cell derived cells for diabetes and proof of principle assessment of these differentiated human stem cells for their safety and efficacy within Sernova's Cell Pouch for the treatment of insulin-dependent diabetes;

- Development of novel local immune protection technologies within the Cell Pouch, to further develop and advance Sernova's therapeutic vision for diabetes of a product consisting of locally immune protected therapeutic cells within the Cell Pouch; and,

- Continue to collaborate with pharmaceutical companies to assess safety and efficacy of our combined technologies in preclinical studies for potential negotiation of a licensing arrangement and commercial development partnership for our diabetes and hemophilia programs.

- As of January 31, 2017, Sernova had $5.5 million in cash, cash equivalents, and bank deposits. The company's net cash used for operating activities was $0.6 million for this quarter. Notably, Management recently purchased a total of 2,044,000 shares as reflected on http://www.sedar.ca.

About Sernova
Sernova Corp is a clinical stage regenerative medicine Company developing medical technologies for the treatment of chronic debilitating metabolic diseases such as diabetes, blood disorders including hemophilia, and other diseases treated through replacement of proteins or hormones missing or in short supply within the body. Sernova is developing its Cell Pouch System, an implantable medical device and therapeutic cells (donor, xenogeneic or stem cell derived therapeutic cells). Sernova's Cell Pouch System, following implantation, is thought to form a vascularized tissue environment for the housing and long-term survival and function of therapeutic cells. It is anticipated that these therapeutic cells may release necessary proteins or hormones missing from the body to treat chronic diseases as an alternative to daily administration of drugs. HemAcure is the name of the consortium developing a product for hemophilia A. This project has received funding from the European Union's Horizon 2020 research and innovation program under grant agreement No 667421.

For more information, visit http://www.sernova.com.

Forward-Looking Information
This release may contain forward-looking statements. Forward-looking statements are statements that are not historical facts and are generally, but not always, identified by the words "expects", "plans", "anticipates", "believes", "intends", "estimates", "projects", "potential" and similar expressions, or that events or conditions "will", "would", "may", "could" or "should" occur. Although Sernova believes the expectations expressed in such forward-looking statements are based on reasonable assumptions, such statements are not guarantees of future performance and actual results may differ materially from those in forward looking statements. Forward-looking statements, which include our beliefs about the functionality of the Cell Pouch and our cell technologies, clinical trials, collaborations and therapeutic indications are based on the beliefs, estimates and opinions of Sernova's management on the date such statements were made. Sernova expressly disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information, future events or otherwise.

Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

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Sernova provides update on its plans for IND filing with US FDA

London, ON -- (SBWIRE) -- 11/02/2016 -- Sernova Corp., a clinical stage company developing disruptive regenerative medicine technologies for the long-term treatment of chronic diseases including diabetes and hemophilia and CTI Clinical Trial and Consulting Services (CTI), are pleased to announce their collaboration on regulatory matters respecting Sernova's Cell Pouch System(TM), a novel implantable and scalable medical device that when combined with therapeutic cells, may provide a convenient, safe and effective long-term therapeutic option for patients with chronic diseases such as insulin-dependent diabetes who seek to improve their quality of life.

CTI as an expert in cell therapy, and immunology among other life-changing therapies in critically and chronically ill patients is supporting Sernova's clinical trial regulatory processes including submission of Sernova's regulatory package with the FDA for the recently announced JDRF supported clinical trial in patients with insulin-dependent diabetes. In this regard CTI has been a part of more than 100 drug and device approvals and has proven success in advancing numerous international drug and device applications.

"We are really enthused to be collaborating with Sernova on filing their Investigational New Drug (IND) application with the US FDA," stated Timothy Schroeder, CTI Founder and CEO. "Sernova is an innovative organization with a regenerative medicine program that could change the standard of care for many chronically ill patients."

"We are pleased to have CTI supporting Sernova's clinical trial regulatory processes as they bring proven expertise in medical device and regenerative medicine technologies targeting chronically ill patient populations," remarked Dr. Philip Toleikis, Sernova President and CEO. "We at Sernova see this collaboration as the beginning of a long-term relationship in supporting the clinical development progression of our therapeutic cell and device applications. With their clinical trial experience across six continents in bringing research sites, patients, and sponsors together, CTI will be an invaluable member of Sernova's development team."

In further developments, Sernova also announced that it has retained Mackie Research Capital Corporation ("Mackie") to provide market making services to the company in compliance with the guidelines of the TSX Venture Exchange (the "TSXV"). Mackie will trade shares of Sernova on the TSXV for the purposes of maintaining an orderly market and improving the liquidity of Sernova's shares. In consideration for their services, Sernova has agreed to pay Mackie $3,000 per month for a period of 12 months which is extendable. The agreement may be terminated at any time by Sernova or Mackie. There are no performance factors contained in the agreement and Mackie will not receive any shares or options from Sernova as compensation for the services. Sernova and Mackie are unrelated and unaffiliated entities, but Mackie and/or its clients may have an interest, directly or indirectly, in the securities of Sernova. The agreement is subject to approval of the TSXV.

About Sernova
Sernova Corp is a clinical stage regenerative medicine Company developing medical technologies for the treatment of chronic debilitating metabolic diseases such as diabetes, blood disorders including hemophilia, and other diseases treated through replacement of proteins or hormones missing or in short supply within the body. Sernova is developing its Cell Pouch System, an implantable medical device and therapeutic cells (donor, xenogeneic or stem cell derived therapeutic cells). Sernova's Cell Pouch System, following implantation, is thought to form a vascularized tissue environment for the housing and long-term survival and function of therapeutic cells. It is anticipated that these therapeutic cells may release necessary proteins or hormones missing from the body to treat chronic diseases as an alternative to daily administration of drugs.

For more information visit http://www.sernova.com

About CTI Clinical Trial and Consulting Services
CTI Clinical Trial and Consulting Services is a global, privately held, full-service contract research organization (CRO), delivering a complete spectrum of clinical trial and consulting services throughout the lifecycle of development, from concept to commercialization. CTI's focused therapeutic approach provides pharmaceutical, biotechnology, and medical device firms with clinical and disease area expertise in rare diseases, regenerative medicine/gene therapy, immunology, transplantation, and other disease populations. CTI has a passion for helping life-changing therapies succeed in chronically and critically ill patient populations. With clinical trial experience across 6 continents, CTI partners with research sites, patients, and sponsors to fulfill unmet medical needs. CTI is headquartered in Cincinnati, OH, with operations across North America, Europe, Latin America, and Asia-Pacific.

For more information visit http://www.ctifacts.com

About Mackie Research Capital Corporation
Mackie is one of Canada's largest independent full service investment firms, and proudly traces its roots back to 1921. Mackie is privately owned by many of its 300 employees. As a fully integrated national investment dealer, Mackie offers a full complement of capital markets and wealth management services to private clients, institutions and growth companies.

For more information visit http://www.mackieresearch.com

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CCRM to establish, optimize and validate methods for producing Sernova’s transformative cell- based therapies for Type-1 diabetes

London, ON -- (SBWIRE) -- 01/27/2016 -- Sernova Corp., a clinical stage company developing medical technologies for the long-term treatment of chronic diseases including diabetes and hemophilia, announced today it has entered into a service agreement with the Centre for Commercialization of Regenerative Medicine (CCRM) to establish, optimize and validate Sernova's licensed technology for creating stem cell derived therapeutic cells that produce insulin and are glucose responsive.

"Sernova's Cell Pouch System(TM) is a novel, preclinically validated and clinically tested platform for multiple types of therapeutic cells, including human islets," said Dr. Philip Toleikis, President and CEO Sernova Corp. "Sernova's CCRM partnership with CCRM's expertise in developing production processes for cellular therapies is an important step in Sernova's plan to commercialize an unlimited supply of glucose responsive, insulin producing cells for the Cell Pouch System. Sernova continues to seek out and evaluate optimal unlimited cell sources both internally developed and through corporate partnerships involving stem cell derived, and xenogeneic cell sources. Our manufacturing partnership with CCRM will provide the ability for the scale up production required to ensure successful commercialization of Sernova's cellular therapies for diabetes," added Dr. Philip Toleikis.CCRM is a unique not-for-profit group that is solely focused on developing and commercializing cell therapy and regenerative medicine technologies. Sernova is a member of CCRM's industry consortium, a group of nearly 50 companies formed to address bottlenecks in cell therapy and regenerative medicine product pipelines by enabling industry to engage with CCRM's broad network of researchers and institutions. Industry consortium members represent key sectors in regenerative medicine – therapeutics, devices, reagents and cells as tools – and tremendous industry experience.

"As a member of CCRM's industry consortium, Sernova is a valued partner in our quest to develop global breakthroughs in regenerative medicine," remarked Michael May, President and CEO of CCRM. "Commercializing a regenerative medicine therapy for diabetes – the goal for Sernova and CCRM – has the potential to disrupt and transform current standard of treatment. We are excited about the timing of this partnership," added Dr. May, "as it is our expectation that projects like this become candidates for the new advanced manufacturing initiative that we announced during a visit by Prime Minister Trudeau in mid-January.

About Sernova
Sernova Corp. is a clinical stage regenerative medicine Company developing medical technologies for the treatment of chronic debilitating metabolic diseases such as diabetes, blood disorders including hemophilia, and other diseases treated through replacement of proteins or hormones missing or in short supply within the body. Sernova is developing the Cell Pouch System, an implantable medical device and therapeutic cells (donor, xenogeneic or stem cell derived therapeutic cells) which then release proteins and/or hormones as required.

Forward Looking Information
This release may contain forward-looking statements. Forward-looking statements are statements that are not historical facts and are generally, but not always, identified by the words "expects", "plans", "anticipates", "believes", "intends", "estimates", "projects", "potential" and similar expressions, or that events or conditions "will", "would", "may", "could" or "should" occur. Although Sernova believes the expectations expressed in such forward-looking statements are based on reasonable assumptions, such statements are not guarantees of future performance and actual results may differ materially from those in forward looking statements. Forward-looking statements, which include our beliefs about the functionality of the Cell Pouch System and our cell technologies, and manufacturing capabilities of CCRM are based on the beliefs, estimates and opinions of Sernova's management on the date such statements were made. Sernova expressly disclaims any intention or obligation to update or revise any forward- looking statements whether as a result of new information, future events or otherwise.

Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

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

London, ON -- (SBWIRE) -- 12/30/2015 -- People with hemophilia have prolonged abnormal bleeding as a result of trauma. Hemophilia A, also called factor VIII (FVIII) deficiency, is the most common form of the genetic disorder caused by missing or defective blood clotting protein called factor VIII. Severe hemophilia occurs in about 60% of cases where the deficiency of Factor VIII is less than 1% of normal blood concentration. While it is passed down from parents to children, about 1/3 of cases are caused by a spontaneous change in the gene.

A new $8.5M (CAD) research grant award by the European commission via its Horizon 2020 program aims to address patients affected by this condition. The funds are earmarked to the HemAcure consortium with the goal to bring treatment of hemophilia A, also called factor VIII (FVIII) deficiency, the most common form of hemophilia A into the clinic for human trials. The genetic disorder is caused by missing or defective factor VIII, a blood clotting protein. The consortium, consisting of Canadian-based Sernova Corp. and five European academic and private partners, will be working jointly to advance development of a GMP clinical grade Factor VIII releasing therapeutic cell product via Sernova's signature technology called the Cell Pouch™ for the treatment of severe hemophilia A.

Delivering the patient's own cells to Treat Hemophilia A via Cell Pouch System

The therapy being developed by the HemAcure consortium is expected to be highly disruptive to the current standard of care treatments for hemophilia A. The therapeutic uses the patient's own cells which have been corrected for the factor VIII gene. Center to the therapy is Sernova's Cell Pouch System™, a novel implantable and scalable medical device which forms a natural environment in the body for the housing and long-term survival and function of therapeutic cells. These therapeutic cells release necessary proteins or hormones missing from the body to treat chronic diseases as an alternative to daily administration of drugs.

The patients corrected cells placed in the implanted Cell Pouch™ will release factor VIII on a continual basis at a rate that would be expected to significantly reduce disease-associated hemorrhaging and joint damage. The constant delivery of factor VIII is also expected to reduce or eliminate the need for multiple weekly infusions which is the current standard of care using plasma-derived or recombinant, genetically engineered factor VIII for the prophylactic treatment of hemophilia A.

According to Dr. David Lillicrap, MD, FRCPC Professor Department of Pathology and Molecular Medicine Queens University, Canada Research Chair in Molecular Hemostasis and member of the HemAcure Scientific Advisory Board. "The therapeutic potential to have a constant release of factor VIII from a Hemophilia A patient's own genetically corrected cells placed within the implanted Cell Pouch™ would be a very significant advance in the treatment of hemophilia A. Sernova's Cell Pouch™ with its vascularized tissue lined chambers for therapeutic cells, which has already been proven for islet safety and survival in human clinical assessment of diabetes, is an ideal, fully scalable first-in-class medical device suitable for the potential treatment of hemophilia," said Dr. Lillicrap.

Global Problem of Hemophilia

According to the US Centers for Disease Control and Prevention, hemophilia occurs in about 1 in 5,000 births. If the prolonged bleeding occurs in the brain of a person with hemophilia, it can be fatal. Prolonged bleeding in joints can cause inflammatory responses and permanent joint damage. Approximately 20,000 people in the United States and 10,000 in Europe have the moderate or severe form of hemophilia A, as well as approximately 2,500 in Canada. All races and ethnic groups are equally affected by hemophilia A. Though there is no cure for the disease, it can be controlled with regular infusions of recombinant clotting Factor VIII.

The condition has an economical toll on patients. Annual costs for the treatment of the disease for each patient may range from $60,000 to $260,000 US for a total cost of between $2-5B per year in North America and Europe. The current standard-of-care involves regular infusions of factor VIII, which achieves normal factor VIII blood levels for only a few hours at a time. The product being developed by the HemAcure consortium will seek to provide constant delivery of Factor VIII to normalize blood levels in an effort to significantly improve the quality of life of patients suffering from hemophilia A.

According to Delfina Siroen, Sr. Director of Sernova's Research and Development team. "In a very short time, Sernova's hemophilia program has achieved great strides and the addition of this European grant and team will ensure the best possible outcome for this program to the clinic." The preliminary preclinical proof of concept data used as a basis to support the foundation of the grant was generated in a collaborative agreement between Medicyte GmbH under the FP7 ReLiver project (No. 304961) and Sernova Corp where cryopreserved cells with the ex vivo inserted corrected gene for factor VIII were successfully shipped and assessed in Sernova's Cell Pouch™ at its headquarters in Canada.

About Horizon 2020 Program
Horizon 2020 is the biggest EU Research and Innovation program ever with nearly EUR80 billion of funding available over seven years (2014 to 2020). It promises more breakthroughs, discoveries and world-firsts by taking great ideas from the lab to the market. The project is funded as part of societal challenges "personalizing health and care" in a specific call about innovative treatments and technologies. New therapies, such as gene or cell therapies, often require technological innovation in the form of development of specific component tools and techniques such as isolation and multiplication of a cell or development of a scaffold, delivery of the therapy to the patient and for following-up the effect of the therapy in the patient. In particular, achieving therapeutic scale production and GMP standards at reasonable cost is often underestimated. The European Union aims to improve the development of advanced methods and devices for targeted and controlled delivery, and to bring these innovative treatments to the patient.

About HemAcure
HemAcure is the name of the consortium developing a product for hemophilia A. This project has received funding from the European Union's Horizon 2020 research and innovation program under grant agreement No. 667421. The consortium members include the University Hospital Wurzburg, Integrierte Management Systeme IMS e.K., Universita del Piemonte Orientale "Amedeo Avogadro," Loughborough University, GABO:mi Gesellschaft fuer Ablauforganisation: milliarium mbH & Co. and Sernova Corp. The main objective of the HemAcure project is to develop and refine the tools and technologies for a novel ex vivo prepared cell based therapy within Sernova's prevascularized Cell Pouch to treat this bleeding disorder that should ultimately lead to improved quality of life of the patients.

About Sernova
Sernova Corp. is a Canadian clinical stage regenerative medicine Company developing medical technologies for the treatment of chronic debilitating metabolic diseases such as diabetes, blood disorders including hemophilia and other diseases treated through replacement of proteins or hormones missing or in short supply within the body. Sernova is developing the Cell Pouch™, an implantable medical device and therapeutic cells (donor, xenogeneic or stem cell derived therapeutic cells) which then release proteins and/or hormones as required.

For more information, log on to http://www.sernova.com

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