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World First: Islet Transplant Into Man Using Sernova's Cell Pouch(TM) for Treatment of Diabetes

Thu, 08/16/2012 - 6:03am
The Associated Press

Sernova Corp. ("Sernova" or the "Company") (TSX VENTURE: SVA) and the University of Alberta today announced the treatment of the first patient with insulin-producing islets transplanted into Sernova's Cell Pouch™ in a Phase I/II clinical study to treat Type-1 diabetes led by Dr. James Shapiro, Professor of Surgery and Medicine, University of Alberta and Director, Clinical Islet Transplant Program. Sernova will host a conference call at 9 a.m. EDT, today, Aug. 16, 2012, to discuss the company's clinical and business developments.

"The Sernova Cell Pouch™ implantation and transplantation processes are simple, rapid minimally invasive procedures, conducted on an outpatient basis under local anesthesia," said Dr. Shapiro. "This offers substantial potential benefit over the Edmonton protocol and the ease of use provides an opportunity for the Cell Pouch™ to become the standard of care for people with diabetes if it proves to be effective in these initial trials."

The objectives of the human clinical trial are to assess the safety and efficacy of the Cell Pouch™ with transplanted islets in up to 20 patients with Type-1 diabetes. The study is sponsored by Sernova Corp and the University of Alberta. In the study, patients who have met the enrolment criteria and provided informed consent are implanted with the Cell Pouch™ prior to transplantation of donor human islets. To prevent islet graft rejection, patients in this study are treated with the best in class standard of care immunosuppression protocol. Interim analysis of the data from this clinical study is expected during H1, 2013. Further information on the trial may be found at www.clinicaltrials.gov (Identifier: NCT01652911).

"The Cell Pouch™ is a breakthrough technology which has the potential to significantly improve the lives of people living with chronic diseases such as diabetes," said Philip Toleikis, Ph.D., President and CEO of Sernova Corp. "Supported by Sernova's strong preclinical results, the treatment of patients in this clinical trial of the Cell Pouch™ further advances our vision for the future of providing millions of diabetic patients with the Cell Pouch™, and an unlimited source of insulin-producing cells protected with a local anti-rejection technology."

Conference Call

The conference call to discuss Sernova's clinical and business developments may be accessed by dialing 866-532-1852 for domestic callers and +443-842-7644 for international callers. Please specify to the operator that you would like to join the "Sernova conference call" or "conference ID: 21155379."

About The Cell Pouch™

The Cell Pouch™ is a proprietary medical device that, following subcutaneous implantation, incorporates with tissue and microvessels forming a natural environment for transplantation of therapeutic cells. Multiple preclinical studies demonstrated the Cell Pouch™ to provide a safe environment for transplantation, as well as long-term efficacy of therapeutic cells. Sernova's goals for the Cell Pouch™ for diabetes include providing a safe and natural site for islets to significantly increase the number of patients currently treated with intraportal delivery of donor islets and to provide a safe environment for virtually unlimited available sources of insulin-secreting cells such as insulin-producing stem cells and xenogeneic cells. This vision combined with local anti-rejection protection of the cells could enable millions of patients with insulin-dependent diabetes to be treated without limitation to availability of cells.

About Sernova

Sernova Corp. is a clinical stage health-sciences company focused on commercializing medical technologies. Sernova is currently developing a platform technology for a number of serious disease indications, starting with a novel treatment for insulin-dependent diabetes, using the novel Cell Pouch System™ for transplantation and long-term survival of therapeutic cells and its patented Sertolin™ cell technology which can provide an immune-protected local environment for therapeutic cells.

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. 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.

Contacts:
Sernova Corp.
Philip Toleikis, Ph.D.
President and CEO
(604) 961-2939
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