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Sernova's Autologous Islet Transplantation Gets Orphan Drug Designation For Type 3c Diabetes Prevention

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Sernova (SVA.TO) has been granted U.S. FDA orphan drug designation for its autologous islet transplantation for the prevention of diabetes due to total pancreatectomy, the company said Wednesday.

The designation offers Sernova the potential for seven years of market exclusivity in the United States upon regulatory approval, plus other development incentives, including tax credits for qualified clinical testing, waiver of certain FDA user fees, if applicable criteria are met.

Chronic pancreatitis causes debilitating pain and can lead to a total pancreatectomy, resulting in the patient developing type 3c diabetes (T3cD) that is treated in the same way as type 1 diabetes with the same long-term co-morbidities, the company said.

"Patients who require total pancreatectomy face a life-changing outcome: the immediate loss of pancreatic endocrine function and the risk of complex, insulin-dependent diabetes," said Melena Bellin, a member of Sernova's Clinical Advisory Board. "Autologous islet transplantation in Sernova's Cell Pouch has the potential to preserve a patient's own insulin-producing cells following pancreatic surgery, without the use of immune suppressing therapies."

Sernova shares fell $0.015, to $0.14 on Tuesday on the Toronto Stock Exchange.

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