Sernova Biotherapeutics, Inc. (SVA.TO), a regenerative medicine company, announced Wednesday that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation for autologous islet transplantation (AIT) for the prevention of diabetes due to total pancreatectomy.
Sernovas proprietary Cell Pouch Bio-hybrid Organ is designed to support the engraftment and long-term function of transplanted therapeutic cells.
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.
Sernova is preparing to initiate a clinical trial with autologous islet transplantation that involves isolating the patients own insulin-producing islet cells from the removed pancreas, placing them in Sernovas Cell Pouch and transplanting them back into the patient, negating the need for immune suppression.
The goal of the procedure is preservation of insulin production and prevention of post-surgical diabetes and its associated complex management and co-morbidities.
For comments and feedback contact: editorial@rttnews.com
June 12, 2026 17:14 ET Major central bank action was the focus this week in economic news. The European Central Bank became the first major central bank to move in response to the rising inflationary pressures in the backdrop of the conflict in the Middle East. In North America, the U.S. inflation and trade data as well as Canada’s central bank decision gained attention. The Chinese trade data was the main news in Asia.