Sernova (SNA.V) Secures FDA Orphan Drug Status for Islet Transplantation System

Sernova Corp. (SNA.V) announced June 17, 2026, that the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation for its Cell Pouch System. This designation applies to the autologous islet transplantation in patients undergoing total pancreatectomy with autoislet transplantation (TPIAT) for chronic pancreatitis. The Orphan Drug Designation provides significant regulatory and financial incentives for Sernova. These benefits include tax credits for clinical research, exemption from FDA user fees, and a potential seven years of market exclusivity upon product approval. The Cell Pouch System aims to create a protective environment for transplanted cells, offering a potential therapeutic option for individuals suffering from severe chronic pancreatitis who require TPIAT to manage diabetes development.