Sernova Corp. announced that the first two patients in the second cohort of its active U.S. Phase 1/2 clinical trial for the treatment of type 1 diabetes (“T1D”) and hypoglycemia unawareness (the “T1D Study”) received their first islet transplant into the higher capacity 10-channel Cell Pouch™. These patients will be monitored for safety and efficacy for three months after which a second dose of islets is anticipated to be transplanted in accordance with the protocol.

Additionally, a third enrolled patient has now been implanted with the higher capacity Cell Pouch and awaits islet transplant in the coming weeks. In November 2022, the Company announced the addition of a second cohort and protocol amendment for its T1D Study. The amended protocol includes a second cohort of up to seven patients for the transplant of islets into Sernova's higher-capacity Cell Pouch.

Enrollment for the new second cohort has occurred rapidly with approximately half of the patients already completed. The amended protocol to use the 10-channel Cell Pouch enables optimized dosing and shorter efficacy evaluation periods to ultimately decrease time to key efficacy endpoints. These endpoints include survival of transplanted islet cells, reduction of severe hypoglycemic episodes, and changes in HbA1c, serum C- peptide production, and insulin requirements.

The higher capacity 10-channel Cell Pouch provides greater than 50% more capacity relative to the Cell Pouches used for the T1D Study's first cohort.