Clinical Trial SuccessSernova continues to stand alone as a company in the space to have reported positive patient outcomes from a study that combines donor islets transplanted into an implantable device in patients with T1D.
Market OpportunitySubmission of an IND application for the Cell Pouch device in hypothyroidism could address a significant market opportunity estimated at approximately $2.2 billion.
Regulatory ProgressEncouragement by the Phase 1/2's progress includes a recent green light from the trial's DSMB, with anticipation for data that should provide welcome guidance related to the design, initiation, and timeline of a possible Phase 3 pivotal study.