Clinical Trial ProgressDeep responses in diabetes patients position the technology for potential commercial success, particularly as competitors exit the space, and the impressive response rates and durability support Sernova's strategy and justify further investigation.
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 MilestonesEncouragement 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.