Harvard Apparatus Regenerative Technology, Inc. (HRGN), a biotechnology company focused on organ regeneration technology, has secured approximately $5 million in funding from a new investor. This investment, obtained through a private placement of shares, will be used to accelerate the clinical development of HRGN’s lead product candidate, the HRGN Esophageal Implant (BEI). The BEI is designed to repair esophageal damage resulting from cancer or injury.
The FDA has granted approval for a Phase 1 and Phase 2 clinical trial involving ten adult patients. This trial aims to evaluate the safety and efficacy of the HRGN Esophageal Implant in repairing damaged esophageal tissue. The study will provide critical data on the implant's performance and potential benefits for patients with severe esophageal conditions.
Following the demonstration of safety in adult subjects, HRGN plans to seek FDA approval to expand the trial to include pediatric patients with esophageal birth defects. This expansion could potentially address a significant unmet medical need in children with congenital esophageal abnormalities. The company believes its regenerative technology could offer a novel therapeutic approach for these young patients.
