Harvard Apparatus Regenerative Technology (HRGN) has announced a strategic collaboration with the Capital Institute of Pediatrics in Beijing, China, to develop innovative treatments for Esophageal Atresia (EA) using HRGN's Cellspan Esophageal Implant (CEI). The partnership aims to conduct Investigator Initiated Trials (IITs) to evaluate the safety and efficacy of CEI in treating EA, potentially accelerating regulatory approval and improving patient outcomes.
Clinical Focus and Objectives
The collaboration will primarily focus on clinical research, product development, and expanding patient access to life-saving treatments. Dr. Lishuang Ma, a chief surgeon at the Children’s hospital Capital Institute of Pediatrics, expressed enthusiasm about leveraging regenerative medicine technology to address Esophageal Atresia, emphasizing the aim to improve patient outcomes and bring hope to affected families.
Cellspan Esophageal Implant (CEI) Potential
Jerry He, HRGN’s Chief Executive Officer, Director and Chairman, highlighted the potential of the CEI product to improve the quality of life for children with Esophageal Atresia. The partnership is expected to accelerate the delivery of this innovation to those who need it most.
About Esophageal Atresia
Esophageal Atresia is a rare birth defect where the esophagus does not form properly. This condition prevents the normal passage of food from the mouth to the stomach, often requiring surgical intervention shortly after birth. Current treatments can involve multiple surgeries and long-term management, highlighting the need for innovative solutions like the CEI.
HRGN's Regenerative Technology
HRGN is a clinical-stage biotechnology company focused on regenerative medicine treatments for gastrointestinal disorders and other organ damage resulting from cancer, trauma, or birth defects. Their cell-therapy platform uses a patient’s own stem cells to regenerate and restore function to damaged organs, eliminating the need for donor organs or artificial implants. In August 2017, HRGN successfully regenerated the esophagus in a patient with esophageal cancer, demonstrating the potential of their technology to restore the integrity and functionality of the esophageal tube.
Regulatory and Market Exclusivity
HRGN holds 13 issued U.S. patents, 2 issued in China, 1 issued in Japan, 2 issued in Europe, and orphan-drug designations that can provide market exclusivity in the US and European markets upon regulatory approval.
