Harvard Apparatus Regenerative Technology, Inc.

Regenerative Biotech is a clinical-stage biotechnology company developing regenerative medicine treatments for gastrointestinal system and other organ disorders caused by cancer, trauma, or birth defects. The company's technology is a proprietary cell-therapy platform that uses a patient's own stem cells to regenerate and restore function to damaged organs. This approach aims to eliminate the need for human donor or animal transplants, the sacrificing of other patient organs, or permanent artificial implants. The technology involves retrieving mesenchymal stem cells from a patient's abdominal adipose tissue via biopsy before surgery. These stem cells are then isolated, expanded, and cultured on a tubular scaffold made from thin polyurethane fibers. The scaffold is incubated in a customized bioreactor, allowing stem cells to grow and adhere to the fibers. The finished graft is surgically implanted to replace the resected portion of the damaged organ. Several weeks post-surgery, once a conduit is established, the implanted scaffold is removed endoscopically, leaving no permanent artificial implant. Regenerative Biotech conducted the world's first successful esophagus regeneration in a cancer patient in August 2017. This surgery, performed by Dr. Dennis Wigle at the Mayo Clinic, involved reconstructing the esophagus after a large chest tumor removal. Results were published in the Journal of Thoracic Oncology Clinical and Research Reports in August 2021, demonstrating successful regeneration of esophageal tissue, including the mucosal lining, to restore integrity, continuity, and functionality using Harvard Apparatus Regenerative Technology, Inc.'s (HRGN's) technology. This first-in-human procedure and over 50 preclinical procedures in pigs form the basis for further development.