EpiBone, Inc. Receives FDA Approval to Initiate Phase 1/2 First-in-Human Trial of EB-CMF for Craniofacial Bone Reconstruction

NEW YORK, May 22, 2019 /PRNewswire/ -- EpiBone, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application for a Phase 1/2 clinical trial. The company’s lead bone product, EpiBone-Craniomaxillofacial (EB-CMF), has the potential to become a novel therapy for treating continuity defects of the mandibular ramus, a critical component of the mandible that connects to the masticatory muscles.

EB-CMF is a living, anatomically accurate bone graft made from the patient’s own adipose-derived stem cells. This eliminates the need to harvest bone from the patient, reducing pain, surgical complexity, and hospital stay, while enabling precise matching to the defect.

Dr. Nina Tandon, CEO and Co-Founder of EpiBone, commented, “We are proud of our IND-enabling work and thank our entire team, as well as all investors, advisors, and supporters in the field, who have made this possible. Our technology has the potential to transform the field of bone reconstruction as we know it. Our goal is to help as many patients as possible restore optimal form and function in the most seamless, durable, and natural way.”

The Phase 1/2 clinical study will directly evaluate the application of the EB-CMF product in patients with mandibular ramus continuity defects requiring reconstruction. In addition to assessing the primary safety of EB-CMF, this study also aims to demonstrate its efficacy in bone reconstruction and its integration with native tissue. The company plans to enroll six patients in this study. The company hopes that this research will help explore potential indications for other facial reconstructive surgeries requiring bone grafting, as well as applications in knee cartilage replacement and other areas of the body.