-- Potential breakthrough technology for stem-cell based bone replacement
EpiBone, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted its Investigational New Drug (IND) clearance to proceed with a Phase 1/2 clinical trial of its lead bone product EpiBone-Craniomaxillofacial (EB-CMF), as a potential treatment for ramus continuity defects in the mandible. The ramus is a key component of the jaw bone which attaches to the muscles associated with chewing.
EB-CMF is a living anatomically correct bone graft manufactured from a patient's own adipose derived stem cells. This eliminates the need to harvest bone from a patient's body, potentially reducing pain, surgical and hospitalization time while creating a precision fit with the defect.
"We are proud of the work that has been put into this IND, and are grateful to our entire team, as well as all our investors, consultants, and champions in the field who have made this possible,"
