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Oct 17, 2019

EpiBone, Inc. Receives FDA Clearance to Commence its First-In-Human, Phase 1/2 Trial of its Bone Product, EB-CMF

Posted by in categories: biotech/medical, innovation

Potential breakthrough technology for stem-cell based bone replacement

NEW YORK, May 22, 2019 /PRNewswire/ — 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.

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