Regenerating Warfighter Mobility with EB-OC– a Next-Generation Living Osteochondral Graft to Treat Combat-Acquired Osteoarthritis

Musculoskeletal injuries (MSKIs) represent the most substantial and enduring threat to U.S. military readiness. MSKIs account for 2.2 million medical encounters in the military each year– more than  any other illness or injury reported– negatively impacting 800,000 military service men, leading to 25 million lost or limited duty days, and approximately $3.7 Billion in taxpayer health care costs each year.   In particular, osteoarthritis (OA) is the most common cause of disability among service members, specifically post-traumatic osteoarthritis (PTOA), a degenerative joint disease that develops following acute joint injuries—such as fractures, ligament tears, or dislocations—sustained during combat or high-impact training with repeated joint stress, leading to chronic pain and reduced mobility. Military service men develop PTOA 2.5x more often  and at a significantly younger age (<30 years) than their civilian counterparts. In the ankle alone, 1.5 million injuries are reported across the DoD each year where 91% of combat-acquired ankle injuries result in permanent disability due to PTOA less than two years after initial injury– often resulting in early medical retirement, and a $60 billion/year burden in OA costs for veterans.  EpiBone, Inc. is the first company to develop a novel tissue-engineered osteochondral graft (composed of both bone and cartilage) that is alive so it can continue growing and remodeling within the patient’s body, just like native tissue– regenerating healthy cartilage to return OA sufferers to normal, pre-PTOA function. Orthopedic surgeons at 59th Medical Wing (59 MDW) and Brooke Army Medical Center (BAMC) are interested in apply Epibone’s EB-OC technology as a replacement for the existing Osteochondral Autograft Transfer System (OATS) procedure where an osteochondral plug is currently harvested from a healthy non-weightbearing site on the back of the joint and transplanted to fill an OA defect– creating two surgical sites for healing and incurring a 20-30% failure rate. EB-OC can additionally replace traditional osteochondral grafting methods rely on cadaveric osteochondral allografts (OCAs) which are in short supply leading to a standard 6-month wait time for procedures. EpiBone will develop an arthroscopic (minimally-invasive) technique for implanting  its EB-OC technology which currently only has IND approval for open procedures. When complete, the study will show EB-OC can be successfully implanted via an arthroscopic method while maintaining the form, fit, and function Epibone has demonstrated through its open EB-OC procedure.  This will serve as evidence to submit for IND approval of the arthroscopic EB-OC procedure, and expedite formal FDA approval, and commercialization of the proposed solution, by up to two years while also generating compelling data to submit for peer-reviewed publication to disseminate current scientific evidence.