PITTSBURGH– Carmell Therapeutics, a pioneer in the development and commercialization of innovative Plasma-based Bioactive Materials (PBMs) to accelerate bone and soft tissue healing, announced that it has gained alignment with U.S. Food and Drug Administration (FDA) on requirements for the evaluation of the Company’s lead product, a Bone Healing Accelerant (BHA) in a second indication, foot and ankle fusion surgery.
“This clinical program is designed to evaluate the safety and efficacy of BHA in the establishment of bony fusion in foot and ankle fusion surgery in patients who currently require bone grafting for successful fusion. With completion of the program, BHA may be used as an alternative to autologous bone grafting, eliminating the need for harvesting of bone from other anatomic locations,” said James Hart, MD, Carmell’s Chief Medical Officer.
The multicenter, randomized controlled study will evaluate the efficacy and safety of the use of Carmell Therapeutics’ Bone Healing Accelerant as an alternative to autologous bone grafting to promote bony fusion during foot and ankle fusion surgery. The study is expected to enroll about 60 patients in 10 centers across the United States.
