Carmell™ to conduct a phase II study to promote bone healing in patients undergoing foot and ankle fusion surgery with its first-of-its-kind Plasma-based Bioactive Material product. Results of this initial trial will inform the design of a Phase III study in this application.

PITTSBURGH–(BUSINESS WIRE)–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.

About the trial

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.

About Carmell Therapeutics

Carmell Therapeutics (Carmell™) is a regenerative medicine biotech company focused on leveraging our core platform technology, Plasma-based Bioactive Material (“PBM”). PBM is a proprietary formulation of multiple Growth Factors (“GFs”) and other regenerative factors contained in allogeneic platelet-enriched plasma designed to accelerate and enhance healing in bone, skin, and other tissues, and has the potential to stimulate hair regrowth and collagen production after severe injury, disease, or aging. The platform technology of PBM is initially targeted to accelerate and enhance healing in bone applications (orthobiologics); Carmell™ believes PBM has the ability to deliver many regenerative factors in spaces like aesthetic medicine (androgenic alopecia), wound care and dental bone substitute. Carmell™ currently has two PBM product candidates in development – a Bone Healing Accelerant (“BHA”) and a Tissue Healing Accelerant (“THA”). BHA for use in open tibia fracture has been granted “Fast Track” designation by the FDA and clinical development is ongoing.

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Sebby Borriello
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