Next-generation craniofacial surgery: Validating EpiBone EB-CMF regenerative bone grafts for use in the maxilla

Dental emergencies, including cranio- and  oral maxillofacial (CMF, OMF) injuries, continue to occur in hostile environments and are only expected to increase in a conflict with China or Russia. OIF and OEF resulted in over 42,000 head and neck injuries, but reconstructing war wounds to the head and neck regions is challenging as they require an extensively planned surgical effort.  In 2020, 579 craniofacial and soft tissue trauma surgeries were performed in the DAF to correct conflict-acquired injuries costing the DAF an estimated $18.8M.   CMF and OMF injuries significantly impact a person’s dental readiness by causing damage to teeth, bone structure, oral function (speaking, eating, swallowing), and breathing. Poor dental status impacts 13,000 active duty service members each year– rendering them non-deployable. Many of these cases require surgery to the surrounding jaw bone, known as the alveolar ridge– the thickened sections of bone which contain sockets for the teeth.  The alveolar ridge requires reconstruction anytime the teeth are knocked loose, when teeth are extracted due to decay, in the event of gum disease, in the presence of congenital malformations, and for age-related bone resorption. Currently, DAF oral surgeons treat alveolar ridge injuries with cadaver-derived and prosthetic bone grafts or perform secondary surgeries to source rib or hip bone autografts, which often leads to donor site morbidity. EpiBone, Inc. is the first company to develop a novel tissue-engineered autologous bone graft material for CMF/OMF surgeries.  Epibone is providing Form, Function, and Bioactivity within its EpiBone Craniomaxillofacial graft (EB-CMF)--revolutionizing the field of regenerative medicine. Unlike traditional grafting methods. EpiBone creates bone grafts that are alive so they have the ability to continue maturing, integrating, and remodeling after implantation–just like normal bone, which allows the patient’s immune system to accept the bone graft. EpiBone’s approach in creating bone grafts ensures a precise anatomical fit while enabling seamless integration, growth, and remodeling within the patient’s native bone tissue. EB-CMF has undergone a Phase I/IIa clinical trial completed in Aug 2023 with 6 patients successfully treated to restore patients mandibular function and aesthetics within 2 months. EpiBone will expand its current EB-CMF product, which already has Investigational New Drug (IND) approval from the FDA for clinical trial use within the mandible (lower jaw), and amend the IND to include the maxilla (upper jaw), instantly doubling the number of oral surgeries EpiBone can positively impact and making EB-CMF the first bioactive bone graft for treatment of the entire jaw structure.  EpiBone will conduct the first ever in-human EB-CMF trial for the maxillary alveolar ridge and submit its findings to the FDA  to receive approval on a pivotal large-scale Phase IIb/III clinical study– expediting formal FDA approval by up to two years.