Drug solution for bone fracture nonunions

ongoing

Bone fracture nonunion (FNU) is one of the leading unmet orthopaedic clinical needs, resulting in billions of healthcare costs annually without any drug approved by regulatory agencies for this debilitating indication. Due to considerable shortcomings of the current best practices in treating bone FNUs, patients are facing increased risks and morbidity. The market has available only bone substitutes and enhancers with limited clinical efficiency, highlighting an essential need for more effective therapies. Genera Research is on its way to filling the gap with its globally patented OSTEOGROW-C product: a novel biological drug transforming patients’ blood into bone. The proposed OSTEOforUNION project aims to develop and commercialize OSTEOGROW-C, an innovative drug for bone regeneration. OSTEOGROW-C is a novel treatment option for bone FNUs, an implant composed of an active substance - recombinant human bone morphogenetic protein 6 (rhBMP6) incorporated in an autologous blood coagulum (ABC) where tricalcium phosphate (TCP) ceramics is added as a compression resistant matrix (CRM). This combination forms a personalized implant that catalyzes bone growth at the implantation site. It is easily prepared in the operating room from the patient's blood without the need for a painful bone harvesting procedure, as in current treatment practices, with associated complications and morbidities (donor site pain, infection, nerve injuries, blood loss or iliac wing fracture etc.) and related additional healthcare costs. OSTEOGROW-C targets the global FNU market, which serves 6M patients yearly. Key overlapping markets are Fracture Fixation, Orthobiologics, Bone Grafts, and BMP. OSTEOGROW-C's unique stance promises to revolutionize the FNU market. The initial market entry will concentrate on the markets in the EU with 180.000 diagnosed long bone FNUs in Europe annually. Simultaneously, OSTEOGROW-C will be launched in the US, addressing more than 120.000 bone FNUs.