BioMimetic Therapeutics, Inc announced positive top-line results from its North American pivotal (phase-III) randomized controlled trial comparing its fully synthetic, off-the-shelf bone growth factor product, Augment Bone Graft (Augment), to autograft for use in hindfoot and ankle fusion surgery. The primary study goal was to establish non-inferiority of Augment compared to autograft. Autograft is the historical standard of care but has the limitation that it must be obtained and transplanted from another bone in the patient's body, often requiring a second surgical procedure. These positive top-line results indicate that, with the use of Augment, patients can expect a comparable treatment outcome while being spared the pain and potential morbidity associated with traditional autograft bone harvesting and transplantation.

"We are excited that our pioneering work at BioMimetic on ways to improve orthopaedic and dental tissue regeneration has again translated into a potential new treatment option for patients with significant debilitating injuries or diseases," said Dr Samuel Lynch, president and CEO of BioMimetic Therapeutics. "These top-line data demonstrate a consistent picture that Augment is at least as efficacious as autograft, while also having the benefit of sparing patients the pain and potential morbidity resulting from autograft bone harvesting and transplantation to the fusion site. We look forward to sharing these positive pivotal trial data with the FDA. Finally, I'd like to once again acknowledge the work of our investigators and thank them for their excellent execution of this complex and rigorous trial."

"These top-line results are very exciting," said Dr Christopher DiGiovanni, principal investigator for the Augment trial and professor of orthopaedic surgery and chief of the division of foot and ankle surgery in the department of orthopaedic surgery at the Warren Alpert School of Medicine at Brown University, Rhode Island Hospital. "The data available thus far support the primary objective of the study which is to find a safe and effective alternative to autograft in foot and ankle fusion surgeries. Should Augment receive FDA approval based on the full data set, I believe it will be widely used by practicing foot and ankle surgeons anxious to spare patients all the pain, potential morbidity, and extra surgical and anaesthesia time associated with traditional autograft bone harvest. I look forward to having Augment available for use in patients."

Joint fusion is the standard surgical treatment for chronic pain in the foot and ankle. This pain is often caused by arthritis, joint instability and congenital defects. The current gold standard for fusion involves the use of autograft, which is bone taken from another location in the patient's body. While effective, the use of autograft creates significant morbidities at a previously asymptomatic harvest site. Some of these morbidities include severe pain, serious infection, numbness and increased anaesthesia time. Autograft also incurs a financial burden when operating room time, instrument cost, anaesthesia cost and surgeon charges are considered. Therefore it is of great value to the surgical community to find a safe and effective off-the-shelf alternative to autograft.

Augment consists of a combination of a sterile solution of 0.3mg/ml purified recombinant human platelet-derived growth factor BB (rhPDGF-BB) and a synthetic tricalcium phosphate (TCP) bone matrix.

BioMimetic Therapeutics is a biotechnology company utilizing purified recombinant human platelet-derived growth factor (rhPDGF-BB) in combination with tissue specific matrices as its primary technology platform for promotion of tissue healing and regeneration.