BioMimetic Therapeutics, Inc. (NASDAQ: BMTI), a biotechnology company specializing in the development and commercialization of innovative bioactive products to promote the healing of musculoskeletal injuries and diseases, reported today that, ahead of previously announced guidance, the Company completed enrollment of 30 patients in a pilot clinical trial to assess the safety and clinical utility of AugmentTM Rotator Cuff Graft for the repair of large rotator cuff tears. The study's objective is to determine the safety and performance of Augment Rotator Cuff for primary surgical treatment of full thickness rotator cuff tears. To date there have been no product related serious adverse events (SAEs) attributed to Augment Rotator Cuff in the study. The Company expects to release data from the trial in the first half of 2012.
"The efficient enrollment of patients in this trial demonstrates both our commitment to our sports medicine program and the support and enthusiasm of the Augment Rotator Cuff trial's investigators and patient community," said Dr. Samuel Lynch, president and CEO of BioMimetic Therapeutics. "Data generated from this study will provide valuable information regarding Augment Rotator Cuff's performance and should be instrumental in designing a successful pivotal trial in this indication. We appreciate the collaboration of the investigators and patients involved in this important effort, and we hope to develop this new treatment as expeditiously as possible."
Providing additional support for the product candidate's use in rotator cuff tears, results of a pre-clinical study demonstrating that rhPDGF-BB promotes healing in tendon-bone injuries has been accepted for publication in The American Journal of Sports Medicine (AJSM). The published study was conducted in collaboration with investigators from the Hospital for Special Surgery and Colorado State University and evaluated the effects of rhPDGF-BB, in combination with a type I collagen matrix, on rotator cuff repair in a sheep model and demonstrated a significant 63% increase in the load at failure of the repair compared to fixation alone at 12 weeks post-repair. The paper, entitled "Augmentation of a Rotator Cuff Suture Repair Using rhPDGF-BB and a Type I Bovine Collagen Matrix in an Ovine Model," is currently available online ahead of the print edition and can be accessed on PubMed (http://www.ncbi.nlm.nih.gov/pubmed/21555508).
"Rotator cuff tears are a painful and debilitating condition in which the rotator cuff tendon no longer fully attaches to the head of the humerus and results in prolonged weakness and pain in the shoulder and an overall impaired quality of life," said Robert Litchfield, MD, principle investigator for the Augment Rotator Cuff pilot study. "Rotator cuff tears are one of the most common problems encountered by orthopedic surgeons, and their repair is among the most commonly performed procedures in orthopedic soft tissue indications. The rapid enrollment of patients in this pilot study speaks to the surgeons' desire to improve the outcomes of this frequent and difficult-to-treat condition. Biologic enhancement of cuff repairs is undoubtedly the next major advancement in the management of these challenging cases, and as principle investigator I am delighted by the ease of use and the absence of any adverse events associated with the application of this product. Additionally, the clinicians involved in this study are very enthusiastic about the potential benefits and safety of this product."
BioMimetic Therapeutics, Inc.