BioMimetic Therapeutics, Inc. (BMTI)

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BioMimetic Therapeutics Completes Enrollment in Augment(TM) Rotator Cuff Graft Pilot Trial

Company Receives Patent Allowance for Treatment of Distraction Osteogenesis Until 2029
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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."

About Augment Rotator Cuff Graft and Clinical Study

Augment Rotator Cuff Graft is an interpositional graft consisting of a collagen matrix hydrated with recombinant human Platelet-Derived Growth Factor-BB (rhPDGF-BB), one of the principal wound healing stimulators in the body. The graft is positioned between the humerus and torn rotator cuff tendon(s) during standard surgical suture repair. BioMimetic is leveraging the same rhPDGF-BB technology around the world for orthopedic applications.

The trial is designed as a multi-center, randomized (2:1), controlled, blinded study to evaluate safety and performance of Augment Rotator Cuff for primary surgical treatment of full thickness (greater-than or equal to 2 cm to < 5 cm) rotator cuff tears. The Canadian study enrolled 30 patients with 20 patients receiving Augment Rotator Cuff plus standard suture repair and 10 patients receiving standard suture repair alone. The primary endpoint of the trial is safety, which will be evaluated by a comparison of adverse events between the two groups. MRIs will also be reviewed to evaluate the safety and durability of the device.

Rotator Cuff Anatomy, Tears and Repair

The rotator cuff is made up of four muscles and their tendons. These combine to form a "cuff" over the upper end of the arm (head of the humerus). The rotator cuff holds the humerus in place in the shoulder joint, enables the arm to rotate, helps to lift and rotate the arm, and stabilizes the ball of the shoulder within the joint. Rotator cuff tear is a common cause of pain and disability among adults. Most tears occur in the supraspinatus tendon, but other parts of the cuff may be involved. Rotator cuff tears are among the most common shoulder injuries, and rotator cuff repair is one of the most commonly performed orthopedic soft tissue procedures performed in the United States.

Operative repair of rotator cuff tears may reduce pain and function, however previous studies have demonstrated that a significant percentage of these repairs fail to heal when evaluated radiologically. Integrity of repair has been correlated with improvements in functional outcomes and results of revision surgeries are less than optimal, reinforcing the notion that prevention of retears with a quality repair is critical for the long term outcome of the patient. There are approximately 450,000 rotator cuff repair procedures annually in the U.S. and the Company estimates an additional 275,000 in other parts of the world. These numbers are expected to increase at a rate of 6.5% annually due to the increasingly active aging population suffering acute sports-related injuries and various degenerative overuse conditions that ultimately require surgical repair.

United States Patent Allowance

Additionally, U.S. Patent Number 7,943,573 entitled "Treatment of Distraction Osteogenesis Using PDGF" was issued by the U.S. Patent and Trademark Office and will remain in force until February 2029. The allowed claims within this patent application cover methods of stimulating osteogenesis (i.e., formation and development of bone) in a bone distraction procedure and certain platelet derived growth factor (PDGF) compositions that are applied to the distraction site to stimulate bone formation. This patent will prohibit the marketing of similar or generic versions of Augment, Augment Injectable, or GEM 21S for use in distraction osteogenesis procedures.

Source: http://investor.biomimetics.com/phoenix.zhtml?c=196896&p=irol-newsArticle&ID=1571488&highlight=