BioMimetic Therapeutics said today it has completed enrollment of 30 patients in a pilot clinical trial to assess the safety and performance of Augment Rotator Cuff Graft for the repair of large rotator cuff tears. The company expects to release data from the trial in the first half of 2012.
“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."
The graft is a combination of BioMimetic's recombinant human platelet-derived growth factor-BB (rhPDGF-BB) and a collagen matrix. BioMimetic has received a patent for the treatment that will remain in force until February 2029.
BioMimetic recently received a recommendation for Food and Drug Administration approval of its Augment Bone Graft for foot and ankle surgeries by an FDA advisory panel. The company's stock (Ticker: BMTI) rose slightly on the news Tuesday morning. The company's shares are trading about 50 percent below their value prior to the FDA panel hearing.
William Plovanic of Canaccord Genuity has reitered his 'buy' rating on shares of BioMimetic Therapeutics following the Franklin company's fourth quarter earnings release yesterday, citing the fact that there were no changes in the company's expeations for the regulatory timeline for approval of Augment for use in foot and ankle fusions.
He also noted that "the distribution strategy and the new VP of sales and marketing show the company's intention to make a big impact in the lower extremity market."
Canaccord has a price target of $17.50 on BioMimetic's shares (Ticker: BMTI). The stock was trading near $13 per share Friday morning, up more than 1.5 percent on the day.
"The test we are developing from discoveries made at St. Jude will yield great improvements in the care of patients with a variety of cancers caused by ALK, including lung cancers, lymphomas, certain sarcomas and other malignancies," said Dr. Josh Nickols, Chief Technology Officer and VP of Research and Development at Insight Genetics. "We believe the test will be able to provide clinicians with the ability to make rapid, informed decisions about therapy selection for their patients during the course of treatment with ALK inhibitors."
“This is a key development milestone for BioMimetic, as this trial represents the first use of our rhPDGF-BB platform technology directed at improving the healing of tendons and ligaments in humans,” said Dr. Samuel Lynch, president and CEO of BioMimetic Therapeutics. “Over 450,000 people have rotator cuff tears surgically repaired in the U.S. every year, and it has been reported that up to half of these patients could experience retears or incomplete healing. Currently, there are no approved recombinant therapies for facilitating the repair of tendons after injury. Based on our preclinical studies, we believe Augment Rotator Cuff has the potential to speed healing, thus shortening recovery and facilitating faster return to sport and other activity and making reinjury less likely.”BioMimetic also is working toward Food and Drug Administration approval of its Augment Bone Graft for use in foot and ankle fusions. The company's stock (Ticker: BMTI) is down about 4 percent year-to-date.
"Personalized medicine is the future of cancer care," said Eric Dahlhauser, Chairman and CEO of Insight Genetics. "Companion diagnostics help physicians identify which patients are likely to benefit from certain cancer treatments and also can be useful tools in monitoring if a cancer therapy is effective or not. Insight Genetics is excited to be developing diagnostic assays to improve the care available to cancer patients.”For details on Insight Genetics' contract, click here. For more background on the company, visit this link.