Musculoskeletal News Roundup 25-Sept-08
BY LAUREN UZDIENSKI, SEPTEMBER 25, 2008
Funding
Anulex Technologies, Inc. secured a $7.0 million growth capital term loan from Silicon Valley Bank. The company plans to use the proceeds to further their R&D efforts, complete their clinical study and expand their sales force. Anulex markets the Xclose and Inclose systems for anular repair.
Product Introduction
Alphatec Holdings, Inc. announced that it received U.S. Food and Drug Administration (FDA) 510(k) market clearance for its Novel Cervical Interbody implant. The Novel Cervical Interbody implant is the latest product in Alphatec Spine's pipeline that provides solutions for disorders affecting the cervical spine. The Novel Cervical Interbody is offered in three footprints in both PEEK and titanium. The implant is designed to optimize endplate contact and has windows that increase the surgeon's ability to insert grafting material into the implant.
Orthovita announced plans to launch the VITOSS Bioactive Foam Pack in September 2008. The company says the product "has the same structure, porosity and handling properties as Orthovita’s VITOSS Foam Pack product." It consists of a beta-tricalcium phosphate bone graft substitute combined with Kensey Nash’s proprietary collagen and also features Orthovita's bioactive glass.
Scient'x announced the launch of the Tribeca Cage System, which allows the surgeon to utilize a unilateral transforaminal approach to interbody cage insertion to minimize dural exposure. The Scient'x Tribeca Cage implants are indicated for use with autogenous bone graft as an intervertebral body fusion device at either one or two contiguous levels in the lumbosacral spine, from L2 to S1, for the treatment of Degenerative Disc Disease (DDD) with up to Grade I spondylolisthesis.
Distribution
Anika Therapeutics, Inc. signed an exclusive, five-year renewable agreement with DePuy Mitek, Inc. whereby DePuy will distribute and market ORTHOVISC and ORTHOVISC mini throughout South America, Central America, the Caribbean and Mexico.
Integra LifeSciences' orthobiologics division has has signed a three-year contract with Novation to supply Integra Mozaik Osteoconductive Scaffold to members of VHA, UHC and Provista. Mozaik is a collagen ceramic bone graft substitute.
Clinical
BioMimetic Therapeutics, Inc. announced that the Data Monitoring Committee (DMC) determined that the company's ongoing U.S. pivotal study could proceed unchanged. The study is evaluating Augment Bone Graft in the treatment of foot and ankle fusions. DMC, an independent organization overseeing the study, reviewed all available safety data from the first 254 patients and a futility analysis on data from the first 79 patients that completed their six-month follow-up visit.
