Musculoskeletal News Roundup 18-Sept-08
BY LAUREN UZDIENSKI, SEPTEMBER 18, 2008
M&A
BoneSupport acquired Ultrazonix, the developer of an ultrasound-based treatment for alleviating pain associated with herniated discs. The product is FDA-cleared and CE-marked. Financial terms were not disclosed.
Funding
Formae received an investment of $0.5 million from BioAdvance, the Biotechnology Greenhouse of Southeastern Pennsylvania. The company was founded by Kevin Mansmann, M.D. and is developing "novel products in arthroscopic joint resurfacing and replacement."
Soft Tissue Regeneration closed a $3.5 million A round led by MentorTech Ventures. The funds will be used to further develop the Laurencin-Cooper Ligament for ACL reconstruction, which features an "FDA-approved polymer already widely used in biomedical devices."
Regulatory
Orthovita responded to the FDA's comments on its 510(k) application for the use of CORTOSS Bone Augmentation Material in vertebral augmentation. The company submitted additional two-year follow-up patient data from its U.S. pivotal study, increasing the number of patients in the pivotal study for whom two-year follow-up data has been submitted to approximately two-thirds of the original pivotal IDE study cohort. The additional data supplements the pilot study and European investigation data Orthovita submitted with its initial application.
The U.S. Senate's Special Committee on Aging held a hearing this week on whether DTC ads required greater regulation by the FDA. AdvaMed President Steven Ubl argued against the heightened scrutiny (including a moratorium on ads for new products while surgeons familiarize themselves with the devices), saying, "the FDA and the FTC already have ample legal authority to regulate false or misleading advertising for medical devices."
Product Introduction and Update
Axial Biotech is developing a DNA-based prognostic test that projects the likelihood of spinal curve progression in patients with Adolescent Idiopathic Scoliosis. The test will be distributed by Depuy Spine under the name ScoliScore.
This week Integra LifeSciences will launch their EndoRelease Endoscopic Cubital Tunnel Release System at the annual meeting of the American Society for Surgery of the Hand. The system is designed for the surgical treatment of cubital tunnel syndrome, which is caused by entrapment of the ulnar nerve at the elbow. Per the company, the system's benefits include "a smaller incision, efficient and reliable surgical technique and more rapid patient recovery."
Salient Surgical Technologies, Inc. launched the Aquamantys Malleable Bipolar Sealer with Light, which utilizes Transcollation technology (a collagen remodeling process) to "significantly reduce bleeding in hard-to-reach anatomy during joint replacement surgery."
Wright Medical Group introduced the BIOTAPE XM Reinforcement Matrix, which the company calls a sterile, acellular xenograft matrix for reinforcement of soft-tissue repairs in foot and ankle surgical procedures.
IP
Smart Disc has received U.S. patent 7,407,513 B2 for its total disc technology. The disc "mimics the functionality of the patient's own intervertebral disc" and is implanted with a posterior approach.
Legal
DePuy Spine and Biedermann Motech agreed to settle a patent infringement suit against Allez Spine. Allez will pay an undisclosed amount and agree to a royalty-bearing license on sales of the company's Laguna system of screw products.
Clinical
The NEJM last week published a paper evaluating the efficacy of arthroscopic knee surgery for the treatment of OA. The study found that patients undergoing arthroscopic surgery were no more likely to experience improvements in physical function, pain or health-related quality of life than those who underwent rigorous physical therapy.
Partnerships
Active Implants Corp. announced plans to test its TriboFit Acetabular Buffer at the InMotion Musculoskeletal Institute, an independent research lab that has worked with Stryker in the past.
ConforMIS and AG Mednet announced a multi-year partnership granting ConforMIS access to AG Mednet's "state-of-the art global imaging network," which includes managed transport services for both external and internal image transfers. Philip Licari, COO of ConforMIS, said AG Mednet offers "a simple, reliable, fast and secure way to send patient CT and MRI images from around the world." Financial terms were not disclosed.
