Musculoskeletal News Roundup 17-Nov-11
BY LAUREN UZDIENSKI, NOVEMBER 17, 2011
M&A
Zimmer acquired Memphis-based ExtraOrtho, Inc., including its external fixation line, XtraFix External Fixation System. In the press release, the company said that "This acquisition further enhances Zimmer's position in the vital and growing external bone fixation market." Terms of the deal were not disclosed.
Regulatory
X-spine received 510(k) clearance for the Calix PC Spinal Implant System, an intervertebral body fusion system consisting of titanium-coated PEEK implants. The company says the coating "improved resistance to device expulsion" versus a non-coated device in laboratory testing.
Product Introduction and Update
BioMedical Enterprises launched Speed, the company's "fully-disposable continuous compressive" bone fixation system for use in extremity procedures. The devices are made from shape-memory material Nitinol.
TranS1 launched its new lateral access fusion system for interbody fusions. The system "features an innovative, two-stage retraction method that focuses on nerve visualization and then controlled retraction." The company says that TranS1 lateral system is designed for direct visualization of the psoas muscles and adjacent nerves prior to muscle dissection.
Intellectual Property
RSB Spine received European Patent 1847240, which covers design iterations of its line of InterPlate cervical and lumbar intervertebral fusion devices.
Clinical
DFINE initiated a prospective randomized clinical study called PRIORi-T (Prospective Randomized Investigation Of Radio Frequency Targeted Vertebral Augmentation). The post-market clinical study will enroll up to 130 patients at up to 15 centers and compare RF-TVA to conservative care in osteoporotic VCFs within six weeks of onset.
Distribution
Misonix entered into an exclusive three-year distribution agreement with JPL Medical Co., Ltd., of Bangkok, Thailand, for the distribution of the BoneScalpel Ultrasonic Bone Cutter. The agreement provides JPL with the right to sell throughout Thailand and includes annual minimum purchase requirements. The company also announced an exclusive four-year distribution agreement with Cure Surgicals, based in New Delhi, India, for the distribution of the SonaStar Ultrasonic Surgical Aspirator and the BoneScalpel Ultrasonic Bone Cutter. That agreement provides Cure Surgicals with the right to sell throughout India and also includes minimum purchase agreements.
Appointments
Alphatec Spine announced two appointments this week. First, Curt Jennewine has been named Senior Vice President, Global Marketing and Asia Pacific. Mr. Jennewine will be responsible for developing and implementing the Company's global marketing program, as well as being the General Manager of the Company's activities in the Asia Pacific region. Additionally, Frances Harrison has been named the Company's Vice President, Regulatory, Clinical Affairs and Quality. Ms. Harrison will be responsible for providing overall strategic direction and leadership to Alphatec Spine's global regulatory, clinical affairs and quality assurance programs.
