Musculoskeletal News Roundup 5-Jan-12
BY LAUREN UZDIENSKI, JANUARY 5, 2012
Earnings
Integra LifeSciences announced that they expect 4Q:11 sales to be approximately 3% below previously-issued guidance at $202.0 million to $203.0 million. The company says "the revenue shortfall resulted from inventory reduction initiatives by our instruments distributors, weakness outside of the U.S. and weaker than expected sales of our domestic Extremity Reconstruction products." Analysts had forecast 4Q:11 sales of $213.1 million.
RSB Spine announced that 2011 sales increased by 46% compared to 2010.
Regulatory
Accentus Medical announced that the first medical device incorporating their Agluna silver anti-infective technology, Stanmore Implants' METS modular tumor replacement system, has received CE mark certification. Accentus added that they are working with Zimmer to further develop Agluna technology for hip and knee applications.
BioMimetic Therapeutics received an FDA request for more information on Augment. The information request includes a re-reading of all 24-week CT scans by the original musculoskeletal radiologist, further analysis of all serious study adverse events and re-categorization of all secondary surgeries as failures and new subgroup analyses. The company thinks they will be able to submit the amendment to the PMA by mid-2012, and, assuming that submission is successful, receive approval for Augment 15-24 months from now.
China Kanghui Holdings announced that their wholly-owned subsidiary TGM Medical, Inc. received FDA clearance for their Helicon Hip System, Milestone Knee System and related surgical instruments.
Product Introduction & Update
Ellipse Technologies announced that the first implantations of the PRECICE Limb Lengthening device in the United States were performed in December at the Advanced Limb Lengthening Institute in West Palm Beach, Florida. The PRECISE is cleared for use in lower extremity lengthening procedures of the femur and tibia, and the company describes it as "the first FDA-cleared implantable limb lengthening device that offers prescribed rate controlled limb lengthening and has the ability to reverse direction."
Pioneer Surgical announced the first clinical use of nanOss Bioactive 3D, a three-dimensionally-shaped bone graft substitute that consists of a proprietary nanocrystalline hydroxyapatite and a collagen-based biopolymer. The material is used in the posterolateral spine.
Wright Medical launched the ORTHOLOC 3Di Ankle Fracture System and the QUICKDRAW Knotless Soft Tissue Fixation System. The QUICKDRAW is available through a distribution agreement with ArthroCare. The company says both products will be immediately available in the U.S. through Wright Medical's specialized foot and ankle sales force as well as OUS through Wright's sales force and distributors.
Legal
Alphatec Spine announced that it has reached a global settlement agreement of two pending lawsuits. In the first lawsuit, Cross Medical Products, Inc. (a subsidiary of Biomet, Inc.) claimed that Alphatec Spine had breached the April 23, 2003 license agreement with Cross Medical by failing to make certain royalty payments. In the second lawsuit, Alphatec Spine claimed that a subsidiary of Biomet, Inc. EBI, LLC, infringed a patent owned by Alphatec Spine. Under the terms of the settlement, all parties obtained a release of all claims that were the subject of the disputes. No party has admitted liability in connection with the settlement. The settlement also includes an amendment to the April 23, 2003 License Agreement.
Partnerships
Smith & Nephew announced a joint venture with Essex Woodlands, whereby Smith & Nephew would spin off its biologics and clinical therapies business to create Bioventus LLC. Bioventus, which will be led by Smith & Nephew's biologics and clinical therapies division president Mark Augusti, will be 51% owned by Essex Woodlands and 49% owned by Smith & Nephew. In association with the deal, Seikagaku entered into a new exclusive distribution agreement to transfer marketing rights for the SUPARTZ joint fluid therapy from Smith & Nephew to Bioventus.
Distribution
Artimplant will resume sales and marketing of the Artelon CMC Spacer, which had previously been licensed by SBi. Sweden-based Artimplant says, "This is an integral part of Artimplant's focus on reinforcing its presence on the very important U.S. market."
CONMED signed an agreement with the Musculoskeletal Transplant Foundation, a tissue bank, for the exclusive distribution of MTF's sports medicine tissue as well as MTF's platelet-rich plasma (PRP) product. The deal will complement CONMED's line of implants and equipment for sports medicine arthroscopy, the company's largest business segment. On January 6th, Cascade Medical Enterprises announced that they sold their proprietary platelet-rich plasma and platelet-rich fibrin matrix technology to Musculoskeletal Transplant Foundation for distribution by CONMED.
Appointments
Globus Medical appointed Richard A. Baron as Senior Vice President and CFO effective January 2, 2012. Prior to joining Globus, Mr. Baron served as Vice President Finance and CFO for Avid Radiopharmaceuticals, ERT, Animas Corporation, Genex Services and Marsam Pharmaceuticals.
Vexim appointed Vincent Gardes Chief Executive Officer. He previously served as General Manager, Iberia, at CR Bard and has held positions in spine at Medtronic and Stryker.
