Musculoskeletal News Roundup 9-Dec-10
BY LAUREN UZDIENSKI, DECEMBER 9, 2010
M&A
Small Bone Innovations sold its shoulder-related assets to Fx Solutions, which the company says will allow it to focus on its small bone and joint product portfolio in the thumb, fingers, hand, wrist, and elbow as well as its foot and ankle products, particularly the STAR Total Ankle joint replacement system.
Stryker announced plans to sell their OP-1 family of products to Olympus for $60 million. These products include the OP-1 Implant, OP-1 Putty, Opgenra and Osigraft, all of which are intended for use in orthopedic applications and are thought to generate sales of around $94 million. In addition, Olympus will acquire the Lebanon, New Hampshire facility where OP-1 is manufactured. Stryker will record a one-time non-cash charge of approximately $75 to $80 million in 4Q:10 to reflect the anticipated loss on the assets.
Funding
Ortho Kinematics closed a $2.0 million funding round led by TEXO Ventures, who were joined by PTV Sciences and Gatebridge Investments. The funds will be used to support a clinical study of the KineGraph VMA Vertebral Motion Analyzer technology, pursue regulatory clearance and hire key sales personnel.
Regulatory
Orthovita received 510(k) clearance to market Vitoss Bioactive Foam-2X Bone Graft Substitute for use as a non-structural bone void filler in the spine, pelvis and extremities. The company plans to launch the product in 1Q:11.
Product Introduction and Update
Life Spine announced that the first cases with the OCTAVE Posterior Fusion System have been completed. The system received 510(k) clearance last month and features an attachment to the spinous processes that, in conjunction with bone graft, is designed to aid in fusion.
Wright Medical announced the limited release of the PRO-TOE VO Hammertoe Fixation System, which the company says offers solid fixation on both sides of the joint and can be repositioned during surgery to optimize outcomes. The company expects full rollout to be completed by 1H:11 in the U.S. and select countries OUS.
Clinical
BioMimetic Therapeutics began enrolling a pilot clinical study to assess the safety and clinical utility of Augment Rotator Cuff Graft for the repair of large rotator cuff tears. The randomized, controlled pilot trial is expected to include enrollment of up to 30 patients. The Augment Rotator Cuff Graft is an interpositional graft consisting of a collagen matrix hydrated with PDGF.
License and Distribution Agreements
Audax Medical entered into a comprehensive license agreement with Brown University for the rights to Arxis, a biomaterial being developed for use in the regeneration of bone, cartilage and other soft tissues. The material consists of "organic nanomolecules." Further, the company signed a research agreement with the Brown University School of Engineering and Department of Orthopedics to further support clinical development of the technology.
Cephalon and Mesoblast entered into a strategic alliance to develop and commercialize stem cell products based on Mesoblast's adult Mesenchymal Precursor Stem Cell (MPC) technology. Applications will include degenerative conditions of the cardiovascular and central nervous systems as well as augmenting hematopoietic stem cell transplantation in cancer patient. Cephalon will make an upfront payment to Mesoblast totaling $130.0 million and milestone payments of up to $1.7 billion.
CONMED entered into three separate, multi-year purchasing agreements with HealthTrust Purchasing Group for the distribution of products from the company's Linvatec and Endoscopic Technologies divisions. HealthTrust Purchasing Group has a network of 1,400 not-for-profit and for-profit acute care facilities and10,600 ambulatory surgery centers, physician practices and alternate care sites.
NeoStem announced that an "affiliated entity" has entered into an agreement with Shijiazhuang Third Hospital in the People's Republic of China to offer NeoStem's licensed treatments for orthopedic applications. The company says Chinese citizens of Shijiazhuang will be able to receive adult stem cell treatments for arthritis and orthopedic conditions based on technology exclusively licensed by NeoStem for Asia.
Investigations
Exactech entered into a Deferred Prosecution Agreement with the United States Attorney's Office for the District of New Jersey and a civil Settlement Agreement with the United States, which resolves an investigation into its consulting relationships with large joint surgeons. The company will pay $3.0 million to the U.S. government and admit no wrongdoing and enter into a five-year Corporate Integrity Agreement with the OIG. An independent monitor will review the company's compliance with its DPA.
