Musculoskeletal News Roundup 29-Nov-07
BY LAUREN UZDIENSKI, NOVEMBER 29, 2007
Regulatory
Amedica received FDA clearance for their Valeo™ Pedicle Screw system, a low profile and modular pedicle screw system intended for non-cervical pedicle fixation from the T1 through L5.
Corin announced FDA clearance for additional sizes of its Cormet hip resurfacing system. Corin expects the first shipments of the new sizes to Stryker in early 2008.
China's State Food and Drug Administration has warned 13 companies, including manufacturers of metal bone and joint implants, about manufacturing unapproved medical devices. The inspections found that an average of 13% of medical devices were unqualified. The SFDA warned the companies to adjust their production methods and strengthen quality control, and companies who don't comply risk fines or shutdowns.
M&A
HealthpointCapital Partners II, L.P., through its HEALTHPOINT (Luxco) II S.à.r.l. subsidiary, has acquired Paris-based Ideal Medical Products, S.A. Ideal Medical Products is the principal shareholder and will remain principal shareholder of leading spinal implant developer Scient’x, S.A. John McCormick, a Managing Director of HealthpointCapital, said, "We are pleased to announce this all-cash acquisition of Ideal Medical Products. This will allow our firm to directly invest in and grow Scient’x by maintaining and leveraging our existing distributor relationships, investing in product innovation, surgeon training and clinical data programs globally and conducting FDA clinical trials in the United States. We look forward to growing Scient’x with its talented management team and employees."
Greatbatch Inc. announced plans to acquire Precimed for $125.0 million in cash, plus an additional earnings-based performance payment of up to approximately $10.0 million. Greatbatch says the deal also includes Precimed's pending acquisition of the operations of another orthopedic company.
Funding
SpinalMotion Inc. closed a $14.0 million loan with GE Healthcare Financial Services, which will be used to fund product expansion and additional clinical evaluation. Mountain View-based SpinalMotion has two investigational artificial discs in development.
Intellectual Property
Theken Spine received U.S. patent 7,278,997 B1 for a multifunctional instrument used in spinal fusions. The device is an instrument guide and implant holder. This instrument is used to hold the Tether™ Anterior Cervical plate while drilling, tapping and advancing the screw into the bone.
Product Introduction and Update
Wright Medical released a biologic grafting system for use in core decompression surgical procedures, such as treatment of avascular necrosis of the hip. The system combines Wright's new X-REAM® Expandable Reamer with a simplified procedure kit that includes Wright's proprietary PRO-DENSE® Injectable Graft.
minSURG Corporation, a wholly-owned subsidiary of Orthopedic Development Corporation, announced that it has certified over 600 surgeons in its TruFUSE spine fusion technique, 400 of which were trained in the basic technique at last month's NASS meeting. To support the increase in surgeon users, minSURG has expanded U.S. coverage with 21 new domestic regional spine distributors with over 300 additional sales representatives.
Smith & Nephew initiated a precautionary recall of knees from the TC-PLUS, VKS and RT-PLUS knee ranges due to a higher than specified iron content, which was attributed to a production error at a supplier’s factory. The finished products have been supplied mainly to customers in Europe, with some to the U.S. and other countries. About 275 of the affected devices have been implanted, and the company is working to determine the status of approximately 300 additional implants. A significant proportion of the devices that have not been accounted for are expected to be located in inventory at distributors and hospitals. The company said the higher iron content of these implants is not expected to pose any toxicity or biocompatibility issues for patients.
Clinical
Osiris Therapeutics announced one-year interim results for its stem cell OA treatment Chondrogen. Among the highlights, compared with HA, patients receiving Chondrogen experienced a statistically significant reduction in pain; the magnitude of improvement in pain was clinically significant and superior to the improvement reported for other approved treatments; The effects were dose dependent and pain scores improved from six months to one year following treatment, suggesting Chondrogen caused a biological modification of OA; and patients receiving HA were 3.5 times more likely to experience degenerative bone changes associated with OA as compared to those receiving Chondrogen. Additionally, no serious adverse events were associated with Chrondogen.
INBONE Technologies announced that they have expanded a clinical study into the INBONE™ Fusion System to include nine additional surgeons from across the country. The press release said that the surgeons represented institutions such as Duke, UCLA, and Yale. The goal of the study is to expand the company's existing clinical data showing accelerated fusion rates as well as show a decrease in non-unions when compared against traditional plates and screws.
Advanced Bio-Surfaces, Inc. released initial clinical data on its OrthoGlide Medial Knee Implant, which has been implanted in 92 patients at six U.S. sites. 14 of the enrolled patients have surpassed the one year implant anniversary. Among the highlights, WOMAC pain scores improved from an average of 35 pre-operatively to 72 at six months and 74 at one year post-operative. The most serious adverse event reported was the need to convert patients to either a unicompartmental knee or TKR. Nine OrthoGlide patients enrolled (10.2%) were converted, which is comparable to the 9% unicompartmental knee conversion rate at two years post-operative. Additionally, only one patient out of 350 total implants (including study and non-study patients) experienced a dislocation.
Operations
SpineVision announced the creation of a wholly-owned direct sales subsidiary in Singapore, SpineVision Singapore. The company adds that its PediGuard™ product is now being used in Asia Pacific by Singapore surgeons.
Appointment
As first announced in May, Ray Elliott will resign as chairman of the board and a member of the board at Zimmer. The resignation is effective November 30th, and John L. McGoldrick will replace him as a non-executive chairman. McGoldrick has served as a director of the company since 2001 and is the chair of the corporate governance committee.
TiGenix announced changes to its Board of Directors. Following the company's listing on Euronext Brussels, Independent Director Mr. Willy Duron succeeds Dr. Koenraad Debackere as Chairman of the Board of Directors. Mr. Luc Van de Steen replaces Mr. Alain Partoens as the board representative of ING Belgium.
Miscellaneous
SpineVision received Singapore's “President’s Design of the Year Award” in the “Product & Industrial Design” category for Pediguard, the company's pedicle preparation instrument designed to detect possible cortex perforation.
