Orthopedic News Roundup 21-June-07
BY LAUREN UZDIENSKI, JUNE 21, 2007
Regulatory
TiGenix submitted an application to market ChondroCelect to European regulatory authority the European Medicines Agency for the Evaluation of Medicinal Products. The application is supported by clinical data comparing ChondroCelect to microfracture, where, according to the company, ChondroCelect was shown to regenerate tissue superior to repair tissue formed following microfracture. Additionally, the new regenerated tissue demonstrated characteristics similar to hyaline cartilage.
Genzyme applied for FDA approval for a new single-dose form of Synvisc, which will be known as Synvisc-One. According to the company, the single injection will provide up to six months of relief from osteoarthritis. Genzyme expects a response from the FDA by the end of the year.
RSB Spine annouced conditional 510(k) approval for its InterPlate™ GC Vertebral Body Replacement System.
New provisions in MDUFMA II could jeopardize industry support, according to House testimony from Advamed CEO Steven Ubl. Among Advamed's concerns are limitations to federal preemption in lawsuits against manufacturers.
Stryker received a warning letter from the FDA regarding a plant in Ireland. Violations at the site included missed deadlines to fix failures in product testing procedures and documenting risk analysis, among other issues. The company says it is working closely with the FDA to resolve the issue.
Funding
Gentis Inc., the developer of the DiscCell™ in-situ polymerizing spinal nucleus augmentation technology, announced the closing of its first institutional financing. The $10.0 million round was co-led by Pappas Ventures of Durham, N.C. and New York-based Easton Capital and also included funding from Ivy Capital Partners and Matignon Technologies. The company plans to use the funds to complete pre-clinical testing and the pilot clinical study required to file an IDE for a pivotal trial with the FDA in 2008.
Product Introduction and Launch
Smith & Nephew launched its 560 Series 3-CCD High Definition (HD) Camera System, a surgical camera system designed for arthroscopic and other minimally invasive surgeries.
Orthosoft Inc. launched Navitracker, a disposable plastic reflector that tracks instruments and the patient's anatomy during orthopedic surgery.
Alphatec Holdings, Inc., announced the release of the NOVEL®-TL Spinal Spacer System. The NOVEL-TL implant was designed to be used with Alphatec's proprietary instrumentation for maximum ease of use and procedural efficiency, thus further enhancing Alphatec's spinal implant solution product line.
Licensing Agreements
Baxter announced a licensing agreement with Intercytex and Spinal Restoration to evaluate the use of Baxter's fibrin sealant TISSEEL® in regenerative medicine therapies. Intercytex, Cambridge, England, will use TISSEEL in combination with allogeneic dermal fibroblasts in the development of two of its products; Spinal Restoration Inc. is working with Baxter to use TISSEEL in the development of its Biostat BIOLOGX™ Fibrin Sealant to augment healing and repair of painful defects in the intervertebral disc area of the spine.
Miscellaneous
IsoTis, Inc. announced that following the conclusion of the Exchange Offer it launched for all of the outstanding shares of ISOTIS SA, ISOTIS SA will no longer be listed on SWX Swiss Exchange, Euronext Amsterdam and the Toronto Stock Exchange. The expected completion date is July 23rd.
