Musculoskeletal News Roundup 4-Oct-07
BY LAUREN UZDIENSKI, OCTOBER 4, 2007
M&A
Orthofix acquired the rights to all of the intellectual property related to the InSWing™ interspinous process spacer. InSWing is designed to relieve pain associated with lumbar spinal stenosis and can be used in a minimally invasive surgical procedure. Orthofix plans to first launch the product in Europe. Terms of the deal were not disclosed.
Funding
According to an SEC filing, Trans1 expects to raise about $64.5 million after expenses from its planned initial public offering of common stock. The offering includes 5.5 million shares expected to price between $12 and $14 per share. Lehman Brothers Inc. and Piper Jaffray are serving as the IPO's lead underwriters. Cowen and Co. and Wachovia Capital Markets are also listed as underwriters.
Legal
The Supreme Court denied Medtronic's appeal of an April ruling that the company's Vertex screw infringed upon a Depuy patent. The outcome in last week's $226.3 million judgment against Medtronic in a Boston court would not have been affected by this latest ruling, as the Supreme Court is a separate and higher court. Medtronic says they are likely to appeal the decision reached in the Boston court as well.
Intellectual Property
ISTO Technologies received U.S. patent protection for the company's technology for cell-based cartilage repair. The patent protects ISTO's "Method for Chondrocyte Expansion with Phenotype Retention," which the company describes as a process for growing chondrocytes without the loss of phenotype, thereby providing a commercially viable number of cartilage cells for clinical applications.
Regulatory
Fziomed announced that the FDA accepted their PMA application for Oxiplex, a gel applied around the spinal nerve root and surrounding neural tissues to reduce pain and symptoms following spine surgery. According to the press release, the gel does not interfere with healing and clears naturally from the body, and it can be used in lumbar laminectomy, laminotomy and discectomy surgical procedures. The company adds that the PMA will receive expedited processing. The gel is already available in 47 countries outside the U.S.
Researchers at the University of Missouri-Columbia received FDA approval for the BioDuct Meniscal Fixation Device, used to repair meniscus tears. The device works by transporting blood and cells from the vascular portion of the knee to the avascular portion of the meniscus, which could help to treat a meniscal tear.
Product Introduction
Scient’x has announced that it will launch four new implants at the Eurospine meeting in Brussels on October 3-6. Among these 4 products are: Lyra, an antero-lateral plate to stabilize thoraco-lumbar segments of the spine; Isobar TTC, a posterior fixation system for the cervical spine; and PCB Evolution, a hybrid cervical plate-cage made of PEEK and titanium. Scient'x will also present its new dynamic plate, Aladyn GII, that has been designed according to Scient'x sound experience in dynamic stabilization systems.
Invibio launched an image contrast grade of its PEEK-OPTIMA® polymer, enabling medical device manufacturers to develop implants that can be observed more clearly with X-ray and CT imaging modalities while remaining compatible with MRI.
Small Bone Innovations, Inc. launched the rHead™ Lateral Radial Head Implant System, which offers a side-loading radial head prosthesis that allows for a minimally invasive approach in radial head replacement surgery. The company also announced the launch of the rHead™ Plating System for internal fixation of proximal radius fractures.
License Agreements
Wright Medical Group entered into a 10-year exclusive worldwide license and distribution agreement with A.M. Surgical, Inc. The agreement covers all of A.M. Surgical's current and future products for the foot and ankle market. Wright will begin offering the company's foot and ankle tissue release systems through its U.S. sales force immediately and plans to expand into its international markets in 2008.
Clinical
Swedish company Ortoviva announced this week that its artificial disc insertion device is "progressing well," with the company planning to begin clinical trials in early 2008. According to the press release, the product consists of an instrument that holds adjacent vertebra apart, a placement device for implanting the artificial disc and a dispenser system for the bone adhesive.
At Eurospine this week, ArthroCare reported results for two clinical trials on plasma disc decompression (PDD), both of which found that the procedure may be effective for treating contained disc herniation. The company's Coblation® technology is used in PDD procedures.
