Musculoskeletal News Roundup 14-Jul-11
BY LAUREN UZDIENSKI, JULY 14, 2011
Earnings
Biomet reported F4Q:11 sales of $715.2 million, down 1% over the year-ago period. Among segments, recon was flat at $549.2 million, with hip flat, knee down 1%, extremity up 15% and dental down 2%. Fixation sales declined by 9%, and spine sales declined by 10%. Other sales, including sports medicine products, increased by 8%. Growth rates exclude the effects of currency. The company reported an operating loss of $847.3 million in F4Q:11, compared to operating income of $83.3 million in the year-ago period.
Medicrea announced 1H:11 EUR 11.0 million ($15.8 million), up 39% over the year-ago period. 2Q:11 sales contributed EUR 5.8 million ($8.3 million). The company noted that their American subsidiary had its "best performance ever" on account of the PASS LP thoraco-lumbar fixation system for complex spinal operations and reports an "excellent outlook for the second half".
Funding
ConforMIS received a $1.4 million loan from MassDevelopment, which the company will use to purchase multiple pieces of fabrication equipment and instruments used to manufacture its customized knee implants. Two weeks ago, the company announced plans to raise $68.0 million in a series E-1 and E-2 convertible preferred stock offering, with funds to be used for working capital.
Product Introduction and Update
IlluminOss Medical announced the first use of its system in the repair and stabilization of a fibula fracture. The Photodynamic Bone Stabilization System consists of a balloon that is placed into a fracture space and filled with a proprietary liquid monomer. The cement is then hardened using a light source.
Integra LifeSciences announced that it will release a line extension for its Uni-CP Compression System for arthrodesis and fracture management for mid- and hindfoot reconstruction. The Uni-CP product line extension includes a four-hole U-shape locking plate designed for second and third metatarsal-cuneiform fusion.
Nextremity Solutions has obtained first-in-man implants for its Nextra Hammertoe Correction System. The company describes the Nextra System as a "key component" of the company's forefoot reconstruction portfolio. The system will be introduced for limited release at the American Orthopaedic Foot & Ankle Society Congress this week in Keystone, Colorado.
Wenzel Spine announced the 26,000th implantation of its Stand-Alone VariLift Expandable Interbody Fusion Device. The company describes the VariLift System as a minimally-invasive, stand-alone device for interbody fusion intended for use in single or two contiguous levels at L2-S1.
Intellectual Property
SpinalCyte received U.S. patent #7,850,983 covering "Methods and Compositions For Repair Of Cartilage Using An In Vivo Bioreactor" to regenerate the spinal disc using human dermal fibroblasts. The company also published a research report describing their technology.
Clinical
Vertos Medical announced that one-year post-study follow-up data on its mild procedure for lumbar spinal stenosis has been published in the peer-reviewed journal Pain Practice. The study found that among the 58 patients enrolled in the 11-center MiDAS I (mild Decompression Alternative to Open Surgery), mild patients continued to experience a statistically significant and clinically relevant reduction in pain and improvement in mobility at one year. Further, 74% of mild patients remained satisfied with their outcomes.
Distribution Agreements
Stryker announced that the company reached a "mutual agreement" with Corin under which Corin will resume direct distribution for the Cormet Hip Resurfacing System. Stryker will no longer act as a distributor of the product.
Stryker Joint Preservation entered into an exclusive collaboration with RegenLab SA to distribute Stryker's RegenKit-THT, an autologous platelet-rich plasma (A-PRP) preparation system. The product can be used at the patient's point of care.
Wright Medical signed a supply and distribution agreement with ArthroCare, whereby ArthroCare will supply Wright with products for soft tissue fixation of the foot and ankle based on ArthroCare's knotless suture fixation technology. The agreement would include a line of products based on the Opus knotless suture device, which Wright would distribute exclusively to foot and ankle surgeons. Financial terms were not disclosed. Wright expects to introduce ArthroCare's products in 2H:11.
