Musculoskeletal News Roundup 8-Jan-09
BY LAUREN UZDIENSKI, JANUARY 8, 2009
Earnings
CONMED Corp. lowered 4Q:08 revenue projections to $176-$178 million, 9% lower than forecast and approximately 7% lower than 4Q:07. Reduced revenues were attributed to unfavorable foreign currency exchange fluctuations and lower than anticipated sales of capital equipment to hospitals.
Funding
DFine raised $35 million in a Series D round, with investors including BBT Fund, Highland Credit Strategies Fund, Prospect Venture Partners and Vanguard Ventures. DFine is developing an electrosurgical system for treating vertebral compression fractures with a novel bone cement.
DiFUSION Technologies, Inc. announced its corporate launch this week. The company will focus on reducing the rising incidence of surgical site infections in spinal surgeries and plan to launch a device in 2009 that can kill up to 650 types of bacteria in the surgical wound for four weeks following surgery. While no funding details were announced, the company is currently funded by angel investors. They will be seeking a second round of funding for marketing and sales support.
OrthAlign Inc., a developer of computer-assisted devices for joint-replacement surgery, received $7.2 million in funding. The round was led by Okapi Venture Capital LLC and Research Corporation Technologies Inc. They were joined by Pieter Wolters, OrthAlign's chief executive, and seed investors D. Ronald Yagoda and Ned Scheetz.
Product Introduction & Update
Medtronic launched the Integrated Power Console platform, its first multispecialty surgical power console for use in spinal, cranial and ENT surgeries. The console powers Medtronic's Midas Rex Legend EHS and Legend EHS Stylus drills for spinal and cranial applications as well as the Midas Rex Spine Shaver for powered tissue removal.
Osiris received a $5.0 million milestone payment for reaching the first production threshold of the Osteocel supply agreement with NuVasive. Osiris expects to receive an additional $45.0 million in milestone payments, including $17.5 million for delivery of product, $12.5 million upon transfer of certain manufacturing assets and a $15.0 million payment upon NuVasive's achievement of $35 million in cumulative Osteocel sales.
Legal
The U.S. Court of Appeals for the Federal Circuit upheld an injunction against Stryker, barring the sale of its T2 PHN screw. A lower court found that the screw, which is used to treat fractures of the humerus, infringed an Acumed patent.
Clinical
BioMimetic Therapeutics, Inc. closed enrollment for its North American pivotal clinical study for Augment Bone Graft. 436 patients are enrolled in the study, which is designed to assess the safety and efficacy of Augment in the treatment of foot and ankle fusions as compared to autograft.
Osteotech initiated a pivotal study for its DuraTech BioRegeneration Matrix in cranial surgical procedures, which will enroll 60 patients and include 30 and 90-day follow-up. The study will evaluate the safety and efficacy of the collagen-based matrix compared to historical surgical procedure outcomes. After the study's completion, Osteotech plans to file a 510(k) for the product as well as pursue orthopedic indications, including rotator cuff repair.
Operations
NuVasive met with the Memphis and Shelby County Industrial Development Board regarding the proposed expansion of its Memphis shipping center, which the company says would call for a $122.3 million capital investment and create 54 new jobs.
Education
Biomet, Inc. partnered with the Orthopaedic Research and Education Foundation (OREF) to provide funding for orthopedic fellowship and resident education programs. Fellowship funding will encompass sub-specialties such as adult joint reconstruction, sports medicine, upper extremity, trauma, spine, pediatrics and oncology.
