Orthopedic News Roundup 31-May-07
BY LAUREN UZDIENSKI, MAY 31, 2007
Regulatory
CMS released a proposed non-coverage decision for lumbar artificial disc replacements following a review of Synthes' Pro-Disc-L. The agency found that LADR is not reasonable and necessary for Medicare recipients over 60 based on lack of relevant data and surgical revision risks, though coverage for patients under 60 will be determined locally. CMS is currently accepting comments on the proposal.
Isotis announced that the 510(k) review process for the company's Accell products will be restarted. The application was originally submitted in July 2006 and put on hold in February 2007. Through discussions with FDA and the submission of a 510(k) supplement, Isotis clarified the claims and labeling for its Accell products and answered questions regarding the Accell process. Based on these discussions, Isotis expects "timely" 510(k) approval.
M&A
A report from shareholder advisory firm Institutional Shareholder Services advised Biomet shareholders against approving a buyout because the $10.9 billion price is too low. Shareholders plan to meet on June 8 to vote on the buyout, which, despite the recommendation, is expected to more forward.
Funding
Isotis has secured a $20.0 million credit facility with Merrill Lynch Capital, a division of Merrill Lynch Business Financial Services Inc., and Silicon Valley Bank. The three-year, $20.0 million credit facility consists of a $10.0 million term loan and a $10 million revolving line of credit. This credit facility expands on and replaces the $5.0 million credit facility IsoTis closed on in June 2006 with Silicon Valley Bank.
Interventional Spine, Inc. closed its Series C financing, raising a total of $24 million. The lead investor in this financing was Ascension Health Ventures, LLC. Other investors were Wexford Capital LLC, HBM BioVentures, Rock Creek Partners and affiliates, The MedFocus Fund, LLC, and a group of current investors. The company plans to use the funds to complete the product launch of its FDA-cleared products, grow its distribution network and seek acquisitions to expand its percutaneous spinal product franchise.
On May 3, Andover Medical closed a $1.7 million follow-on private financing. Funds will be used for working capital, including pending acquisitions.
Legal
Biomet reported that federal prosecutors have subpoenaed company documents related to products manufactured, marketed and sold by its subsidiary EBI Ltd. Biomet acquired EBI to join the electrical bone growth stimulation market, and the division has since expanded to include spinal and bracing products. The latest subpoena follows an earlier investigation that is expected to be resolved soon, as well as an ongoing antitrust investigation that was initiated last summer. Regarding the company's backdating concerns, Biomet also disclosed that a special board committee has found that most of the stock options in question were issued on dates other than the grant dates.
Product Introduction & Launch
Globus Medical launched the MARS™ Minimal Access Retractor System. MARS is designed to provide access to the lumbar spine through small incisions. The system's retractors, ports and other instruments are customizable, and the system was described as the "most versatile on the market" by Group Engineering Manager Andy Iott.
Clinical
SPORT trial data evaluating laminectomy with or without fusion v. nonsurgical treatment for spondylolisthesis was published yesterday in the New England Journal of Medicine. Like the discectomy data before, there was signficant patient crossover between randomized groups. On an as-treated basis, patients who had surgery experienced less pain, lower ODI scores and higher function post-op than patients who received nonsurgical treatment.
A new report from the Canadian Institute for Health Information showed that while 65% of hip fracture patients aged 65 and older had surgery within 48 hours of being admitted to the hospital, patients who waited longer for surgery had a 22% greater likelihood of dying within 30 days of admission when other mortality factors are controlled. Research has also shown that patients who wait longer for surgery have more complications, longer hospital stays and are less likely to regain full function.
