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Orthopedic and Dental Industry News Complete Archive »

Musculoskeletal News Roundup 14-May-09 BY LAUREN UZDIENSKI, MAY 14, 2009

Earnings
aap Implantate reported 1Q:09 revenues of EUR 8.4 million ($11.1 million), representing a 5% increase over the year-ago period. EBITDA for the quarter declined 47% to EUR 0.05 million ($1.1 million). The company says that for the full-year 2009, they expect "a recovery of the sales growth by launching new products, expanding and acquiring new OEM partners," which would also improve earnings.

Funding
Anulex raised $10.2 million a fourth round of funding. Investors were not named, though Delphi Ventures, New Enterprise Associates, St. Paul Venture Capital, Affinity Capital Management, MB Venture Partners and SightLine Partners have participated in previous rounds. The company also received $7.0 million growth capital term loan from Silicon Valley Bank, according to peHUB.com.

Soteira, who are developing VCF therapies, closed on $6.6 million of a $12 million Series C funding round. The funds are expected to be used to support clinical trials. Contributors to this round were not named, through previous investors include Delphi Ventures, HLM Venture Partners, Federated Kaufman Fund, Partech International and Prism VentureWorks.

Regulatory
AxioMed received CE mark clearance for its Freedom lumbar artificial disc, which the company describes as a "viscoelastic, next-generation total disc replacement featuring a polymer core." Supporting the company's CE mark application was a multi-center European clinical study that is also serving as the company's U.S. IDE study.

Stryker received an FDA warning letter regarding a craniomaxillofacial implant that the company says has been off the market since a recall in 2008. The affected products were distributed from the company's Portage, Michigan facility.

The FDA will review its 510(k) clearance for ReGen Biologics' Menaflex device following a letter from acting FDA commissioner Joshua Sharfstein that suggested the regulatory process had been "compromised." The Wall Street Journal has published several reports on ReGen's role in the 510(k) decision, alleging that the company made substantial campaign contributions to politicians who supported the device as well as named the members of their own FDA panel.

Product Introduction and Update
Disc Motion Technologies announced the first implantation of the Inlign MLH system in the U.K. The company describes the system as a "posteriorly-implanted, multi-level hybrid system" that consists of an artificial disc and a motion-preserving rod for an adjacent-level fusion.

License Agreements
NeoStem signed an exclusive, royalty-bearing license agreement with Regenerative Sciences, LLC to bring its Regenexx treatment to Asia. Regenexx is an autologous stem cell treatment for use in musculoskeletal procedures, whereby mesenchymal stem cells are harvested, cultured and injected into joints to aid in the healing of bone, cartilage or other tissues. Terms of the agreement were not disclosed.

Investigations
Stryker was subpoenaed by the New Jersey Attorney General for documents related to financial relationships between the company and physician-investigators in certain clinical trials.

Legal
Biomet has reached settlements with 24 of 27 plaintiffs in cases relating to bone-stimulation devices they allege were misused by a West Virginia osteopath. The devices named in the suits are EBI's Ionic Spine Spacer System and its SpF and OsteoGen implants. The dollar amounts of the settlements are not being made public and are pending approval from a judge, though Biomet has said they expect to take a $39.0 million charge in FQ4:09 relating to the cases.

Clinical
The New York Times is reporting that a former Walter Reed surgeon and Medtronic consultant falsified data on InFuse. The study, published as a review in JBJS and since retracted, alleged a 92% fusion rate among soldiers treated at Walter Reed for gaping lower-leg wounds with open fractures between March 2003 to March 2005. Following an investigation into that data, Walter Reed found "higher numbers of patients and injuries than the hospital could account for," according to the Times.

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