Musculoskeletal News Roundup 19-July-07
BY LAUREN UZDIENSKI, JULY 19, 2007
M&A
DJO announced on Monday plans for merger with ReAble (formerly Encore Medical). ReAble will acquire all outstanding shares of DJO stock, a transaction valued at approximately $1.6 billion and including the assumption of debt. The transaction will be funded by an affiliate of the Blackstone Group through ReAble and is expected to close in 4Q:07.
Earnings
JNJ reported 2Q:07 earnings of $3.1 billion, or $1.05 per share, beating analyst estimates of $1.00. Additionally, revenue of $15.13 billion estimates of $15.06 billion. Depuy reported revenues of $1.14 billion worldwide, up 7% from the comparable quarter. U.S. sales were $663.0 million, up 3% from 2Q:06.
Regulatory
Exactech announced FDA approval for the Novation™ Ceramic Articulation Hip System. The press release notes that Novation introduces a "high-demand, hard-bearing" option into Exactech's product portfolio.
Medtronic received conditional FDA approval for its Prestige® Cervical Disc, the first cervical disc to be marketed in the U.S. Approval is contingent upon a seven-year post-marketing study to evaluate long-term safety and effectiveness, which the company will perform alongside a five-year enhanced surveillance study. Additionally, Medtronic's second cervical disc, the BRYAN, received a recommendation for approval from an FDA panel as equivalent, but not superior, to cervical fusion.
Funding
Amedica Corp. said in a regulatory filing that the company expects to raise $57.8 million after expenses from a planned IPO of 4.7 million shares, which will be priced between $13 and $15 per share. Amedica reported 2Q:07 losses of $5.6 million and plans to use the proceeds from the IPO to "develop and commercialize its lead products; to build the company's sales, marketing and distribution capabilities; to establish commercial-scale manufacturing operations; to fund research and development for its pipeline products and for other general corporate purposes."
License Agreements
Exactech announced that they have been informed by manufacturing partner Dimicron that Dimicron will not be able to produce on schedule the diamond hip bearings it has been developing. Exactech plans to take an impairment charge of $1.5 million in the 2Q:07, which represents the current full carrying value of the asset.
Clinical
BioMimetic Therapeutics reported interim results from their ongoing U.S. and Canadian studies of GEM OS1. In its 20-patient U.S. pilot clinical trial for foot and ankle indications, 14 received GEM OS1; all but two fused, and those cases were attributed to complications from smoking and diabetes and a surgeon overstuffing the site. Benefits included less time in the OR. In the 60-patient Canadian study, 70% of patients had fused by 12 weeks. Like the U.S. study, many of the GEM OS1 patients had risk factors for delayed healing or non-union. No GEM OS1-related, serious adverse effects were reported in either study.
