Musculoskeletal News Roundup 20-Aug-09
BY LAUREN UZDIENSKI, AUGUST 20, 2009
Earnings
aap Implantate reported 1H:09 sales of EUR 14.7 million ($20.7 million), representing a 10% decreased from 1H:08. Adjusting for one-time income, sales were down 3%, and in the second half of 2009, the company "anticipates a recovery in demand and an improvement in sales and earnings." EBITDA for 1H:09 was EUR 1.2 million ($1.7 million), down 64% over the year-ago period.
HydroCision Inc. announced that 2Q:09 revenue increased 43% over the year-ago period and 21% sequentially. The company markets the SpineJet platform, which has applications for spinal fusion preparation and minimally invasive discectomy.
Kensey Nash reported FQ4:09 revenue of $20.5 million, representing a 7% decrease from the year-ago period and missing estimates by $0.2 million. Orthopedic product sales declined 16% to $7.0 million for the quarter. Fourth quarter diluted EPS was $0.41, improved from a per-share loss of $0.09 in FQ4:08, and beating estimates by $0.02.
US Spine announced that fiscal year 2009 revenues grew 40% over fiscal 2008. Additionally, sales in the first quarter of the current fiscal year increased approximately 40% over the year-ago period. The company notes that more than 5,300 surgical procedures have been completed utilizing US Spine technology.
Funding
ArthroCare Corp. will issue $75.0 million in Series A convertible preferred stock to One Equity, the private equity arm of J.P. Morgan, to be converted into shares of ArthroCare common stock at $15 a share. ArthroCare plans to use the funds to pay down its debt and for general corporate purposes. Per the agreement, One Equity partners Chris Ahrens and Greg Belinfanti will join ArthroCare's board.
MAKO Surgical Corp. raised $54.4 million in a public offering managed by Piper Jaffray & Co and co-managed by Leerink Swann LLC. The company plans to use the funds to support commercialization, sales, marketing and general administrative activities, for research and product development activities and to fund working capital and other general corporate purposes.
Regulatory
Anika Therapeutics received Health Canada approval to market MONOVISC, its single-injection HA indicated for the treatment of osteoarthritis of the knee. The product has been available in Europe since 2Q:08, and the company anticipates U.S. FDA approval by the end of 2009.
An FDA panel unanimously determined that DePuy's ceramic-on-metal hip, the Pinnacle CoMplete, is safe and effective, essentially recommending it for market approval. The news follows somewhat disappointing clinical study data, specifically a two-year controlled, randomized, blinded, prospective, multicenter study that found limited benefit for CoMplete compared with a metal-on-metal system.
Mesoblast received FDA clearance to begin a 24-patient, phase II clinical study evaluating the use of its allogeneic adult stem cell product, NeoFuse, in minimally invasive lumbar spinal fusion surgery. The study will test the safety and effectiveness of NeoFuse against autograft.
Q-Med AB's Durolane viscosupplement, which would be distributed in the U.S. by Smith & Nephew, was not recommended for FDA approval by an agency panel. The panel raised efficacy concerns, citing studies showing that Durolane was not more effective than placebo.
Product Introduction and Update
Wright Medical Group launched the patent-pending CORETRAK Articulating External Fixator in the U.S. and select O.U.S. countries. The device is designed to "simplify the procedure for the surgeon" and features a "low profile, patient-friendly design and adaptability to multiple conditions in the foot."
Intellectual Property
US Spine was awarded patent number 7,563,275 to cover the Facet Fixation System, which was launched in 2008. The system includes the Facet Gun and Facet Bolt, which comprise a two-step delivery system that allows a surgeon to "lock a spinal motion segment in just minutes, rather than the hours required from traditional stabilization methods," according to the company.
Collaborations
Synthes and Kensey Nash Corporation announced a strategic agreement relating to Kensey Nash's porcine-derived extracellular matrix (ECM) technology. Per the agreement, Kensey Nash will develop and manufacture ECM products, and Synthes will market and distribute the products for certain reconstructive applications. Terms of the agreement were not disclosed.
Legal
Creative NeuroScience Applications LLC filed a lawsuit against bankrupt IST and former CEO Scott Schorer, accusing them of breaching a patent licensing agreement for a percutaneous screw and rod system. The suit alleges that Schorer and IST agreed to develop the screw technology into an IST device and commercialize it. IST also allegedly agreed to revenue and milestone payments, the balance of which the plaintiffs are demanding within 30 days of an IST acquisition or asset sale.
Clinical
Applied Spine Technologies announced that the 15 patients in their Stabilimax System IDE cohort have reached the 24-month milestone. The company describes the Stabilimax System as a posterior dynamic stabilization device "designed to support an injured or degenerative spine without eliminating motion."
Data on SpineAlign Medical's SpineAlign device, which is designed to reconstruct and augment the vertebral body, was presented at the American Society of Spine Radiology/European Society of Neuroradiology conference in Rome this week. Among the results in a 34-patient study, researchers found that patients treated with the device experienced a 7.4-point reduction in pain scores, ODI score improvements from Oswestry 70.3% to 5.4% and significant vertebral height gain.
Appointments
Orthofix appointed Michael R. Mainelli to the company's Board of Directors. Mr. Mainelli has spent eight years with Stryker, serving as the President of Stryker Japan and the President of Stryker Spine. Additionally, the company named Kevin Unger as President of the company's spinal implants division. Prior to his appointment, Mr. Unger served as MedSurg division leader at Stryker.
