Wells Fargo Healthcare Conference In Brief
This article was originally published in The Gray Sheet
Executive Summary
Orthovita: The company is in discussions with FDA regarding a 510(k) for a next-generation Vitoss bone graft substitute; it hopes to launch the device in the first quarter of 2011, Chief Financial Officer Nancy Broadbent said during a June 23 presentation at the Wells Fargo Healthcare Conference in Boston. The device will incorporate a drug that has "demonstrated positive impact on bone regeneration," she noted. Orthovita also plans to study new indications for Cortoss bone augmentation material, which was cleared last year for vertebral compression fractures, but Broadbent declined to be specific (1"The Gray Sheet" June 15, 2009). She explained that the company decided to lower the average selling price of Cortoss from $2,000 to $1,300 after the launch to better compete with existing vertebroplasty products, which cost about $950, she noted. "Our accounts have [since] grown steadily every month," she claimed
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NMT PFO stroke trial comes up short: Preliminary results of the 910-patient CLOSURE I study of NMT Medical's STARFlex patent foramen ovale closure device show it is not superior to best medical therapy for preventing stroke and transient ischemic attack, the trial's primary endpoint, the firm reports June 17. Closure rates for STARFlex were 86.5%. NMT is now in discussions with FDA about the next steps relating to the stroke/TIA indication. The firm had planned to submit a PMA this year (1"The Gray Sheet" April 13, 2009). Although not statistically significant, "The preliminary data did demonstrate that our implant device provided a small benefit over current best medical therapy and maintained an excellent safety profile," NMT CEO Frank Martin notes. The company will discuss full results of the trial in November at the American Heart Association annual meeting. STARFlex is currently approved for ventricular septal defect and atrial level shunt patients. In a same-day research note, Wells Fargo analyst Larry Biegelsen speculates the CLOSURE I results could spell bad news for AGA Medical, which is conducting the RESPECT study of its Amplatzer PFO occluder in stroke. "Although there are significant differences between the CLOSURE I and RESPECT trials, we believe the CLOSURE I results will make it more challenging for physicians to close a PFO," he writes
Orthovita Touts Cortoss As Alternative To Cement For Vertebral Fractures
Orthovita aims to position its Cortoss bone augmentation material as a favorable alternative to polymethylmethacrylate (PMMA) cement for treatment of vertebral compression fractures when it launches the device in July
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