Long-Term Onyx Implant Follow-Up, Labeling Conditions Stipulated By Panel
This article was originally published in The Gray Sheet
Executive Summary
The FDA Neurological Devices Panel's cautious endorsement of Micro Therapeutics, Inc.'s Onyx LES liquid embolic system underscores the dearth of technologies available to treat brain arteriovenous malformations
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Home Stretch For Onyx PMA? Micro Therapeutics Adds Sparkle To Sales Force
Micro Therapeutics' U.S. launch of the Onyx LES liquidembolic system for treating brain arteriovenous malformations (AVMs) will be supported by a 15-rep sales team, according to the Irvine, Calif. manufacturer
Home Stretch For Onyx PMA? Micro Therapeutics Adds Sparkle To Sales Force
Micro Therapeutics' U.S. launch of the Onyx LES liquidembolic system for treating brain arteriovenous malformations (AVMs) will be supported by a 15-rep sales team, according to the Irvine, Calif. manufacturer
MTI regulatory, revenue projections
Micro Therapeutics, Inc. expects FDA approval for an AVM indication of Onyx LES liquid embolic system in Q1 2004, preceded by clearance of Echelon-14 catheter this quarter, according to President and CEO Tom Wilder. In an Oct. 8 earnings call, Wilder projects 2003-2004 revenue at $28 mil. -$32 mil., and 2004-2005 sales at approximately double the current year's $22 mil.-$24 mil. He also noted that operating expenses - estimated at $37 mil.-$39 mil. this year - should decline to $28 mil.-$32 mil. in coming years, due partly to the absence of regulatory expenses incurred by the Onyx AVM PMA, which earned a favorable review from FDA's Neurological Devices Panel Aug. 5 (1"The Gray Sheet" Aug. 11, 2003, p. 10). Wilder predicts MTI will receive FDA sign-off by 2005 for a brain aneurysm indication, though he did not specify a regulatory path. The pivotal study is suffering from poor enrollment (2"The Gray Sheet" Aug. 11, 2003, p. 9)...