Healthcare Industry News: SilverHawk
News Release - January 8, 2007
ev3 Inc. and FoxHollow Technologies, Inc. Announce a Clinical Collaboration and Distribution Agreement for SpideRX(R) and RockHawk(R) TechnologiesPLYMOUTH, Minn. and REDWOOD CITY, Calif., Jan. 8 (HSMN NewsFeed) -- ev3 Inc. (Nasdaq: EVVV ) and FoxHollow Technologies, Inc. (Nasdaq: FOXH ) today announced they have entered into an agreement to conduct a joint clinical study of FoxHollow's calcium cutting device (The RockHawk) and ev3's SpideRX endovascular devices to seek approval for the treatment of calcified lesions in peripheral artery disease. As part of the agreement, FoxHollow will have the exclusive right to market the two devices together in the United States.
The SpideRX Embolic Protection Device is the only available embolic protection device that permits physicians to use their guidewire of choice to access the target lesion, and also is cleared by the FDA for use in both carotid arteries and saphenous vein grafts.
The RockHawk device, currently under development, is a specialized version of FoxHollow's SilverHawk® Plaque Excision System that is optimized for the treatment of calcified lesions in the peripheral arteries.
Peripheral artery disease is a condition that occurs when blood vessels become narrowed or blocked by a build-up of fatty substances called plaque. In a significant number of cases, the plaque build-up or lesion becomes calcified. Currently, there are no products approved in the United States for the treatment of calcified lesions in the peripheral vasculature. There remains a meaningful opportunity to offer improved technology to treat these patients with endovascular therapies, as fewer than 25 percent of patients are treated today.
John Simpson, Ph.D., M.D., CEO of FoxHollow stated, "The RockHawk is an important and complementary addition to the company's SilverHawk product family. The RockHawk was designed to treat calcified lesions, whereas the SilverHawk is indicated for general plaque excision in the peripheral vasculature. We believe the use of SpideRX with the RockHawk will improve the safety and efficacy of treating this unmet clinical need. This collaboration is a key element of our ongoing strategy to expand FoxHollow's ability to treat peripheral artery disease."
Jim Corbett, CEO, ev3 stated, "We are excited to partner with FoxHollow. The combination of these two devices in a clinical study will provide physicians with increased options as well as the clinical data to support their decision making."
About ev3 Inc.
ev3 is a global medical device company focused on catheter-based technologies for the endovascular treatment of vascular diseases and disorders. For more information, please visit www.ev3.net.
About FoxHollow Technologies, Inc.
FoxHollow Technologies, Inc., develops and markets minimally invasive devices for the removal of plaque and thrombus for the treatment of peripheral artery disease (PAD). PAD results from plaque that accumulates in the arteries and blocks blood flow in the legs. These blockages can result in severe pain for patients and very limited physical mobility. The company's SilverHawk Plaque Excision System is a minimally invasive method of removing the obstructive plaque and restoring blood flow to the legs and feet. The company's Rinspirator thrombectomy system removes thrombus, or blood clots, from occluded arteries in patients suffering from PAD or coronary artery disease (CAD). For more information, please visit our website at http://www.foxhollowtech.com.
Statements contained in this press release that are not historical information are forward-looking statements as defined within the Private Securities Litigation Reform Act of 1995. Forward-looking statements, such as expectations regarding the improvement in treatment due to the use of the SpideRX with the RockHawk, are subject to risks and uncertainties that could cause actual results to differ materially from those projected or implied. Such potential risks and uncertainties relate, but are not limited to, in no particular order: product demand and market acceptance, the impact of competitive products and pricing, and success of clinical testing. More detailed information on these and additional factors which could affect ev3 Inc's and FoxHollow Technologies, Inc.'s operating and financial results are described in each of the company's filings with the Securities and Exchange Commission, including their most recent quarterly reports on Form 10-Q. ev3 Inc. and FoxHollow Technologies, Inc urge all interested parties to read these reports to gain a better understanding of the many business and other risks that these companies face. Additionally, ev3 Inc. and FoxHollow Technologies, Inc. undertake no obligation to publicly release the results of any revision to these forward-looking statements, which may be made to reflect events or circumstances occurring after the date hereof or to reflect the occurrence of unanticipated events.
ev3 and the ev3 logo are trademarks of ev3 Inc., registered in the U.S. and other countries. SpideRX is a registered trademark of ev3 Inc.
FoxHollow and the FoxHollow logo are trademarks of FoxHollow Technologies, Inc., registered in the U.S. and other countries. SilverHawk and RockHawk are registered trademarks of FoxHollow Technologies, Inc.
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