ev3 Inc. and FoxHollow Technologies, Inc. Announce a Clinical Collaboration and Distribution Agreement for SpideRX(R) and RockHa
January 08 2007 - 8:30AM
PR Newswire (US)
PLYMOUTH, Minn. and REDWOOD CITY, Calif., Jan. 8
/PRNewswire-FirstCall/ -- 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. (Logo:
http://www.newscom.com/cgi-bin/prnh/20050615/CGEV3LOGO ) 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(R) 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
http://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.
http://www.newscom.com/cgi-bin/prnh/20050615/CGEV3LOGODATASOURCE:
ev3 Inc. CONTACT: Patrick Spangler, CFO of ev3 Inc.,
+1-763-398-7000, ; or Matt Ferguson, CFO of FoxHollow Technologies,
Inc., +1-650-421-8449, , or Robin Gaffney, of FoxHollow
Technologies, Inc., Media Relations, +1-650-421-8614, Web site:
http://www.ev3.net/ http://www.foxhollowtech.com/
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