FoxHollow Technologies Provides Update on Corporate Strategy; Announces Preliminary Fourth Quarter 2006 Revenue of $44.7 Million
January 08 2007 - 8:25AM
PR Newswire (US)
REDWOOD CITY, Calif., Jan. 8 /PRNewswire-FirstCall/ -- FoxHollow
Technologies (NASDAQ:FOXH), which manufactures and markets
minimally invasive devices for the treatment of peripheral artery
disease, today provided an update on the company's strategic
direction. John Simpson, Ph.D., M.D., chief executive officer, will
discuss these announcements in a presentation today at 7:30 p.m.
Eastern Time (4:30 p.m. Pacific Time) at the 25th Annual JPMorgan
Healthcare Conference. As previously announced by the company, a
live audio webcast of the presentation will be available via the
Internet at http://investor.foxhollowtech.com/ and will be
available for replay for approximately three months. The company
also announced that preliminary unaudited revenue for the fourth
quarter of 2006 was approximately $44.7 million, a 7 percent
increase over revenue of $41.9 million in the fourth quarter of
2005. Revenue for the fourth quarter of 2006 includes approximately
$39.9 million related to product sales and approximately $4.8
million related to the company's research collaboration with Merck
& Co., Inc. Revenue for the full year 2006 was approximately
$193 million. Separately, FoxHollow announced today that it has
entered into an agreement with ev3, Inc. to jointly conduct a
clinical study involving FoxHollow's RockHawk and ev3's SpideRX
Embolic Protection Device for the treatment of calcified lesions in
peripheral vascular disease. As part of this agreement, FoxHollow
will have the exclusive right to market the two-device system in
the United States. The company also announced the appointment of
Dr. Michael Ennen as vice president, global marketing, and the
departure from the company of Richard Zimmer, senior vice president
of sales. The company is conducting a search for Zimmer's
replacement. The company's sales and marketing functions will now
report to Duke Rohlen, FoxHollow's president of strategic
operations. "Our mission as a company is to provide physicians and
patients with effective treatments for vascular disease. As part of
our efforts to identify growth opportunities for our platform in
peripheral artery disease (PAD), we have recently conducted an
extensive market analysis, surveying more than 200 clinicians
regarding their treatment patterns in PAD. The results of this
project, which was completed just in the past two weeks, have
confirmed both the significant PAD market opportunity and the
sizable growth potential for SilverHawk," Rohlen noted. "From our
market analysis, we have identified three key trends in the PAD
market that we believe create an advantageous position for
FoxHollow. In addition to continued growth in prevalence of the
disease, we also expect the use of endovascular therapies for the
treatment of infrainguinal PAD to grow in the range of 10 percent
annually," he continued. "Our survey results also highlight the
fragmented treatment landscape that exists in PAD today. There are
significant differences in the practice patterns of the multiple
physician types treating the disease, as well as variability in the
disease itself. Based on these market trends in PAD, FoxHollow has
identified several growth drivers as key components to our strategy
moving forward -- allowing us to grow market share through
expansion of our SilverHawk product line and by broadening our
product portfolio." Discussing the company's growth drivers, Dr.
John Simpson, CEO, noted that the market analysis has validated
FoxHollow's increased focus on optimizing its sales force,
continued product development, clinical trial programs, and
business development activities. "Our market research has helped us
understand that PAD-treating physicians can be segmented into
distinct categories, based on treatment preferences and specific
treatment needs. By tailoring our strategic initiatives to address
each physician segment, we believe we will be able to grow our
penetration in the PAD market substantially," added Simpson. "Chief
among our initiatives is the more effective use of our
market-leading sales force in order to solidify our sales
performance over the near-term." Simpson also highlighted continued
new product development and enhancement as another key component of
the company's strategy, allowing FoxHollow to grow SilverHawk
uptake by providing technology to reduce procedure time and
increase ease of use. The company also reiterated plans to generate
data for SilverHawk in the randomized controlled trial setting,
targeting that physician segment that is heavily influenced by
clinical data. FoxHollow's clinical program currently includes the
PROOF trial, which began enrolling patients in late November. PROOF
is a 40-center, 400-patient study comparing SilverHawk treatment to
surgical bypass in patients who are at extremely high risk for limb
loss due to critical limb ischemia. Furthermore, the company said
it is in the process of designing a trial that would randomize the
SilverHawk against another mainstream endovascular treatment for
PAD. The company also announced its decision to discontinue its
SWIFT study, an independent registry utilizing duplex ultrasound
and CT angiography. The company plans to reallocate the resources
previously committed to SWIFT to the new randomized trial under
development. In addition to growing SilverHawk penetration, the
company's strategy for growth within PAD also targets broadening
the FoxHollow product portfolio, driven by continued business
development activities. "We are addressing an enormous market
opportunity in which awareness of interventional therapies is
growing. We have a strong foundation of SilverHawk users within the
clinical community upon which to build further growth, and the
addition of similarly innovative technologies to our product
offerings will fuel further market penetration," Simpson
emphasized. "We recognize that our success at achieving both
greater market share and our overall growth objectives will be
predicated on several key factors. These include our ability to
optimize our market development and sales programs, introduce
enhanced devices into the market, realize favorable clinical trial
results, and capitalize on strategic partnership or acquisition
opportunities. We will also continue to pursue additional
opportunities in the biologics area with Merck and other
prospective partners," he added. About FoxHollow Technologies
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/. Forward-Looking
Statements This press release contains forward-looking statements
within the meaning of the U.S. Private Securities Litigation Reform
Act of 1995. Statements in this press release regarding FoxHollow's
businesses that are not historical facts may be "forward-looking
statements" that involve risks and uncertainties. Specifically,
statements regarding the company's future financial performance,
ability to introduce new products, grow market share, realize
favorable clinical trial results and complete partnerships and
acquisitions, are forward-looking statements involving risks and
uncertainties. Forward-looking statements are based on management's
current, preliminary expectations, and are subject to risks and
uncertainties that could cause actual results to differ from the
results predicted. These risks and uncertainties are included under
the caption, "Factors Affecting Future Operating Results," in
"Management's Discussion and Analysis of Financial Condition and
Results of Operations," in our most recent quarterly report on Form
10-Q for the quarter ended September 30, 2006, filed with the SEC
on November 9, 2006, and available on our investor relations
website at http://www.foxhollowtech.com/ and on the SEC's website
at http://www.sec.gov/. Undue reliance should not be placed on
forward-looking statements, which speak only as of the date they
are made. FoxHollow undertakes no obligation to update publicly any
forward-looking statements to reflect new information, events or
circumstances after the date they were made, or to reflect the
occurrence of unanticipated events. Contacts: Matt Ferguson Chief
Financial Officer 650-421-8449 Robin Gaffney Media Relations
650-421-8614 DATASOURCE: FoxHollow Technologies, Inc. CONTACT: Matt
Ferguson, Chief Financial Officer, +1-650-421-8449, or , or Robin
Gaffney, Media Relations, +1-650-421-8614, or , both of FoxHollow
Technologies, Inc. Web site: http://www.foxhollowtech.com/
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