Healthcare Industry News:  peripheral artery disease 

Devices Interventional

 News Release - January 8, 2007

FoxHollow Technologies Provides Update on Corporate Strategy; Announces Preliminary Fourth Quarter 2006 Revenue of $44.7 Million

REDWOOD CITY, Calif., Jan. 8 (HSMN NewsFeed) -- 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 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

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 and on the SEC's website at 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.

Source: FoxHollow Technologies

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