Healthcare Industry News: benign prostatic hyperplasia
News Release - April 6, 2006
FDA Approves New Urologix CoolWave(TM) Control UnitMINNEAPOLIS--(HSMN NewsFeed)--April 6, 2006--Urologix®, Inc. (NASDAQ:ULGX ), has received permission, through the approval of three PMA supplements relating to new hardware and software, from the U.S. Food and Drug Administration to market its new CoolWave(TM) control unit. Urologix plans to launch CoolWave in the first quarter of fiscal 2007 (July-September), following select post-approval trials. A preview of CoolWave will be available in Urologix' booth at the 2006 AUA Annual Meeting in Atlanta.
Fred B. Parks, Urologix Chairman and Chief Executive Officer commented, "CoolWave is the most important product development for Urologix in many years and reaffirms our company's technological leadership position. This product represents the culmination of over a decade of focus on the treatment of BPH, and incorporates the recommendations of our physician base. The introduction of CoolWave will intensify competition in the office-based BPH market."
"The new user interface and increased processing power of CoolWave allow our urologists to set customized treatments for their BPH patients, including those with small glands and symptomatic BPH, while maintaining the ease of use they are accustomed to," said David A. Montecalvo, Vice President, Operations & Business Development. "CoolWave will support our current Cooled ThermoCath® and Targis® catheter lines as well as serve as a platform for future product introductions and technologies such as the thermal imaging technology under development with ProUroCare, Inc. (OTCBB:PRRC.OB ), and Rennselaer Polytechnic Institute."
Urologix, Inc., based in Minneapolis, develops, manufactures and markets minimally invasive medical products for the treatment of urological disorders. The company has developed and offers non-surgical, anesthesia-free, catheter-based treatments that use a proprietary cooled microwave technology for the treatment of benign prostatic hyperplasia (BPH), a condition that affects more than 23 million men worldwide. Urologix' products include the CoolWave(TM), Targis® and Prostatron® control units and the Cooled ThermoCath®, Targis® and Prostaprobe® catheter families. All of Urologix' products utilize Cooled ThermoTherapy(TM) - targeted microwave energy combined with a unique cooling mechanism to protect healthy tissue and enhance patient comfort - and provide safe, effective, lasting relief of the symptoms of BPH.
Certain statements in this news release contain forward-looking information. Actual results may vary significantly from those anticipated in these forward-looking statements due to risks and uncertainties, including the need to maintain profitability and increase revenues; the rate of adoption of Cooled ThermoTherapy products, Urologix' sole products, by the medical community; approval by the FDA of the Company's products; the ability of third-party suppliers to produce and supply products; the impact of competitive treatments, products and pricing; the company's ability to develop and market new products, including the company-owned Cooled ThermoTherapy mobile service, and the company's ability to generate revenue from new products; the development and effectiveness of the company's sales organization and marketing efforts; developments in the reimbursement environment for the company's products including the determination of reimbursement rates for Cooled ThermoTherapy (transurethral microwave thermotherapy); the company's ability to successfully defend its intellectual property against infringement and the cost and expense associated with that effort; and other risks, including those set forth in the company's reports filed with the Securities and Exchange Commission, including its most recently filed Annual Report on Form 10-K.
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