Urologix gets FDA approval for CoolWave control unit

By Elaine Rigoli

Tampa, Fla., April 6 - Urologix, Inc. has received permission, through the approval of three premarket approval supplements relating to new hardware and software, from the Food and Drug Administration to market its new CoolWave control unit for the treatment of benign prostatic hyperplasia (BPH).

Urologix said it plans to launch CoolWave in the first quarter of fiscal 2007, following select post-approval trials.

"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," chairman and chief executive officer Fred B. Parks said in a news release.

The user interface and increased processing power of CoolWave allow urologists to set customized treatments for their BPH patients, including those with small glands and symptomatic BPH, officials said.

Urologix, based in Minneapolis, develops, manufactures and markets minimally invasive medical products for the treatment of urological disorders.

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