MINNEAPOLIS, April 3 /PRNewswire/ -- Urologix, Inc. (Nasdaq: ULGX), today
announced it received notification that the Food and Drug Administration (FDA)
has completed an initial review of the company's pre-market approval (PMA)
application for its Targeted Transurethral Thermo-ablation Therapy (T3(R))
System and has determined that the PMA is suitable for filing.  Further, the
FDA stated that, based on its initial review, the PMA for the T3 System
-- designed to treat enlarged prostate disease or benign prostatic hyperplasia
(BPH) -- would not to be referred to an FDA advisory panel for review and
recommendation.
    "We are pleased that the FDA has accepted our PMA for filing," said Jack
Meyer, president and chief executive officer of Urologix.  "This is a positive
indication that our efforts to obtain the regulatory approval necessary for
marketing the T3 System in the important U.S. market remains on track.
Because of this, we are refining our marketing strategy for the U.S.  Once
approved, we plan to reach the estimated 7,500 urologists who treat BPH
patients in the U.S. through a direct sales force.  In addition, Jack
Costello, our recently appointed executive vice-president for sales and
marketing, is actively recruiting to build the domestic sales management
infrastructure necessary to launch the T3 System after FDA commercial
marketing approval has been achieved."
    The FDA will proceed with a substantive review of the T3 PMA.  Prior to
PMA approval, the company's manufacturing facilities will be subject to an FDA
inspection to determine compliance with applicable device Good Manufacturing
Practice (GMP) regulations.  Also, several clinical trial sites have already
been inspected by FDA for Good Clinical Practice (GCP) regulatory compliance,
which indicates the FDA's forward movement in the PMA review process.
    According to the FDA, its determination of the PMA's suitability for
filing does not imply that an in-depth evaluation of safety and effectiveness
has taken place or that any decision regarding the ultimate approvability of
the application has yet been made.  Further review could result in the
identification of deficiencies in the PMA.  Also, the FDA's decision to not
refer the T3 PMA to an FDA advisory panel is subject to change should the
substantive review of the T3 System's data supporting its safety and
effectiveness produce information or issues which the FDA believes warrants
review by an FDA advisory panel.
    Note:  Certain statements in this press release are "forward-looking" and
are subject to risks and uncertainties inherent in the development, regulatory
approval and marketing of the company's products.  These risks and
uncertainties include:  uncertainties about the regulatory approval process
and timing, the Company's ability to successfully market its product in the
United States if FDA commercial marketing approval is achieved, competition
from other treatments for BPH and other risks inherent in the company's
business as discussed in the company's reports filed with the SEC, including
its Form 10-K for the year ended June 30, 1996 and its Form 10-Q for the
quarter ended December 31, 1996.
    Urologix, Inc., based in Minneapolis, is a rapidly emerging developer and
marketer of minimally invasive medical products for the treatment of
urological disorders.  The company has developed the Targeted Transurethral
Thermo-ablation (T3(R)) System, a non-surgical, anesthesia-free, catheter-
based therapy that uses a proprietary microwave technology for the treatment
of BPH.

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