U.S. Launch Expected in Fourth Calendar Quarter
MINNEAPOLIS, Aug. 26 /PRNewswire/ -- Urologix, Inc. (Nasdaq: ULGX), a
rapidly emerging developer and marketer of minimally invasive medical products
for the treatment of urological disorders, announced today that it has
received Food and Drug Administration (FDA) approval to market its new
microwave system for the treatment of benign prostatic hyperplasia (BPH),
commonly known as enlarged prostate disease. The system, known as the T3(R)
System during its development and clinical trials, will be introduced to the
market as the Targis(TM) system. With approval in the U.S., the company now
has clearance to market the Targis system in the world's most influential
health care markets -- the 18 European Union countries, the U.S., Japan and
Canada.
"The U.S. approval is the most significant regulatory milestone in
Urologix's history," said Jack Meyer, president and chief executive officer.
"We are delighted with the cooperation received from the FDA and believe
receipt of FDA approval in only 180 days after filing our application is
indicative of the high quality and integrity of the Targis system clinical
results and manufacturing processes. We are anxious to introduce our
breakthrough microwave technology and provide this anesthesia-free, cost-
effective treatment alternative to the millions of men in the U.S. whose
quality of life is significantly effected by the troublesome symptoms
associated with BPH."
"Because of the earlier than expected FDA clearance, the Targis system
launch has been moved up to the middle of the fourth calendar quarter. We
plan on using a direct sales approach in the U.S. to target the approximately
7,800 urologists here. We began preparing for our U.S. launch in the June
quarter and are now accelerating those activities which include building
inventory, hiring sales representatives and developing promotional materials,"
added Meyer.
The Targis system is a non-surgical, catheter based system that treats
BPH, a condition affecting over 23 million men worldwide. In the U.S., more
than six million men suffer from moderate-to-severe BPH symptoms and over
$3 billion is spent annually treating the disease. The company estimates that
less than 30 percent of these patients are currently treated for their BPH
symptoms because available treatments are either invasive, ineffective, or can
cause undesirable side effects. This presents an opportunity for Urologix to
penetrate the domestic market by providing a compelling alternative solution,
enticing more men to seek treatment.
Results from the pivotal clinical study submitted to the FDA indicate that
the Targis system significantly improves BPH symptoms and urinary flow rates
as compared to pre-treatment rates, and as compared to a control group of
patients. Complications were minimal, and the treatments were well tolerated
with no requirements for anesthesia services.
"The Targis system represents a completely new microwave technology,
because of its unique ability to target heat delivery into the confines of the
prostate, while maintaining patient comfort during the procedure," said Thayne
Larson, M.D., urologist at the Mayo Clinic and first U.S. clinical
investigator for the Targis system. "Urologists are now able to destroy the
diseased tissue while preserving healthy tissue. This gives us an effective,
durable treatment that can be delivered in a clinic as a truly anesthesia-free
therapy."
In comparison to currently available treatments, the Targis system is
favorably positioned. The most common surgical solution, TURP, is more costly
and invasive than the Targis system and carries a higher risk of
complications. Clinical results of the Targis system demonstrate superior
relief of BPH symptoms compared to published clinical results of drug therapy,
without the reported side effects or the costs of long-term medication use.
As compared with interstitial therapy, which employs a rigid scope with
electrodes or laser fibers used to pierce through the sensitive urethra to
reach the diseased tissue behind it, the Targis system uses a flexible
catheter that does not require puncturing the urethra to destroy the diseased
cells, enabling it to be administered without general or regional anesthesia
or intravenous sedation.
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 Targis(TM) system, a non-
surgical, anesthesia-free, catheter-based therapy that uses a proprietary
microwave technology for the treatment of BPH.
Statements included in this press release that are not historical or
current facts are "forward-looking statements" made pursuant to the safe
harbor provisions of the Private Securities Litigation Reform Act of 1995 and
are subject to certain risks and uncertainties that could cause actual results
to differ materially. These factors include: (1) competition from other
existing or new BPH treatments or devices; (2) the Company's ability to
successfully market its product in the United States through sales
representatives; (3) the ability of the Company's distributors to successfully
market and sell the Company's products in markets outside the United States;
(4) the Company's ability to successfully manufacture the Targis system in
sufficient quantities to meet future demand for the products (5) the extent to
which the physicians performing the Targis system procedures are able to
obtain third party reimbursement.
SOURCE Urologix, Inc.
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CONTACT: Jack Meyer, President & CEO, or Wes Johnson, CFO, both of Urologix, 612-475-1400; or Mike Arneth, Leslie Hunziker, or Analyst Inquiries, Kathy Brunson, of The Financial Relations Board, 312-266-7800
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