Tuesday August 26 9:15 AM EDT
Company Press Release
Source: Urologix, Inc.
Urologix Receives FDA Approval on New Microwave System
for Treating Enlarged Prostate Disease
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. |
