PR Newswire, Thursday, December 18, 1997 at 09:25
NEEDHAM, Mass., Dec. 18 /PRNewswire/ -- UroMed Corporation (NASDAQ:URMD),
a company committed to men's and women's health care, today announced that
UroMed's Impress(TM) Softpatch manufacturing equipment has passed vendor
factory acceptance and is in the process of being installed at the company's
Needham headquarters. Installation is expected to be completed in January
1998.
The Impress Softpatch was developed to aid women with mild to moderate
stress urinary incontinence (SUI). The device has received marketing
clearance from the Food and Drug Administration. The product is an external,
non-invasive, comfortable and discreet device which creates a seal to block
urine leakage. UroMed's continuum of continence care products also includes
the Reliance(R) Urinary Control Insert, the INTROL(R) Bladder Neck Support
Prosthesis, the PelvicFlex(TM) Personal Trainer Video, and the BEACON
Technology System(TM) minimally invasive surgical line. All of these products
are intended to offer relief to the millions of American women who suffer from
stress urinary incontinence.
John G. Simon, UroMed's chairman of the board and chief executive officer
commented, "With this important manufacturing milestone accomplished, we
anticipate commencing commercialization of the Impress Softpatch in a targeted
way early next year. Our U.S. launch is currently targeted for the
March/April timeframe following our in-house validation and inventory build
efforts."
"In preparing for the commercial launch of Impress, we have identified
some critical success factors: reimbursement, patient and physician education,
co-promotional efforts and other marketing strategies which expand patient
access, and the importance of prescribing the device to the correct patient
group," Simon continued. "The group for which we project the best results is
women with mild to moderate stress urinary incontinence. This is the largest
segment within the urinary incontinence market, and it is the segment at which
Impress must be targeted. We are actively addressing each of these critical
success factors to prepare for opportunities within this emerging market."
"In addition, we are aggressively pursuing co-promotion partnerships and
other activities that would allow us to better address the large number of
mild to moderate stress urinary incontinence sufferers. These efforts are
critical for our ultimate success with the significant opportunity we have
with our Impress product line. We anticipate reporting in more detail on
these efforts in the first quarter of 1998 as we finalize our Impress
Softpatch commercialization plans," Simon concluded.
UroMed, founded in October 1990, is dedicated to establishing itself as a
leader in the development of male and female healthcare products. UroMed has
three primary areas of initial focus: breast cancer, prostate cancer and
incontinence. In the area of incontinence UroMed offers the Reliance(R)
Urinary Control Insert and the INTROL(R) Bladder Neck Support Prosthesis --
both FDA-cleared for marketing, as well as the PelvicFlex(TM) Personal Trainer
Video. Next year, in addition to the Impress(TM) Softpatch, UroMed will be
offering its FDA-cleared continuum of care products and the BEACON Technology
System(TM), a minimally invasive incontinence surgical line for use by
urological and gynecological surgeons. In the area of prostate cancer UroMed
will be offering its FDA-cleared CaverMap(TM) Surgical Aid system next year as
well. CaverMap aids the urological surgeon in the important effort of
locating and sparing important nerves during prostrate cancer removal
operations. In the area of breast cancer, UroMed is developing its
BreastCheck(TM) breast self examination device together with its physician-use
BreastExam(TM) counterpart device. Both devices may potentially enhance
detection of suspicious breast lumps. The BreastCheck technology is an
investigational technology and may be available to women in the U.S. as early
as the first half of 1999 if FDA approval is obtained within that timeframe.
UroMed also continues to dedicate significant resources to the development
and/or acquisition of new options that fit into UroMed's continuum of care in
key complementary areas of male and female healthcare.
For more information on UroMed's products, please visit our web site
at www.uromed.com.
The Company recognizes that the previous paragraphs contain forward-
looking statements relating to the Company's future activities, including
timing related to the commencement of marketing activities for and the
commercial launches of the Impress Softpatch, BEACON Technology System,
BreastCheck, BreastExam, and the CaverMap Surgical Aid, the timing related to
regulatory clearance for certain of these products, the size of the potential
market for products based on such technology, coordination of products based
on such technology with UroMed's other products, and the Company's
expectations for progress with respect to its U.S. revenue build due to
product launches, and the development of new products. These forward-looking
statements are based largely on the Company's expectations and are subject to
a number of risks and uncertainties beyond the Company's control. Actual
results could differ materially from these forward-looking statements as the
result of certain risks, including the risk that physicians will not prescribe
or use its products in significant numbers, the risk that patients or
physicians using its products will not develop into long term users, the
uncertainty of receiving required regulatory clearance, the uncertainty of
manufacturing scale-up and general market acceptance of the BreastCheck,
BreastExam, the CaverMap Surgical Aid and the Company's incontinence product
line, as well as the Company's dependence on these products going forward and
the risk that the Company will not be able to successfully develop any new
products. There can be no assurance that these risks would not have a
material adverse effect on the Company. Other relevant risks are described in
the Company's Annual Report on Form 10-K for the year ended December 31, 1996,
under the headings "Forward-Looking Statements and Associated Risks" and "Risk
Factors," which are incorporated herein by reference.
NOTE: INTROL(R) Bladder Neck Support Prosthesis and Reliance(R) Urinary
Control Insert are registered trademarks of UroMed Corporation. Impress(TM)
Softpatch, PelvicFlex(TM) Personal Trainer Video, BEACON Technology
System(TM), BreastCheck(TM), BreastExam(TM) and CaverMap(TM) Surgical Aid are
trademarks of UroMed Corporation.
SOURCE UroMed Corporation
-0- 12/18/97
/CONTACT: Kristen Galfetti, Manager of Investor Relations of UroMed
Corporation, 781-433-0033, or James R. Buckley, Senior Consultant of Sharon
Merrill Associates, Inc., 617-542-5300/
/Web site: uromed.com |
