Company Press Release
UroMed Unveils Innovative Breast Cancer Detection And
Prostate Cancer Surgery Product Lines
NEEDHAM, Mass., Oct. 21 /PRNewswire/ -- UroMed Corporation (Nasdaq:URMD) today unveiled two new product lines: the first product offering, the BreastCheck(TM) breast self examination device together with its physician- use BreastExam(TM) counterpart device, may
potentially enhance breast cancer detection. The second product offering, the CaverMap(TM) Surgical Aid, assists in sparing vital nerves typically damaged during prostate cancer surgery. Both of
these unique and innovative products potentially offer significant benefits to the millions of American women and men who are at risk.
John G. Simon, UroMed's chairman of the board and chief executive officer commented, ''Today's unveiling presents innovative products that are aimed at addressing two significant areas of public
health disorders with large prevalence. This product unveiling is a huge milestone for us, representing the culmination of many years of effort and millions of dollars of work on our part.''
''Breast cancer afflicts more than 180,000 newly-diagnosed women annually in the United States and an estimated 46,000 American women die of this disease every year. Although breast cancer cannot be prevented, if detected at an early, treatable stage, the survival rate can be as high as 96 percent. The BreastCheck device is designed to assist women with their monthly breast self exams by potentially improving sensitivity for suspicious breast lumps and roviding a greater level of comfort to women. Our BreastExam product addresses a similar challenge that physicians face when performing clinical breast exams. Together we hope these products will potentially increase the
sensitivity of detection at an earlier stage for both women and physicians,'' Simon continued.
Alan West, Managing Director of UroMed Corporation's Assurance Medical Division -- the unit developing this BreastCheck technology -- stated, ''While these new hand-held breast exam devices are simple to operate, they utilize advanced electronics and miniature pressure sensors which
are glided over the breast, gently ''palpating'' the breast in a manner similar to the human hand. Based on the preliminary results to date, we anticipate that using these devices might potentially
discover more lumps at an earlier stage, when the outcome of medical intervention is significantly better.''
Gary John Bowers, M.D., F.A.C.S., Associate Director of the University of Florida Cancer Center in Jacksonville, stated, ''As a breast surgeon, I am excited about the prospects for the devices
UroMed is developing. The technology of electronic palpation offers the potential opportunity to provide women, as well as physicians, with a more sensitive and objective breast examination. There
are 90 million American women in whom breast self exams and clinical breast exams could be potentially improved with this technology.''
The BreastCheck technology is an investigational technology which requires a Pre-Market Approval (PMA) application regulatory process with the U.S. Food and Drug Administration (FDA). The PMA application is designed for the approval of new technology where no 'substantially equivalent'' technology has been approved by the FDA. The Company has had several productive meetings with representatives from the FDA, and a clinical protocol has been tentatively agreed upon. UroMed has been granted Expedited Review Status from the FDA for this product line. UroMed has completed numerous preliminary clinical studies involving more than 500 women to finalize the sensor and electronics, develop the algorithms and test different protocols for the BreastCheck
technology. The PMA clinicals are slated to begin in early 1998 at a number of prominent U.S. medical institutions. The technology may be available to women in the U.S. as early as the first part
of 1999 if FDA approval is obtained within that time frame.
UroMed's second unveiling features the CaverMap Surgical Aid which may potentially be used to help physicians identify and spare nerves associated with prostate cancer surgery.
''It is estimated that in 1997 approximately 334,500 new prostate cancer cases will be diagnosed and 41,800 prostate cancer-related deaths will occur in the United States,'' stated John G. Simon.
''It is also estimated that 60 percent of these cases will be localized cancer and may benefit from surgery or radiation treatment. UroMed believes that the use of the CaverMap Surgical Aid during
prostate cancer surgery may help the surgeon improve outcomes by reducing complications. Our goal in developing the CaverMap Surgical Aid is to provide physicians with a device capable of helping them locate nerves which may significantly affect the lives of men undergoing prostate cancer surgery. We are pleased to announce that our 510(k) application for our CaverMap Surgical Aid
technology is currently pending at the U.S. FDA. The technology may be commercially available to men in the U.S. as early as the first half of next year if FDA clearance is obtained within that time
frame.''
Richard Epstein, Managing Director of UroMed's Urovations Division -- the unit developing this CaverMap Surgical Aid technology -- said, ''This innovative system assists the surgeon in locating
and mapping the cavernosal nerve filaments in a manner analogous to a metal detector finding hidden objects. By knowing the precise location of these nerve filaments, the surgeon can make the best
possible decision on what tissue to extract in order to best remove the cancer while sparing nerves vital for potency and other functions.''
Dr. Laurence Klotz, Research Director, Division of Surgical Oncology, Toronto Bayview Regional Cancer Center, Toronto, Canada added, ''There are approximately 120,000 to 140,000 prostate cancer surgeries performed each year in the United States. The initial results from a Canadian single-centre trial suggest that this technique could enhance the outcome of surgery in many patients.''
UroMed's patented technology for the CaverMap Surgical Aid system uses state-of-the-art electronics to stimulate and sense the function of the microscopic cavernosal nerves that control erectile function. This system integrates leading edge nerve stimulation technology, ultra-sensitive strain gauge technology and advanced software algorithms with an ergonomic design for use deep in the pelvic cavity. The system includes a reusable portion, a monitor, and a disposable portion for each nerve-sparing prostate cancer surgery.
UroMed, founded in October 1990, is dedicated to establishing itself as a leader in the development of male and female healthcare products. Its initial area of commercial focus is the provision of a unique integrated system of continence care for health professionals, patients and payors. Currently, UroMed's system includes the Reliance(R) Urinary Control Insert and the INTROL(R) Bladder
Neck Support Prosthesis -- all FDA-cleared for marketing, as well as the PelvicFlex(TM) educational training video. In addition, next year UroMed will be offering its FDA-cleared continuum care products, the Impress(TM) Softpatch, as well as its FDA-cleared BEACON Technology
System(TM), a minimally invasive incontinence surgical line. With today's announcement, UroMed broadens its surgical therapeutic interest to prostate cancer as well as incontinence. Most
significantly, it also broadens its female healthcare interest into the critically important area of early breast cancer detection. UroMed continues to dedicate significant resources to the development
and/or acquisition of new options that fit into UroMed's continuum of care in male and female healthcare.
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 BreastCheck, BreastExam, and the CaverMap Surgical Aid, the timing related to regulatory clearance for 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 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. |
