Matritech's NMP22 BladderChek Test Featured in Presentation on Detection and Screening of Bladder Cancer at American Urological Association Annual Meeting.

SAN ANTONIO -- BladderChek(R) Point-of-Care Test Detected Three Times More Malignancies than the Currently Used Laboratory Based Urine Cytology Test

Matritech (Amex: MZT) a leading developer of protein-based diagnostic products for the early detection of cancer, today announced that its NMP22(R) BladderChek(R) Test was featured in a presentation on "Advances in Bladder Cancer Detection and Screening" at the American Urological Association (AUA) annual meeting. Urologists Giora Katz, M.D., Department of Surgery-Urology Service, Lake City Veterans Administration Hospital, and Lake Shore Urology, Manitowoc, Wisconsin and Edward Messing, M.D., Department of Urology, University of Rochester Medical Center, Rochester, New York reported results from a large multi-center clinical study that showed the NMP22 BladderChek Test, a point-of-care cancer diagnostic test, detects three times as many bladder cancer malignancies as cytology, a commonly used laboratory based urine test.

"This is good news for people at risk for bladder cancer," stated Dr. Katz. "Our challenge is to improve the detection of bladder cancer; and our research showed that the BladderChek Test enhances the detection of bladder cancer, especially when combined with cystoscopy. It's very common for people with bladder cancers to be diagnosed much later than we'd like. This test is easy - it is performed in the doctor's office and results are available while the patient waits - and it may save lives."

Earlier this year, the Journal of the American Medical Association (JAMA), published similar NMP22 BladderChek Test results, citing in its news, "New Test Improves Detection of Bladder Cancer." The study results published in JAMA showed the NMP22 BladderChek point-of-care Test identified four, life threatening cancers missed during cystoscopic examination. The study further showed that when the BladderChek(R) Test is combined with cystoscopic examination, it increases overall bladder cancer detection to 94%.

Dr. Edward Messing, a co-author with Dr. Katz, explained that the BladderChek Test could reduce the need to do the invasive cystoscopic urethral procedure twice, once for detection and a second time in the operating room to remove tumors.

Dr. Messing commented, "With the NMP22(R) BladderChek(R) Test, we would know the cancer cells exist. Then we could schedule the cystoscope procedure under anesthesia to remove the tumors in the operating room." He added, "The NMP22 Test can be completed in an office setting in less than an hour. This certainly advances our ability to diagnose bladder cancers more easily and less expensively. Hopefully, more at risk patients will be encouraged to be evaluated."

Hematuria, an Early Sign of Bladder Cancer

In his presentation, Dr. Katz explained how he uses the NMP22 BladderChek Test to screen patients for bladder cancer when they have blood in their urine. Hematuria (blood found visually or microscopically in the urine) is a symptom of bladder cancer, but it can also be present in other non-cancerous conditions. In this multicenter study, 92% of the 1,331 patients in the study had traces of blood in their urine.

"Almost all patients with bladder cancer have hematuria, but many others, more than 10 times as many, have hematuria from non-cancer related causes," explained Dr. Katz. "Since hematuria is an important and early sign of bladder cancer we need to investigate everyone with it to save lives, but we end up investigating about 20 people with hematuria to find one with bladder cancer."

Dr. Katz continued, "Previously this work-up has been costly and involved a variety of tests and X-rays. The NMP22 BladderChek Test helps us focus our search closer to those with cancer, expediting early diagnosis and helping the urologist to be more confident in determining the cause of the hematuria."

If diagnosed at an early stage, bladder cancer is treatable and the five-year survival rate is 95%. If found at an advanced stage, however, the five-year survival rate for bladder cancer can be less than 10%.

Dr. Katz said that he uses the NMP22 BladderChek Test to help distinguish between benign and malignant causes of hematuria. In his urology practice "the BladderChek Test is doing just that," he explained.

Dr. Katz's clinical experience with the NMP22 BladderChek Test includes the Veterans Health Administration (VA) Hospital in Lake City, Florida, which was one of 23 sites participating in this clinical study. He noted that the VA is the largest provider of health care in the country and observed, "A majority of the patients in the VA are at high risk for bladder cancer because they are males, over 50 years of age, and have a history of smoking." According to Dr. Katz, the VA uses a variety of resources to investigate patients with hematuria. "We found we can use the BladderChek Test to help direct resources to patients with the highest suspicion of cancer."

About the NMP22(R) BladderChek(R) Test

The NMP22 BladderChek Test was developed and commercialized by Matritech, a Massachusetts based biotechnology company.

The NMP22 BladderChek Test detects elevated levels of the NMP22 protein in a single urine sample. Healthy individuals generally have very small amounts of NMP22 protein in their urine. NMP22 protein levels, however, are often elevated in the urine of patients with bladder cancer, even at early stages of the disease.

The NMP22 BladderChek Test, a painless and non-invasive assay, is the only in-office test approved by the FDA for the diagnosis of bladder cancer. The BladderChek Test, which is reimbursed by Medicare at about $24, is more cost effective than cell-based laboratory cytology tests. It is approved for use in a physician's office with results available during the patient visit, allowing a rapid, accurate and cost-effective way to aid in the detection of bladder cancer. NMP22 Tests have been approved by the FDA four times for two formats and claims, most recently in April 2003 for point-of-care use for diagnosis.

About Bladder Cancer

Bladder Cancer is the fifth most common form of cancer in the United States and the ninth most common form of cancer in the world today. The American Cancer Society estimates that over 63,000 new cases of bladder cancer will be diagnosed in the United States this year (over 47,000 men and 16,000 women), and over 13,000 people will die of the disease (nearly 9,000 men and 4,000 women). Worldwide it accounts for 330,000 new cases and 100,000 deaths each year. It is also one of the most chronic cancers, recurring in almost 70% of patients.

Bladder cancer occurs primarily in men age 60 and older and roughly twice as frequently in white men as in black men. Men are four times more likely to be diagnosed with bladder cancer than women; age-adjusted mortality rates from bladder cancer are similarly higher for men than for women. Among U.S. males, the incidence of new bladder cancer cases is almost as large as the incidence of colon cancer.

The most common risk factor for bladder cancer is smoking. Smokers are twice as likely to develop bladder cancer as nonsmokers. In the United States, smoking is estimated to be associated with about 50% of bladder cancer deaths among men and 30% among women. The most common symptom of bladder cancer is blood in the urine, a condition referred to as hematuria.

Occupational exposures to chemicals (aromatic amines) used in dry cleaning facilities and the production of dyes, paper, rope, apparel, rubber and petroleum products have been associated with increased risk for bladder cancer. Other industrial exposures implicated as risk factors for developing bladder cancer include combustion gases and soot from coal, chlorinated aliphatic hydrocarbons, and chlorination by-products in heated water.

If diagnosed in its early stages, bladder cancer has a five-year survival rate of 95%. If diagnosed at an advanced stage, however, the five-year survival rate can be less than 10%. It has been estimated that this year in the United States about 25% of bladder cancer patients will be diagnosed after their disease has become invasive or metastatic, significantly lowering the five year survival rate.

About the Study

The blinded study was conducted in 23 academic, private practice and veterans' facilities in 10 states. Participants included 1,331 patients at elevated risk of bladder cancer based on hematuria (92%), history of smoking or irritative voiding symptoms. Patients provided a voided urine sample for analysis of NMP22 protein and cytology prior to cystoscopy.

The study was designed to evaluate the clinical utility of the NMP22(R) BladderChek(R) Test, a new point-of-care proteomic test, in enhancing the detection of bladder cancer. The performance of the NMP22 BladderChek Test, that measures the NMP22 nuclear matrix protein in urine, was compared to voided urine cytology, which must be analyzed in a clinical laboratory. Both are adjunctive tests to cystoscopy in diagnosing bladder cancer. Unlike cell-based laboratory tests, detection of NMP22 protein in the urine does not depend on recovery of intact cells. Malignant transitional cells contain up to 80 times higher concentration of NMP22 protein than normal transitional cells.

The BladderChek Test was also shown to be more effective than cystoscopy alone in detecting later stage bladder cancers. Initial cystoscopy visualized 60% of the invasive tumors, compared with the BladderChek Test which was positive for 90% of those with the life threatening condition. By comparison, cytology was positive for only 22% of the patients with muscle invasive cancer. The BladderChek Test was also positive for a patient with carcinoma in situ (cancer that had not spread to surrounding tissues) after an initial cystoscopy report of benign disease.

About Matritech

Matritech is using its patented proteomics technology to develop diagnostics for the detection of a variety of cancers. The Company's first two products, the NMP22(R) Test Kit and NMP22(R) BladderChek(R) Test, have been FDA approved for the monitoring and diagnosis of bladder cancer. The NMP22 BladderChek Test is based on Matritech's proprietary nuclear matrix protein (NMP) technology, which correlates levels of NMPs in body fluids to the presence of cancer. Matritech's patent portfolio includes three patents exclusively licensed from the Massachusetts Institute of Technology and more than 15 other U.S. patents. In addition to the NMP22 protein marker utilized in the NMP22 Test Kit and NMP22 BladderChek Test, the Company has discovered other proteins associated with cervical, breast, prostate, and colon cancer. The Company's goal is to utilize these protein markers to develop, through its own research staff and through strategic alliances, clinical applications to detect cancer. More information about Matritech is available at www.matritech.com.

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