Matritech's NMP22 BladderChek Found Approvable By The FDA; Rapid Test Format Easy to Use in Physician's Office, Returns Results in 30 Minutes.

Business Editors/Health/Medical Writers

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NEWTON, Mass.--(BUSINESS WIRE)--March 3, 2003

The U.S. Food and Drug Administration has completed its review of the first urine screening test that physicians can use in their offices to help diagnose patients with bladder cancer. The FDA notified Matritech (NASDAQ: NMPS) that the NMP22(R) BladderChek(TM), which detects bladder cancer proteins in patients' urine, is approvable as an aid in diagnosing bladder cancer patients. The point-of-care test will be permitted for this expanded use upon successful completion of a routine manufacturing facility inspection, expected to be completed promptly.

NMP22 BladderChek is a simple to use device, like a home pregnancy test, and provides results in 30 minutes while the patient is in the physician's office. By placing four drops of urine on the BladderChek cassette, a physician is able to detect the presence of elevated NMP22, a nuclear matrix protein correlated with bladder cancer. A purple line appears to indicate bladder cancer.

"This is excellent news for the early detection of bladder cancer," said Mark Soloway, M.D., professor and chairman, department of urology at the University of Miami School of Medicine. "Too many men and women with bladder cancer are diagnosed at a time when the cancer is at an advanced stage. Early diagnosis provides a better opportunity for a cure. Examination of the urine for tumor related substances such as NMP22 will provide an opportunity for men and women with risk factors for bladder cancer, for example cigarette smokers, to be tested. The results of the comprehensive, 22-site clinical study with NMP22 BladderChek indicate that this protein is often elevated in the urine of those with bladder cancer."

In July 2002, Matritech received FDA clearance to market NMP22 BladderChek for monitoring patients previously diagnosed with bladder cancer. Cytogen Corporation (NASDAQ:CYTO), a company with extensive experience and relationships in the urologic oncology field, distributes the test to urologists in the United States. NMP22 is one of only two immunoassay fluid tests approved by the FDA for screening patients for cancer; the other is the Prostate Specific Antigen test.

According to the American Cancer Society, 41,500 new cases of bladder cancer are diagnosed in men each year. This incidence in men is almost as great as colon cancer. If diagnosed in its early stages, the five-year bladder cancer survival rate exceeds 90 percent. However, 12,400 people in the United States died of bladder cancer in 2001. Many of these died because the disease was not caught in its earliest stages. If the cancer reaches an advanced stage, the five-year survival rate can be less than 10 percent.

"Bladder cancer is a serious malignancy faced by a large number of people each year. It is critical that we fight bladder cancer with the best diagnostic tools possible," said Steve Chubb, chairman and CEO of Matritech. "The earlier physicians can detect cancer, the more effective treatment can be and the greater the chance of patient survival."

Smoking, the most common cause of bladder cancer, can double a person's risk for developing bladder cancer. Those at risk also include people in specific occupations, including rubber, chemical and leather industry workers, hairdressers, machinists, metal workers, printers, painters, textile workers and truck drivers.

"Smokers need to be acutely aware of their risk for bladder cancer," said Dr. Robert Schlesinger, the senior urologist for the Massachusetts Department of Health. "Heavy smokers and those exposed to excessive secondhand smoke should talk with their physician and be further evaluated for bladder cancer, especially if there is evidence of blood in the urine. The Matritech NMP22 BladderChek should be performed in preference to a urine cytology."

NMP22 BladderChek is a notable improvement over cytology, a current urine laboratory test for bladder cancer. Clinical trial results reviewed by the FDA show NMP22 BladderChek detected 3 times more early stage bladder tumors and twice as many life threatening, high-grade tumors as cytology.

Physicians are using BladderChek in conjunction with cystoscopy, the primary clinical procedure used by urologists to visually identify tumors in the bladder.

Clinical Results

Matritech's clinical trial included 1,331 individuals from 22 trial sites in 9 states. In addition to the trial results that showed increased accuracy over cytology, previous study findings showed that NMP22 BladderChek results are not hindered by the common occurrence of blood in urine samples. Other urine tests often exhibit false-positives or do not return an answer when blood contaminates the sample.

Matritech's laboratory test for NMP22 received FDA approval in 1996. This test also measures the level of NMP22 in urine and has been approved by the FDA both for diagnosing patients with bladder cancer as well as monitoring previously diagnosed patients.

Rapid Results

NMP22 BladderChek provides a patient with an answer about his or her status in 30 minutes. With other cancer tests, the patient must often go home and wait several days for lab test results. With NMP22 BladderChek, the patient receives an answer in the comfort of the doctor's office where he or she can ask additional questions and discuss next steps.

How NMP22 BladderChek Works

The technology identifies proteins that are highly overexpressed in bladder cancer patients. Matritech and Massachusetts Institute of Technology researchers discovered 10 years ago that high levels of the nuclear matrix protein, NMP22, in urine frequently indicated the presence of cancer. NMPs are found in the nuclei of cells where they contribute to the nuclear structure and regulate various cell functions. NMP22 is elevated in bladder cancer cells 20 to 80 fold and is released into the urine of bladder cancer patients.

Matritech's Product Pipeline

FDA approval for NMP22 BladderChek marks a significant milestone for the company by providing further validation of Matritech's proprietary technology. The company will seek to apply the BladderChek point-of-care format to other cancer tests under development, including tests for prostate and breast cancer.

About Matritech

Matritech is a leading developer of proteomics-based diagnostic products for the early detection of cancer. Using its patented proteomics technology, Matritech has identified proteins correlated with bladder, cervical, breast, prostate and colon cancers. Matritech is one of the first companies to successfully employ proteomics to create diagnostic products. The Company holds one of only two FDA tumor marker approvals for the initial detection of cancer. The FDA-approved NMP22(R) bladder cancer test is currently used by urologists. In addition, the Company has blood-based tests for breast cancer (NMP66(TM)) and prostate cancer (NMP48(TM)) under development. NMP technology is licensed exclusively to Matritech from the Massachusetts Institute of Technology.

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