MATRITECH REPORTS NOTIFICATION OF MARKETING APPROVAL IN JAPAN FOR ITS NMP22(R) BLADDERCHEK(R) TEST
Matritech, Inc. (Amex: MZT) a leading developer of protein-based diagnostic products for the early detection of cancer, today announced it b>has been notified by its distribution partner in Japan that its point-of-care cancer diagnostic NMP22(R) BladderChek(R) Test received marketing approval from the Japanese Ministry of Health, Labor and Welfare for testing of bladder cancer. Matritech's Japanese distributor, Medical & Biological Labs. Co., Ltd. (MBL) has begun sales and distribution of BladderChek Test, which is now referenced on its website (http://www.mbl.co.jp/index.html).
"We are very pleased about the approval in Japan," said David L. Corbet, Matritech's President and COO. "This represents another milestone in the recognition of the clinical benefits of our BladderChek Test and in our continued efforts to bring BladderChek Test to patients and physicians for the earlier and improved detection of bladder cancer."
In June 2005 Matritech announced that more than 600,000 BladderChek Tests had been sold for testing of bladder cancer. In May, 2005 the NMP22 BladderChek Test was featured in a number of platform presentations at the 100th annual meeting of the American Urological Association (AUA); these included clinical trial results and a cost effectiveness study. Earlier in the year, the Journal of the American Medical Association (JAMA), published results from a large scale multi-site clinical trial of the NMP22 BladderChek Test 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 life threatening cancers missed during cystoscopic examination, and it detected three times as many bladder cancer malignancies as cytology, a commonly used laboratory based urine test. The study further showed that when the BladderChek Test is combined with cystoscopic examination, it increases overall bladder cancer detection to 94%.
About the NMP22(R) BladderChek(R) Test
The NMP22 BladderChek Test was developed and commercialized by Matritech, an international biotechnology company headquartered in Massachusetts.
The NMP22 BladderChek Test detects elevated levels of the NMP22 protein in a single urine sample. Some healthy individuals have very small amounts of the NMP22 protein in their urine. Bladder cancer patients commonly have elevated NMP22 protein levels, even at early stages of the disease.
A painless and non-invasive assay, the NMP22 BladderChek Test is the only in-office test approved by the FDA for the diagnosis of bladder cancer. The BladderChek Test, which is reimbursed by Medicare and other medical insurers, 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(R) 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 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. Beginning with a patent portfolio licensed exclusively from the Massachusetts Institute of Technology (MIT), Matritech's patent portfolio has grown to 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.
Statement under the Private Securities Litigation Reform Act
Any forward-looking statements relate to the Company's current expectations of the Company's product sales and technology. Actual results may differ materially from those predicted in such forward-looking statements due to the risks and uncertainties inherent in the Company's business, including without limitation risks and uncertainties in obtaining and maintaining regulatory approval, market acceptance of and continuing demand for the Company's products, the impact of competitive products and pricing, and technical challenges in completing product and technology development. Please refer to the risk factors detailed in the Company's periodic reports and registration statements as filed with the Securities and Exchange Commission. These forward-looking statements are neither promises nor guarantees. There can be no assurance that the Company's expectations for its products or future financial performance will be achieved. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Matritech undertakes no responsibility to revise or update any such forward-looking information.
Matritech, Inc. Kathleen O'Donnell, 617-928-0820 x270 |
