Healthcare Industry News: BladderChek
News Release - November 6, 2006
Matritech and Inverness Medical Innovations Sign Agreements for the Manufacturing and OTC Distribution of the NMP22(R) BladderChek(R) Test
Companies Embark on First At-home Cancer TestNEWTON, Mass.--(HSMN NewsFeed)--Matritech (Amex: MZT ), a leading developer of protein-based diagnostic products for the early detection of cancer announced today that it has signed agreements for the manufacture and distribution of Matritech's NMP22® BladderChek® Test with Inverness Medical Innovations, Inc. (Amex: IMA ), a leading manufacturer and supplier of rapid diagnostic products for the consumer and professional markets. Inverness will begin supplying the point-of-care urine test that is used in the diagnosis of bladder cancer. Under a separate agreement, Inverness will become the exclusive U.S. distributor of the test to be sold through over-the-counter retail channels.
The NMP22 BladderChek Test is a prescription diagnostic test. Under the terms of the distribution agreement, the companies plan to collaborate in assessing the market opportunity and preparing and submitting a regulatory filing to seek FDA approval to distribute and sell the NMP22 BladderChek Test as a non-prescription or over-the-counter (OTC) test as an aid for the diagnosis and monitoring of bladder cancer. The companies anticipate the OTC distribution would be introduced in the U.S. as soon as FDA approval is received.
"The signing of these agreements marks a significant milestone for Matritech," said Stephen D. Chubb, Chairman and CEO of Matritech. "The collaboration is the first step in the U.S. in implementing our strategy of expanding the market for the NMP22 BladderChek Test. In support of that goal, we have assessed our manufacturing capabilities. Inverness is a leader in point-of-care lateral flow intellectual property and technology and has the capacity to support high volume demand. We also believe that there is a significant retail market opportunity and expect that Inverness will be able to achieve widespread distribution of the NMP22 BladderChek Test. We are looking forward to working with Inverness to increase our penetration of the point-of-care cancer diagnostics market and improve the early detection of cancer."
The NMP22 BladderChek Test is the only physician-office test approved by the FDA for both the diagnosis and monitoring of bladder cancer. The test is also FDA approved for prescription home use, although non-prescription OTC use will require additional clinical studies and regulatory approvals. Similar to an at-home pregnancy test, the NMP22 BladderChek Test requires only four drops of urine and results are available in 30 minutes, allowing a rapid and accurate way to aid in the detection of bladder cancer.
Commenting on the agreements, Ron Zwanziger, CEO of Inverness, said, "We are very pleased to be able to work with Matritech to manufacture and distribute the NMP22 BladderChek Test. The test has gained widespread adoption by urologists in the diagnosis and monitoring of bladder cancer. Most recently, screening high risk groups with the NMP22 BladderChek Test is reported to be cost effective because of its low cost and high accuracy for detecting bladder cancer. We know that early cancer detection saves lives. This collaboration will allow us to meet the growing demand for the test and, we anticipate, make it more accessible to the people who are at risk for bladder cancer and truly revolutionize how cancer is detected."
Matritech indicated that the current manufacturer of the NMP22 BladderChek Test will work with Inverness to ensure continuity and prevent interruption in inventory supply.
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® Test Kit and NMP22® BladderChek® 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 14 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 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 in this press release including those related to the Company's expectations regarding future manufacture and supply of the Company's NMP22 BladderChek Test, sales of and markets for the Company's products, and business prospects are subject to a number of risks and uncertainties, many of which are beyond the Company's control, including the potential for FDA approval of OTC sales of the NMP22 BladderChek Test and future demand and markets for the product. Actual results may differ materially due to numerous factors, including without limitation, the content and timing of submissions to and decisions by regulatory authorities including the FDA; the potential market acceptance of an OTC version of the product; the ability of Inverness to efficiently commence manufacturing and distributing the product and to manufacture sufficient quantities of the product. 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.
About Inverness Medical Innovations
Inverness Medical Innovations is a leading global developer of advanced diagnostic devices and is presently exploring new opportunities for its proprietary electrochemical and other technologies in a variety of professional diagnostic and consumer-oriented applications including immuno-diagnostics with a focus on women's health, cardiology and infectious disease. The Company's new product development efforts, as well as its position as a leading supplier of consumer pregnancy and fertility/ovulation tests and rapid point-of-care diagnostics, are supported by the strength of its intellectual property portfolio. Inverness is headquartered in Waltham, Massachusetts. For more information about Inverness Medical Innovations, please visit their website at http://www.invernessmedical.com.
Source: Matritech
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