Matritech Receives 510(k) Response from FDA
PMA Studies Underway
NEWTON, Mass., May 19 /PRNewswire/ -- Matritech, Inc. (Nasdaq: NMPS - news) announced today that it has received a
determination from the U.S. Food and Drug Administration (FDA) that its NuMA(TM) Test Kit for colon cancer does not
meet the criteria for 510(k) marketing clearance. The Company is continuing its discussions with the FDA regarding clearance
for this product and is also continuing with ongoing studies necessary for a premarket approval application (PMA).
''From the beginning, we have been pursuing a dual-track regulatory strategy, to ensure that we are able to expedite the
clearance of our NuMA(TM) Test Kit for colon cancer,'' said David L. Corbet, President of Matritech. ''We are proceeding
with our evaluation of the NuMA(TM) test kit using a sample bank of over 1,800 specimens we have already collected. The
data from this study should form the basis of a PMA filing, which we plan to submit by early 1999.''
The NuMA(TM) test kit is a blood-based assay that utilizes the Company's nuclear matrix protein (NMP) technology for the
management of colon cancer patients. The test kit detects a specific NMP, NuMA, using proprietary antibodies, to differentiate
cancerous from normal specimens. Matritech has retained worldwide manufacturing and marketing rights for NuMA.
The Company also announced that Martin Zelbow has been appointed Acting Vice President of Finance, replacing Leslie
Teso, who is leaving the Company.
Matritech, Inc., based in Newton, MA, is using its proprietary NMP technology, discovered at the Massachusetts Institute of
Technology and licensed exclusively to Matritech, to develop and commercialize innovative serum-, cell-, and urine-based
diagnostics that enable physicians to reliably detect and monitor the presence of bladder, breast, cervical, colorectal and
prostate cancers. The Company's first product, the NMP-22 Test Kit for bladder cancer, is on the market. All of Matritech's
diagnostic assays are based on the discovery that nuclear matrix proteins in cancer cells differ from those in normal cells.
Any forward-looking statements related to the Company's expectations regarding clinical trials and regulatory approvals are
subject to a number of risks and uncertainties, many of which are beyond the Company's control. These include, but are not
limited to, risks related to unforeseen delays in specimen collection, conduct of trials, analysis of data, preparation of FDA
submission and review and approval by the FDA and by other regulatory authorities. There can be no assurance that the
Company's current and future products will obtain necessary regulatory approvals in a time period consistent with the
Company's past experience, or at all.
SOURCE: Matritech, Inc.
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