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Biotech / Medical : Matritech (NASDAQ - NMPS)

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To: M.A. Caccavo who wrote (628)	5/20/1998 11:50:00 AM
From: Damon Pham	of 849

Matritech/FDA-2: 510(k) Rejection Doesn't Hurt Approvability (Copyright (c) 1998, Dow Jones & Company, Inc.) NEWTON, Mass. (Dow Jones)--Matritech Inc.'s (NMPS) premarket approval application filing with the Food and Drug Administration for its NuMA Test Kit for colon cancer is "on track" for approval early in 1999. In a press release Wednesday, Matritech said the FDA's decision to reject NumMA for for 510(k) marketing clearance "does not imply a decision about the approvability of the product." The 510(k) clearance is given when a product is found to be substantially similar to another product that has already received FDA clearance. Martritech said its 510(k) application was an attempt to speed up marketing clearance. The company said it is one of the first concerns to try to use new regulations on tumor markers to prove equivalence between two completely different markers. The FDA's decision on the 510(k) was based on Matritech's test's "equivalence" to another test in a legal sense, Matritech said.

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