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Biotech / Medical : Photoelectron Corp. (PECX)

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To: Clayleas who wrote ()	7/17/1997 12:48:00 AM
From: Clayleas	of 16

LEXINGTON, Mass., June 25 (Reuter) - Photoelectron Corp said Wednesday that it has received 510 (k) market clearance from the Food and Drug Administration to treat intracranial tumors with its Model 3 Photon Radiosurgery System (PRS). The Photon Radiosurgery System, developed by the company, is a a proprietary x-ray delivery system for tumor therapy. The Model 3 PRS has been used in all of the company's Phase II human brain tumor clinical trials, it said. Clinical trials of the PRS for treatment of breast and skin tumors are planned for later this year, the company said. The system works by delivering through its nonradioactive radiation source a precisely controlled high dose of x-rays directly into the tumor through a thin, minimally invasive needle-like probe. The radiation is substantially confined to the tumor site, the company said. It said it has developed an advanced version of the PRS, the PRS 400, which incorporates improved operating features and "ease of use" enhancements while remaining equivalent in radiative output. The company said it intends to seek quickly FDA clearance for the PRS 400. 16:09 06-25-97

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