To: Moe Green who wrote (9 ) 4/7/1998 1:01:00 PM From: John Mattessich Read Replies (1) | Respond to of 16
Moe : Good to see someone other than myself on this thread. Finally, some news : Tuesday April 7, 10:49 am Eastern Time Company Press Release SOURCE: Photoelectron Corporation Photoelecton Corporation Announces Medical Device Agency Authorization UK Clinical Breast Tumor Trials with the PRS Expected to Begin Soon LEXINGTON, Mass., April 7 /PRNewswire/ -- Photoelectron Corporation (Nasdaq: PECX - news), developer of the Photon Radiosurgery System (PRS), a proprietary x-ray delivery system for tumor therapy, announced today that it has received authorization from the UK Medical Devices Agency (MDA) to commence intraoperative clinical breast tumor trials in the United Kingdom. These trials had been delayed as a result of a request by the MDA for additional data on the sterility assurance and biological safety of the applicators used in the treatment. The PRS will be used as an adjunct treatment following breast conservation surgery. An applicator mounted on the x-ray source of the PRS enables controlled delivery of radiation to the tumor bed (the area from which a tumor has been removed) and distributes the radiation to eliminate remaining malignant cells. The intraoperative clinical trials will be performed at the Middlesex Hospital in London under the direction of Professor Michael Baum and Dr. Jeffrey Tobias. The Company is preparing and additional submission to the MDA for image- guided interstitial use of the PRS in the treatment of early stage breast tumors. After biopsy and confirmation of a malignancy, the x-ray source of the PRS will be mounted on a commercially available stereotactic breast biopsy table and inserted directly into the tumor. Initially these interstitial trials will also be performed at the Middlesex Hospital. ''Safe Harbor'' statement under the Private Securities Litigation Reform Act of 1995: Any statements which are not historical facts contained in this release are forward looking statements that involve risk and uncertainties, including but not limited to those relating to product demand, pricing, market acceptance, the effect of economic conditions, the validity and enforceability of intellectual property rights, the outcome of government regulatory proceedings, competitive products, risks in product and technology development, the ability to complete transactions, and other risks identified in the Company's Securities and Exchange Commission filings. SOURCE: Photoelectron Corporation