CYBeR-CARE Responds to Reports of Alleged FDA Investigation.Business Wire/Health & Medical Writers BOYNTON BEACH Boynton Beach, city (1990 pop. 46,194), Palm Beach co., SE Fla., on the Atlantic coast; inc. 1920. A major suburban area, it is also a beach resort and vegetable-shipping point. , Fla.--(BW HealthWire)--May 16, 2000 CYBeR-CARE (Nasdaq:CYBR CYBR Copy Byte Right ) has become aware of reports that there is an ongoing Food and Drug Administration ("FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ") investigation of the Company's marketing practices in connection with devices that have not yet received premarket clearance. The Company is not aware of any such investigation nor has the Company been contacted by the FDA regarding its marketing practices. The Company takes these reports seriously and is taking steps to clarify this matter with the FDA. Moreover, CYBeR-CARE is reviewing its promotional practices to assure that the Company is fully in compliance with the FDA's regulations in this area. Based in Boynton Beach, FL, CYBeR-CARE is a technology-assisted disease management company with four business lines. The Company is developing the Electronic HouseCall(TM) System, a patented Internet-based technology system that provides remote monitoring of individuals for health care purposes, which is currently seeking 510(k) clearance from the Food and Drug Administration. In addition, CYBeR-CARE operates physical, occupational and speech therapy centers, an e-pharmacy and one of the world's largest air ambulance air ambulance Emergency medicine A helicopter or, less commonly, a fixed wing aircraft, used to evacuate a person who requires immediate medical attention that cannot be provided at his/her current location transport services. Safe Harbor Safe Harbor 1. A legal provision to reduce or eliminate liability as long as good faith is demonstrated. 2. A form of shark repellent implemented by a target company acquiring a business that is so poorly regulated that the target itself is less attractive. Statement under the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and of 1995: The statements which are not historical facts contained in this press release are forward-looking statements that involve certain risks and uncertainties including but not limited to risks associated with the uncertainty of future financial results, additional financing requirements, development of new products, government approval processes, the impact of competitive products or pricing, technological changes, the effect of economic conditions and other uncertainties detailed in the Company's filings with the Securities and Exchange Commission. |
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