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Hypertension Diagnostics Receives ISO 9002/EN-46002 Certification and its HDI/PulseWave™ CR-2000 Instrument Receives EC Certificate ST. PAUL, MN –
November
30, 1999 – Hypertension Diagnostics, Inc. ("HDI") (Nasdaq
SmallCap: HDII; HDIIW; HDIIU), today announced that it is now fully
certified in accordance with ISO 9002/EN-46002 standards and the European
Union Medical Device Directive (MDD).
The Company’s non-invasive
HDI/PulseWave™
CR-2000 Research CardioVascular Profiling Instrument now carries the ‘CE
0123’ mark, indicating that the CR-2000 is certified for sale throughout
the European Union and that the product complies with applicable safety
and quality standards. |
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HDI recently exhibited at the MEDICA ’99 in Düsseldorf, Germany, the largest medical distribution exposition in Europe, and is now establishing partners throughout the European Union for distribution of the CR-2000. Hypertension Diagnostics has developed proprietary cardiovascular profiling technology that analyzes non-invasively derived arterial pulse pressure waveform data as a means of providing parameters that are useful in assessing the cardiovascular system. The Company has designed two models of the HDI/PulseWave™ CardioVascular Profiling Instrument: (1) the CR-2000 which is currently in use by physician scientists for research purposes only; and (2) the DO-2020 which is intended to assist physicians and other health care professionals in screening, diagnosing and monitoring the treatment of patients with cardiovascular disease. The Company has not yet received permission to market the DO-2020 from the Food and Drug Administration. Forward-looking statements in this press release are made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. The Company wishes to caution readers not to place undue reliance on any forward-looking statements and to recognize that the statements are not predictions of actual future results. Actual results could differ materially from those anticipated in the forward-looking statements due to the risks and uncertainties set forth in the Company's 1999 Annual Report on Form 10-KSB under the caption "Risk Factors," as well as others not now anticipated. These risks and uncertainties include, without limitation, the Company's ability to receive regulatory approval for its Model DO-2020 product; the availability of third-party reimbursements; market acceptance of the Company's products; timely development of the Central Data Management Facility (CDMF); the ability of third parties to manufacture the Company's products on a commercial scale and in compliance with regulatory requirements; the availability of integral components for the Company's products; the Company's ability to develop distribution channels; increased competition; changes in government regulation; health care reform; exposure to potential product liability; and the Company's ability to protect its proprietary technology. HDI/PulseWave is a trademark of Hypertension Diagnostics Inc. Contact: Greg H. Guettler, President
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