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Hypertension Diagnostics Announces Exclusive Distribution Agreement with Higa Medical Systems of Japan ST. PAUL, MN – November 30, 1999 – Hypertension Diagnostics, Inc. ("HDI") (Nasdaq SmallCap: HDII; HDIIW; HDIIU), today announced the signing of an exclusive distribution agreement with Higa Medical Systems, a division of Higa Industries headquartered in Tokyo, for distribution of HDI products throughout Japan.
"Japan represents a sizeable and strategic market opportunity for
HDI," said Greg Guettler, President of Hypertension Diagnostics. |
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"The excellent business reputation and twenty-year history of medical distribution success makes Higa Medical Systems an excellent representative of the HDI/PulseWave™ CR-2000 technology in Japan. In addition, their ‘can do’ corporate culture, their leadership position in bringing innovative, leading-edge medical technologies to market, and their experience in working with American firms, represent an excellent match of people, skills, opportunities and resources between our two companies." Higa Industries, founded forty years ago for the purpose of bringing U.S. concepts and products to Japan, has four divisions: 1) Higa Medical Systems, providing the Japanese healthcare industry with state-of-the-art technologies imported from the United States and other countries and distributed through a nationwide network of 68 dealers and over 600 medical sales representatives; 2) Bridgeside Higa Forest Industries, a major supplier of North American and Scandinavian lumber products to the Japanese housing market; 3) Domino’s Pizza, the exclusive provider of Domino’s Pizza through more than 200 Domino’s Pizza home delivery outlets throughout Japan; and 4) the New Opportunities Division, the exclusive distributor of American Greeting Cards throughout Japan. "We believe that in order to be a truly successful organization in the 21st Century, we need to identify ‘unique’ businesses that have an exciting growth potential, and we believe that Hypertension Diagnostics represents just such an opportunity," said Ernest M. Higa, President and Chief Executive Officer of Higa Industries. "Following Ministry of Health and Welfare (MHW) approval, the HDI/PulseWave™ CR-2000 will provide Japanese physicians with an opportunity to play an important role in cardiovascular disease research and, ultimately, disease management," said Mr. Ikuo Hasegawa, Director and General Manager of Higa Medical Systems. "Blood vessel elasticity is increasingly recognized as a sensitive and specific marker for disease, disease progression and disease management. We see HDI’s technology playing a key role in Japan’s future," said Mr. Hasegawa. Of the 126 million people in Japan, nearly 12 million have been diagnosed with cardiovascular disease and 7 million of those suffer from hypertension. The distribution agreement between HDI and Higa Medical Systems grants Higa Medical Systems the exclusive rights to market and distribute the CR-2000 System and the international version of the DO-2020 System, the MD-3000 (previously referred to as the DO-2020i), currently in development, throughout Japan. Under terms of the agreement, Higa Medical Systems will manage all aspects of MHW product clearance. Japan requires that all medical products manufactured or imported into Japan must receive the approval of the Ministry of Health and Welfare, a process that will take about two years to complete. Hypertension Diagnostics has developed proprietary cardiovascular profiling technology that analyzes non-invasively derived arterial pulse pressure waveform data as a means of providing hemodynamic parameters that are useful in assessing the cardiovascular system. The Company has developed two models of the HDI/PulseWaveä 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 in screening patients for underlying 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; the ability to operate and maintain the Central Data Management Facility (CDMF) on a commercial scale; 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. Hypertension Diagnostics and HDI/PulseWave are trademarks of Hypertension Diagnostics, Inc. Contact: Greg H. Guettler, President
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