Profilor approved for marketing in Japan
Monday January 8, 8:38 am Eastern Time
Press Release
SOURCE: Hypertension Diagnostics, Inc.
Hypertension Diagnostics Receives Notice of MHW Approval to Market CR-2000 Cardiovascular Profiling System in Japan and Japanese Patent
ST. PAUL, Minn., Jan. 8 /PRNewswire/ -- Hypertension Diagnostics, Inc. (Nasdaq: HDII; HDIIW; HDIIU), announced today that it has been advised by Higa Medical Systems, HDI's exclusive Japanese distributor, that they have received approval from the Ministry of Health and Welfare (MHW) in Japan to import and market the HDI/PulseWave(TM) CR-2000 CardioVascular Profiling System to physicians for non-invasively screening, diagnosing and monitoring the treatment of patients with cardiovascular disease, and to research scientists for conducting clinical research studies including evaluations of cardiovascular drugs.
For the 126 million people living in Japan, cardiovascular disease is the second largest cause of death. Of the 237,000 physicians who practice in Japan, approximately 150,000 cardiovascular disease specialists, internal medicine physicians and family practice physicians are potential users of the CR-2000 System.
HDI has an exclusive distribution agreement with Higa Medical Systems, a division of Higa Industries headquartered in Tokyo, for distribution of HDI products throughout Japan. ``We are very pleased with the MHW approval and with the fact that we may now move forward in providing physicians with a most trustworthy diagnostic medical device for cardiovascular disease,'' said Mr. Ikuo Hasegawa, Director, New Medical Products Development. ``The people in Japan are known worldwide for their longevity; however, many aged people are suffering from cardiovascular disease. We believe that the CR-2000 System will play an important role in improving the quality of life by means of the early detection of cardiovascular disease prior to the occurrence of disabling or life-threatening events,'' added Mr. Hasegawa.
``Higa Medical Systems is known throughout Japan as a well-respected distributor of high-quality medical equipment,'' said Greg Guettler, President of HDI. ``Their professionalism and marketing strength make them uniquely qualified to distribute this product throughout Japan, and the work they have done to obtain MHW approval for the CR-2000 System in record time exemplifies their commitment to this technology.''
The HDI/PulseWave(TM) CR-2000 CardioVascular Profiling System utilizes HDI's patented, proprietary and validated blood pressure waveform analysis technology. The System is non-invasive, user-friendly and involves no specific medical risk to the patient. The System's screen and printer-generated CardioVascular Profile Report display an independent assessment of the patient's arterial elasticity or flexibility of both large and small arteries (referred to as C1 and C2 parameters, respectively), as well as several other hemodynamic parameters.
Filed during 1989, Hypertension Diagnostics has just been notified that a Japanese Letters Patent No. 3,122.105 entitled, ``Method and Apparatus for Diagnosing and Treating Hypertension'' was issued by the Japanese Patent Office on October 20, 2000. This patent describes the pulse contour analysis method of evaluating blood pressure waveforms and how the method is used for medical applications which is the essence of the CR-2000 System technology. The issuance of this patent should strengthen the marketing position of Higa Medical Systems and thereby the business opportunity in Japan for Hypertension Diagnostics.
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 presented and anticipated in the forward-looking statements due to the risks and uncertainties set forth in the Company's 2000 Annual Report on Form 10-KSB, as amended, under the caption ``Risk Factors,'' as well as others not now anticipated.
SOURCE: Hypertension Diagnostics, Inc.
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