“The completion of fiscal year 2001 represented another important milestone in HDI’s progressive development,” said Greg H. Guettler, President. “Of most significance to the Company’s future, was the FDA clearance of the
CVProfilor® DO-2020 CardioVascular Profiling System for use by U.S. physicians. The initial launch of the
CVProfilor® began in March 2001 with the objective of validating key sales and marketing assumptions prior to a broader nationwide marketing of the device in July 2001. By June 30, 2001, HDI attended four key medical conventions, provided CVProfile™ Reports to nearly 1,000 physicians, and placed 35
CVProfilor® Systems in clinics throughout the United States,” said Guettler. “This initial level of product acceptance provided us reason to add a Director of U.S. Sales and three Regional Sales Managers to our direct sales team. We now have begun the process of a nationwide launch that is directed toward product placements in approximately 25 major U.S. markets by the end of our fiscal year 2002.”
“During fiscal year 2001, the HDI/PulseWave™ CR-2000 Research CardioVascular Profiling System was included in a number of clinical trials that led to a nearly five-fold increase in revenue as compared to revenue from the prior fiscal year,” said
Guettler.
“Although the CR-2000 Research System gave us a year as planned, we expect revenue in Fiscal Year 2001 to shift from the CR-2000 Research System to the
CVProfilor® DO-2020 System since the majority of our time and attention is now, and will continue to be, focused on expanding
CVProfilor® placements and utilization. This shift in our strategic focus was already evident during the fourth quarter of fiscal year 2001.”
HDI also benefited from 17 new scientific articles which were published in several peer-reviewed prestigious medical journals and which utilized or referenced both the
HDI/PulseWave™ CR-2000 Research System and the CVProfilor® DO-2020 System. These published articles lend further credibility to the clinical merit of HDI’s pulsewave analysis methodology. In addition, the Company was granted two additional U.S. patents and three international patents protecting our intellectual property, yielding to date a total of 12 issued patents.
“Building on the initial success of the CVProfilor® DO-2020 System is HDI’s number one priority,” said Guettler. “We are moving forward with our per-patient-test marketing model at the same time that we continue to build our U.S. distribution network. With about 60 million people in the U.S. diagnosed with cardiovascular disease and another 16+ million suffering from diabetes (which causes vascular disease), we are taking full advantage of this market opportunity both in terms of the potential we provide to physicians for improving patient management and in maximizing the long-term potential growth for our Company.”
2001 Financial Summary
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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 a
prediction 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.
Hypertension Diagnostics, HDI/PulseWave™ and CVProfilor® are
trademarks of Hypertension Diagnostics, Inc. All rights reserved.
Contact: Greg H. Guettler, President