Seems like HDII is on the verge of real and substantial revenue.
In other words, the inclusion of ``for research purposes only'' as part of the profiler's 'instruction manual' appears about to become a thing of the past.
>>>Wednesday June 28, 1:28 pm Eastern Time
Company Press Release SOURCE: Hypertension Diagnostics, Inc.
Hypertension Diagnostics Announces That a New 510(k) Premarket Notification Submission has Been Forwarded to the FDA
ST. PAUL, Minn., June 28 /PRNewswire/ -- Hypertension Diagnostics, Inc. (Nasdaq: HDII; HDIIW; HDIIU) today announced that it completed a multi-site clinical trial with its CVProfilor(TM) DO-2020 CardioVascular Profiling System and has included the results in a new 510(k) Premarket Notification submission which has been forwarded to the FDA for review. It is unknown how long it will take the FDA to review this 510(k) submission, or when the FDA will clear the CVProfilor(TM) DO-2020 System for marketing in the U.S., if at all. Pending FDA approval, the CVProfilor(TM) DO-2020 System is intended to be used by health care professionals to measure blood pressure as well as arterial compliance (that is, elasticity) as an initial screening device to determine if patients have potential underlying cardiovascular disease that might require more specific diagnostic evaluations by physicians or other health care providers.
HDI continues to market its HDI/PulseWave(TM) CR-2000 Research CardioVascular Profiling System to research scientists at pharmaceutical firms, university medical centers and related research institutions. The CR-2000 Research System is intended ``for research purposes only'' in the U.S. In the European Union, the CR-2000 Research System has met the European Medical Device Directives requirements, carries the CE Mark, is commercially available in six different languages, and is presently being marketed worldwide. Mr. Hartmut Loos, who is based in Belgium, has been retained by HDI as a Director of European Operations to oversee marketing and sales efforts throughout Europe, the Middle East and Africa.
A U.S. patent recently issued by the U.S. Patent Office under Number 6,048,318 was invented by Drs. Chesney, Finkelstein and Cohn. This patent addresses the core technology being commercialized by the Company, and it, along with seven other U.S. issued patents and one European patent, offers a measure of protection for the Company's intellectual property. Additional domestic and foreign patents are pending.
At the Company's regularly scheduled Board of Director's meeting on June 5, 2000, Mr. Melville R. Bois resigned as Chairman of the Board due to anticipated future business endeavors that will demand more of his time. Mr. Bois will remain as a Director of the Company. Upon unanimous Board approval, Mr. Kenneth W. Brimmer, a current Board Member, was elected Chairman to replace Mr. Bois.
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 CVProfilor(TM) DO-2020 System; the availability of third-party reimbursements; and market acceptance of the Company's products.<<< |
