Non-invasive CR-2000 Research System to be used in START clinical trial

Sep 10 2009

Hypertension Diagnostics, Inc. (OTCBB: HDII), today announced that its non-invasive HDI/PulseWave™ CR-2000 Research System (CR-2000) has been selected for use in the Strategic Timing of AntiRetroviral Treatment (START) substudy on Arterial Elasticity that will examine blood vessel function and cardiovascular risk during HIV infection.

START is a randomized, international multicenter trial that is examining the early initiation of antiretroviral therapy (ART) in HIV-infected individuals in approximately 88 sites in 22 countries. START is funded primarily by the National Institute of Allergy and Infectious Diseases (NIAID) and the National Heart, Lung, and Blood Institute (NHLBI), both part of the National Institutes of Health (NIH), through a grant awarded to the University of Minnesota and is being conducted by the International Network for Strategic Initiatives in Global HIV Trials (INSIGHT).

The START Arterial Elasticity substudy is a novel study designed to determine if early initiation of ART is superior to deferral of ART in increasing arterial elasticity and, thereby, preventing cardiovascular disease. Measurement of arterial elasticity using the CR-2000 will be used to study blood vessel function and cardiovascular disease risk during HIV infection. The substudy will enroll approximately 300 patients over three years at 16 sites located in the U.S. and six other countries around the world. Patients will be followed for a period of four and one-half years.

Greg H. Guettler, president of HDI, said, "There are over 500,000 people in the U.S. in active treatment for AIDS. Over the last several years, cardiovascular disease has become more common in people with HIV infection and it now ranks as a major cause of death with the risk for heart attack 70 to 80 percent higher among people with HIV than among those who do not have HIV. We are, therefore, very proud to have been selected to play a key role in the START substudy designed to determine whether arterial elasticity measurements can provide additional insight into the prevention of cardiovascular disease in HIV patients. The selection of our technology in this ground breaking trial shows the importance of measuring arterial elasticity in detecting and managing cardiovascular disease and is a further demonstration of HDI's mission to become the standard for identifying and monitoring patients with cardiovascular disease."