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Vicor Technologies, Inc. (VCRT.OB) Receives Approval for PD2i® Testing

Vicor Technologies, Inc., a biotechnology company focused on the development of innovative, non-invasive medical devices using its patented, proprietary PD2i® nonlinear algorithm and software, announced today that it has received Institutional Review Board (IRB) approval for a study to identify normal ranges for the PD2i® values from tests performed with its PD2i Analyzer™. In collaboration with the University of Mississippi, this study will be performed on patients at rest and in response to controlled exercises and paced respirations done.

David H. Fater, CEO of Vicor Technologies, Inc. commented, “We’re pleased to have IRB approval permitting us to commence this important study. Being able to identify normal ranges for values obtained from tests performed with the PD2i Analyzer™ will enhance the ability of those physicians using the PD2i Analyzer™ to identify — and treat — their at-risk patients. With this approval, we will begin enrolling patients and our intention is to include these results in a revised 510(k) submission to the FDA at the conclusion of the study.”

Vicor has successfully developed unprecedented technologies with its PD2i nonlinear algorithm. These patented technologies provide a powerful mean of evaluating heart rate variability and are being further studied and developed as a means to evaluate the human autonomic system. Simply stated, the PD2i Analyzer is a premier diagnostic tool that can detect the risk of cardiac arrest so it can be treated before it happens.

PD2i also has strong diagnostic value for diabetics. In fact, physicians who have purchased the PD2i Analyzer™ are largely using it to test their diabetic patients for autonomic nervous system (ANS) dysfunction, also known as diabetic autonomic neuropathy, or “DAN.” Rather than waiting to witness the nerve damage that DAN leaves behind, the proprietary algorithm directly measures the health of a patient’s autonomic system to assess the risks beforehand. Within minutes, the PD2i score is derived simply and painlessly, allowing doctors to take the necessary therapeutic actions for their diabetic patients.

Vicor is not sitting idly by with this valuable algorithm. The Company currently has three products at various stages of development that use PD2i as its foundation. They are as follows:

• The PD2i Analyzer™, which has FDA 510(k) marketing clearance, measures heart rate variability; physicians performing diagnostic tests with the PD2i Analyzer™ are able to receive reimbursement under existing CPT codes.

• The PD2i VS™ (Vital Sign), in clinical trials under a collaborative effort with the U.S. Army Institute for Surgical Research (www.usaisr.amedd.army.mil), risk stratifies combat and civilian trauma victims.

• The PD2i CA™ (Cardiac Analyzer), in multiple clinical trials, identifies patients at risk of sudden cardiac death.

More information on Vicor Technologies and PD2i can be found on the Company’s website at vicortechnologies.com.

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