Vicor's PD2i to Be Tested on Trauma Patients in U.S. Army's New Critical Combat Care Engineering (C3E) Program Area

Colonel Cancio's identification of the PD2i as a heart-rate complexity metric to be tested on trauma patients in C3E is contained in "Bridging the Critical Care Chasm," an article describing the C3E. C3E is a new program area within the U.S. Army Medical Research and Materiel Command's Combat Casualty Care Research Area Directorate (RAD II) that was created to improve battlefield care and, specifically, address the "critical care technology gap." The article appears in the August 2009 issue of Military Medical/CBRN Technology (Volume 13, Issue 5).

"We're extremely gratified to have our patented, proprietary PD2i included for testing in the new C3E program," stated Mr. Fater. "All of the clinical trials of our PD2i conducted with the U.S. Army Institute for Surgical Research (USAISR), under our collaborative research and development agreement entered into in January 2008, reveal the PD2i to be the only diagnostic capable of consistently and accurately determining severity of injury and the probability of survival in critically injured soldiers and civilians utilizing both 'raw' and 'noisy' EKG data. This is consistent with the EKG data that will be collected from trauma victims in actual battlefield conditions to identify those in need of an immediate lifesaving intervention. As such, we believe the PD2i is a vital sign that can significantly enhance the Army's current combat trauma triage efforts, as well as those in the civilian emergency response sector," Mr. Fater concluded.

As described in the article, C3E is committed to three specific tasks, the first of which is to identify new vital signs, such as improved patient monitors able to predict the need for lifesaving interventions more quickly and accurately. Colonel Cancio describes the four basic approaches to deriving new vital signs that the C3E will explore. The PD2i is the only diagnostic identified within the extraction category. Extraction refers to obtaining additional information from an existing sensor such as the electrocardiogram.

Colonel Cancio writes, "Extraction of more information from the EKG of the heart by means of complexity or variability analysis is particularly appealing, because it uses a sensor (the EKG) that is uniformly used in patient care already. Our laboratory has pursued this line of research for several years, demonstrating that heart-rate complexity served as a superior method of predicting the need for lifesaving interventions in trauma patients... and will likely be embodied in decision support monitors. We have identified a heart-rate complexity metric, PD2i, which is now FDA approved and marketed by Boca Raton, Fla.-based Vicor Technologies. This device will be tested in trauma patients under C3E."

Vicor's patented, proprietary point correlation dimension algorithm (PD2i) is a deterministic, non-linear measure that analyzes electrophysiological potentials to predict future pathological events with a high degree of accuracy in target populations. Specifically, its PD2i Analyzer has 510(k) marketing clearance from the U.S. Food and Drug Administration to measure heart rate complexity.

About Vicor Technologies, Inc.

Vicor Technologies is a development-stage biotechnology company creating innovative non-invasive diagnostics employing its patented, proprietary point correlation dimension algorithm (PD2i.) The PD2i is a deterministic, non-linear measure that analyzes electrophysiological potentials to predict future pathological events with a high degree of accuracy in target populations.

Vicor currently has three products employing the PD2i algorithm. The PD2i Analyzer, which has FDA 510(k) marketing clearance, measures heart rate variability and Vicor will be commencing a clinical trial to determine its efficacy to detect the presence of diabetic autonomic neuropathy (DAN). The PD2i VS (Vital Sign), in clinical trials under a collaborative effort with the U.S. Army Institute for Surgical Research (http://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.

Vicor anticipates additional applications employing the PD2i to enable early detection and risk stratification for a variety of other disorders and diseases. Additional information is available at www.vicortech.com.

The appearance of name-brand institutions or products in this media release does not constitute endorsement by the U.S. Army Medical Research and Materiel Command, the Department of the Army, Department of Defense or the U.S. Government of the information, products or services contained therein.

Caution Regarding Forward-Looking Statements

Forward-looking statements in this press release are based on current plans and expectations that are subject to uncertainties and risks, which could cause our future results to differ materially. The following factors, among others, could cause our actual results to differ: our ability to obtain FDA approval of the PD2i VS for military and civilian applications and the PD2i Cardiac Analyzer, our ability to continue to receive financing sufficient to continue operations and complete the critical clinical trials; our ability to continue as a going concern; our ability to successfully develop products based on our technologies; our ability to obtain and maintain adequate levels of third-party reimbursement for our products; the impact of competitive products and pricing; our ability to receive regulatory approval for our products; the ability of third-party contract research organizations to perform preclinical testing and clinical trials for our technologies; the ability of third-party manufacturers to manufacture our products; our ability to retain the services of our key personnel; our ability to market and sell our products successfully; our ability to protect our intellectual property; product liability; changes in federal income tax laws and regulations; general market conditions in the medical device and pharmaceutical industries; and other matters that are described in Vicor's Annual Report on Form 10-K for the fiscal year ended December 31, 2008 and subsequent filings with the Securities and Exchange Commission. Forward-looking statements in this press release speak only as of the date of the press release, and we assume no obligation to update forward-looking statements or the reasons why actual results could differ.

Release 09-16

 
CORPORATE CONTACT
David H. Fater
Vicor Technologies, Inc.
561.995.7313
dfater@vicortech.com
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Cameron Associates
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