Trial Findings for Vicor Technologies, Inc.'s PD2i Vital Sign Diagnostic to Be Presented at the American Heart Association’s Resuscitation Science Symposium 2009

October 6, 2009 |

6 min read

BOCA RATON, FL--(Marketwire - October 06, 2009) - David H. Fater, CEO of Vicor Technologies, Inc. (OTCBB: VCRT), today announced that Andriy Batchinsky, MD, a researcher with the U.S. Army Institute of Surgical Research (USAISR), will present findings from a study of Vicor’s PD2i VS™ (Vital Sign) at the American Heart Association’s Resuscitation Science Symposium 2009 on November 14-15, 2009 in Orlando, Florida. Vicor Technologies is a biotechnology company focused on the commercialization of innovative, non-invasive medical devices and diagnostics using its patented, proprietary PD2i® nonlinear algorithm and software to stratify patients at risk of sudden cardiac death and trauma victims in need of lifesaving intervention.

Dr. Batchinsky will present “Does Heart-Rate Complexity Analysis Work in the Real World? Changes in the Point Correlation Dimension of Heart Rate During Prehospital Lifesaving Interventions” on November 14, 2009 at 9:30am EST. The study is one of several that have been performed under a collaborative research and development agreement (CRADA) between Vicor and the USAISR entered into in January 2008. The collaboration is continuing. The American Heart Association’s Resuscitation Science Symposium (ReSS) is an international forum for fundamental, translational, clinical and population scientists and care providers to discuss recent advances related to treating cardiopulmonary arrest and life-threatening traumatic injury.

“We’re extremely pleased and honored to have our PD2i VS™ diagnostic presented at the American Heart Association’s Resuscitation Science Symposium by Dr. Batchinsky. Dr. Batchinsky has been actively involved in all of the clinical trials of the PD2i VS™ conducted under our collaborative agreement with the USAISR,” stated Mr. Fater. “As we steadily advance commercialization of our PD2i® nonlinear algorithm diagnostics, visibility at prestigious conferences such as this enhances our opportunity to explore new strategic relationships and collaborative efforts that may enable us to identify new applications for the PD2i® nonlinear algorithm,” he continued. “All of the clinical trials of our PD2i VS™ conducted under our agreement with the Army reveal the PD2i® nonlinear algorithm 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,” Mr. Fater concluded.

The objective of “Does Heart-Rate Complexity Analysis Work in the Real World?” was to evaluate the ability of the PD2i VS™ to distinguish trauma patients receiving lifesaving interventions from those who did not based on analysis of ECGs from 325 prehospital trauma patients. The PD2i® nonlinear algorithm value was calculated on both unedited (raw) and on manually verified, noise- and ectopy-free (clean) ECG sections. In conclusion, researchers found that analysis of complex heart rate variability using the PD2i® nonlinear algorithm and software identifies trauma patients with good sensitivity (low percentage of false negatives) and that results are similar using “raw” or “clean” ECGs. Additional studies of automated trauma triage using the PD2i VS™ are planned.

Dr. Batchinsky has also made the following presentations of the USAISR’s continuing studies of the PD2i VS™:

“Are We Listening to Music or Noise? Use of the Lyapunov Exponent for Comprehensive Assessment of Heart Rate Complexity During Hemorrhage in Sedated Conscious Miniature Swine” 8th International Conference on Complexity in Acute Illness August 28-30, 2009 -- Palo Alto, CA “Complexity in Animal Models” “Continuous Complexity Analysis and Remote Battlefield Triage” International Experts of Complexity and Variability at the Bedside Round Table August 24-25, 2009 -- Wakefield, CA “Does Heart Rate Complexity Add to Traditional Vital Signs for Trauma Patient Triage?” ATACCC 2009 Conference August 10-12, 2009 -- St. Petersburg Beach, FL “Toward Automated Detection of Life-threatening Injury Using Comprehensive Assessment of the Electrocardiogram” Smart Monitoring 2009 Conference August 9, 2009 -- St. Petersburg Beach, FL

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® nonlinear algorithm is a deterministic, nonlinear 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® nonlinear 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® nonlinear algorithm 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™ (Vital Sign) for military and civilian applications and the PD2i CA™ (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.