SOURCE: Vicor Technologies, Inc.

Vicor Technologies, Inc.

March 17, 2011 08:30 ET

Sports Medicine Physician Steve Watts Suggests Cardiac Screening for Young Athletes Requires Augmentation of Existing Diagnostics to Achieve Greater Accuracy, Become Cost-Effective

BOCA RATON, FL--(Marketwire - March 17, 2011) - Sports medicine physician Steve Watts says cardiac screening for young athletes is useful in preventing sudden cardiac death and suggests new diagnostics have the potential to add value and change the debate about the viability of cardiac screening for young athletes in the United States. Dr. Watts is Visiting Professor in Sports Medicine in the Division of Surgical & Interventional Science at University College London and Director of Sports Medicine at Vicor Technologies, Inc. (OTCBB: VCRT). Vicor Technologies is a biotechnology company focused on the commercialization of its PD2i Analyzer™, an innovative, non-invasive diagnostic employing its patented, proprietary PD2i® nonlinear algorithm. The PD2i Analyzer™ enables physicians to accurately risk stratify specific target populations for future pathological events, including diabetics for the presence of diabetic autonomic neuropathy (DAN), cardiovascular disease patients for death resulting from arrhythmia or congestive heart failure, and trauma victims for imminent death absent immediate lifesaving intervention.

Dr. Watts is an experienced sports medicine clinician, educator, and researcher, who has made more than 95 presentations on a variety of sports medicine and athlete care topics. The recipient of an honorary academic appointment, Dr. Watts is currently Visiting Professor in Sports Medicine in the Division of Surgical & Interventional Science at University College London. He is a tenured Associate Professor in the UMMC Department of Orthopedic Surgery and Rehabilitation and the Department of Family Medicine, where he instituted the Family Medicine Sports Medicine Curriculum in the UMMC Family Medicine Residency Training Program.

"The continuing debate about whether to provide cardiac screening using ECG and echocardiograms to young athletes is primarily based on a simple cost/benefit equation. The naysayers contend that the cost does not justify the end. In other words it is too expensive to save such a relatively small population of young athletes from sudden cardiac death. They reference the relatively small size of the population to receive testing, the rarity of sudden cardiac death in that population, and that there is a higher incidence of sudden cardiac death in the general population that does not receive such testing. In addition, the number of pediatric cardiologists nationwide is not sufficient to adequately address the task. Chief among their concerns is the high cost related to 12-lead ECG testing, and the higher cost of follow-on testing associated with the large number of false-positives it produces," stated Dr. Watts.

"Clearly, with advances in technology and our understanding of SCD we should not conclude that cardiac screening for young athletes isn't viable. There is conflicting data about the benefit of screening with current methods used -- 12-lead ECG testing and echocardiogram -- and currently-used diagnostics aren't able to identify all of the many causes of sudden cardiac death," Dr. Watts continued.

Currently, most young athletes in the U.S. undergo a physical exam and are asked to provide a family history of heart problems, whereas young athletes in some other countries receive pre-sports participation screening involving an ECG and/or an echocardiogram. Studies reveal conflicting results. In Italy, which initiated nationwide cardiac testing in 1982, there has been a significant drop in the incidence of sudden cardiac death among young athletes. In Israel, which initiated pre-sports participation testing and cardiac screening in 1997, there has been no benefit. A 2008 study by Dr. Aurelio Pinheiro of the Johns Hopkins School of Medicine involving the use of echocardiograms and ECG, plus other tests such as blood pressure and listening for abnormal heart rhythms or murmurs discovered abnormalities in 36 of 134 U.S. male and female athletes; 22 were found via EKG alone, nine by echocardiogram alone, and five by both tests. According to Dr. Pinheiro and his colleagues, the findings argue for routine testing of athletes and suggest that such testing should be comprehensive and not reliant on any single diagnostic. In 2005, the European Society of Cardiology (ESC) issued a consensus statement recommending that every young competitive athlete undergo cardiovascular screening. The recommended protocol calls for a complete physical examination, personal and family medical history, and a 12-lead ECG. Lead author Domenico Corrado (University of Padova in Italy) and colleagues suggest that including the ECG in cardiac screening may decrease cardiac deaths in Europe by 50% to 70% if implemented in every European country.

"New diagnostics could significantly alter this debate by providing improved accuracy, the ability to detect more of the causes of sudden cardiac death, and being less expensive and easier to use. For instance, measuring heart rate variability to assess autonomic nervous system health or dysfunction -- and, in turn, cardiac health or risk -- is understood in the scientific world but largely unused in the clinical setting for lack of a practical diagnostic. A practical diagnosis for measuring heart rate variability -- such as Vicor's PD2i Analyzer™ -- has the potential to profoundly alter the cost/benefit ratio and alter this debate in favor of providing cardiac screening for young athletes," he concluded.

Vicor Technologies' PD2i Analyzer™ has demonstrated accuracy in risk stratifying diabetics for the presence of diabetic autonomic neuropathy (DAN), cardiovascular disease patients for death resulting from arrhythmia or congestive heart failure, and trauma victims for imminent death absent immediate lifesaving intervention. In a study performed by the University of Rochester, researchers found that the PD2i Analyzer™ is predictive of total mortality, cardiac death, and heart failure in patients with left ventricular ejection fraction of less than or equal to 35 percent. With a hazard ratio of 2.34 and a P value of 0.023 for congestive heart failure mortality, a hazard ratio of 1.89 and a P value of 0.13 for cardiac mortality, and a hazard ratio of 1.95 and a P value of 0.004 for total mortality, the study results are highly statistically significant and demonstrate the ability of the PD2i Analyzer™ to identify those patients at an elevated risk of total mortality, cardiac mortality, and congestive heart failure death.

The PD2i Analyzer™ is currently involved in numerous clinical trials, including studies to identify student athletes at risk of cardiac death, assess concussion in professional athletes, and predict mortality in victims of brain trauma.

About Steve Watts, MD
Dr. Watts was named Vicor Technologies' Director of Sports Medicine, a part-time position, in early February 2011. He is a tenured Associate Professor in the UMMC Department of Orthopedic Surgery and Rehabilitation and the Department of Family Medicine, where he instituted the Family Medicine Sports Medicine Curriculum and Clinical Experience for resident physicians in the UMMC Family Medicine Residency Training Program. He also serves as Director for the Sports Medicine Fellowship Program, as well as University Sports Medicine staff physician at UMMC, team physician for the Mississippi Braves, Belhaven University Blazers, Provine High School Rams, Lanier High School Bulldogs, and Canton High School Tigers, and a member of the Dixie National Rodeo Sports medical staff. He was recently awarded an honorary academic appointment as Visiting Professor in sports medicine in the Division of Surgical & Interventional Science at University College London. 

About Vicor Technologies, Inc.
Vicor Technologies' PD2i Analyzer™ employs its patented, proprietary point correlation dimension algorithm (PD2i®), a deterministic, nonlinear measure of electrophysiological potentials that predicts future pathological events with a high degree of accuracy in target populations. The PD2i Analyzer™, which has FDA 510(k) marketing clearance, measures heart rate variability with an easy-to-interpret binary score; physicians performing diagnostic tests with the PD2i Analyzer™ are able to receive reimbursement under existing CPT codes. Vicor anticipates use of its PD2i Analyzer™ to enable early detection and risk stratification for a variety of other disorders and diseases. Additional information is available at www.vicortech.com.

Disclaimer
The appearance of name-brand institutions, such as the University of Mississippi Medical Center; Bellhaven University; Mississippi Braves; Belhaven University Blazers; Provine High School Rams; Lanier High School Bulldogs; Canton High School Tigers; Dixie National Rodeo Sports Medicine; and University College London in this media release does not constitute endorsement by institutions 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 successfully complete the normal range study for PD2i® values; our ability to generate revenues from the sale of the PD2i Analyzer™; our ability to obtain the necessary regulatory approvals to market the PD2i Analyzer™; our ability to develop additional applications for the PD2i Analyzer™; our ability to continue to receive financing sufficient to continue operations and complete 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, 2009 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.

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