None of the tests (to separate patients who would benefit from ICDs from those who don't) are any good.
Boca Raton, FL (Vocus) September 16, 2009
According to Dr. Daniel Weiss, the recent untimely death of filmmaker John Hughes is a call for Americans to better understand sudden cardiac death -- the leading cause of natural death in the U.S. -- and the controversy surrounding the use of implantable cardioverter defibrillators (ICDs), currently the only known treatment for SCD prevention. Dr. Weiss is a cardiologist and chief medical officer of Boca Raton-based Vicor Technologies. Vicor Technologies, Inc. (OTCBB: VCRT) is a biotechnology company focused on the commercialization of innovative, non-invasive medical devices and diagnostics using its patented, proprietary PD2i algorithm and software to stratify patients at risk of sudden cardiac death (SCD) and trauma victims in need of life saving intervention.
With as many as 300,000 reported cases annually, SCD is the leading cause of natural death in the U.S. Swift, unexpected, and often occurring in previously asymptomatic individuals, SCD generally results in death within six minutes in the absence of appropriate medical attention. Even with such prompt emergency medical attention, only five percent of SCD victims survive. Contrary to common perception, SCD is not the same as a heart attack.
As Dr. Weiss explained in a NPR-affiliate station radio interview following Tim Russert's death from SCD last year. "A heart attack is considered a cardiac 'plumbing' problem wherein part of the heart muscle’s blood supply is interrupted, resulting in its loss. Typically a heart attack is not immediately fatal in and of itself. An event of SCD is the result of a fatal arrhythmic event, which is now theorized to be the result of a breakdown of the normal neurological communication between the heart and the brain."
According to current statistics, approximately 12 million U.S. cardiac patients meet the criteria for being at an elevated risk of SCD and, as a result, are able to receive an ICD as a preventative measure.
Dr. Weiss continued, "Unfortunately, ICDs aren't protecting those who could benefit from them, as is sadly demonstrated by the deaths of John Hughes, Tim Russert, and other luminaries, including Robert Palmer and Dave Debusschere. Studies show that 76 percent of ICDs implanted using those criteria never fire, suggesting a lack of true need in those patients and resulting in unnecessary ICD implantations with all of the associated health risks and costs (~$75,000/person). Conversely, and perhaps more importantly, only 20-30 percent of those who experience an episode of SCD would meet/have met thecurrent criteria for preventative ICD implantation, leaving the remaining 70-80 percent unprotected."
The problem, as summarized by Dr. Robert Califf, a Duke University cardiologist speaking at a conference of the American College of Cardiology in April 2008, (as reported in The Wall Street Journal ((Heart Device's Sales Slow as Wider Use is Sought - 4/1/08)), "None of the tests (to separate patients who would benefit from ICDs from those who don't) are any good." Dr. Califf described the current diagnostic situation as "chaos."
"Fortunately, as numerous clinical trials attest, Vicor Technologies' PD2i CA (Cardiac Analyzer), which employs Vicor's patented, proprietary point correlation dimension algorithm (PD2i), has demonstrated the ability to predict SCD, with an extremely high degree of accuracy, with as little as 15 minutes worth of ECG data. Additionally, the PD2i CA has numerous significant advantages over competitive diagnostics, including greater accuracy, ease of use, and lower cost, as well as none of the associated risk for patients of competitive diagnostics, as it requires neither a stress test nor suspension of heart medication as they do," Dr. Weiss concluded.
Based on the PD2i CA's ability to accurately predict SCD, the U.S. Army Institute of Surgical Research (USAISR) entered into a collaborative research and development agreement with Vicor to explore how the PD2i may be utilized to improve its efforts to risk-stratify the severity of injury and probability of survival of critically injured soldiers in order to improve its trauma triage efforts. All of the findings, to date, show the PD2i VS (Vital Sign) to be the only diagnostic capable of accurately determining severity of injury and probability of survival in critically injured soldiers and civilians. The collaboration is continuing.
FDA clearance to market the PD2i CA is expected by year-end 2009. FDA clearance to market the PD2i VS is expected during the fourth quarter of 2009, pending receipt of the USAISR's final analysis of trial results.
About Daniel N. Weiss, MD, FACC
Dr. Weiss has extensive experience in the practice of cardiology and electrophysiology. In addition to serving as Vicor's chief medical officer, Dr. Weiss is a partner with Florida Arrythmia Consultants, and has served as a consultant to Fortune 500 medical device manufacturers such as Medtronics, St. Jude Medical, and Guidant. He also served as a clinical investigator on the two most important clinical trials involving the study of ICDs and SCD (MADIT-II (MultiCenter Automatic Defibrillator Implantation Trial) and SCD HeFT (Sudden Cardiac Death Heart Failure Trial). He is a former director of the cardiac physiology laboratory at Boca Raton Hospital. Dr. Weiss earned his MD (with Distinction in Research) from Mount Sinai School of Medicine, from which he also received the Nathan A. Setz Award for Research in Cardiovascular and Renal Disease. He holds a BSE, cum laude, in Electrical Engineering and Computer Science from Princeton University.
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 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 suffering 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.
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.