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March 2005 - Volume 1 - Issue 8

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New Device Could Help Save Thousands From Sudden Cardiac Death

In the United States alone, estimates attribute between 250,000 and 500,000 deaths per year to sudden cardiac death (SCD) a phenomenon related to fatal disturbances in cardiac rhythm. These disturbances are due to malignant arrhythmias, errors in the electrical signals which govern the proper beating of the heart. These irregularities in heartbeat often go unnoticed and undiagnosed. When such abnormal arrhythmias are discovered in patients, a frequent treatment includes an implantable defibrillator (ICD). However, while there are ways to identify risk factors relating to the ‘plumbing’ problems related to heart disease such as clogged arteries and hypertension, identifying risk factors for individuals with arrhythmias is much more difficult. Unfortunately for the undiagnosed, the result may be unanticipated ‘sudden’ cardiac death.

Having a diagnostic tool which can reliably and accurately identify patients with arrhythmias which lead to SCD would be of great value to the medical community and save lives.

Vicor Technologies, Inc. headquartered in Boca Raton, Florida feels it has such a diagnostic tool which will save thousands of lives, the PD2i Cardiac Analyzer. According to David Fater, CEO of Vicor Technologies, "We think the Analyzer will revolutionize the practice of cardiology because it will finally provide cardiologists the ability to accurately risk stratify their patients."

The PD2i unit looks like a laptop computer to which the patient is connected using electrodes. While similar to an ECG machine which is widely used to monitor a patient’s heartbeat and record the heart’s electrical activity, unlike an ECG the PD2i utilizes a series of patented algorithms which analyze heart rate variability to identify patients at risk for SCD. The test is non-invasive and the patient is at rest during the test.

To come to this conclusion about a patient, the PD2i Cardiac Analyzer requires a fifteen to twenty minute data collection of heartbeat activity. Upon completion of the data collection, with the click of a button the results appear as a negative or positive test that can be easily interpreted by a physician.

Daniel N. Weiss, MD, FACC, Chief Medical Officer of Vicor comments that, "The ultimate decision that the cardiologist has to make in their sick patient is should I, or should I not give the patient an implantable defibrillator like Vice President Dick Cheney has. Even though the defibrillator companies paid for many studies to develop the guidance which exists today for implanting defibrillators, it is very imprecise." He continues, "The best statistic I can give you to illustrate this is that ninety percent of all implanted defibrillators never fire which means they were not really necessary for those patients. But the physician had no other information on which to make the judgment not to put one in the patient."

Vicor sees the benefit of the PD2i Analyzer as having the ability to definitively identify those patients who are subject to sudden cardiac death, or not. For those with the risk factors, as indicated by the Analyzer, their life can be saved through aggressive treatment. For those patients whom the Analyzer shows a negative result, by eliminating the need to implant defibrillators in patients who have questionable risks it can save the healthcare system enormous amount of money.

Vicor reports it has demonstrated that the Analyzer can predict future SCD based on clinical trial data of 400 emergency room patients. Vicor is now in the early stages of a more extensive study of the Analyzer involving 30 sites and up to 900 patients. This study is being conducted in conjunction with the Harvard Clinical Research Institute (HCRI) after which the FDA will review the data.

Vice President and Associate Director of Scientific Research, Jerry Anchin, Ph.D reports, "The study we are undertaking is the pivotal trial which we will use to gain FDA approval for the PD2i Analyzer. The study design calls for evaluating approximately 900 patients at 30 sites, several of which will be in South Florida. One site will be the Jim Moran Heart and Vascular Center at Holy Cross Hospital in Fort Lauderdale."

Vicor expects to sign up the first patients in March of 2005. Between enrollment and the twelve month follow up they expect the study to conclude by about September of 2006. At that time they will file for approval of the PD2i with the FDA and, if approved, begin to market the Analyzer in early 2007.

If all goes well, Vicor sees a broad market for the PD2i in both acute care and non-acute settings. For example, the PD2i could be used in emergency departments, intensive care units and critical care units where patients who are already exhibiting cardiac related symptoms can be evaluated for SCD. For example, in an emergency department the PD2i would be used in the diagnostic workup for patients complaining of chest pain.

In non-acute settings such as physician offices or clinics, the PD2i could be used as a monitoring device for patients who have already had a heart attack or have undergone corrective surgery for heart problems to assess their risk for SCD. The PD2i analysis could also be incorporated into routine exams such as annual physicals.

Vicor also believes the Analyzer has other uses such as to help identify patients with early Alzheimer’s disease, Mad Cow disease and even has potential to be used in lie detection.

Regarding its ability to convince the medical community of the efficacy of the Analyzer, James Skinner, Ph.D, Vice President, Director of R & D and Co-Founder of Vicor commented, "It is important for a biotechnology company to attract the thought leaders to enhance its credibility with the physician community. We have been able to attract to our scientific advisory board Dr. Mark Josephson who is the chief of Cardiology at Beth Israel Deconess and Harvard, and Professor Hein Wellens in Europe. Between those two individuals, they have written about a 1,000 manuscripts, two dozen textbooks, and are generally considered to be the world’s authorities on the types of arrhythmias which we are studying. So we believe we have the scientific community solidly behind us."

Vicor is also pursuing a drug discovery platform as well as the PD2i Analyzer.

For more information, you can reach Vicor Technologies, Inc. at 1-800-998-9964 or visit the website www.vicortech.com.
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