Vicor Technologies, Inc. (VCRT-OTC: BB)
May 22, 2009 Issue
The Most Powerful Name In Corporate News and Information
Vicor Technologies Achieved A Major Milestone With Receipt Of FDA 510(k) Marketing Clearance For Its PD2i Analyzer On December 29, 2008
Vicor Technologies, Inc. (OTCBB: VCRT) is a development-stage biotechnology company focused on the development of innovative, non-invasive diagnostics using its patented, proprietary PD2i algorithm and software. The PD2i algorithm is a deterministic, non-linear analytic measure that accurately evaluates biological signals to predict with high sensitivity and high specificity future pathological events in target populations.
Vicor currently has three products employing the PD2i algorithm and software. The PD2i Analyzer received 510(k) marketing clearance from the Food and Drug Administration (FDA) on December 29, 2008. The PD2i Analyzer displays and analyzes electrocardiographic information and measures heart rate variability (HRV). The clinical significance of HRV and other parameters must be determined by a physician. Such approval enables Vicor to market and distribute the PD2i Analyzer for use while its other products undergo clinical trials and proceed through the FDA regulatory process. In anticipation of further regulatory approvals in 2009, Vicor has entered into an original equipment manufacturer (OEM) agreement with Nasiff Associates in New York to sell a private label EKG machine, the Vicor PD2i Cardiac Analyzer EKG, for which Vicor will receive revenue both from the sale of the equipment and from the analysis of the test results.
The PD2i VS
(Vital Sign), which is in clinical trials under a collaborative effort with
the U.S. Army Institute for Surgical Research, risk stratifies combat and
civilian trauma victims. The PD2i CA (Cardiac Analyzer), which is currently
involved in multiple clinical trials, identifies patients at risk of
suffering sudden cardiac death. FDA 510(k) clearance to market the PD2i
VS and the PD2i CA is expected later this year.
Interview conducted by: Lynn Fosse, Senior Editor, CEOCFOinterviews.com, Published – May 22, 2009
Mr. Fater: “The most significant and game-changing event at Vicor Technologies was that on December 29th 2008, we received FDA 510-k marketing clearance for our first product. This enables us to commercialize the remainder of our products in a much more efficient and time-sensitive fashion. We were very excited about that, as it is a major milestone event for the company.”
CEOCFO: Would you explain your products to the new readers?
Mr. Fater: “Vicor is in the process of commercializing what we consider to be break-through, non-invasive, risk stratification technology products for cardiovascular and trauma use. We are collaborating with the U.S. Army on the development of the PD2i VS (Vital Sign) for use in triaging combat and civilian trauma victims. Our PD2i CA (Cardiac Analyzer) risk stratifies those patients at high-risk of sudden cardiac death (SCD) so they can be appropriately treated with an implantable cardioverter defibrillator. Our PD2i Analyzer, which received FDA 510(k) marketing clearance late last year, is currently in clinical trials to establish it as a diagnostic tool for diabetic autonomic neuropathy. The American Diabetes Association has recommended that all 18 million diabetics in the United States receive annual screenings for this silent killer disease.”
CEOCFO: Is the technology the same in diabetes?
Mr. Fater: “Interestingly enough it is the same technology. Everything we do is based on the analysis of an electrocardiogram recorded over a fifteen-minute interval using our PD2i algorithm and software, both of which are patented and proprietary. Based on the results of the analysis, the physician is easily able to accurately determine whether his patient is either at high or low risk of suffering from either sudden cardiac death within a six month period or having diabetic autonomic neuropathy. Those at high risk need to be treated aggressively and with some degree of urgency. Those at low risk can be managed more conservatively. All of these potential life-saving functions will be able to be done with one technology, one 15 minute analysis of an ECG.”
CEOCFO: What differentiates your technology from what is currently being used?
Mr. Fater: “Right now, there is really no effective risk stratification technology for sudden cardiac death. There are established criteria that were developed years ago to identify those patients who were at the highest risk of sudden cardiac death and should receive an implantable defibrillator. If needed, the defibrillator is implanted in the chest, where it monitors the heart rhythm. If it detects a potentially fatal heart rhythm, it sends a shock to knock the heart out of the fatal rhythm. The extraordinary statistics are that of the people who have received an implantable defibrillator, 76% of them have never received an appropriate shock. On the other hand, of the people who are dying every year from sudden cardiac death, only 20% of them would have met the current criteria for a defibrillator. This indicates that the entire risk stratification arena for sudden cardiac death is in utter chaos. We believe our technology, when approved for marketing by the FDA -- which we hope will occur in the second half of this year -- will be a major break-through for those at risk of sudden cardiac death because of its ease of use and accuracy.”
CEOCFO: Is special training needed to analyze the results?
Mr. Fater: “No, it is a simple binary result, positive/negative, nothing in-between.”
CEOCFO: What is the status today of your three products?
Mr. Fater: “Our FDA strategy was to obtain 510(k) clearance for the PD2i Analyzer without a specific claim. The approved application is for displaying electrocardiographic information and measuring heart rate variability. Heart rate variability is the key to all of our diagnostic tools using the PD2i algorithm. Now that the PD2i Analyzer is cleared for marketing, we’re accumulating the clinical data to support use of the heart rate variability measure specifically for application in trauma triage, sudden cardiac death, and diabetic autonomic neuropathy. As these applications are modifications to our existing 510(k) for the PD2i Analyzer, we anticipate more rapid clearance and commercialization for them. It’s feasible that all three applications could be cleared for marketing during the second half of this year.”
CEOCFO: That is pretty fast!
Mr. Fater: “It is. That was the intention of our FDA strategy: obtain ‘plain vanilla” approval for measuring heart rate variability rather than its use for a specific application. So now the approval process is a notification to the FDA and modification of our existing 510(k), versus the onerous approval process for a new product.”
CEOCFO: How do you get doctors to pay attention?
Mr. Fater: “Physicians in the sudden cardiac death arena are already paying attention in the sense that they are clamoring for something that will help them better serve their patients and cut the cost to the healthcare system of putting implantable defibrillators in patients who don’t really need them. We have a world-class scientific advisory board behind our technology. We anticipate that these physicians will participate in thought-leader seminars we intend to organize in major U.S. cities once we receive FDA clearance. Under a collaborative research agreement with the University of Rochester and the Catalan Institute of Cardiovascular Sciences in Barcelona, the PD2i CA is currently being evaluated to test its ability to retrospectively predict sudden cardiac death in congestive heart failure patients who participated in an earlier clinical trial. The results from this trial, which we anticipate will be available next month, will serve as the foundation for our submission to the FDA for modification of our existing 510(k) for an application for sudden cardiac death. Given its significance, we anticipate that this trial will be the subject of a manuscript authored by the University of Rochester scientists involved and will also, perhaps, be the basis of a presentation at one of the major cardiac conferences later this year. A published manuscript and presentation would certainly help get the word out to the cardiologist population. We also have a national cardiac panel consisting of 450 cardiologists from around the country who have kept up with Vicor, since its inception. Additionally, we have approximately 350 physician stockholders who have actively followed the developments of our technology and are very interested in using it in their practice as soon as it becomes available. They are the early adopters who, we believe, will create a kind of viral marketing network that will expand awareness for our technologies among other physicians.”
CEOCFO: Are you looking at world markets?
Mr. Fater: “We signed a letter of intent to distribute our products in India during the second half of this year. We are also in the early stages of obtaining CE mark approval so we can distribute our technology to countries in the European Union, which requires CE mark approval to do so. While the U.S. market is huge, we think our technology can benefit people around the world. In the U.S. alone, there are 18 million diabetics who need annual screening and as many as 12 million patients at risk of sudden cardiac death. In India, which has a total population of more than a billion, there are more than 140 million diabetics at risk of diabetic autonomic neuropathy, a serious complication that occurs when diabetes is not monitored and managed correctly. Given the size of at-risk populations worldwide, we will market our products globally. Obviously, our initial efforts have been directed toward the U.S. given our location, the importance of the U.S. medical market, and the size of our targeted at-risk populations.”
Would you touch on the difference between sudden cardiac death and a heart
CEOCFO: Would you tell us more about your collaboration with the U.S. Army Institute of Surgical Research?
Mr. Fater: “In October of 2007, the Army was trying to solve a triage problem with wounded soldiers in Iraq. In order to administer immediate life saving intervention, they needed to accurately identify those most severely wounded. One of the indicators they were exploring was heart rate variability or heart rate complexity. None of the metrics they were using was working. During this time, they discovered the manuscripts of early studies conducted by our inventor of the PD2i algorithm, and approached us about a collaborative research effort. We signed the collaboration agreement in January of 2008 and conducted a series of experiments, all of which were successful. The Army has already had one abstract about their experiments with our technology published and has submitted several more abstracts and papers for consideration in prestigious journals. The last study conducted by the U.S. Army Institute of Surgical Research and our scientists involved 325 civilian trauma victims, 20 of whom actually died. The PD2i accurately identified the 20 who died. Of these, however, 14 were not identified as needing and did not receive immediate life saving intervention in the field by personnel on the scene using traditional triage techniques. This suggests that the tools currently being used to determine who is in need of immediate life saving intervention are inadequate. Given these results, we believe the PD2i can make a significant contribution to improving military and civilian trauma triage efforts.”
CEOCFO: Why should potential investors look at Vicor?
Mr. Fater: “We think Vicor represents a truly unique value proposition. Vicor’s common stock has appreciated almost 300% this year. Right now – pre-revenue -- it is trading somewhere around $.80 to $.85 cents a share. Following FDA marketing clearance, we fully anticipate being able to generate meaningful revenue in the second half of this year, which we think will further drive interest and investment in Vicor. We believe we are just about at the proverbial tipping point. Having completed our long journey to FDA marketing clearance, we’re ready to enjoy the rapid rise in our stock price as we begin to generate revenues and move quickly into profitability.
CEOCFO: Final thoughts, what should people remember most about Vicor Technologies?
“Vicor Technologies is producing what we believe is a significant new vital
sign that will be widely adopted for use by physicians because of its
ease-of-use and accuracy in helping them identify those patients most in
need of their assistance.”
“The most significant and game-changing event at Vicor Technologies was that on December 29th 2008, we received FDA 510-k marketing clearance for our first product. This enables us to commercialize the remainder of our products in a much more efficient and time-sensitive fashion. We were very excited about that, as it is a major milestone event for the company.” - David H. Fater
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