Vicor Technologies, Inc. (OTCBB: VCRT) Working
Written by StockGuru on December 25, 2009
You know by now that I believe Vicor Technologies has developed a product which has the potential to become a foundation in the medical industry with a product that has the potential to become a mainstay in diagnostics. The market is huge.
The Company has FDA marketing clearance for a measure of Heart Rate Variability, CPT codes in place that physicians already use, products in a limited number of physician offices.
The PD2i™ nonlinear algorithm and software:
- Provides a simple noninvasive test for identifying patients at risk of sudden cardiac death
- Provides a simple noninvasive test for identifying patients with Diabetic Autonomic Neuropathy
This risk stratifies target populations to predict future pathological events. As a predictor of sudden cardiac death it has been shown to be highly accurate, with a sensitivity approaching 100% and a specificity of ~86%.
FDA Marketing Clearance and Reimbursement under exisitng CPT Codes
FDA Marketing Clearance and Existing Reimbursement Codes represent a huge step for ANY biotech company. This means green lights ahead and time to capitalize on the long hard road biotech companies face.
The timing on this company for our readers could NOT BE BETTER.
Vicor’s Three Products Employing the PD2i™ Nonlinear Algorithm.
- PD2i Analyzer(TM) has FDA 510(k) marketing clearance. It measures Heart Rate Variability. Physicians performing diagnostic tests with the PD2i Analyzer™ are able to receive reimbursement under existing CPT codes.
- PD2i VS(TM) (Vital Sign) stratifies risk in combat and civilian trauma victims and is in clinical trials under a collaborative effort with the U.S. Army Institute for Surgical Research. (http://www.usaisr.amedd.army.mil/)
- PD2i CA(TM) (Cardiac Analyzer) identifies patients at risk of sudden cardiac death and is in multiple clinical trials.
FDA Approval for Measure of Heart Rate Variability
The PD2i Analyzer™ has been cleared by the FDA for marketing as a measure of Heart Rate Variability. It quantifies the relationship between the patient’s heart and brain by measuring the heart rate variation over time.
This represents a huge hurdle for ANY biotech company. This means the PD2i Analyzer is ready for sales.
The company has placed it in selected physician offices for evaluation.
Vicor’s long hard road of design and development – the hard time for any biotech company – has reached the sweet spot of fruition.
Here’s the Science:
Heart Rate Variability as a Diagnostic
Vicor’s PD2i™ nonlinear algorithm evaluates the neurological relationship between the heart and brain. It does this by measuring the degrees of freedom of the patient’s Heart Rate Variability over time, beat-to-beat.
Several sensory-motor loops such as temperature, pH, baroreceptor reflex and others have been found to control heart rate. The degree of cooperation between those loops is reflected in the degrees of freedom of the heart rate’s variability — a phenomenon caused by the brain’s influence.
In healthy individuals, these loops tend to work in opposition and more or less independently. But when the loops begin to coordinate to a high degree, paradoxically, it’s a sign that the body is not doing well and that the brain is “marshalling the forces” to work together to keep the body alive. Yet this “hyper coordinated” condition is not sustainable and can lead to ventricular tachycardia, ventricular fibrillation, and sudden cardiac death.
Knowing the degrees of freedom permits far more accurate evaluation of near-term risk of death than previously possible. The PD2i™ nonlinear algorithm and software precisely calculate the degrees of freedom, even in the presence of data issues that confound other methods and is the results are exceedingly easy to interpret.
Sudden Cardiac Death is not a Heart Attack
- A Heart Attack is an “Internal Plumbing Problem”
- Sudden Cardiac Death is caused by breakdown of the heart-brain axis
- Sudden Cardiac Death is swift and unexpected
- 95% of victims of Sudden Cardiac Death die outside of hospital
- Sudden Cardiac Death often occurs in asymptomatic individuals
The PD2i™ CA is able to accurately risk stratify patients into those at high or low risk of suffering a fatal arrhythmic event, or Sudden Cardiac Death within a six to twelve month time frame.
Sudden Cardiac Death is the leading cause of natural death in the U.S. each year with more than 300,000 reported cases annually.
I want to share the incredible business model here and more on the science but this company has the Papers, Presentations and Prestigious Studies to back up their science.
This is a Sweet Time and a Sweet Spot for Vicor Technologies. 2010 should be their pivotal year and you have the opportunity to capitalize on this knowledge.
Vicor Technologies, Inc.
2300 NW Corporate Blvd.
Suite 123
Boca Raton, FL 33431
877.528-PD2i (7324)
info@vicortech.com
Disclaimer and Forward-Looking Statements
The appearance of name-brand institutions or products in this profile does not constitute endorsement by the U.S. Army Institute of Surgical Research, 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.
Forward-looking statements in this profile are based on current plans and expectations that are subject to uncertainties and risks, which could cause the Company’s future results to differ materially. The following factors, among others, could cause the Company’s actual results to differ: the Company’s ability to obtain FDA approval of the PD2i VS™ (Vital Sign) for military and civilian applications and the PD2i CA™ (Cardiac Analyzer), the Company’s ability to continue to receive financing sufficient to continue operations and complete the critical clinical trials; the Company’s ability to continue as a going concern; the Company’s ability to successfully develop products based on the Company’s technologies, included but not limited to the Company’s ASP distribution model for the PD2i Analyzer™; the Company’s ability to obtain and maintain adequate levels of third-party reimbursement for the Company’s products; the impact of competitive products and pricing; the Company’s ability to receive regulatory approval for the Company’s products; the ability of third-party contract research organizations to perform preclinical testing and clinical trials for the Company’s technologies; the ability of third-party manufacturers to manufacture the Company’s products; the Company’s ability to retain the services of the Company’s key personnel; the Company’s ability to market and sell the Company’s products successfully; the Company’s ability to protect the Company’s 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 Vicor assume no obligation to update forward-looking statements or the reasons why actual results could differ.
Pentony Enterprises LLC is STOCKGURU.COM. 10604 Robincreek Lane; Frisco, Texas 75035. (469) 252-3030. Disclosure: Pentony Enterprises LLC was compensated fifty thousand restricted common shares and seventy-two hundred dollars by the company for profile coverage for the period ending March 31, 2010. Pentony Enterprises is not a registered investment adviser or a broker/dealer. Pentony Enterprises LLC makes no recommendation that the purchase of securities of companies profiled in this web site is suitable or advisable for any person, or that an investment in such securities will be profitable. In general, given the nature of the companies profiled and the lack of an active trading market for their securities, investing in such securities is highly speculative and carries a high degree of risk. We will not be buying or selling shares of Vicor during the promotional period.
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