Vicor Technologies, Inc. (OTCBB: VCRT)
New (2nd) FDA Approval Now In – Market Could be Very Large
Vicor Technologies, Inc. (OTCBB: VCRT) has received its second FDA approval. This means VCRT now has all of the regulatory approvals in place already for the to PD2i ® to generate substantial revenues. This new approval, just received in April has the potential to open up the VCRT market to 77 million patients for the PD2i Analyzer™.
This market could be substantial.
Current procedural terminology (CPT) codes enable physicians using the PD2i® Analyzer to be reimbursed by insurance carriers, creating a recurring source of revenue from test analysis for Vicor.
The PD2i ® Algorithm represents a noninvasive monitoring technology that physicians and other members of the medical community could potentially use as a new and accurate vital sign.
Two proprietary diagnostic medical products are being commercialized which employ software utilizing the PD2i ® Algorithm:
- First – the PD2i® Analyzer
- Second – the PD2i Cardiac Analyzer ™
- The PD2i VS ™ Vital Sign Monitor for trauma, triage, and other hospital uses in still under development.
FDA Approval of PD2i Analyzer™ for BOTH Heart Rate Variability and Cardiovascular Disease Testing
Vicor’s PD2i Analyzer™ has FDA 510(k) marketing clearance to both:
- Measure heart rate variability (HRV) for physician-determined use which can assess autonomic nervous system dysfunction in diabetics.
- And be used specifically in patients undergoing cardiovascular disease testing.
Vicor is now able to broaden its marketing message and could significantly increase interest in the Analyzer particularly with cardiologists. Physicians are able to use the Analyzer for indications believed to be useful. FDA clearance of specific indications allows Vicor to explicitly market for those indications.
The PD2i® Analyzer is used as a diagnostic for heart rate variability, which is a widely-accepted measure of autonomic nervous system health and by extension cardiac health.
The PD2i ® Algorithm facilitates the ability of physicians to accurately risk stratify a specific target population to predict future pathological events such as autonomic nervous system dysfunction, cardiac mortality (either from arrhythmic death or congestive heart failure) and imminent death from trauma.
StockGuru’s Profile for Vicor Technologies, Inc.
This is the condensed version – Full StockGuru Profile Found Here:
http://stockguru.com/about/vcrt/
Vicor Technologies, Inc. (OTCBB: VCRT) is a medical diagnostics company focused on commercializing noninvasive diagnostic technology products based on its patented, proprietary point correlation dimension algorithm the PD2i ® Algorithm and software.
With the second FDA approval under its belt in April, Vicor is fully in the process of transforming itself into a commercial company with a national sales force and international reach.
The Company has all of the regulatory approvals in place already with regards to PD2i ® to generate substantial revenues.
FDA Approval of PD2i Analyzer™ for BOTH Heart Rate Variability and Cardiovascular Disease Testing
Vicor’s PD2i Analyzer™ has FDA 510(k) marketing clearance to both:
- Measure heart rate variability (HRV) for physician-determined use which can assess autonomic nervous system dysfunction in diabetics.
- And be used specifically in patients undergoing cardiovascular disease testing.
Potential Market PD2i Analyzer™
The potential market for the PD2i Analyzer™ with 77 million potential patients could be in the multi-billions of dollars. This market is supported by the recent FDA approval to market the PD2i Analyzer™ for cardiovascular disease testing is anticipated to spur market acceptance of the PD2i Analyzer™ as a valuable new diagnostic.
The groundbreaking 510(k) obtained in April of 2011, for the use of the PD2i® metric includes the classical Ewing maneuvers with the PD2i® metric in patients undergoing cardiovascular disease testing.
This FDA Approval is an accomplishment of incredible significance for VCRT as both national and international acceptance begin to accelerate. This landmark approval has been sought since the first introduction of the PD2i ® technology by Vicor in 2003.
These populations are significant:
- 23.6 million diabetics
- 15 million at-risk cardiac patients
- 38 million trauma incidents
PD2i ® Analyzer Provides Additional Revenue Source for Physicians and Improves Patient Care
Physicians can now expect a higher return on investment with the April 2011 FDA 501(k) for cardiovascular disease testing.
Vicor is now able to broaden its marketing message and could significantly increase interest in the Analyzer particularly with cardiologists. Physicians are able to use the Analyzer for indications believed to be useful. FDA clearance of specific indications allows Vicor to explicitly market for those indications.
Current procedural terminology (CPT) codes enable physicians using the PD2i® Analyzer to be reimbursed by insurance carriers, creating a recurring source of revenue from test analysis for Vicor.
The PD2i® Analyzer is used as a diagnostic for heart rate variability, which is a widely-accepted measure of autonomic nervous system health and by extension cardiac health.
The PD2i ® Algorithm facilitates the ability of physicians to accurately risk stratify a specific target population to predict future pathological events such as autonomic nervous system dysfunction, cardiac mortality (either from arrhythmic death or congestive heart failure) and imminent death from trauma.
PD2i ® Algorithm New and Accurate Vital Sign
The Company believes that the PD2i ® Algorithm represents a noninvasive monitoring technology that physicians and other members of the medical community can use as a new and accurate vital sign.
Two proprietary diagnostic medical products are being commercialized which employ software utilizing the PD2i ® Algorithm:
- First – the PD2i® Analyzer
- Second – the PD2i Cardiac Analyzer ™
- The PD2i VS ™ Vital Sign Monitor for trauma, triage, and other hospital uses in still under development.
FDA Clearance
In April 2011 the Company received 510(k) clearance from the U.S. Food and Drug Administration for its PD2i® nonlinear algorithm and software to be used as a measure of heart rate variability at rest and in response to controlled exercise and paced respiration (Ewing Maneuvers) in patients specifically undergoing cardiovascular disease testing.
Physician use of the PD2i® Analyzer is supported by an expanding body of literature demonstrating the value of the PD2i® nonlinear algorithm as a metric for risk stratifying specific target populations for future pathological events.
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This is the condensed version – Full StockGuru Profile Found Here:
http://stockguru.com/about/vcrt/
Contact Vicor Technologies, Inc.
David H. Fater, CEO
Vicor Technologies, Inc.
561.995.7313
[email protected]
.
VCRT Disclosure: StockGuru entered into an investor relations consulting and market awareness contract with VCRT. We are also doing a video on ShareholderVision.com that will be released shortly. The Company will pay us a total of seventy two hundred dollars and fifty thousand shares of restricted 144 stock for the period ending August 31, 2011. We still hold hold these shares. To avoid all potential conflicts of interest, we never sell shares into the open market during an active market awareness or investor relations program. This means that as we release new information about a particular client company either on our site or otherwise authored by us, you can be confident we are not selling shares at the same time. StockGuru is not a registered investment adviser or a broker/dealer. StockGuru 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 early 2010, the Company paid us seventy two hundred dollars and fifty thousand shares of restricted 144 stock for a prior round of coverage that ended. 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. StockGuru – 1601 Berwick Drive – McKinney, Texas 75070 – (469) 252-3031.