Vicor Technologies, Inc. (OTCBB: VCRT)
This is a simple, straight forward bio-tech company with a product in the market. It is at the very beginning of marketing.
The multi-facted part of the very simple concept behind the product “A NEW VITAL SIGN” with a business model of giving them the razor and selling the razor blades is broad. The expansive and pervasive application of this product is great shareholder news — but there is a lot to it.
The market for Vicor’s products is incredibly broad and I invite you to read about it (or if time permits just scan it). It is included below. Then watch the interview which explains this market and the product application as no words can.
Let’s bring this to life — get the BIG PICTURE. Watch Shareholder Vision’s Interview with David Fater.
David H. Fater
President, Chief Executive Officer, Chief Financial Officer, Director
Joined Vicor in 2002, from ALDA & Associates International Inc., a business and financial consulting firm specializing in healthcare and life sciences.
Prior to forming ALDA & Associates in 1993, Mr. Fater held senior executive positions with three public healthcare companies. He led the initial public offering process for BMJ Medical Management, Inc. (1997-1999) and Community Care of America (1995-1996), and led Coastal Physician Group, Inc. (1993-1995) to a NYSE listing and $1 Billion market capitalization. Before this, Mr. Fater was employed by Ernst & Young, where he completed his 24-year tenure as a Senior International Partner advising senior management and boards of directors (1969-1992).
Mr. Fater is a certified public accountant in Georgia, Illinois, North Carolina, and New York. He holds a BS in Accounting from the University of North Carolina.
Large Total Potential Market Opportunity
The PD2i™ diagnostics enable inexpensive, accurate, and early identification of disease states in at-risk populations prior to costly treatments for advanced disease or inaccurate identifications which are garnering increased attention in the current healthcare debate.
These populations are significant, representing:
- 12 million at-risk cardiac patients,
- 23.7 million diabetics, and
- 38 million trauma incidents
This represents 70 million potential patient encounters translating into a more than a $5 Billion annual market.
Emergency Response
Vicor anticipates that the PD2i-VS™ will play a role in the over 38 million emergency response calls annually in the United States.
It should prove invaluable by enabling paramedics to assign a level of severity to patients being transported to the emergency room. At the E.R. the PD2i-VS™ is expected to play an important role in helping ER personnel triage patients in-hospital.
Diabetic Autonomic Neuropathy Market
Studies indicate that as many as a quarter of the 23.6 million diabetics in the U.S. may be suffering nerve damage from Diabetic Autonomic Neuropathy and many of them are without the symptoms which would alert them to seek treatment.*
Diabetic Autonomic Neuropathy is best diagnosed by measuring a patient’s Heart Rate Variability (HRV). Vicor’s PD2i Analyzer™ measures HRV quickly, accurately and inexpensively.
Though gradual in onset, Diabetic Autonomic Neuropathy has grave consequences. Since the autonomic nervous system undergirds so many of the Company’s body’s key functions, damage to these nerves can result in:
- Heart disease and sudden death
- Loss of urinary and bowel control
- Kidney failure
- Impotence
- Blindness
* Source: Full Accounting of Diabetes and Pre-Diabetes in the U.S. Population in 1988–1994 & 2005–2006. Diabetes Care, 32:287-294, 2009
Diabetic autonomic neuropathy is gradual in onset so the disease may be fairly well advanced by the time symptoms are detectable by conventional means. Thus, tragically, treatment is often not commenced until the patient is already experiencing vision problems, incontinence or sexual dysfunction. At this point, nerve damage is well underway, and patients are at significantly increased risk of sudden cardiac death
A diagnostic is needed which can detect diabetic autonomic neuropathy long before significant nerve damage has occurred. Vicor believes that PD2i Analyzer™ is that diagnostic.
Conventional tests can only detect the nerve damage Diabetic Autonomic Neuropathy leaves in its wake; the PD2i™ nonlinear algorithm uses advanced mathematics to directly measure the health of a patient’s autonomic system. A PD2i™ score can be simply and painlessly determined within minutes and will reveal if a patient has developed diabetic autonomic neuropathy, enabling doctors to intervene to protect their patients from further debilitating disease.
Vicor’s PD2i Analyzer™ has already received FDA 510(k) marketing clearance as a measure of Heart Rate Variability. Vicor expects to secure an expanded claim through the 510(k) application process for a diabetic autonomic neuropathy indication.
PD2i ™ Marketing
International Marketing
Vicor has signed a distributorship agreement with Glotecx, Inc. (Coral Springs, FL) covering India and four other countries in East Africa. The agreement, which employs the Company’s ASP model, is expected to generate revenue in early 2010. This agreement calls for payment of a guaranteed minimum number of collection devices and tests per month paid in advance.
While the agreement was intended to commence late in the fourth quarter, there is a delay due to situations beyond the Company’s control.
Vicor is in discussions with distributors in other countries including Israel, Ecuador, Brazil, Philippines, United Kingdom, Thailand, and China. Vicor believes the value of the Company’s technology, per test pricing, and alternative regulatory climate (non-U.S.) in these countries create the opportunity to realize significant future international revenues and possibly sooner revenues than would be realized in the United States.
Domestic Physician Market
There currently are established CPT codes that enable physician reimbursement from third-party payors for the performance of tests which use the PD2i Analyzer™. The PD2i CA™ is being beta tested in a large cardiology practice in California.
In anticipation of a product launch in early 2010, Vicor has identified several of the Company’s physician shareholders and their practices for early adoption of the PD2i Analyzer™.
Physician acceptance is a critical success factor. The Company’s strategy has always been to establish a large physician base – 350 shareholders and 450 members of the Company’s National Cardiac Panel – as early adopters of the Company’s technology to ensure that:
The product is well received by physicians interested in Vicor’s success
Product enhancement suggestions provided by these early adopters can be incorporated into the technology before a national rollout.
The PD2i test offers several advantages over competing diagnostics:
- More predictive than competing tests
- Non-invasive
- Performed by nurse or technician on resting patient
- Uses inexpensive, non-proprietary EKG electrodes
- Result available in less than twenty minutes
- Easy to use
- Yields simple Positive/Negative result
- Compact and no treadmill required
- Forgiving of data issues plaguing other diagnostics; not derailed by irregular or ectopic beats
- Can be performed on patients taking beta-blockers
- Low up-front cost
- Low per test cost
Pre-Hospital and Hospital Markets
The PD2i VS™ is expected to be rolled out initially with the U.S. Army and several international armed forces. Ultimately, the Company’s goal is to license the technology for inclusion in existing vital sign monitors for pre-hospital and hospital use and combat care.
Inclusion in vital sign monitors will not preclude the development of the Company’s own hardware in a size permitting easy battlefield transport by combat care providers.
High Incentive for Physician Use
- More definitive and higher quality patient care
- Minimal disruption to office patient flow
- Simple to use with Positive/Negative result
Short-term Business Milestones
1. Commencement of revenue in January 2010, from physician market in the United States.
2. International revenue is scheduled to commence during the first half of 2010.
3. Submit 510K for claim for Sudden Cardiac Death in Q1 2010. While the claim for Sudden Cardiac Death will enhance marketing efforts, it will not impact currently existing CPT codes and revenue recognition prospects.
4. Submit 510K for claim for Trauma in 2010 upon receipt of data from U.S. Army Institute of Surgical Research
5. Complete Normal Range Study and 510(k) submission to enable identification of normal ranges of PD2i values for physicians.
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.
