SOURCE: Vicor Technologies

November 28, 2006 14:40 ET

Vicor Technologies Initiates Clinical Sites for Pivotal Vital Trial; Enrolls First Two Patients; Targets FDA 510(k) Submission in 2008

Company's Chief Medical Officer Comments on American Heart Association Findings

BOCA RATON, FL -- (MARKET WIRE) -- November 28, 2006 -- Vicor Technologies, Inc., developer of the Vicor PD2i Cardiac Analyzer, a patented device utilized in the risk stratification of patients for Sudden Cardiac Death (SCD), announced that it had completed the initiation process for two of the initial five clinical sites selected for its VITAL Trial. The Company also has enrolled two patients in the VITAL Trial. The two sites are the VA Hospital and Massachusetts General Hospital, both in Boston, MA. These sites are now actively screening additional patients for enrollment in the VITAL Trial.

In making the announcement, Vicor Technologies President and CEO David H. Fater said, "We are very pleased to enroll our first two patients into the VITAL Trial for our proprietary PD2i Cardiac Analyzer. Other patients are now actively being screened for enrollment in the VITAL Trial. The VITAL Trial is being coordinated by the Harvard Clinical Research Institute, a Harvard University affiliate. Two of our initial five sites are enrolling or ready to enroll patients. We hope to have all of the first five sites initiated as soon as possible in early December." Mr. Fater added, "This is a critical step in the evolution of the Company as we move towards commercialization of the PD2i Analyzer which is expected at the completion of the VITAL Trial in 2008."

Separately, the Company's Chief Medical Officer, Daniel N. Weiss, M.D., FACC, commented on findings announced at the American Heart Association Meeting held in Chicago, Illinois on November 12-15.

Dr. Weiss said, "Two important points were made clear by the studies presented at this AHA meeting. First and foremost is that in the future, properly stratifying patients' risk for Sudden Cardiac Death is going to be critical. As a society we simply cannot carry the burden of implanting defibrillators in all those patients who meet current criteria, the vast majority of whom will never receive therapeutic benefit from the device. Secondly, the currently available risk stratification technology is inadequate. In one study, 41% of patients referred for testing could not perform the test, and many of those who could perform it had indeterminate results. Thus, there is a pressing need for a simple, easily obtainable test that lets physicians and their patients know who really does or does not need defibrillator therapy. This is the market need addressed by our PD2i Cardiac Analyzer which we expect to be confirmed by the results of the VITAL Trial."

About the VITAL Trial

The VITAL Trial (acronym for "Prospective, Multi-Center Study of the Ability of the PD2i Cardiac Analyzer to Predict Risk of VentrIcular TachyArrhytmic Events such as, Sudden Cardiac Death (SCD), VentricuLar Fibrillation (VF) or Ventricular Tachycardia (VT) in High Risk Patients") was initiated in August 2006 and will be conducted by Harvard Clinical Research Institute (HCRI) which is responsible for the overall coordination and monitoring of the trial. The FDA, in pre-IDE (Investigational Device Exemption) meetings, agreed to the final PD2i protocol and study design for the pivotal VITAL study. Target Health, Inc., a full service contract research organization, is responsible for developing the electronic case report form to permit the gathering of patient data via the Internet, and will be responsible for preparing and submitting Vicor's Premarket Notification 510(k) application.

About Vicor Technologies, Inc.

Vicor Technologies' medical device, the PD2i Cardiac Analyzer, which is based on a patented, proprietary algorithm, accurately risk stratifies patients who are at high or low risk of suffering a fatal arrhythmic event or Sudden Cardiac Death (SCD) within a six month time frame. SCD is the leading cause of natural death in the United States each year with over 500,000 reported cases.

Vicor's PD2i Cardiac Analyzer addresses a significant health care issue which involves a patient cohort of at least 12,000,000 patients. This patient cohort is composed of the MADIT-II (Multicenter Automatic Defibrillator Implantation Trial II)/SCD-HeFT (Sudden Cardiac Death in Heart Failure Trial) patient population; many of which may need an ICD (Implantable Cardioverter Defibrillator) as life saving therapy. However, it has been noted in recent registry studies that over 70% of implanted ICD's never have an appropriate firing. This over-implantation has led to a substantial and unnecessary medical cost burden. Over-implantation of this patient cohort also puts them at risk because of the complications which can accompany this surgery.

Vicor's PD2i Cardiac Analyzer addresses the growing need for the medical community to be able to accurately risk stratify patients who are at high or low risk of suffering a fatal arrhythmic event. This will lead to a higher quality of patient care, minimization of medical expenses, and enhancing the patient's Quality of Life. Vicor Technologies is uniquely positioned to address this substantial unmet medical need. For more information visit the company web site www.vicortech.com.

Caution Regarding Forward-Looking Statements: Forward-looking statements in this press release are based on current plans and expectations that are subject to uncertainties and risks, which could cause our future results to differ materially. The following factors, among others, could cause our actual results to differ: our ability to continue to receive financing sufficient to complete the critical clinical trials; our ability to continue as a going concern; our ability to successfully develop products based on our technologies; our ability to obtain and maintain adequate levels of third-party reimbursement for our products; the impact of competitive products and pricing; our ability to receive regulatory approval for our products; the ability of third-party contract research organizations to perform preclinical testing and clinical trials for our technologies; the ability of third-party manufacturers to manufacture our products; our ability to retain the services of our key personnel; our ability to market and sell our products successfully; our ability to protect our intellectual property; product liability; changes in federal income tax laws and regulations; general market conditions in the medical device and pharmaceutical industries; and changes in laws and regulations. Forward-looking statements in this press release speak only as of the date of the press release, and we assume no obligation to update forward-looking statements or the reasons why actual results could differ.

Contact Information

  • Investor Contact:
    Robert Giordano
    ROI Associates
    212.495.0201
    Email Contact

    Company Contact:
    David Fater
    President & CEO
    Vicor Technologies, Inc.
    800.998.9964
    www.vicortech.com