His advice andinsight could make very meaningful contributions, especially in suchimportant areas as the FDA approval process and obtaining reimbursement forphysicians.
To further enhance Vicor's image and recognition within the medical andhealth care communities, Vicor has published in peer reviewed,professionally accredited journals and publications, various studies withregard to its PD2i technology.
In February, Vicor announced that Therapeutics and Clinical Risk Managementhad accepted for publication in April 2008 a study titled "NonlinearAnalysis of the Heartbeats in Public Patient ECG's Using An Automated PD2iAlgorithm for Risk Stratification of Arrhythmic Death." The study enrolled37 patients (30 of which completed the study) and achieved a sensitivity of100% and a specificity of 81%.
The study highlighted Vicor's proprietary PD2i Analyzer technology anddemonstrated the ability to accurately risk stratify patients into thosewho require Implantable Cardioverter Defibrillator (ICD) intervention andthose who do not.
In May, Vicor announced that Therapeutics and Clinical Risk Management alsoaccepted for publication in its August 2008 issue, positive results of aclinical study conducted by the Company titled "Risk Stratification forArrhythmic Death in an Emergency Department Cohort: a new method ofnonlinear PD2i analysis of the ECG."
The study enrolled 918 patients (876 of which completed the study) in sixemergency departments. The study achieved a sensitivity of 96% and aspecificity of 85% with a negative predictive value of 99%, for the PD2iCardiac Analyzer.
Mr. Fater stated the study further increased the company's high degree ofconfidence that the pivotal VITAL Trial will be successfully completed andserve as the basis for Vicor to obtain FDA clearance through the 510(k)process at the conclusion of the trial.
In October, 2007, Vicor announced issuance of its fourth patent entitled"Method and system for detecting and/or predicting cerebral disorders."Issuance of this patent expanded Vicor's future product portfolio andvalidated its platform technology. Importantly, it will also serve as thecatalyst for the commencement of a pilot study for the early detection ofAlzheimer's Disease to be conducted in collaboration with Florida AtlanticUniversity and their Louis and Anne Green Memory and Wellness Center. Thestudy is anticipated to commence during 2008, and other applicationscovered by this patent may also be initiated in the near future.
The Company continues to seek patent protection for its platformtechnologies, and anticipates additional patents to be issued in thefuture.
To strengthen its financial position, in April the Company announced theconversion of $2,998,000 of its corporate debt into shares of its commonand preferred stock and warrants to purchase shares of its common stock.Mr. Fater noted the Company was pleased it was able to substantially reduceits outstanding indebtedness and increase its equity through this exchangeand conversion. He indicated management of Vicor appreciated theconfidence in the Company's future that stockholders expressed by theirconversion and exchange of indebtedness for additional equity.
Mr. Fater, on behalf of Vicor management, expressed confidence that theCompany would be successful in its efforts to receive FDA approval of itsPD2i technology during 2008 for trauma and introduce the PD2i device forcommercialization shortly thereafter.
About Sudden Cardiac Death (SCD)
SCD is the leading killer in the U.S. with over 500,000 annual deaths. Itis a fatal arrhythmic event and is different than a heart attack. A heartattack is analogous to a plumbing problem, where the blood supply to a partof the heart is choked off, leading to the death of that portion of theheart muscle. SCD is theorized to be caused by a breakdown of the normalneurological communication pattern between the heart and brain, more likean electrical problem, which can lead to a rapid, life-threatening heartrhythm that is usually fatal within minutes, if untreated. It is swift,unexpected, and often has no advance warning or symptoms.
About Vicor Technologies, Inc.
Vicor's medical device, the PD2i Cardiac Analyzer, is based on a patented,proprietary algorithm. Vicor believes the PD2i Cardiac Analyzer accuratelyrisk stratifies patients who are at high or low risk of suffering a fatalarrhythmic event or SCD within a six-month time frame.
Vicor's PD2i Cardiac Analyzer addresses a significant health care issueinvolving a patient cohort of at least 12,000,000 patients. This patientcohort is composed of the MADIT-II (Multicenter Automatic DefibrillatorImplantation Trial II)/SCD-HeFT (Sudden Cardiac Death in Heart FailureTrial) patient population. Many in this patient cohort may need anImplantable Cardioverter Defibrillator (ICD) as life-saving therapy.
However, recent registry studies have noted that over 70% of implantedICD's never have an appropriate firing. This over-implantation has led to asubstantial and unnecessary medical cost burden.