Vicor Technologies, Inc. filed its premarket notification paperwork with the U.S. Food and Drug Administration in 2010 required to receive 510(k) clearance for a Cardiac Marketing Claim on its proprietary PD2i® nonlinear algorithm. The Company’s algorithm and software are to be used in cardiovascular testing and have shown stunning accuracy in testing done to date.
Vicor Technologies is a biotechnology company focused on the commercialization of its PD2i Analyzer™, a non-invasive diagnostic employing its patented PD2i® nonlinear algorithm. The PD2i Analyzer™ enables physicians to accurately risk stratify specific target populations for future pathological events, including diabetics for the presence of diabetic autonomic neuropathy (DAN), cardiovascular disease patients for death resulting from arrhythmia or congestive heart failure, and trauma victims for imminent death absent immediate lifesaving intervention.
Today, Vicor announced that on March 30th the Company submitted a response to the FDA addressing inquiries primarily concerned with obtaining clarity and greater detail concerning the clinical trial data originally submitted and its internet-based delivery model. This situation is not something that should cause concern to members of the investment community as this is a standard practice of the review process by the FDA.
It is important to note that Vicor is already marketing the PD2i Analyzer™ through 510(k) regulatory approvals that have previously been granted and creating revenue (as announced in a February press release that showed January 2011 revenues topped the revenues reported for the full fourth quarter period of 2010). Many cardiologists across the country are presently using the PD2i Analyzer™ and a new distribution agreement has been inked with Hadar Training and Medical Services for the marketing and sale of its PD2i Analyzer™, PD2i CA™ (Cardiac Analyzer) and PD2i VS ™ (Vital Sign) in Israel and Palestine. What the new marketing clearance will do is allow Vicor to expedite its marketing efforts in an attempt to generate even larger revenues.
More information on Vicor Technologies and its technologies can be found on the Company’s website at www.vicortech.com