Vicor Technologies, Inc. Submits Response to FDA Regarding 510(k) for Cardiac Marketing Claim for Its PD2i(R) Nonlinear Algorithm
Published: Apr 05, 2011
This submission is a response to inquiries received from the FDA during its routine review of the Company's 510(K) premarket notification originally submitted in 2010. Commenting on the submission, Mr. Fater said, "The inquiries from the FDA were primarily concerned with obtaining clarity and greater detail concerning the clinical trial data originally submitted and our novel internet-based delivery model."
"This marketing clearance will be an important milestone because it will enable us to accelerate our marketing efforts. However, it is important for our current and potential investors to understand that we already have all the regulatory approvals we need to generate substantial revenue; our PD2i Analyzer™ is already being marketed to and being utilized by cardiologists as part of their practice protocols," concluded Mr. Fater.
About VicorTechnologies, Inc. Vicor Technologies' PD2i Analyzer™ employs its patented, proprietary point correlation dimension algorithm (PD2i®), a deterministic, nonlinear measure of electrophysiological potentials that predicts future pathological events with a high degree of accuracy in target populations. The PD2i Analyzer™, which has FDA 510(k) marketing clearance, measures heart rate variability with an easy-to-interpret binary score; physicians performing diagnostic tests with the PD2i Analyzer™ are able to receive reimbursement under existing CPT codes. Vicor anticipates use of its PD2i Analyzer™ to enable early detection and risk stratification for a variety of other disorders and diseases. Additional information is available at www.vicortech.com.
Disclaimer The appearance of name-brand institutions, such as the U.S. Food and Drug Administration (FDA), in this media release does not constitute endorsement by institutions of the information, products or services contained therein.
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 successfully complete the normal range study for PD2i® values; our ability to generate revenues from the sale of the PD2i Analyzer™; our ability to obtain the necessary regulatory approvals to market the PD2i Analyzer™; our ability to develop additional applications for the PD2i Analyzer™; our ability to continue to receive financing sufficient to continue operations and complete 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 other matters that are described in Vicor's Annual Report on Form 10-K for the fiscal year ended December 31, 2009 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 we assume no obligation to update forward-looking statements or the reasons why actual results could differ.
Release 11-11 Contact:
CORPORATE CONTACT David H. Fater Vicor Technologies, Inc. 561.995.7313 email@example.com INVESTOR CONTACT Richard Moyer Cameron Associates 212.554.5466 firstname.lastname@example.org MEDIA CONTACT Robin Schoen Robin Schoen Public Relations 215.504.2122 email@example.com