Ventripoint Announces Response to Interactive Review for
Recent 501(k) Submission to FDA
Seattle, Washington, April 8, 2015 – Ventripoint Diagnostics Ltd. ("Ventripoint") (TSXV:VPT) is pleased to announce that it has completed the first round of review concerning the most recent 510(k) submission to the U.S. Food & Drug Administration ("FDA"). On March 26th, 2015, Ventripoint received a request for additional information via Interactive Review. The Company responded promptly and delivered the requested information to the FDA for evaluation.
"Receiving this communication from the Lead Reviewer only a week after the application was accepted is encouraging. We were able to supply the additional information as it was readily available in our documentation files," stated Jim Bodtke, Vice-President, Development and Clinical Affairs for Ventripoint.
The advantage of the Interactive Review is that it provides the Company with the opportunity to communicate directly with the Lead Reviewer, allowing further clarification of the information on a timely basis during the assessment process, should it be needed.
As announced in the Company’s News Release on March 16, 2015, the 510(k) submission addresses the addition of Ventripoint’s newest catalog, simply named ‘Right Ventricle’, which was developed to provide right ventricular volumes of individuals being evaluated, regardless of their cardiac diagnosis. The review process can take up to 90 days from the date of acceptance by the US FDA, which was March 19, 2015.
For more information about the Interactive Review process please see: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/
Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release
FORWARD-LOOKING STATEMENTS: The statements made in this news release that are not historical facts may contain forward-looking information that involves risk and uncertainties. All statements, other than statements of historical facts, which address Ventripoint’s expectations, should be considered forward-looking statements. Such statements are based on management’s exercise of business judgment as well as assumptions made by and information currently available to management. When used in this document, the words "may", "will", "anticipate", "believe", "estimate", "expect", "intend" and words of similar import, are intended to identify any forward-looking statements. You should not place undue reliance on these forward-looking statements. These statements reflect a current view of future events and are subject to certain risks and uncertainties as contained in the Corporation's filings with Canadian securities regulatory authorities. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results could differ materially
from those anticipated in these forward-looking statements. A description of assumptions used to develop such forward-looking information and a description of risk factors that may cause actual results to differ materially from forward-looking information can be found in Ventripoint's disclosure documents on the SEDAR website at www.sedar.com. The Corporation undertakes no obligation, and does not intend, to update, revise or otherwise publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof, or to reflect the occurrence of any unanticipated events. Although management believes that expectations are based on reasonable assumptions, no assurance can be given that these expectations will materialize.