Ventripoint Receives Response from FDA for Application of VMS ™ for use in Pulmonary Arterial Hypertensionadmin
Seattle, Washington, November 15, 2013 – Ventripoint Diagnostics Ltd. ("Ventripoint") (TSXV:VPT) announces that the FDA has closed its review of the Company’s 510(K) application for approval of the Ventripoint Medical System (VMS(TM)) for use in Pulmonary Arterial Hypertension (PAH). The FDA has found that despite achieving an average agreement between VMS and MRI results within the allowable 10% mean difference, the substantial equivalency was not sufficiently proven to warrant approval. The FDA stated that Ventripoint is welcome to submit a new 510(K) application with data that would show substantial equivalency.
Management is currently reviewing the Company’s options. Among them, is to apply for Premarket Approval (PMA) as a class III device, which would not require showing substantial equivalency.
"We are actively seeking the best avenue of approach to get the VMS(TM) to market. As a Company, we remain dedicated in our belief of the benefit our product has to offer the medical community as a whole, most importantly the patients. As such, we will continue to work within the FDA guidelines to meet the requirements necessary to achieve approval of the VMS(TM)," stated Dr. George Adams, CEO of Ventripoint. "This ruling has no affect on the Company’s ability to market and sell the VMS(TM) outside the USA."
The VMS(TM) is approved for clinical use for multiple heart conditions in Canada and Europe and continues to be available for investigational use only in the United States.
About Ventripoint Diagnostics Ltd.
Ventripoint has created diagnostic tools to monitor patients with heart disease, a leading cause of death in developed countries. VMS(TM) is the first cost-effective and accurate diagnostic tool for measuring right ventricle heart function. The Corporation has a suite of applications for all major heart diseases and imaging modalities including congenital heart disease, left or right heart failure and normal hearts – a multi-billion dollar market potential. The VMS(TM) is approved for clinical use in PAH patients in Canada and Europe and is for investigational use only in the United States.
For further information, please contact:
Dr. George Adams, CEO
Telephone: (206) 910-9125,
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FORWARD-LOOKING STATEMENTS: This news release may contain certain forward-looking information and statements, including without limitation, statements pertaining to the closing of the Offering including the Corporation’s ability to obtain necessary approvals from the TSX Venture Exchange. 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.
Posted: November 15th, 2013 under ACCESSWIRE.