Ventripoint Announces Planned Response to FDA Notification and Expanded Sales Efforts Outside of the United Statesadmin
Seattle, Washington, November 25, 2013 – Ventripoint Diagnostics Ltd. (TSXV:VPT) is pleased to announce that after careful review of the information received from the U.S. Food and Drug Administration (FDA) regarding market clearance of the Ventripoint Medical System ("VMS(TM)") for use in Pulmonary Arterial Hypertension (PAH), the Company has developed a strategy for addressing the concerns raised by the Agency.
The results of the clinical trial demonstrated that the calculated parameters between right ventricular volumes computed from echocardiograms by VMS and MRI images computed with Simpson’s rule were within the pre-specified 10% range for each of the mean difference and 95% confidence interval (4.8+/-1.4% for EDV, 1.8+/-1.5% for ESV, and 2.0+/-0.7% for EF). Nevertheless, the Agency had some concerns about the routine use of the VMS in this patient population.
In advance of filing a formal appeal, Ventripoint has received an invitation to meet with the review team to gain an understanding of the reasoning behind the current decision. This is an important first step in the appeals process and will form the basis of discussions throughout the appeal.
"It is important for us to fully engage the FDA through the available engagement and appeal processes", stated Jim Bodtke, Vice-President of Clinical Affairs. "We currently have other submissions for requesting regulatory approval of various applications for the VMS and we need to better understand the current criteria for acceptance before initiating these submissions."
In addition to the above, Ventripoint has reached distribution agreements for France, Germany, Austria and Switzerland for the VMS with further expansion planned. "We look forward to the upcoming EuroEcho meeting December 11-14, 2013 in Istanbul to meet with the cardiology community and distributors for Western and Eastern Europe as well as the Middle East," said Jerry Gatewood, Vice-President of Global Sales and Marketing. "Many areas in the world have expressed interest in offering VMS in their respective regions for a more comprehensive evaluation of the right ventricle."
The VMS 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 is the first cost-effective and accurate diagnostic tool for measuring right ventricle heart function. The Company 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. VMS is approved for clinical use in cardiac patients in need of right heart analysis 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 25th, 2013 under ACCESSWIRE.