Ventripoint Applies for CE Mark for VMS+ Device and Complete Heart Analysis System
Toronto, Ontario, December 20, 2017 – Ventripoint Diagnostics Ltd. (“Ventripoint” or the “Company”, TSXV:VPT) is pleased to announce that it has applied to its Notified Body in Europe to add the new product, VMS+, to its CE Mark and to its certified quality system.
“This is a major milestone for the Company as it shows the VMS+ device, including the 4-chamber analysis software package, was ready for addition to the Company’s product registration in Europe,” stated Dr. George Adams, CEO of Ventripoint.
The submission references the data wherein Ventripoint fully assessed and measured the safety, quality, and performance of the product. As previously announced (See NR December 19, 2017) the VMS+ device has passed the ISO 60601 testing.
The CE Mark is also recognized worldwide and will allow the Company to register these products in many additional countries and regions. The Company will begin this process as soon as the VMS+ has been added to its CE Mark.
In other news, the Company has undergone a successful re-certification audit for its ISO13485:2003 certification for its quality management system that is specific to Medical Devices.
“I congratulate Dr. Macanovic and her team for their excellent work in preparing the CE Mark application, preparing for the audit and its successful outcome”, stated Desmond Hirson, President of Ventripoint. “It has been a busy fall with ISO60601 testing, ISO14385 audit and the CE Mark application. With the excellent EuroEcho meeting earlier this month in Lisbon, we can now advance the European strategy and begin to sign up partners to market VMS+ systems in Europe.”
About Ventripoint Diagnostics Ltd.
Ventripoint has created tools to monitor patients with heart disease, a leading cause of death in developed countries. VMSTM is the first cost-effective and accurate tool for measuring heart function. The Corporation has developed a suite of applications for all major heart diseases and imaging modalities including congenital heart disease, left or right heart failure and normal hearts.
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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.