Seattle, Washington, December 13, 2013 - Ventripoint Diagnostics Ltd. (TSXV:VPT) (the Company or Ventripoint) is pleased to announce that the it has responded within the specified 30-day period to the non-substantially equivalent (NSE) letter received from the U.S. FDA on November 14, 2013, and has had numerous discussions with the FDA to identify the best and quickest pathway to obtain clearance for the VMS(TM) heart analysis system for use in Pulmonary Arterial Hypertension (PAH).
"The FDA has been encouraging and specific in their advice to streamline the process to seek approval," stated Jim Bodtke, Vice President, Clinical Affairs for Ventripoint.
The Company and the FDA have agreed that the best approach is to submit a new 510(k) as a software-only Class II device and positively address the issues identified in the NSE letter. The Company will file this new 510(k) early in the new year and expects to have a response from the FDA in the first quarter of 2014.
"I think our greatest opportunity for success is to reach the U.S. market and so we have identified ways to economize to ensure that we have the resources to complete the new 510(k) process", stated Dr. George Adams, CEO. "We owe it to ourselves, as well as to our shareholders, to reach this endpoint without further dilution."
In order to ensure that sufficient financial resources are available to complete the FDA process, the Company will:
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1.Reduce development staff and reassign others to manufacturing and quality control,
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2.Reassign installation staff to maintain operations to support our existing and future users,
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3.Accrue salaries for executive staff, where possible,
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4.Maintain relationships with distributors in Europe and continue to look for distributors for other regions while reducing direct sales staff in Europe, and
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5.Complete existing sales where the VMS(TM) evaluation periods are finished and customers wish to acquire the devices.
Ventripoint has cancelled its previously announced plans for participating at EuroEcho. According to Mr. Bodtke, "Trade shows, such as EuroEcho, cost thousands of dollars to participate in. Given that our primary focus is on the FDA at present, we felt it prudent to place all attention and resources on this subject in order to reach our goal as fast as possible. We will maintain our current strategies for Western and Eastern Europe, as well as other areas, as we continue developing partnerships for distribution, all of which were planned to take place outside of EuroEcho."
About Ventripoint Diagnostics Ltd.
Ventripoint has created diagnostic tools to monitor patients with heart disease, a leading cause of death in developed countries. VMSTM 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. VMSTM 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
email: [email protected]
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FORWARD-LOOKING STATEMENTS: The statements made in this press release that are not historical facts 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. 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.