|By Marketwired .||
|January 23, 2014 07:00 AM EST||
SEATTLE, WASHINGTON -- (Marketwired) -- 01/23/14 -- Ventripoint Diagnostics Ltd. (TSX VENTURE: VPT) is pleased to announce that it has submitted to the US Federal Drug Administration ("the Agency") a new 510(k) for clearance for the VMS heart analysis system for use in Pulmonary Arterial Hypertension (PAH).
"We have included in the submission significant additional information concerning the accuracy, reproducibility and clinical use of various imaging approaches in patients with PAH," according to Jim Bodtke, Vice-President, Clinical Affairs for Ventripoint. "We feel we have appropriately addressed the Agency's concerns as expressed in their letter of November 8, 2013."
The Company affirms that it has maintained an open dialog with the Agency in preparing the submission and as a result changed the submission from a "software-only" application, as previously recommended by the Agency and announced by the Company, to a submission with software and hardware descriptions. The Company continues to expect the review process to be completed by the end of the first quarter of 2014.
"The team did an excellent job re-writing the submission so quickly, which allowed us to re-submit the 510(k) in record time," stated Dr. George Adams, CEO of Ventripoint. "I would like to thank our consultants as well the Agency for all their assistance."
In other news, the Company also announces, subject to all necessary regulatory and TSX Venture Exchange approval, that it intends to issue 2,187,913 Common Shares at a deemed price of $0.05 per Common Share in payment of CDN$109,395.67 of accrued interest owing to the holders of outstanding notes and debentures of the Company. The 2,187,913 Common Shares will have a hold period of four months from the date of issuance in accordance with applicable securities legislation.
The Company would also like to inform its shareholders that 4,953,195 warrants to purchase Common Shares expired unexercised on December 23, 2013, and a further 1,133,650 warrants expired unexercised on January 18, 2014.
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.
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: This news release may contain certain forward- looking information and statements. 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 Company'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 Company 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.
Ventripoint Diagnostics Ltd.
Dr. George Adams