VentriPoint Diagnostics Ltd (VPTDF)

[theabbevillekid]

Resubmission by Ventripoint to get its VMS system approved by the FDA, and 4 million warrants go unexercised:

SEATTLE, WASHINGTON--(Marketwired - Jan. 23, 2014) - 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


http://finance.yahoo.com/news/ventripoint-announces-510-k-submission-120000439.html

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