Ventripoint Diagnostics Ltd.
TSX VENTURE : VPT

Ventripoint Diagnostics Ltd.

January 13, 2015 16:00 ET

Ventripoint Announces Completion of Initial Establishment Inspection by FDA

SEATTLE, WASHINGTON--(Marketwired - Jan. 13, 2015) - Ventripoint Diagnostics Ltd. ("Ventripoint") (TSX VENTURE:VPT) is pleased to announce that it has completed an initial Establishment Inspection by the U.S. Food and Drug Administration (FDA) on January 8, 2015. This initial Establishment Inspection following 510(k) clearance of the Ventripoint Medical System in March, 2014, was started on December 29, 2014 at the Company's Bellevue, Washington location. It was a pre-announced Good Manufacturing Practices (GMP) facility inspection. "This was a very detailed inspection of our Quality System as it relates to Federal Regulations," stated Jeff Jellum, Director of Operations. The inspection reported only two observations as noted on FDA Form 483. "While we strive for perfection, we are pleased to have only two minor items that are easily addressed following our first FDA inspection."

Previously, on December 3, 2014, Ventripoint completed an ISO 13485 re-certification audit which is carried out every three years. "The combined success of the re-certification audit and the FDA Establishment Inspection are a testament to the robust nature of our Quality System and our commitment to providing a quality product to our customers," said Jim Bodtke, VP Clinical Affairs and Development. "Now that we have these events behind us, we are eager to move forward to capitalize on the sales and marketing momentum we were generating at the end of 2014."

About Ventripoint Diagnostics Ltd.

Ventripoint has created tools to monitor patients with heart disease, a leading cause of death in developed countries. The VMS is the first cost-effective and accurate tool for measuring right ventricle heart function, and is approved for clinical use for cardiac indications in Canada, Europe and cleared for use in adult pulmonary arterial hypertension patients by the FDA in the United States. The Company is developing 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.

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: 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.

Contact Information