VentriPoint Diagnostics Ltd.
TSX VENTURE : VPT

VentriPoint Diagnostics Ltd.

February 19, 2009 07:42 ET

VentriPoint Diagnostics Receives Health Canada Regulatory Approval to Sell Device; Quality Assured Through ISO Certification

SEATTLE, WASHINGTON--(Marketwire - Feb. 19, 2009) -

NOT FOR DISSEMINATION IN THE UNITED STATES OF AMERICA

VentriPoint Diagnostics Ltd. (the "Corporation") (TSX VENTURE:VPT) has today made the significant announcement that its wholly-owned subsidiary, VentriPoint, Inc. ("VentriPoint") has been granted a medical device license by Health Canada to sell and market its VentriPoint Medical System ("VMS") to provide key measurements and accurate reconstructions of the right ventricle of a patient's heart from standard two-dimensional ultrasound images.

"This regulatory milestone is a major advancement in VentriPoint's efforts to provide cost effective monitoring and treatment for patients with heart disease. Having achieved this milestone VentriPoint can proceed with its commercialization plans to introduce the VMS diagnostic tool for Canada's congenital heart disease population and to advance its use for other heart diseases, including pulmonary hypertension," stated Joe Ashley, President & CEO of the Corporation. "The availability of the VMS to quickly and inexpensively provide critical information of a patient's right ventricle is expected to help enable Canadian healthcare organizations to better monitor and treat patients suffering from heart disease."

Concurrently, VentriPoint also announced today that its Quality Management System, which covers the design and development of its VMS, has met the requirements of the ISO 13485:2003 standard. This certification was obtained following a successful audit in January 2009 by Intertek Testing Services NA Ltd. This certification is an internationally recognized management system standard developed by the International Organization for Standardization (ISO). "The certification is an important measure of the Company's quality capabilities. ISO certification is another significant achievement for VentriPoint and reflects our commitment to excellent performance in our internal design and manufacture of the VMS," said Scott Ashley, Vice President of Research & Development. "Our proven quality management system will facilitate regulatory approvals of our products on a global basis."

About VentriPoint Diagnostics Ltd.

VentriPoint creates diagnostic tools to monitor patients with heart disease - the number one cause of death in developed countries. By using images produced from existing medical imaging systems, the VentriPoint Medical System ("VMS") generates critical heart measurements in a rapid and inexpensive manner not currently available. Health Canada has granted licensed approval for the VMS breakthrough diagnostic tool which is based upon technology received by VentriPoint through its exclusive technology license with the University of Washington. The VMS, together with its associated online service, is being expanded to cover a variety of heart related disease states, including congenital heart disease.

To receive press release, please email chris@chfir.com and mention VentriPoint in the subject line.

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 Corporations 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.

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.

Contact Information

  • VentriPoint Diagnostics Limited
    Ed Garth
    Chief Financial Officer
    (206) 283-0221, ext. 402
    (206) 283-2309 (FAX)
    or
    CHF Investor Relations
    Christopher Haldane
    Account Manager
    (416) 868-1079, ext.237
    (416) 868-6198 (FAX)
    Email: chris@chfir.com