News
VentriPoint Diagnostics (TSX VENTURE:VPT) (PINKSHEETS:VPTDF) announces
it has completed the validation test, which compared the VentriPoint
Medical System (VMS) to cardiac Magnetic Resonance Imaging (MRI) in
patients with Pulmonary Arterial Hypertension (PAH).
"This a world's first - accurate cardiac information with the
convenience and speed of 2-D ultrasound", stated Dr. George Adams,
VentriPoint President and CEO. "The Company will begin sales efforts
for the PAH application in Europe and Canada as soon as regulatory
approvals are received, which should be in the second calendar quarter
this year."
The company will immediately begin to write the submission to the
European Notified Body and Health Canada to extend its already
received approvals to include PAH. A multicenter clinical trial in the
United States has been in planning for many months and will now be
initiated. As a first step, VentriPoint will install the VMS at each
centre and train the sonographers and cardiologists. An announcement
of the complete study design and the participants will be made as soon
as contractual arrangements have been finalized.
The VMS is for investigational use only in the United States and is
approved for clinical use in Canada and Europe.
About Pulmonary Arterial Hypertension
Pulmonary arterial hypertension (PAH) is the most serious form of the
five recognized groups of pulmonary hypertension. PAH is a devastating
disease with an average patient lifespan of less than 3 years after
diagnosis if untreated. It affects individuals of all ages from
infancy to the elderly. Although treatment started early after
detection appears more effective than when started later, the majority
of patients with PAH continue to be diagnosed too late for treatment
to be fully effective. PAH can occur for no known reason but will
typically occur in association with many common conditions such as
chronic liver disease and liver cirrhosis; connective tissue disorders
such as scleroderma or systemic lupus erythematosus (lupus);
congenital heart disease (even if repaired) and HIV. With increasing
availability of effective therapies, and evidence-based treatment
guidelines recommending starting treatment early, tests enabling
detection as early as possible should prove invaluable.
About VentriPoint Diagnostics Ltd.
VentriPoint has created a diagnostic ultrasound tool to monitor
patients with heart disease, a leading cause of death in developed
countries. The VMS is the first cost-effective and accurate
diagnostic tool for measuring right ventricle heart function.
Monitoring congenital heart disease is the first application in a
suite of applications for all major heart diseases including pulmonary
hypertension, cardiovascular disease and heart failure - a
multibillion-dollar market potential. Canada and Europe (CE Mark) have
granted approval for the sale of VentriPoint's VMS heart analysis
system and VentriPoint is pursuing US-FDA approval through the 510(k)
process.
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.
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
