FDA Clears Ventripoint VMS(TM) Heart Analysis System for Use in Patients with Pulmonary Arterial Hypertension
March 10 2014 - 7:23AM
Marketwired
FDA Clears Ventripoint VMS(TM) Heart Analysis System for Use in
Patients with Pulmonary Arterial Hypertension
SEATTLE, WASHINGTON--(Marketwired - Mar 10, 2014) - Ventripoint
Diagnostics Ltd. ("Ventripoint") (TSX-VENTURE:VPT) announces that
the US Food and Drug Administration (FDA) has cleared the VMS™
heart analysis system to be an adjunct to all existing 2D
ultrasound imaging devices to allow computation of the 3D volume
and ejection fraction of the right heart in patients with Pulmonary
Arterial Hypertension (PAH).
"We are pleased to affirm the FDA's marketing clearance today
for the VMS - the first ultrasound method to give accurate right
ventricle functional measurements using conventional 2D
ultrasound," said Dr. George Adams, President and CEO of
Ventripoint. "People with PAH require frequent monitoring and
adjustments to their treatments, which requires a detailed
assessment of right heart function."
Right heart function remains one of the most significant
prognostic parameters in PAH. The VMS heart analysis system enables
physicians to quickly and non-invasively determine the size and
function of the right heart - transforming patient care and
reducing healthcare costs.
"We thank the cardiology teams at The Hospital for Sick Children
and Brigham and Women's Hospital for being the Core Labs on the
clinical trial and the Allegheny Hospital, Mayo Clinic, Brigham and
Women's Hospital, Baylor College of Medicine, University of
Chicago, and the University Hospital Network (Toronto General
Hospital) where the clinical testing was performed for this
application," said Jim Bodtke, Vice-President of Clinical Affairs
for Ventripoint.
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. PAH is the most serious
form of the five recognized groups of pulmonary hypertension and is
a devastating disease with an average patient lifespan of less than
3 years after diagnosis if untreated. It affects individuals 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. With increasing availability of
effective therapies, and evidence-based treatment guidelines
recommending frequent monitoring, functional tests should prove
invaluable for managing patients with PAH.
The VMS™ is approved for clinical use in PAH patients in Canada
and Europe, and now in the United States.
About Ventripoint Diagnostics Ltd.
Ventripoint has created tools to monitor patients with heart
disease, a leading cause of death in developed countries. VMS™ is
the first cost-effective and accurate tool for measuring right
ventricle heart function. The Corporation 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.
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.
Ventripoint Diagnostics Ltd.Dr. George AdamsCEO(206)
910-9125gadams@ventripoint.com
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