PRINCETON, N.J., Nov. 29, 2011 /PRNewswire/ -- NewCardio, Inc.,
(OTC BB: NWCI) a cardiovascular diagnostic solutions developer,
announced today that a top 3 Clinical Research Organization (CRO)
will utilize QTinno®, automated cardiac safety solution, to support
a Phase I drug safety study for a biopharmaceutical sponsor.
Fully automated ECG analysis, empowered by QTinno, will be
delivered at the CRO's clinical pharmacology research unit under
the terms of an existing Master Services Agreement with
NewCardio.
NewCardio has been asked to install QTinno at the second of this
CRO's Phase 1 units, enabling them to complete an ongoing
study for their biopharmaceutical sponsor. The study is expected
to provide more refined data compared to previous analysis
conducted for the cardiac safety profile of the compound.
NewCardio expects to recognize the revenue from this study during
the fourth quarter of 2011.
"The recommendation by the CRO to the sponsor to utilize QTinno
for this Phase 1 study is recognition that QTinno provides accuracy
and timeliness, at lower cost," said Vincent Renz, NewCardio's Chief Executive
Officer. "We are excited to have achieved this milestone, and
look forward to this leading to additional business with the
clinical resources provider and their sponsors in the future."
NewCardio's innovative 3-D ECG platform technology dramatically
improves the accuracy and significantly increases the diagnostic
value of the standard 12-lead ECG. NewCardio's lead product,
QTinno, is a software suite that provides automated, comprehensive
cardiac safety analysis as defined in the ICH E14 Guidance for
Clinical Evaluation of QT/QTc Interval Prolongation and
Proarrhythmic Potential for Non-Antiarrhythmic Drugs. The Company
believes that QTinno, based on NewCardio's technology and approach,
is the industry's most advanced, validated solution for performing
high quality, cost effective automated cardiac safety analysis in
drug development.
About QTinno Technology
NewCardio's patented QTinno 3-D ECG software technology is a
novel, fully automated program for evaluating QT and other timing
intervals relevant for assessing drug cardiac toxicity in drug
development. It provides fast, accurate and precise QT data from a
broad range of challenging ECGs and enables reliable, automated
identification of key cardiac events. Pharmaceutical sponsors and
clinical research organizations, which are mandated by the FDA to
test new drugs for potential cardiac toxicity, are expected to
benefit from QTinno's faster, more accurate and less expensive
assessment of cardiac status.
About NewCardio, Inc.
NewCardio is a cardiac diagnostic and services company
developing and marketing proprietary software platform technologies
to provide higher accuracy to, and increase the value of, the
standard 12-lead ECG. NewCardio's 3-D ECG software platform
reduces the time and expense involved in assessing cardiac status
while increasing the ability to diagnose clinically significant
conditions which were previously difficult to detect.
NewCardio's software products and services significantly improve
the diagnosis and monitoring of cardiovascular disease, as well as
cardiac safety assessment of drugs under development. For more
information, visit www.newcardio.com.
Forward-Looking Statements
This press release contains forward-looking statements.
Forward-looking statements include, but are not limited to,
statements that express our intentions, beliefs, expectations,
strategies, predictions or any other statements relating to our
future activities or other future events or conditions. These
statements are based on current expectations, estimates and
projections about our business based on currently available
information and assumptions made by management. Although we believe
that the assumptions on which the forward-looking statements
contained herein are based are reasonable, any of those assumptions
could prove to be inaccurate given the inherent uncertainties as to
the occurrence or nonoccurrence of future events. These statements
are not guarantees of future performance and involve risks and
uncertainties that are difficult to predict. Therefore, actual
outcomes and results may, and are likely to, differ materially from
what is expressed or forecasted in the forward-looking statements
due to numerous factors, including the potential risks and
uncertainties set forth in Item 1A of our Annual Report on Form
10-K for the year ended December 31,
2010 and relate to our business plan, our business strategy,
development of our proprietary technology platform and our
products, timing of such development, timing and results of
clinical trials, level and timing of FDA regulatory clearance or
review, market acceptance of our products, protection of our
intellectual property, implementation of our strategic, operating
and people initiatives, benefits to be derived from personnel and
directors, ability to commercialize our products, our assumptions
regarding cash flow from operations and cash on-hand, the amount
and timing of operating costs and capital expenditures relating to
the expansion of our business, operations and infrastructure,
implementation of marketing programs, our key agreements and
strategic alliances, our ability to obtain additional capital as,
and when, needed, and on acceptable terms and general economic
conditions specific to our industry, any of which could impact
sales, costs and expenses and/or planned strategies and timing. We
assume no obligation to, and do not currently intend to, update
these forward-looking statements.
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Investor Contact:
Hayden IR
Jeff Stanlis, Partner
(602) 476-1821
jeff@haydenir.com
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SOURCE NewCardio, Inc.