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Germantown,
Maryland and San Diego, California – June 14, 2008 – Amarex
Clinical Research, LLC and CardioDynamics (Nasdaq: CDIC) announced
today that the companies have entered into a strategic alliance
which enables advanced data analysis services through Amarex’s Secure
WebView sm Portal.
Through Amarex’s proprietary, parallel-processing system, detailed
cardiovascular tables and graphs created from real-time trial data
enable Sponsors to make advanced cardiac safety assessments in their
Phase I-IV clinical development programs. Amarex has taken the concept
of parallel processing from biometrics-computer sciences and has
teamed this with noninvasive hemodynamic data outputs from CardioDynamics’
proprietary BioZ® Impedance Cardiography (ICG) technology and
BioZport® application software to provide highly-detailed and
customized individual and group data displays of critical cardiac
safety and performance variables. Investigators and Sponsors can
easily view these reports online via the WebView sm Portal, allowing
instantaneous decisions relating to dose selection, safety outcomes,
and therapeutic efficacy of cardioactive agents.
The agreement authorizes Amarex to utilize CardioDynamics’ ICG noninvasive
hemodynamic data outputs for advanced processing of ICG data. CardioDynamics
ICG products enable Amarex to provide expanded biometrics and data
management services in support of clinical trials. Combining the
strengths of both companies will allow biotechnology, pharmaceutical,
and device companies and clinical research sites to obtain the benefits
of CardioDynamics’ non-invasive hemodynamic ICG technology and Amarex’s
expertise in data management; thus enhancing cardiac safety monitoring
in Phase I through IV clinical trials including registries directed
at the assessment of adverse cardiovascular signals after market
release of new drugs.
CardioDynamics’ proprietary BioZport® application software was
designed to meet the US Food and Drug Administration’s Title 21
Code of Federal Regulations (21 CFR Part 11) and Health Insurance
Portability and Accountability Act (HIPPA) requirements and will
provide real-time transmission of ICG data to Spacelabs core laboratory
for rapid assessment of both desired and adverse effects of candidate
compounds. With the increasing focus of regulatory agencies on cardiac
safety assessment of new compounds, CardioDynamics and Amarex are
pleased to provide this enhanced capability to the clinical trial
market.
Dr. Kazem Kazempour, President and Chief Executive Officer of Amarex
Clinical Research said, “We believe that CardioDynamics’ ICG technology
provides the pharmaceutical industry with an important new level
of hemodynamic data that will clearly enhance decision making regarding
dosing, patient safety, and patient selection. We are delighted
to offer our clients an integrated view of this data, by achieving
a comprehensive real-time, parallel-based analysis process that
ensures rapid data interpretation from single or multiple sources
during clinical trials and post marketing registries.”
Commenting on the strategic alliance, Michael K. Perry, Chief Executive
Officer of CardioDynamics, added “We are very pleased to partner
with Amarex and believe that their “parallel processing of data”
philosophy, highly-regarded reputation in the biometrics and data
management field, and extensive global experience in the biopharmaceutical
clinical trial arena make them an excellent strategic alliance partner.
With the recent challenges of FDA-approved drugs having serious
cardiac side effects, including death, we believe this is an ideal
application for our proprietary technology.”
Both companies will be exhibiting their products and services at
the Drug Information Association Meeting in Atlanta, June 17 – 20,
2008. Amarex will be located at booth number 1254 and CDIC will
be at booth number 855.
About Amarex Clinical Research
Amarex Clinical Research, Inc. is a global clinical research organization
supplying a full range of clinical trial services to the pharmaceutical,
biotech, and medical device communities. Amarex has managed studies
in a breadth of therapeutic areas in Phase I through Phase IV study
development. The company employs approximately 50 personnel in its
offices located in the United States, and reaches clients worldwide
through its Internet-based data collection and reporting capabilities.
Amarex is headquartered in Germantown, MD. For more information,
please visit the company’s Web site at http://www.amarexcro.com.
About CardioDynamics
CardioDynamics (Nasdaq: CDIC), the ICG Company, is the innovator
and leader of an important medical technology called impedance cardiography
(ICG). The Company develops, manufactures and markets noninvasive
ICG products and medical device electrodes. The Company's ICG Systems
are being used by physicians around the world to help battle the
number one killer of men and women – cardiovascular disease. Partners
include GE Healthcare and Philips Medical Systems. For additional
information, please refer to the company’s Web site at http://www.cdic.com.
| Contact Information |
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Amarex Clinical Research
Patrick J. Burke
Director Business Development
Email address: patrickb@amarexcro.com
Phone number: (301) 528-7000 x704
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CardioDynamics
Rhonda Rhyne
President
Email address: rrhyne@cdic.com
Phone: (858) 535-0202 x1013
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Except for historical and factual information
contained herein, this press release contains forward-looking statements
within the meaning of Section 27A of the Securities Act of 1933,
as amended, and Section 21E of the Securities Exchange Act of 1934,
as amended. Such statements include information regarding the Companies’
expectations, goals or intentions about the future, including, but
not limited to, statements regarding the capabilities and performance
of the Companies’ activities and reports. The actual results may
differ materially from those described in or implied by any forward-looking
statement. Other important factors are set forth in the Companies’
Securities and Exchange Commission filings. All forward-looking
statements speak only as of the date made, and the Companies’ undertake
no obligation to update these forward-looking statements.
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