CardioDynamics (Nasdaq:
CDIC), the innovator and leader of BioZ(R) impedance cardiography (ICG)
technology, today announced the presentation of three new hypertension
studies at the American Society of Hypertension's 22nd Annual Scientific
Meeting in Chicago.
The three clinical studies offer new insights into ICG's value in
hypertension (also referred to as high blood pressure) and provide the
rationale and framework for the Company's new hypertension research
strategy. This strategy is targeted to address the questions raised in the
2006 Centers for Medicare and Medicaid Services (CMS) reconsideration of
ICG coverage for hypertension. Currently, ICG is covered nationally by CMS
for five indications, including patients with heart failure and shortness
of breath, and CMS allows local carrier discretion for drug resistant
hypertension. The Company's new research strategy has three primary
objectives: 1) identify which ICG parameters provide the most additive
information to traditional blood pressure measurements in the development
and perpetuation of hypertension; 2) identify which ICG parameters will
best predict a favorable blood pressure reduction in response to
hypertension drug therapies to develop a new ICG-based treatment algorithm
for hypertension; 3) demonstrate that using the new ICG-based treatment
algorithm results in long-term improvements in blood pressure control rates
compared to other approaches.
In the first study, Drs. Ronald Smith and Carlos Ferrario from Wake
Forest University presented data from the CONTROL trial on 164 patients
from over 790 patient visits. The study demonstrated that the traditional
blood pressure measurement offered little ability to identify which
specific ICG hemodynamic abnormalities were present in an individual
patient. The investigators concurred that the variation in ICG parameters,
within and between blood pressure categories, may indicate vascular and
hemodynamic risk that is not apparent with blood pressure alone and that
knowledge of these abnormalities is significant because they are targets
for antihypertensive drug therapy.
In the second study, Dr. John Flack from Wayne State University
presented data from the CONTROL trial on 164 patients in 492 patient visits
in which antihypertensive medications were adjusted. In these visits,
patients with a higher ICG-determined systemic vascular resistance were
more likely to benefit from vasodilating therapies that reduced systemic
vascular resistance, such as ACE inhibitors, angiotensin II receptor
blockers, and calcium channel blockers. Dr. Flack stated, "ICG may allow
better individualization of antihypertensive therapies by identifying which
patients will receive the most benefit from each of the various
hypertensive drug classes."
In the third study, Dr. Julio Chirinos of the University of Miami
presented preliminary data from 590 patients from the PREVENCION study, a
large population-based study being conducted in Peru. The study
demonstrated that ICG abnormalities were directly associated with obesity
and the development of hypertension. When completed, PREVENCION will
include ICG measurements on at least 1,600 patients with a multi-year
follow-up period. Dr. Chirinos commented, "ICG hemodynamic profiling will
likely help clinicians identify which specific circulatory abnormalities
are involved in specific populations or individual patients with high blood
pressure, thereby improving our ability to target therapeutic
interventions."
The Company also announced that Dr. Flack will be the principle
investigator for a new company-sponsored observational study called
BETTER-HTN (Bioimpedance Evaluation of Therapeutic Titration in Essential
Resistant Hypertension). The BETTER-HTN study is projected to commence near
the end of 2007 and will evaluate up to several thousand hypertensive
patient visits at multiple sites in support of the Company's new research
objectives.
"We are very encouraged by the new hypertension evidence presented at
the American Society of Hypertension meeting," stated Michael K. Perry,
Chief Executive Officer. "We already know that ICG can play an important
role in the evaluation and treatment of hypertension, the most prevalent
cardiovascular condition in the United States. We believe the results from
PREVENCION and BETTER-HTN will allow us to strategically design a
randomized controlled trial to answer the remaining scientific questions
and, upon success completion, allow CMS and private insurers to cover ICG
more broadly for patients with hypertension."
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 under its patented and proprietary
BioZ(R) brand of ICG products. 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 cdic.
Forward-Looking (Safe Harbor) Statement
Except for historical and factual information contained herein, this
press release contains forward-looking statements, such as publication of
clinical trials and commencement and anticipated benefits of new clinical
trials, the accuracy of which is necessarily subject to uncertainties and
risks including the Company's primary dependence on the BioZ product line,
and various uncertainties characteristic of early growth companies, as well
as other risks detailed in the Company's filings with the SEC, including
its 2006 Form 10-K. The Company does not undertake to update the
disclosures contained in this press release.
CardioDynamics
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