COMPANY CONTACT:
Rhonda Rhyne, President
rrhyne@cardiodynamics.com
800-778-4825 Ext. 1013
Local Medicare Contractors Expand Hypertension Coverage
for CardioDynamics' BioZ(R) ICG Technology
Positive Local Coverage Changes Affect Region
with Higher Incidence of Hypertension in United States
SAN DIEGO, CA-August 7, 2007--CardioDynamics (Nasdaq: CDIC), the innovator and
leader of BioZ(R) impedance cardiography (ICG) technology, today announced that
two contractors for the Centers for Medicare and Medicaid Services (CMS)
recently made changes to their coverage policies that allowed expanded coverage
of ICG for patients with high blood pressure, also referred to as hypertension.
The involved local contractors provide coverage for patients in Mississippi,
Alabama, Georgia and South Carolina. These states are known for having higher
rates of hypertension in the United States and have struggled to find innovative
means of treating and controlling hypertensive patients. The new local coverage
allows treatment for resistant hypertension (uncontrolled blood pressure on
three or more drugs) and complements the currently covered national indications,
including heart failure, shortness of breath, and pacemaker optimization.
The changes in local coverage allowing ICG hypertension coverage occurred after
a November 2006 CMS decision not to expand ICG hypertension coverage to a
national indication. The Company believes the CONTROL Trial, along with evidence
from 22 additional studies including over 2,300 subjects, were major factors for
the expanded local coverage. Favorable clinical evidence was published in 2006
from the multi-center CONTROL trial, which demonstrated that use of BioZ(R) ICG
led to an 8 mm Hg greater systolic blood pressure reduction and 7 mm Hg greater
diastolic blood pressure reduction than standard care. Patients being treated
with BioZ(R)-assisted therapy were 35% more likely to reach goal blood pressure
of less than 140/90 mm Hg and more than two times as likely to achieve a more
aggressive blood pressure control of less than 130/85 mm Hg. The CONTROL trial
was the second randomized controlled hypertension trial demonstrating notably
improved blood pressure control results when BioZ(R) ICG was used to direct
therapy. The Company believes that these trials represent a strong,
evidence-based rationale for local Medicare coverage expansion.
"We are encouraged by the recent changes by two local Medicare contractors that
allow hypertension coverage for our ICG technology. After CMS decided against a
national indication for hypertension coverage, but allowed contractor
discretion, we set out to work with the local contractors to garner coverage for
this important indication. We are pleased that the clinical evidence was
objectively evaluated and resulted in a positive outcome for the Medicare
patients who suffer from hypertension in these states," stated Michael K. Perry,
Chief Executive Officer of CardioDynamics.
"A Medicare patient who does not already have high blood pressure has a 90%
chance of developing it before they die. The results of the CONTROL trial, along
with the previous results from the Mayo Clinic and other clinical studies,
provide compelling evidence that ICG is effective at helping physicians improve
their patients' blood pressure control," stated renowned hypertension specialist
Carlos Ferrario, M.D., Director of Hypertension and Vascular Disease Center at
Wake Forest University School of Medicine and Principal Investigator of the
CONTROL study. "The Southeastern United States has the highest rates of
uncontrolled hypertension in the United States. We believe that allowing
coverage of ICG for hypertension improves patient outcomes in a cost-effective
manner."
Hypertension affects roughly 65 million Americans, is the most common reason
adults visit their physicians, and costs the U.S. healthcare system over $63
billion annually. The long-term benefits of blood pressure reductions of as
little as 2 mm Hg are well known and have been proven to significantly reduce
the risk of stroke, coronary artery disease, heart failure, and overall
mortality. The Company's noninvasive and cost-effective BioZ(R) ICG technology
aids physicians in objectively administering hypertensive drugs that are optimal
and specific to each patient.
Perry concluded, "Through increased market awareness of the clinical evidence
from our CONTROL, PREDICT and ED-IMPACT trials, we have begun to experience a
recovery in our ICG business during the past two fiscal quarters. Our near-term
efforts are focused on ensuring our current customers are appropriately using
ICG in their clinical care; containing expenses while strategically targeting
our sales and marketing efforts in areas that have demonstrated growth
potential; and continuing clinical studies that have the potential to place our
technology into the clinical guidelines for hypertension and heart failure. Our
goal remains to show continued improvement in operating performance and
returning the business to positive operating cash flow."
About CardioDynamics:
CardioDynamics (Nasdaq: CDIC), the ICG Company, is the innovator and leader of
an important medical technology called BioZ(R) Impedance Cardiography (ICG). The
Company develops, manufactures and markets noninvasive BioZ(R) ICG products and
medical device electrodes. The Company's BioZ(R) 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 www.cdic.com.
Forward-Looking (Safe Harbor) Statement:
Except for the historical and factual information contained herein, this press
release contains forward-looking statements, such as future reimbursement,
quarterly operating improvement and return to positive cash flow, the accuracy
of which is necessarily subject to uncertainties and risks including the
Company's sole dependence on the BioZ(R) 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.