CardioDynamics (Nasdaq:
CDIC), the innovator and leader of BioZ(R) impedance cardiography (ICG)
technology, today announced that The Centers for Medicare and Medicaid
Services (CMS) released the final version of its national coverage decision
(NCD) maintaining coverage for high blood pressure (also known as
hypertension). The decision will maintain the carrier discretion policy for
coverage of ICG for patients' with resistant hypertension, defined as those
whose blood pressure is not controlled on three or more medications. This
coverage decision for hypertension, along with prior NCD indications for
shortness of breath and heart failure will enable both clinicians and
patients to benefit from ICG utilization.
The primary clinical evidence reviewed by CMS was from the multi-center
CONTROL trial, which demonstrated that use of BioZ(R) ICG led to an eight
millimeters of Mercury (mm Hg) greater systolic blood pressure reduction
and seven 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 adequate evidence from 23 studies including 2,483 subjects
led to the continuation of carrier discretion coverage for resistant
hypertensive patients.
"The CMS decision to maintain our current policy for hypertension after
a thorough review further demonstrates the value of ICG. Although the
coverage decision was not expanded as we had requested, we are pleased with
the continuation of coverage and will work with CMS to create a new ICG
clinical study designed to support expanded coverage for hypertensive
patients," stated Michael K. Perry, CardioDynamics' Chief Executive
Officer.
"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
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. "Medicare makes very difficult
decisions that can significantly affect their budget, and this particular
NCD proves challenging because of the magnitude of the hypertensive patient
population in our country. Therefore, additional studies may be necessary
to allow a more expansive coverage policy."
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 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 added, "Through increased market awareness from our PREDICT,
CONTROL, and ED-IMPACT trials, we anticipate further market penetration,
growth in revenue and improved operating results in 2007 and beyond.
Thousands of physicians derive clinical benefit from using ICG in their
daily patient care and increasingly rely on our technology to provide the
most effective healthcare. Our team remains motivated by the opportunity to
enhance patients' lives and make a genuine contribution to healthcare with
our safe, cost-effective ICG technology."
Additional details of the decision may be found at the CMS website
cms.hhs/mcd/viewdecisionmemo.asp?id=179
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
cdic.
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, market penetration, and reduced breakeven points, 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
2005 Form 10-K. The Company does not undertake to update the disclosures
contained in this press release.
CardioDynamics
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