BioTelemetry, Inc. Announces FDA Approval of Its Next Generation Device, the MCOT™ Patch
July 26 2016 - 8:30AM
BioTelemetry, Inc. (NASDAQ:BEAT), the leading wireless medical
technology company focused on the delivery of health information to
improve quality of life and reduce cost of care, is pleased to
announce that it has received U.S. Food and Drug Administration
(“FDA”) 510(k) clearance of its next generation Mobile Cardiac
Outpatient Telemetry™ device, the MCOT™ Patch. The
MCOT™ Patch is a four-lead, two-channel system which provides
the same best in class technology as the current MCOT™, in a more
convenient form factor. The MCOT™ devices, through the
use of a proprietary algorithm, offer the most accurate remote
arrhythmia detection available on the market.
The new device was developed in partnership with Belgium-based
IMEC, a leading developer of nanoelectronics. The system also
incorporates proprietary patch technology that the Company recently
acquired from DELTA Danish Electronics, Light and Acoustic.
The Company expects the MCOT™ Patch to be commercially
available later this year.
Joseph H. Capper, President and Chief Executive Officer of
BioTelemetry, commented: “We are extremely excited to announce this
latest milestone in the evolution of our
MCOT™ technology. Validated by numerous clinical
publications and abstracts, MCOT™ is widely recognized among
remote monitoring options as the “gold standard” in terms of
sensitivity and accuracy in the detection of arrhythmias such as
atrial fibrillation. The MCOT™ Patch incorporates this
same unmatched detection capability into a light-weight,
easy-to-use patch form factor, which we believe will lead to higher
utilization. Moreover, due to its advanced capabilities and
flexible design, our new sensor is also anticipated to have
commercially viable applications in other areas of
healthcare. The introduction of the new system demonstrates
our ongoing commitment to reaching as many patients as possible
with our life-saving technology and service.”
About BioTelemetry
BioTelemetry, Inc., formerly known as CardioNet, Inc., is the
leading wireless medical technology company focused on the delivery
of health information to improve quality of life and reduce cost of
care. The company currently provides cardiac monitoring
services, original equipment manufacturing with a primary focus on
cardiac monitoring devices and centralized cardiac core laboratory
services. More information can be found at
www.biotelinc.com.
BioTelemetry’s Cautionary Statement Regarding
Forward-Looking Statements
This document includes certain forward-looking statements within
the meaning of the "Safe Harbor" provisions of the Private
Securities Litigation Reform Act of 1995. These statements may be
identified by words such as "expect," "anticipate," "estimate,"
"intend," "plan," "believe," "promises" and other words and terms
of similar meaning. Such forward-looking statements are based on
current expectations and involve inherent risks and uncertainties,
including important factors that could delay, divert, or change any
of these expectations, and could cause actual outcomes and results
to differ materially from current expectations. These factors
include, among other things, our ability to defend our patent
portfolio and obtain favorable results, effects of changes in
health care legislation, effectiveness of our cost savings
initiatives, relationships with our government and commercial
payors, changes to insurance coverage and reimbursement levels for
our products, the success of our sales and marketing initiatives,
our ability to attract and retain talented executive management and
sales personnel, our ability to identify acquisition candidates,
acquire them on attractive terms and integrate their operations
into our business, the commercialization of new products, market
factors, internal research and development initiatives, partnered
research and development initiatives, competitive product
development, changes in governmental regulations and legislation,
the continued consolidation of payors, acceptance of our new
products and services, patent protection, adverse regulatory
action, litigation success, our ability to successfully create a
new holding company structure and to anticipate the benefits of
such structure. For further details and a discussion of these and
other risks and uncertainties, please see our public filings with
the Securities and Exchange Commission, including our latest
periodic reports on Form 10-K and 10-Q. We undertake no obligation
to publicly update any forward-looking statement, whether as a
result of new information, future events, or otherwise.
Contact:
BioTelemetry, Inc.
Heather C. Getz
Investor Relations
800-908-7103
investorrelations@biotelinc.com
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