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BioTelemetry, Inc. Announces FDA Approval of Its Next Generation Device, the MCOT™ Patch

July 26, 2016

Company provides best in class arrhythmia detection in a patch form factor

MALVERN, Pa., July 26, 2016 (GLOBE NEWSWIRE) -- 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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BioTelemetry, Inc.