LifeWatch AG

EQS-Adhoc: LifeWatch AG: LifeWatchTM Mobile Cardiac Telemetry Patch application filed with the U.S. FDA

EQS Group-Ad-hoc: LifeWatch AG / Key word(s): Regulatory Admission
LifeWatch AG: LifeWatchTM Mobile Cardiac Telemetry Patch application
filed with the U.S. FDA

13.05.2015 / 07:15
Release of an ad hoc announcement pursuant to Art. 53 KR.
The issuer is solely responsible for the content of this announcement.

---------------------------------------------------------------------

LifeWatchTM Mobile Cardiac Telemetry Patch application filed with the U.S.
FDA

Neuhausen am Rheinfall/Switzerland, May 13, 2015 - LifeWatch AG (SIX Swiss
Exchange: LIFE), a leading developer and provider of medical solutions and
remote diagnostic monitoring services in the digital health market, is
pleased to announce that on May 12, 2015, it filed a 510(k) application for
clearance of its internally-developed LifeWatch Mobile Cardiac Telemetry
patch, a 1-lead ECG system, with the U.S. Food and Drug Administration
(FDA). LifeWatch will also soon be filing for CE Mark and other
international clearances to enable the Company to market and provide its
services globally.

The LifeWatch Mobile Cardiac Telemetry patch will be the newest addition to
LifeWatch's diagnostic monitoring offering, and continues to build on
LifeWatch's commitment to becoming a truly global provider of remote
diagnostic monitoring devices and services. Once cleared by the appropriate
governmental agencies, LifeWatch will be able to provide patients with a
new diagnostic monitoring patch alternative, capable of watching every
heartbeat for adverse cardiac events and transmitting significant findings,
in near real time, to a clinical service center for immediate follow-up.

The LifeWatch Mobile Cardiac Telemetry patch also represents yet another
addition to the growing family of LifeWatch patch solutions, including the
previously announced Vital Signs Patch (VSP) and the partnership with Vital
Connect, Inc. for the integration of its patch into LifeWatch's diagnostic
monitoring offering for the U.S. cardiac monitoring market. Patch
technology is an easy to use, discrete and lightweight alternative to
traditional recording and transmitting devices, which is more comfortable
for the patient and should therefore lead to an increase in the diagnostic
yield as a result of improved patient compliance.

Dr. Stephan Rietiker, CEO of LifeWatch, commented, "We see our filing for
clearance of the LifeWatch Mobile Cardiac Telemetry patch as a key step in
the expansion of our successful U.S. diagnostic monitoring services into
the global healthcare market. This technology is the culmination of years
of research by LifeWatch, and represents our commitment to the development
of innovative wearable technologies."



For further questions:

LifeWatch AG
c/o Dynamics Group, Philippe Blangey / Doris Rudischhauser
Phone: +41 43 268 32 35 / +41 79 410 81 88
E-mail: investor-relations@lifewatch.com

 About LifeWatch AG:
LifeWatch AG, headquartered in Neuhausen am Rheinfall and listed on SIX
Swiss Exchange (LIFE),
Switzerland, is a leading healthcare technology and solution company,
specializing in advanced digital health systems and wireless remote
diagnostic patient monitoring services. LifeWatch's services provide
physicians with critical information to determine appropriate treatment and
thereby improve patient outcomes. LifeWatch AG has operative subsidiaries
in the United States, in Switzerland and in Israel, and is the parent
company of LifeWatch Services Inc., and LifeWatch Technologies, Ltd.
LifeWatch Services, Inc. is a leading U.S.-based provider of cardiac
monitoring services and home sleep testing of Obstructive Sleep Apnea
(OSA). LifeWatch Technologies Ltd., based in Israel, is a leading developer
and manufacturer of telemedicine products. For additional information,
please visit www.lifewatch.com.

Sign up for customized e-mail alerts and documentation requests at
http://www.irlifewatch.com/alert-service.aspx

This press release includes forward-looking statements. All statements
other than statements of historical facts contained in this press release,
including statements regarding future results of operations and financial
position, the business strategy, and plans and objectives for future
operations, are forward-looking statements. The words "believe," "may,"
"will," "estimate," "continue," "anticipate," "intend," "expect" and
similar expressions are intended to identify forward-looking statements.
LifeWatch AG has based these forward-looking statements largely on current
expectations and projections about future events and financial trends that
it believes may affect the financial condition, results of operations,
business strategy, short-term and long-term business operations and
objectives, and financial needs. These forward-looking statements are
subject to a number of risks, uncertainties and assumptions. In light of
these risks, uncertainties and assumptions, the forward-looking events and
circumstances described may not occur and actual results could differ
materially and adversely from those anticipated or implied in the
forward-looking statements. All forward-looking statements are based only
on data available to LifeWatch AG at the time of the issue of this press
release. LifeWatch AG does not undertake any obligation to update any
forward-looking statements contained in this press release as a result of
new information, future events or otherwise.

THIS PRESS RELEASE IS NOT BEING ISSUED IN THE UNITED STATES OF AMERICA AND
SHOULD NOT BE DISTRIBUTED TO UNITED STATES PERSONS OR PUBLICATIONS WITH A
GENERAL
CIRCULATION IN THE UNITED STATES. THIS PRESS RELEASE DOES NOT CONSTITUTE AN
OFFER OF SECURITIES OF LIFEWATCH AG OR ANY OF ITS SUBSIDIARIES FOR SALE IN
THE UNITED STATES, OR AN INVITATION TO SUBSCRIBE FOR OR PURCHASE ANY
SECURITIES OF LIFEWATCH AG OR ITS SUBSIDIARIES IN THE UNITED STATES. IN
ADDITION, THE SECURITIES OF LIFEWATCH AG AND ITS SUBSIDIARIES HAVE NOT BEEN
REGISTERED UNDER THE UNITED STATES
SECURITIES LAWS AND MAY NOT BE OFFERED, SOLD OR DELIVERED WITHIN THE UNITED
STATES OR TO U.S. PERSONS ABSENT FROM REGISTRATION UNDER OR AN APPLICABLE
EXEMPTION FROM THE REGISTRATION REQUIREMENTS OF THE UNITED STATES
SECURITIES LAWS. ANY PUBLIC OFFERING OF SECURITIES TO BE MADE IN THE UNITED
STATES WILL BE MADE BY MEANS OF A PROSPECTUS THAT MAY BE OBTAINED FROM
LIFEWATCH AG OR ITS SUBSIDIARIES, AS APPLICABLE, AND WILL CONTAIN DETAILED
INFORMATION ABOUT THE ISSUER AND ITS MANAGEMENT AS WELL AS FINANCIAL
STATEMENTS OF THE ISSUER.

End of ad hoc announcement

+++++
Additional features:

Document: http://n.equitystory.com/c/fncls.ssp?u=JONIMCUDGB
Document title: LifeWatchTM Mobile Cardiac Telemetry Patch application
filed with the U.S. FDA

---------------------------------------------------------------------

13.05.2015 News transmitted by EQS Schweiz AG. www.eqs.com - news
archive: http://switzerland.eqs.com/de/News

The issuer is responsible for the contents of the release.

---------------------------------------------------------------------


Language:    English
Company:     LifeWatch AG
             Rundbuckstrasse 6
             8212 Neuhausen am Rheinfall
             Switzerland
Phone:       +41 52 632 00 50
Fax:         +41 52 632 00 51
Internet: www.lifewatch.com
ISIN:        CH0012815459
Valor:       811189
Listed:      Regulated Unofficial Market in Berlin, Stuttgart; Open
             Market in Frankfurt ; SIX


End of News    EQS Group News-Service
---------------------------------------------------------------------
355777 13.05.2015
 

 


Weitere Meldungen: LifeWatch AG

Das könnte Sie auch interessieren: