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LifeWatch announces its new product Vital Signs Patch (VSP)and informs about its smartphone(Tensid Regulatory Via Acquire Media NewsEdge) Ad hoc release LifeWatch announces its new product Vital Signs Patch (VSP)and informs about its smartphone Neuhausen am Rheinfall, 29 October 2013 -LifeWatch AG (SIX Swiss Exchange: LIFE), the leading wireless cardiac monitoring service provider in the U.S., opens a new chapter in the company's history. LifeWatch announced today that it filed a 510(k) Premarket Notification with the U.S. Food and Drug Administration (FDA) for regulatory clearance of its new Vital Signs Patch (VSP) technology. LifeWatch also expects FDA approval for its smartphone LifeWatch V in the first half of 2014. The chest patch VSP is a reusable portable device with embedded sensors that attaches to a patient's chest via a disposable adhesive part. The VSP system is an ambulatory patient monitor that enables the continuous and accurate remote monitoring of the vital signs of a patient routinely checked by nursing staff. It automatically analyzes and wirelessly transmits continuous patient data that can be reviewed by healthcare professionals and support coordination of care. Being small in size, easy to affix, comfortable to wear and far less restrictive and cumbersome than numerous wired devices currently used, the VSP will work in hospital, ambulance, nursing care and home environments, replacing multiple hardware devices with a far more comfortable and cost effective approach to care. Parameters can be customized and set for alerts; data can be configured and accepted into an EMR system. The VSP system is comprised of: Patch: A disposable adhesive strip with embedded sensors (ECG, heart rate, respiration rate, temperature, saturation, accelerometer), cradle and battery which, attached to the body, acquires vital signals for 5 to 7 daysBrain: hardware unit that saves and transmits data to the gatewayBlood Pressure: ambulatory blood pressure cuff with radio frequency component to transmit the captured data to the gatewayGateway: An Android-based smartphone with special software for monitoring, detecting and alerting, designed to transmit data to the backendBackend: Receives and analyzes data, generates reports and alerts, provides location information. The VSP's ability to communicate data and to generate alerts and reports makes it ideally suited to the telehealth market, where home care is benefiting from technology advances. The VSP patch will also enable a more efficient use of health system resources in hospitals as nursing staff can focus on their core strength. Routine procedures can be handled fast and effectively via the VSP limiting human errors and improving medical quality. In emergency medicine, the VSP patch offers additional benefits: The patch is immediately applied at the emergency site to capture, analyze and transmit relevant medical data to the hospital. All necessary hospital resources can then be deployed before the patient arrives, saving valuable time to start the emergency treatment. LifeWatch just filed 510 (k) with the FDA for regulatory approval of the VSP. The company is planning a launch of the patch in mid 2014, starting with the U.S. hospital market and then branching into alternate care sites. The VSP will be operated under a service model, which shall allow leveraging existing infrastructure of the company and minimizing cost of materials also at possibly small coverage of the market. The service shall allow healthcare professionals to focus on their core strengths and hospitals to improve efficiency and security. FDA approval for LifeWatch V expected in the first half of 2014 Healthcare smartphone LifeWatch V was presented to the market in 2012. It combines multiple embedded medical sensors with health and wellness applications analyzing the sensor data. A cloud-based services platform creates a unique personal health solution for consumer market, which enables health-conscious individuals and patients to monitor their health and well-being anywhere, at any time. LifeWatch V measures heart rate, blood glucose level, body temperature, body fat, blood oxygenation and stress level through its array of integrated sensors. All data can be tracked, saved and analyzed by the user and made available to healthcare providers or family members. As a modular offering, LifeWatch V is able to empower patients and assist in providing better care at lower cost, thus improving the use of health resources worldwide. LifeWatch V is currently in the FDA approval process for the U.S. and expects to complete the approval process in the first half of 2014. It has already received the CE mark and admissions in India and Israel. LifeWatch is working on setting up its partnering model that will vary depending on the market. Correspondingly, the Company will provide services at different levels. It will offer its broadest service in those markets where it has its own infrastructure, such as in the U.S. where it will leverage its current service centers. In markets where it has no infrastructure, LifeWatch will mainly support partners in their service offerings (cloud solution). Given the main target groups and the readiness for mobile health, LifeWatch estimates the total global market size for offerings similar to LiveWatch V currently at about 16 million customers. For the U.S. market, LifeWatch estimates a market size of currently about 3 million customers, for China about 2 million customers, for India about 0.8 million customers and for Western Europe about 1.9 million customers. Driven by economic and demographic developments in emerging markets, LifeWatch expects that the global market will double in size in the next three years. The experience resulting from LifeWatch's efforts to implement its partner model provides the basis to adjust and specify the business plan for LifeWatch V. Considerable sales are expected for 2014. LifeWatch expects financial results from LifeWatch V to be driven by the Company's service offering and EBIT margin to reach high single digit percentage once the sale of devices exceeds a certain threshold. More guidance will be given as soon as first agreements have been concluded. Ken Melani, Chairman of LifeWatch, comments: "Mobile health management offers a paradigm shift in the gathering and analysis of health information as high quality medical data is becoming readily available for individuals and patients' healthcare providers. With our LifeWatch V smartphone and the VSP vital signs patch our team led by CEO Yacov Geva developed innovations that will define new, easy ways of checking one's personal health and capturing patient data for healthcare professionals." For further questions Yacov Geva, CEO LifeWatch, O: +972 54-433-8822, E: [email protected] About LifeWatch AG LifeWatch AG, headquartered in Neuhausen am Rheinfall and listed on the SIX Swiss Exchange (LIFE), Switzerland, is the leading healthcare technology and solution company, specializing in advanced tele-health systems and wireless remote patient monitoring services. LifeWatch services cater to individuals, ranging from high-risk and chronically ill patients, to consumers of health and wellness products. 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. Press Release (PDF) ProviderChannelContactTensid Ltd., Switzerland www.tensid.chnewsbox.ch www.newsbox.chProvider/Channel related enquiries [email protected] +41 41 763 00 50 (c) 2013 Tensid Ltd., Switzerland. |