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LifeSignals Announces FDA Clearance of Health Care Vital Sign Wireless Monitoring Patch and ECG Application

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FDA Approval Paves Way for Next Generation of Remote Patient Diagnostics

LifeSignals announced today that it received FDA clearance for its
wireless LP1100 Life Signal Patch for enabling the next generation of
wearable, healthcare monitoring devices. It is built on two solid
technology foundations to provide unprecedented attributes unachieved by
another ECG patch product to date. It deploys the company's recently
launched LC100 Life Signal Processor (LSP) Platform and a patented,
integrated multi-electrode architecture.

It opens the door for OEMS using the Life Signal Processor™ to develop
ECG and other vital sign monitoring wearables with wireless connection
to the cloud. The approval also provides a needed biosensor patch for
companies looking to deliver certain health applications in the low
acuity patient monitoring space, consumer wellness, senior care and
animal health.

"This FDA approval is not only a great milestone for our company but
also an indicator of what's to come: a new era focused on the Internet
of me, my body data, my life, wellness and health captured and
faithfully delivered by products enabled by LifeSignals technology,"
said Surendar Magar, co-founder and CEO of LifeSignals. "Using our LSP
technology, data can be captured inexpensively with clinical grade
accuracy, and faithfully transmitted wirelessly to existing medical
monitoring systems in current hospitals or via new cloud-based systems
for analysis," he explained.

LifeSignals worked with 3M (NYSE:MMM) and STMicroelectronics (NYSE: STM) to develop and industrialize the Life Signal Processor product
family, targeting high-volume markets. LifeSignals' LC1100 chip enables
continuous scaling of products to incorporate new features. The
integrated multi-electrode ECG sensor architecture, which was proven in
the company's previous FDA clearance in 2014, enables multi-lead ECG
monitoring in a small form factor.

Life Signals Processor Innovations

Until now, traditional wireless ECG biosensor patches have been too
expensive in both cost and power consumption, have not been fully
disposable (single-use), and not reliable enough for the
mission-critical applications healthcare demands. The LSP technology and
LP1100 patch family changes all that.

  • LP1100 LS Patch is a clinical-grade, two-lead ECG (extendable to three
    leads) and heart rate monitoring patch, providing three days of
    monitoring with continuous wireless data transmission using two
    zinc-air batteries.
  • The LS Patch has attributes previously unachieved by any other patch
    product – fully disposable, a small form factor, comfortable to wear
    under regular daily clothing, continuous data transmission on a Wi-Fi
    network, reliable coexistence of multiple patches while transmitting,
    and low cost.
  • LS Patch is intended to be a baseline reference design for OEMs
    addressing various markets such as healthcare, consumer wellness,
    senior care and animal health, accelerating time to market of their
    diagnostic and monitoring systems. It can also be adapted as-is by
    OEMs under their private label to create their own end-products based
    on LS Patch.
  • LS Patch is in high volume production at LifeSignals contract
    manufacturing partner – Dreamtech of Korea.

Developer Support Items for OEMs

Life Signals product family supports a full suite of hardware and
software development tools, including a development board and a software
development kit (SDK) to design customized devices based on LSP. In
addition, production-ready reference designs are available for multiple
product types – including patches, smart clothing-based designs and
receiver devices. Various apps are available for iOS and Android devices.

About LifeSignals, Inc.

LifeSignals (formerly HMicro Inc.) is the Silicon Valley based creator
and producer of the patented Life Signal™ Processor, a semiconductor
platform designed to faithfully capture and communicate vital life
signals from humans and animals to the cloud. LifeSignals is a venture
capital backed, healthcare targeted, silicon and solutions company,
enabled by equity investments from Flex, Uniquest, Dreamtech, Renew
Group, Seraph Capital, XSeed Capital, and Reddy Capital. Further
information can be found at www.lifesignals.com.

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