MADISON, Wis., Nov. 7, 2016 /PRNewswire/ -- Propeller Health, the leading digital solution for respiratory
medicine, today announced U.S. Food and Drug Administration 510(k) clearance to market its Propeller platform for use with GSK's
Ellipta® inhaler, the pharmaceutical company's innovative, patented, dry powder inhaler (DPI). The sensor for the Ellipta inhaler
was built and cleared as part of a development agreement and R&D collaboration between Propeller and GSK that was announced
on December 1, 2015.
"Today, we are pleased to announce the FDA clearance of the Propeller platform for use with GSK's Ellipta inhaler," said
David Van Sickle, CEO and co-founder of Propeller. "Inclusion of GSK's Ellipta inhaler in
Propeller's digitally-guided therapy platform is an important step in our goal of modernizing the management of respiratory
disease. We look forward to working closely with GSK to deploy sensors for the Ellipta inhaler in the U.S. and abroad, in the
near term."
This FDA clearance follows CE Mark and Health Canada registration for the device and system earlier this year.
Propeller is FDA-cleared to help patients and their physicians better understand asthma and COPD, and help to improve the
symptoms and outcomes of these chronic respiratory diseases. With proprietary sensor technology, software, and services,
Propeller's digitally-guided therapy platform integrates information from multiple sources, including connected medications, then
uses machine intelligence to help individuals manage their condition.
Dave Allen, head of respiratory R&D at GSK, said, "While it is still in the early stages of
development, the emerging field of digital healthcare holds great promise for respiratory medicine. The approval of the Propeller
platform for use with the Ellipta inhaler will help us understand how patients interact with the Ellipta inhaler accurately and
in real-time. By exploring the benefits of sensor technology in this way, we hope to gain valuable insights into usage patterns
with the ultimate goal of driving improvements in patient care while reducing the complexity and cost of clinical trials."
The Propeller Health platform has been used by patients with asthma or COPD in over 45 commercial programs across the US,
including major healthcare systems, payers, employers and other commercial partners. This clearance marks the eighth FDA
clearance, as well as the eighth international clearance, received by Propeller to date.
About Propeller
Propeller empowers people with asthma and COPD to live measurably better lives. In 2010 Propeller set out to modernize
respiratory medicine, empower people to minimize the impact of asthma and COPD on their daily lives, and connect them to their
physicians, environment and community. Propeller's information-powered approach to respiratory management guides physicians and
patients to the optimal path of therapy for each individual. With connected inhalers, digital interfaces, and real time
personalized insights, participants receive personal guidance and expert direction anytime. Backed by 3M Ventures (NYSE: MMM), SR
One, Hikma Ventures (LON: HIK),, Safeguard Scientifics (NYSE: SFE), Social Capital and other investors, Propeller has been used
by patients with asthma or COPD in over 45 commercial programs across the US at major healthcare systems, payers, employers and
other commercial partners. The company has been recognized as the recipient of the American Telemedicine Association's 2016
President's Award for Innovation in Remote Healthcare and as one of the top "Fierce 15" medical device companies in 2015 by
FierceMedicalDevices. For more information visit: www.propellerhealth.com
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SOURCE Propeller Health