Adherium Receives Additional U.S. FDA 510(k) Clearance, Setting in Motion a Full U.S. Consumer Launch of the Hailie™ Solution
26 Jul 2018
San Mateo, CA - July 26, 2018: Adherium (ASX: ADR), an award-winning digital health platform that improves medication adherence, patient outcomes and engagement, today announced the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for over-the-counter (OTC) sales of its Hailie™ sensor for use with ProAir® HFA, Ventolin® HFA and Flovent® HFA asthma inhalers.
Adherium’s Hailie sensor, previously known as Smartinhaler™, is a device that attaches to a patient’s asthma or COPD medication inhaler to monitor and promote adherence as part of a self-management plan. This FDA clearance means access by consumers to Adherium’s Hailie online platform now expands from those using AstraZeneca’s SYMBICORT® (budesonide/formoterol fumarate dihydrate) to consumers using ProAir HFA, manufactured by Teva Pharmaceuticals, and Ventolin HFA and Flovent HFA, manufactured by GSK.
“This latest clearance kicks off our official entry into the U.S. consumer market, giving the tens of millions of US patients suffering from chronic respiratory conditions their own sidekick for asthma and COPD. Hailie is always there to support patients, helping them partner with their physicians to better manage and understand their condition,” said Arik Anderson, CEO of Adherium. “Clinically-proven monitoring and engagement, supported by 15 years of research and development, is on its way directly to patients in the U.S. through our e-Commerce portal at www.hailie.com.”
A wide body of clinical evidence supporting the benefits of the Hailie technology has been accumulated, including 74 peer-reviewed journal publications to date.
Adherium’s Hailie™ solution is designed to help patients achieve better adherence and provide visibility to parents and caregivers. It does this by tracking medication use and reminding the user with helpful nudges when it’s time to take doses, and by providing access to usage history to better understand patterns in their asthma and COPD. These tools ultimately enable people who live with asthma or COPD to more easily manage their condition alongside their physician.
Adherium is also launching an online portal for healthcare professionals and clinicians that uses Bluetooth® wireless technology to provide patient-group data collection and reporting from Hailie™ sensors. This platform will support engagement between healthcare professionals and patients by enabling sharing and monitoring of patient inhaler usage.
Adherium is a digital health platform and global leader in connected respiratory medical devices, with over 100,000 sensors distributed. The Company develops, manufactures and supplies patients, pharmaceutical companies, healthcare providers and contract research organizations with the broadest range of connected medical devices for respiratory medications. The sensors and accompanying technology address sub-optimal medication use and strive to improve health outcomes in chronic disease. Adherium is headquartered in the U.S., and operates globally from bases in the U.S., Europe and Australasia. Learn more at adherium.com.
Vik Panda, Adherium
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