Melbourne, Australia – 28 November 2022: (Link Here) Adherium Limited (“Adherium”; ASX: ADR), a leader in respiratory eHealth, remote monitoring and data management solutions, today announced that is has received U.S. Food and Drug Administration (FDA) 510(k) clearance to market application, connecting GlaxoSmithKline’s (GSK) Ventolin®, Advair®, and Flovent® pressurised metered dose inhaler (pMDI) users with its new, next generation Hailie® sensor with physiological parameters.
“This is the third 510(k) market clearance of the next-generation Hailie sensors capturing physiological data, following the Hailie sensors for AstraZeneca’s Symbicort® pMDI inhaler and GSK’s Ellipta® dry powder inhalers enabling even more medication coverage for US remote patient monitoring reimbursement. Achieving these significant milestones for the Company, we continue to broaden our regulatory footprint to be the drug agnostic, global digital partner of choice on our path toward building a sustainable, cash flow positive business,” commented Mr Rick Legleiter, Adherium Chief Executive Officer.
With these 510(k) market clearances and an integrated and highly scalable digital platform allowing multiple data inputs, Adherium is well positioned to offer a singlesource customer solution to capitalise on remote patient monitoring opportunities.
As shown in the attached competitive analysis graphic, with this Hailie for GSK pMDI 510(k) clearance together with the Ellipta 510(k) clearance received earlier this year, Adherium progressed from covering U.S. top 20 branded inhaler medications by sales
volume as follows:
• 91% today up from 71% in 2021 for adherence usage remote patient monitoring enabling access by healthcare providers for the US Centers for Medicare and Medicaid Services (CMS) Remote Therapeutic Monitoring reimbursement codes,
• 51% today up from 11% in 2021 to be the clear market leader with physiological parameter sensors enabling the CMS Remote Physiological Monitoring reimbursement codes.
Using Adherium’s drug agnostic platform, doctors and healthcare partners always own the medication decision and receive the data and insights for improving patient care without changing a patient’s prescriptions.
These new generation devices provide superior data and insights into patient inhaler technique and usage giving healthcare providers immediate, real-time feedback enabling physicians to enhance patient care by capturing clinical data supporting patient management and treatment. Adherium’s broad medication market coverage makes possible a total patient view with digital sensor technology applied in a combined monitoring of both maintenance and reliever (rescue) medications. A recently published clinical study demonstrates digital physiological sensors can predict impending asthma exacerbation within 5 days prior to the start of the event.
Tara Creaven-Capasso, Adherium’s Vice President of Quality, Regulatory and Clinical Affairs, commented, “Our objective with each generation of the Hailie sensor is the pursuit of our mission – to be the leading digital solution for remote patient monitoring; integrating devices and data to optimise outcomes for patients, healthcare professionals and payors. With CMS focused on providing new and expanded reimbursement options for virtual care management programs, more reimbursement opportunities for doctors are available, which gives access to comprehensive patient data for more effective care delivery, better care coordination, and improved health outcomes.”