Adherium Limited announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance to market application, connecting Teva Pharmaceutical Industries Ltd. (Teva) HFA pressurised metered dose inhalers (pMDIs) including ProAir®, and Albuterol Sulphate with its new, next generation Hailie® sensor with physiological parameters. Adherium is first to market with 510(k) cleared respiratory flow rate sensors with physiological data capabilities allowing multiple data inputs. Adherium is well positioned to offer a single-source customer solution to capitalise on remote patient monitoring opportunities.

With Adherium, the doctors always own the medication decision. As shown in the twocompetitive analysis graphics shown below, with Hailie for Teva's ProAir® HFA and Albuterol Sulphate pMDIs, this FDA 510(k) clearance together with the GSK 510(k) clearances received last year, Adherium progressed from covering U.S. top 20 branded inhaler medications by sales volume as follows: 79% coverage up from 11% in 2021 to be the differentiated market leader with physiological parameter sensors enabling the US Centers for Medicare and Medicaid Services (CMS) Remote Physiological Monitoring reimbursement codes published in 2019, 91% coverage today up from 71% in 2021 for adherence usage remote patient monitoring enabling access by healthcare providers for the CMS Remote Therapeutic Monitoring reimbursement codes published in 2022. Using Adherium's drug agnostic platform, doctors and healthcare partners 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.