Melbourne, Australia , December 4, 2023 -- Adherium Limited (ASX: ADR), a leader in digital health technologies, is pleased to announce it has commenced production and market release of its advanced Hailie® Smartinhaler® connecting Teva Pharmaceutical Industries Ltd. (Teva) available authorized generic option of ProAir® HFA Albuterol Sulphate pressurised metered dose inhalers (pMDIs) with its new, next generation sensor capturing physiological data such as inhalation flow rate.
This advanced digital sensor further supports respiratory-focused hospitals, medical groups and payors to actively manage respiratory disease for improved health outcomes, enabling reimbursement, and saving healthcare costs through remote patient monitoring.
Adherium is currently working with its initial large scale strategic partners, Allergy Partners and SENTA, to enroll patients on its Hailie platform using its range of US FDA 510(k) cleared Smartinhalers to generate and transmit the data enabling remote patient monitoring reimbursement. The production and sale of the Hailie platform underpins Adherium reaching a cash flow positive position.
Questions around this news
What data can the new inhaler sensor capture?
The release says the next-generation sensor can capture physiological data, including inhalation flow rate. It describes that information as a way to provide insights into inhaler technique. The announcement also says the sensor is compatible with an authorized generic version of a pressurised metered dose inhaler.
How is remote patient monitoring used in respiratory care?
Remote patient monitoring uses connected devices to collect and share health-related information when a patient is away from a clinical setting. Care teams may use the data to follow aspects of a condition or treatment and support decisions about care. The release presents connected inhaler data as a tool for respiratory-focused hospitals and medical groups managing respiratory disease.
What does FDA 510(k) clearance mean for a medical device?
A 510(k) clearance is a US regulatory decision that allows a medical device to be marketed after the FDA finds it substantially equivalent to a legally marketed device, subject to applicable requirements. It is distinct from FDA approval through the premarket approval pathway, which applies to certain higher-risk devices.
Which US partners is Adherium working with to enroll patients?
The release names Allergy Partners and SENTA as its initial large-scale strategic partners. It says the partners are working with the company to enroll patients on its digital platform using its range of FDA 510(k)-cleared inhaler sensors, with data transmission intended to support remote patient monitoring reimbursement.
Now achieving four market release milestones of the next generation Hailie Smartinhalers, Adherium progressed on its commercial strategy to 79% market coverage for sensors capturing physiological data such as inhalation flow rate, and 91% market coverage for adherence tracking of US top 20 branded inhaler medications by sales volume. Hailie Smartinhalers are the only FDA 510(k) cleared drug agnostic sensor available today to offer physiological data insights on inhaler technique.
Francis White, Vice President of Global Business Development at Adherium, states: “We are pleased to be able to provide access to Hailie Smartinhalers to tens of thousands of patients through our growing partnerships with US respiratory hospital and medical group systems, equipping patients with the most advanced tools to manage their respiratory health and vastly improve their quality of life.”
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At a glance
- Company
- Adherium Limited
- Ticker
- ASX: ADR
- Announcement
- Product
- Location
- Melbourne, Australia
Key figures
- Market coverage for sensors capturing physiological data
- 79%
- Market coverage for adherence tracking
- 91%
- US branded inhaler medications in the adherence-tracking coverage measure
- top 20
- Market release milestones achieved
- four
People
- Francis WhiteVice President of Global Business Development at Adherium
