Adherium’s Hailie Smartinhaler receives FDA approval for use with leading AstraZeneca devices

Medical device developer Adherium (ASX: ADR) has been given clearance by the US Food and Drug Administration (FDA) for its Hailie Smartinhaler to be used with AstraZeneca’s Airsupra and Breztri inhalation devices.

Airsupra is the first FDA-approved rescue medication for asthma patients and Breztri is a triple combination for patients with chronic obstructive pulmonary disorder (COPD).

Both devices are considered to be at the forefront of respiratory care.

The FDA clearance of the Hailie Smartinhaler is expected to offer patients and healthcare providers enhanced monitoring capabilities and personalised treatment approaches.

The compatibility with Breztri gives Adherium 100% coverage for triple therapy inhalers in the US.

The option to combine Hailie with Airsupra and Breztri will give patients and clinicians real-time data and insights into their usage patterns and inhaler technique feedback, fostering better adherence to the medications and enabling tailored treatment regimens.

Personalised approach

Adherium chief executive officer Dr Paul Mastoridis said the personalised approach to management was expected to enhance overall treatment efficacy and dramatically improve patient quality and outcomes.

“Our mission at Adherium has always been to revolutionise the way respiratory conditions are managed,” he said.

“By securing FDA clearance for our Smartinhaler with Airsupra and Breztri, we are bringing that vision to life, offering patients and healthcare providers a powerful tool in the fight against chronic respiratory diseases.”

He said the approval was a significant milestone and “just the beginning of our journey to transform respiratory care”.

CEO appointment

Dr Mastoridis was appointed to the role of chief executive officer in February.

He is a recognised global pharmaceutical innovator in the asthma and COPD markets with more than 25 years’ experience in pioneering and leading digital solutions for the management of these conditions.

Prior to joining Adherium, Dr Mastoridis was the global medical head of respiratory for Swiss multinational Novartis, where he helped develop and patent the first artificial intelligence technology to differentiate and diagnose asthma from COPD.

Strategic partnership

Adherium announced earlier this month that it had secured a strategic partnership with US-based clinical management platform developer Rimidi to optimise clinical workflows and enhance the outcomes for patients with chronic respiratory disease.

The collaboration will focus on integrating the Hailie Smartinhaler into Rimidi’s comprehensive platform used by health systems, capitated health plans and medical practices across 17 US states.

It is expected to “empower clinicians” to make informed decisions, tailor interventions and personalise their care plans to effectively improve patient outcomes.