FDA clearance received for yet another Adherium device

Chronic respiratory disease is a growing concern, especially in the age of COVID-19, with a snowballing amount of studies examining the effects of ‘long COVID’- where symptoms persist long after the virus has cleared. 

Medtech company Adherium (ASX: ADR) has what could be a very relevant and consequently very profitable suite of products designed to improve adherence to treatment for respiratory illness. 

Adherium has been granted FDA 510 (k) clearance for their next generation Hailie sensor with physiological measures to better monitor medication use in asthma and chronic obstructive pulmonary disease (COPD) sufferers. 

The Hailie sensor attaches to a patient’s inhaler and captures clinical data for better patient management. The sensor is integrated with related digital platforms of online portals, apps and data management and analytics software. Validated in more than 85 studies, the clinically proven solution increases adherence to preventative medication by 180% in children and 59% in adults. It can also reduce the risk of severe exacerbations in adults by 60%, improving the quality of life for those with chronic respiratory conditions. Non adherence to medication in respiratory patients incurs $34 billion in preventable costs in the US alone. With over 170,000 medical devices sold globally, Adherium is addressing the need for improved patient adherence and reducing the cost burden on healthcare systems. 

Commenting on the FDA approval, Adherium CEO Rick Legleiter said: “The FDA’s first clearance of our next generation Hailie sensors with physiological measures is a significant regulatory step for the business. The stage is now set for physiological measures to be coupled with our existing adherence sensor capability giving us the total ‘one-two punch’ to deliver the best value proposition of any smart inhaler digital solution in the world. 

“As we deliver our clearly defined development roadmap including new additional physiological enabled sensors and alongside digitally enabled peak flow and spirometers, Adherium will expand its addressable respiratory medication market coverage and establish a preeminent business partnering position for providers, payors and digital health affiliates.” 

The Company now has 10 US FDA cleared devices and is committed to ongoing product development to further expand their reach.