Inhaler monitoring company Adherium has submitted a 510(k) application for a new Hailie sensor designed to work with the Symbicort MDI the company announced. The company recently rejected a takeover bid from another Australian asthma monitoring company called Respiri and then named a new CEO, its sixth chief executive since 2017, saying that it “must continue ‘business as usual.'” Mike Motion, who had been CEO since April 2020, has stepped down for personal reasons the company said, and will be replaced by former Universal Biosensors CEO Rick Legleiter.
According to Adherium, the next generation inhaler is “designed to enable physicians and providers to enhance patient care and clinical workflow by capturing clinical data and supporting patient management” which will allow for reimbursement for patient monitoring. Adherium got OTC clearance for the Hailie inhaler monitoring platform in the US in 2018, and launched direct-to-consumer sales soon afterward. In April 2020, the company announced that Monaghan Medical would market the Hailie system in the US.
Adherium Chief Technology Officer Geoff Feakes commented, “This is an important step in the extension of our digital respiratory management ecosystem. This latest development signals the start of Adherium’s next generation of sensors that capture physiological measures. Clinicians globally have told us of the importance of building on our core adherence capability to extend the range of clinical data we capture and expand our market coverage of inhaled medications for Asthma and COPD. Physiological measures were consistently identified as a key data set to improve patient management and importantly, access reimbursement to enable the widest possible patient population to benefit from the technology. As part of Adherium’s market expansion we intend to release a further four new sensors with physiological measures over the next 18 months, taking our anticipated Asthma and COPD medication coverage in the US to over 80% by volume and supporting 18 medications.”
Read the Adherium press release on the 510(k) submission.
Read the Adherium press release on the new CEO.
