Hailie inhaler monitoring system maker Adherium announced that the FDA has cleared the company’s new version of the Hailie sensor for use with Ellipta dry powder inhalers. Adherium submitted the 510(k) application to the FDA in March 2022. The company said that the new clearance means that Hailie is now eligible for reimbursement on 18 of the top 20 branded inhalers marketed in the US.
Adherium CEO Rick Legleiter said, “The FDA’s clearance to connect Ellipta inhaler users with our new, next generation Hallie platform represents another major step forward in our drug agnostic strategy. In addition, this further broadens the pathway for doctors and hospital groups in the US to access reimbursement for remote monitoring of patients prescribed Asthma and COPD medications on our path toward building a sustainable, cash flow positive business.”
Adherium has also announced a three-year distribution agreement with Perigon Health 360, which has integrated the Hailie platform into its Medesto patient monitoring platform. Adherium recently announced a deal with Helicon Health for distribution of Hailie sensors in the UK. According to Adherium, Perigon has already purchased a number of Hailie sensors and has begun enrolling patients.
Legleiter commented, “Given the rapid development of remote patient monitoring and telehealth, particularly accelerated by the COVID-19 pandemic, this distribution agreement marks a major step in the execution of the commercial strategy for Adherium’s Hailie platform in the US. With our sophisticated devices and integrated platform, the company is well positioned to lead the market.”
Perigon CEO Ted Mills said, “Innovation is crucial to our future, and we’re extremely pleased to be collaborating with Adherium to support their continued focus on improving clinical outcomes and reducing exacerbations, hospital admissions and health system costs in managing respiratory patient populations. This partnership will expand our product portfolio and enable both companies to continue to achieve commercial success accelerating momentum in the digital healthcare industry.”
Read the Adherium press release on the Hailie approval.
Read the Adherium press release on the Perigon deal.
