Wheezo device and app technology developer, Respiri (ASX: RSH) has received the greenlight from the United States Food and Drug Administration (FDA) to market and sell the technology as a class II medical device in the country.
The regulatory approval enables wheezo to be sold OTC (over-the-counter) to patients with or without a prescription.
Similar to Australia and Europe, Respiri will initially target asthma patients in the US – promoting its device and technology’s capability to monitory wheeze severity in collaboration with a treating doctor.
Respiri chief executive officer and managing director Marjan Mikel said the US FDA clearance was a “highly significant and major milestone” for the company as it continues its global expansion strategy.
“The FDA is one of the most stringent regulatory bodies in the world and this clearance further validates the efficacy and utility of our wheezo device and algorithm.”
“To our knowledge, [this is] the first time the FDA has cleared a device/mobile application for the detection, recording and changes of wheeze rates.”
Mr Mikel added its wheezo device and app represented a “step change” in technology for patients with respiratory wheeze seeking effective monitoring and measurement.
He said it was also important to note the FDA approval was for OTC – enabling the device to be sold without a prescription.
“Further, although we remain heavily focused on asthma, we are pleased that the approval was indication agnostic where wheezo can be used in any respiratory condition where wheeze is a symptom,” Mr Mikel added.
US market entry
In the US, about 8% of the adult population suffers from asthma, with 7.5% of all children in the country living with the disease.
Respiri noted this equates to about 24.7 million asthma patients in the region, which accounts for 9.8 million physician office visits and a further 1.6 million emergency department trips annually.
The company estimates the financial burden of uncontrolled asthma is about US$300 billion in direct costs and with indirect costs this amounts to US$964 billion over 20 years.
As part of its US entry strategy, Respiri will focus on 60% of children with persistent and severe asthma which representing 3.3 million patients.
The official US launch is planned for Q3 2022, with distribution partner Cipla retaining first right of refusal to sell in the US under an agreement inked in July last year.