Respiri (ASX:RSH) receives FDA tick for Wheezo
- Respiri (RSH) has received United States Food and Drug Administration (FDA) clearance for its wheezing aid, Wheezo
- Wheezo monitors wheezing to manage and improve asthma
- With the green tick from the FDA, the company can now market and sell the technology in the United States
- On the market this afternoon, Respiri is in the grey and trading at 17 cents per share
Respiri (RSH) has received United States Food and Drug Administration (FDA) clearance for Wheezo.
Wheezo monitors wheezing to help manage and improve asthma. The technology can also share data with caregivers, physicians and other health care professionals.
With the green tick from the FDA, the company can now market and sell its technology in the United States.
Asthma is a significant problem in the U.S., with around 8 per cent of the population and 7.5 per cent of children living with the disease.
Respiri is aiming to launch Wheezo in the U.S. market in the third quarter of 2022.
CEO Marjan Mikel says FDA approval is a major milestone as Respiri continues to expand its footprint for Wheezo.
“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 the first time the FDA has cleared a device/mobile application for the detection, recording and changes of wheeze rates,” he said.
“This represents a step-change in technology for patients with respiratory wheeze seeking an effective, replicable and rapid device measurement and associated App that monitors this important measurement of lung function,” he added.
Notably, the product has been granted over-the-counter approval, which means Wheezo can be provided to patients with or 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,” Marjan said.
On the market this afternoon, Respiri is in the grey and trading at 17 cents per share at 1:31 pm AEDT.