- Respiri’s (RSH) wheezo device has been given the CE Mark and TGA clearance to be listed in the Australian Therapeutics Goods Register
- The wheezo device is the world’s first digital wheeze monitoring solution which is set to help millions of asthma sufferers monitor their condition
- Respiri has found a suitable manufacturing partner in Malaysia for wheezo production
- Additionally, the company has entered a clinical study agreement with Swinburne University in Melbourne to examine wheeze rates against current hospital measures
- The company hopes this will provide physicians with evidence the device is an accurate monitory tool for asthma
- Respiri is up 6.25 per cent following today’s news and shares are trading for 8.5 cents each
Respiri’s (RSH) wheezo device has been given the CE Mark and TGA clearance to be listed in the Australian Therapeutics Goods Register (ARTG).
The wheezo device is the world’s first digital wheeze monitoring solution, comprising sensor, smartphone application and a state-of-the-art platform, to help people with respiratory diseases better manage their condition.
Currently, there are over 40 million asthma sufferers in the European Union (EU) and nearly three million in Australia who cannot effectively monitor their condition daily.
“The CE Mark and TGA clearance is a major accomplishment for Respiri as the submission required rigorous regulatory review against high clinical and safety standards,” Respiri Chairman Nicholas Smedley said.
The company submitted relevant documents to show wheezo will perform safely and achieve the claims for its intended use. Respiri also undertook the second audit of its Quality Management System to achieve ISO 13485 certification that is required for medical device manufacturers.
This resulted in a re-classification of the device to allow immediate application of the approvals for sale in the EU member countries as well as immediate listing in the ARTG.
“With this regulatory step completed, we are now at the point of commercialisation, with focus on our go to market strategy to make this innovative
monitoring solution available to people with asthma as soon as possible,” Nicholas added.
Additionally, Respiri has found a suitable manufacturing partner in Malaysia for wheezo production.
“We are confident of finalising an agreement with our partners in Malaysia in the New Year,” CEO Marjan Mikel said.
Good news for the company continues as it has also announced it will enter a clinical study agreement with Swinburne University in Melbourne.
The study is required to examine wheeze rates against current standard hospital used asthma measured such as the Forced Oscillation Technique (FOT) and Multiple Breath Washout (MBW).
This is necessary before commercialising wheezo as will provide physicians with evidence that the device is an accurate monitory tool for asthma.
“Once we have this, we will be able to approach potential big pharma partners to help us introduce wheezo to physicians who can then recommend wheezo to their patients,” Marjan continued.
Respiri expects to have the first 500 pilot batch completed in January to be used with clinicians and patients.
It’s also working on finishing the premium features of the wheezo app which is set to be a diary app for the global asthma population to manage their condition anywhere, anytime.
These milestones are significant to the company and have been delivered on a timely basis.
Respiri is up 6.25 per cent following today’s news and shares are trading for 8.5 cents each at 1:04 pm AEDT.