BreatheSuite Receives FDA 510(K) Clearance for Metered-Dose Inhaler V1 Device

BreatheSuite Inc., a Canadian connected respiratory health company, has received 510(K) clearance from the U.S. Food and Drug Administration (FDA) for its BreatheSuite Metered-Dose Inhaler (MDI) V1 device. Approved for both prescription and over-the-counter use, the BreatheSuite device turns existing MDIs into smart inhalers by automatically and objectively monitoring and providing feedback on inhaler adherence and technique for people with asthma and COPD.
 
Tens of millions of Americans currently use MDIs. Techniques such as shaking the MDI 10-15 times, as well as breath timing and positioning, can greatly impact the amount of medication that reaches the lungs. For every 100 people who use an inhaler, 90 are using it incorrectly; 66 are not adherent to the medication as prescribed (skipping doses, etc.). Inhaler misuse makes up about $5- $7 billion of the approximately $25 billion spent on inhalers annually.
 
The BreatheSuite System – composed of a disposable, battery-powered, portable BreatheSuite MDI add-on device and a mobile application based on behavior change strategies – is designed to work with an MDI by attaching to the top of the canister of the patient’s inhaler. The device and mobile app work together to evaluate and “score” a person’s inhaler technique and usage patterns, storing results in the cloud so the person can track and use this information to improve how they use their inhaler. With consent, this information can also be remotely monitored by the person’s healthcare team to promote customizable care plans. By promoting more effective inhaler use and remote patient monitoring (RPM), BreatheSuite aims to improve quality of care and health outcomes while reducing the economic burden associated with these conditions. Medical costs for chronic COPD were estimated to reach $49 billion in 2020, and the annual economic cost of asthma from 2008-2013 was more than $81.9 billion – with medical costs alone accounting for $50.3 billion.
 
“We are extremely excited to have obtained FDA clearance, which is a critical step in achieving our vision of improving the lives of respiratory patients worldwide,” said Brett Vokey, founder and CEO of BreatheSuite. “The COVID-19 pandemic has underscored that now is the time for remote patient monitoring to take a front seat in providing better, more transparent care for all people with asthma or COPD. With FDA clearance, we are poised to become a leader in providing actionable insights to people with asthma or COPD across the United States.”
 
“By having a real-time way to digitally monitor and provide feedback to patients, we hope to enhance healthcare outcomes,” said Dr. Meshari F. Alwashmi, chief scientific officer, BreatheSuite. “Furthermore, having an objective measure of adherence and technique from each user with asthma and COPD will advance the sphere of knowledge regarding the effectiveness of inhaled medications.”
 
The BreatheSuite device does not interfere with regular MDI usage and can be removed and reattached to a new inhaler with ease. The device is compatible with 90% of MDIs on the market, including those manufactured by GlaxoSmithKline (GSK), Teva and Prasco.
 
In addition to FDA clearance, which is a first for a Newfoundland and Labrador-based company, the BreatheSuite device has also been cleared for sale in Canada.