St. John’s-based medtech company BreatheSuite Inc. has received 510(K) clearance from the U.S. Food and Drug Administration for its device that helps people to user their inhalers properly.

Receiving FDA clearance means that BreathSuite can now sell its BreatheSuite Metered-Dose Inhaler V1 device in the U.S. The company said in a statement on Tuesday it is the first company from Newfoundland and Labrador ever to receive FDA approval.

Founded in 2018, BreatheSuite has developed software and hardware that aim to correct the improper use of inhalers. Its goal is to improve treatment for the millions of people who suffer from asthma and chronic obstructive pulmonary disease, or COPD, 90 percent of whom are said to use their inhalers improperly.

“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 BreatheSuite Founder and CEO Brett Vokey in a statement. “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.”

BreatheSuite in January closed a $1.2 million equity financing round, led by Venture NL, the fund overseen by Pelorus Venture Capital. It follows on from a $550,000 round in October 2019. The investors in the most recent round included St. John’s-based Killick Capital, which is investing in the company for the first time, and other private investors.

The company said the FDA approved the BreatheSuite device for both prescription and over-the-counter use.

Tens of millions of Americans currently use MDIs, said the release, and inhaler misuse makes up about $5 billion to $7 billion of the roughly $25 billion spent on inhalers annually.

The BreatheSuite System – composed of a disposable 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.

“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, BreatheSuite’s Chief Scientific Officer. “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.”