BreatheSuite's Over-the-Counter Device Converts Conventional Metered-Dose Inhalers to Smart Inhalers

MedTech Outlook | Monday, October 18, 2021

The removable device/mobile application improves inhaler technique and medication adherence in people with asthma and COPD and enables improved remote patient monitoring.

FREMONT, CA: The use of smart inhalers enables patients and physicians to monitor their status and the efficacy of treatment in individual patients over time, without the need for diaries or other written records. BreatheSuite Inc., a Canadian connected respiratory health startup, confirms that its BreatheSuite Metered-Dose Inhaler (MDI) V1 device has been granted 510(K) clearance by the United States Food and Drug Administration (FDA). BreatheSuite, approved for prescription and over-the-counter use, transforms conventional MDIs into smart inhalers by monitoring and delivering feedback on inhaler adherence and technique for persons with asthma and COPD.

“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,” says Brett Vokey, Founder and CEO of BreatheSuite regarding the smart inhaler. “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.”

The FDA has approved BreatheSuite’s metered-dose inhaler device. BreatheSuite aims to improve the quality of care and health outcomes related to asthma and COPD by supporting more effective inhaler use through remote patient monitoring (RPM).

Currently, tens of millions of Americans use MDIs. Shaking the MDI 10-15 times and breath timing and position can significantly affect the amount of medication that reaches the lungs. For every 100 patients who misuse an inhaler, 90 misuse it; 66 do not take their prescription as advised (skipping doses, etc.). Misuse of inhalers accounts for around $5-$7 billion of the nearly $25 billion spent on inhalers each year.

The BreatheSuite System—comprised of a disposable, battery-powered, portable BreatheSuite MDI add-on device and a mobile application focused on behavior change methods—is intended to be used with an MDI and is attached to the top of the canister of the patient’s inhaler. The gadget and mobile app work in tandem to analyze and “score” an individual’s inhaler technique and usage habits, storing findings in the cloud so the individual may track and improve their inhaler use. With the individual’s approval, this information can also be monitored remotely by the healthcare team to promote personalized care plans. BreatheSuite aims to improve the quality of care and health outcomes related to these illnesses by promoting more effective inhaler use and remote patient monitoring (RPM). Medical expenditures for chronic COPD are expected to exceed $49 billion by 2020, while the yearly economic cost of asthma was more than $81.9 billion between 2008 and 2013—with medical costs accounting for $50.3 billion of that total.

“By having a real-time way to digitally monitor and provide feedback to patients, we hope to enhance healthcare outcomes,” says 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 obstruct regular MDI use and can be easily removed and reattached to a new inhaler. The device is compatible with around 90 percent of available MDIs, including those made by GlaxoSmithKline (GSK), Teva, and Prasco.

Along with FDA authorization, a first for a firm located in Newfoundland and Labrador, the BreatheSuite device has been cleared for sale in Canada.