FDA approves app-connected lung-function monitor

Missouri-based Sparo Labs has received FDA "over-the-counter" approval for its app-connected spirometer, Wing. The device plugs into a smartphone and, via an app, allows people with respiratory conditions such as asthma to track their lung function. The results are then given using a traffic-light system. Sparo currently has no agreements with healthcare providers or pharmaceutical companies and is targeting patients as its primary audience in the short term.

Wing, an app-connected spirometer from St. Louis, Missouri-based Sparo Labs, is ready to take flight. The FDA recently cleared the device with an over-the-counter clearance, meaning the company can market it directly to consumers, but Sparo sees provider and pharma channels as important ones too.

With Wing, Sparo aims to help people manage asthma and other respiratory conditions, such as COPD and cystic fibrosis, with a pocket-size sensor and corresponding app to track lung function.



The device works by hooking the sensor up to a smartphone, then measuring the fastest speed and maximum volume a person can exhale in one second (forced exhalation and peak flow volume). The results are displayed on the smartphone screen with a “stoplight zone” system, giving a green, yellow or red indicator and an explanation of how the lungs are faring in that moment. Rather than waiting until an asthma attack to adjust medication or avoid particular triggers, patients will ideally learn how to anticipate an attack before it happens.



“Today, most patients just have to wait until they literally cannot breathe,” said Abigail Cohen, who is co-founder of Sparo with fellow Washington University alum Andrew Brimer. “They’re reacting to that, grabbing their rescue medication, taking some of that, hoping it works and going to the emergency room if it doesn’t.”



The idea is, by gathering enough daily information on when lungs are declining, patients can act accordingly with medication or environmental adjustments (for instance, limiting time outdoors during peak allergy season) to prevent asthma attacks.



“One of the benefits of using a smartphone as a platform is you get metadata, like location, to provide more information and value to the user,” said Cohen. “Asthma is a complex condition that affects everyone a little differently. For some, a trigger may be humidity and heat, for others, it may be exercise and cold air. So people able to track your lung function and symptoms over time and pull in environmental factors, you can start correlating those things and adjusting the NIH-recommended asthma action plan from there.”

Patients are the primary Wing target audience for the next few months, as Sparo currently has no formal partnerships with healthcare providers or pharmaceutical companies.

The pair began working on the device while they were still undergraduate engineering students, initially finding a focus on asthma through the program Engineers Without Borders. About one in 10 people in the US has asthma, but Cohen and Brimer learned there was a dearth of tools available for patients to manage their disease on a daily basis.



“For us, it really started with focusing on the person who had asthma themselves and seeing what they needed,” said Brimer. “How can we make the patient’s life easier and give them the data and the tools they need to better care for their asthma, rather than just providing a tool for a doctor to help diagnose or monitor that?”



When they sought FDA clearance, Sparo compiled over 1,200 pages of research and documentation related to the design and testing of Wing. This diligence included full performance testing, biocompatibility testing, electrical safety testing, electromagnetic compatibility testing, software verification testing, and mechanical aging testing, among product documentation.



Wing isn’t necessarily just for people with respiratory conditions. Athletes or even people who play wind instruments could use it to monitor their lung health. Marketing Wing solely as a fitness device could have spared Sparo the intensity of the FDA process, but they decided they wanted to build a tool that could be used for medical purposes by providing actionable data that would lead to better care long-term.



“We didn’t want to be something that people just wondered whether or not it would come to fruition, but rather, something on the medical side that could become a necessity,” said Brimer.



Today, their total funding caps at around $2.2 million, and most of their funding over the years has come from academic-style financing. While participating in a program called Engineers Without Borders, Cohen and Brimer secured funding from grant competitions such as Arch Grants, a seed round from angel investors, and a $50,000 Indiegogo campaign. Last year the startup presented Wing at a White House Demo Day.



Over the next few months, Cohen and Brimer will commercially launch Wing for patients as they look for potential pharma and provider partners.



“The biggest thing we want in the communication of data is making sure that it’s used,” said Cohen. “The big step is figuring out how it works into a physician’s current workflow and seeing how it can fit into their process.”

Many of the companies attacking the asthma and COPD spaces are using connected inhalers, rather than connected spirometers, though some companies, such as Cohero, offer both. A polish company, HealthUp, received $1.1 million in funding last year for its MySpiroo platform.