Devices & Diagnostics, Startups

Sparo Labs gets FDA clearance for OTC device to help asthma patients track lung function

The co-founders have adopted a direct to consumer model but see interest from insurers, self-insured employers and clinical researchers.

Wing photo from Sparo LabsFrom their modest start as Washington University seniors interested in applying biomedical engineering to developing countries, Sparo Labs Co-founders Andrew Brimer and Abigail Cohen have brought their startup to a crucial stage in its development. Its Wing device and companion app received 510(k) clearance from the U.S. Food and Drug Administration to market in the U.S. an over-the-counter tool to help asthma patients measure daily lung function, according to a company statement.

Sparo Labs seeks to advance connected health for people with respiratory problems in addition to asthma beyond tracking medication adherence.

In a phone interview with Brimer and Cohen, Brimer, said they had seen interest in the connected inhaler space since its technology can show not only whether patients took their meds, but the impact of those meds on their lungs and the ability to share that data with physicians.

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“There’s a lot of fear and uncertainty with asthma,” Brimer said. “For us, it is about addressing those fears by putting power in patients’ hands.”

The device measures two metrics: Peak flow, or the fastest users can inhale, and FEV1: The amount of forced respiratory volume in 1 second: intended to measure the amount of constriction in the lungs. “These two metrics help measure the level of inflammation,” Brimer said.

A dominant trend in connected health has been for technology developers to connect inhalers used to deliver medication for asthma and COPD patients so that they can transmit data to physicians and patients to track medication adherence. Companies such as Propeller Health have attracted partnerships from pharmaceutical companies such as GlaxoSmithKline and Boehringer Ingelheim along with drug delivery company businesses like Aptar Pharma.

“Asthma reflects a constellation of symptoms,” said Cohen “It can be triggered by different things and affects people differently.

Beyond the direct to consumer market it sees applications such as remote monitoring by physicians, clinical research by specialists for asthma and other respiratory conditions such as COPD and cystic fibrosis. “We have been working very closely with CF patients, Brimer said. “One key thing is they are at risk for developing significant respiratory infections and losing lung function for good. This product could be life saving,” by spotting early warning signs of deteriorating lung function.

It’s also having conversations with insurers, self-insured employers and pharmacy benefit managers.

The company was built on grant money and funding from family offices in St. Louis and angel investors in that region along with Michigan and New York.

Although they declined to disclose the price tag, Brimer and Cohen did say they expect the device to be available to consumers this fall.

Cohen and Brimer shared a mutual interest in engineering through the Washington University chapter for Engineers Without Borders. The business is based out of the St. Louis incubator, T-Rex.

Photo: Sparo Labs