Santa Ana, California-based startup Cognita Labs has won FDA clearance for its first device, a smart cap for inhalers used by people with asthma, chronic obstructive pulmonary disease and other respiratory disorders.
The device, called CapMedic, sits on top of the inhaler and houses sensors that guide users and collect data for remote patient monitoring.
“The sensors are measuring everything the patient is doing,” Gaurav Patel, Cognita Labs’ co-founder and chief technology officer, said in a phone interview.
As Cognita Labs moves forward, it faces some large competitors. Chief among them is Propeller Health, which makes smart inhalers and was acquired by San Diego-based medical device maker ResMed. Others include New York-based Cohero Health and New Zealand-based Adherium, which began selling smart inhalers in the U.S. in 2018.
The market, however, is growing fast. It is expected to hit $152.9 million in sales worldwide by 2023, up from $23.8 million in 2017, according to research firm KD Market Insights. Another firm, Global Markets Insights, sees the smart inhaler market reaching $260 million in revenue by 2025.
Despite competing devices, there are notable differences, Patel argued. While other devices track patient usage and other data, CapMedic is the first one designed to communicate directly to patients and help them use inhalers more effectively, he asserted.
The reusable and rechargeable caps emit visual, audio and haptic signals that let users know when an inhaler has been adequately shaken and is fully upright, among other parameters that ensure a full dose of medication. It costs $99, fits most inhalers on the market and pairs with a smartphone app that can send data back to a clinician, Patel said. It is available only by prescription.
The company cites studies that show up to 90% of patients use inhalers incorrectly, reducing the amount of medication that reaches their lungs.
“The Cognita team has conducted drug deposition studies that have seen a tenfold improvement in the delivery of medication from just 4-5% to 45% when inhalers are used correctly,” Rajoshi Biswas, chief scientific officer and co-founder at Cognita Labs, said in a statement.
A smart device could prove helpful, said Dr. Marilyn Li, co-director of the Los Angeles Breathmobile, a mobile asthma clinic, in a phone interview. CapMedic could be particularly good for children and the tech-savvy, she added.
But she did not think smart devices would be able to replace face-to-face education by providers.
“If people are engaged and they’re listening and they try, they can do quite well,” said Li, who is also an associate clinical professor of pediatrics in the allergy division of the University of Southern California’s Keck School of Medicine.
While no device will replace face-to-face interaction, Patel said, CapMedic and other technologies can fill the gaps. Patients, for example, may forget the instructions they are given and they may not be retrained. Cognita Labs offers a free CapMedic trainer for use in clinics. It comes with an automated workflow to help busy staff train patients on every visit, Patel said.
Cognita Labs was founded in 2013 and builds on research done by Patel, Biswas and Ashutosh Sabharwal at Rice University in Texas. It took two years to get FDA clearance for CapMedic, largely because it impacts the way people take their medication, Patel said.
“This is not just a passive device,” he said. “We are actively guiding patients on inhaler use.”
The device also incorporates a spirometer, which measures air capacity of the lungs. It connects via Bluetooth to a smartphone app, which can help patients manage their conditions but also can send data to clinicians for remote monitoring.
A six-month subscription to the app is included in CapMedic’s $99 price, Patel said. A six-month renewal costs $49, he added. But there also are plans available for providers or insurers that want to pay for the remote monitoring features.
The device has been pilot tested at Texas Children’s Hospital and Ben Taub Hospital, both in Houston, Patel said. It is currently being tested at Ventura County Medical Center, north of Los Angeles. The tests are demonstrating whether the use of CapMedic leads to improved inhaler use. Results should be public by mid to late February, Patel said.
In the meantime, Cognita Labs is working on a second device, called PulmoScan. The device, which is under FDA review, is designed to make accurate pulmonary testing faster and easier for patients such as young children and the elderly who may struggle with existing devices.
Photo: Michael Burrell, Getty Images and Cognita Labs
