For decades, the standard way to monitor the heart of a patient at home was the Holter monitor, a bulky yet portable device that records electrical signals. Heart monitoring has advanced with smaller, wearable devices that offer more features than the Holter, but capturing lung sounds hasn’t gone much further than the stethoscope.
Nick Delmonico, founder and CEO of Strados Labs, knows the gap in lung monitoring firsthand. When he was a child he had asthma, and he recalls having no way to track or measure the changes in his breathing, nor the ability to easily convey those changes to a physician. Those experiences were part of his motivation for launching Strados, a startup that has developed a wearable device that tracks breath sounds throughout the day (and night). Pulmonologists have told him the device is like a Holter monitor for the lungs.
“It’s just like a stethoscope, but imagine the same data you would get from a stethoscope without having to put the stethoscope on the patient,” Delmonico said.
In five years, Philadelphia-based Strados has gone from an idea to a commercialized product. The company was one of the startups that presented in the Pitch Perfect competition during MedCity News’ recent INVEST Digital Health Conference. It was judged the winner in the “Chronic Disease Management and Value-Based Care” category.
“Nick did an excellent job describing where the product is today and his vision for transforming pulmonary health,” said Margaret Malone, senior associate at Flare Capital Partners and one of the judges for the category. “The data collected by the Strados device has the potential to further patient care and influence drug discovery while helping to reduce costs and improve outcomes for people suffering from pulmonary and respiratory conditions.”
The oval-shaped Strados device, called Remote Electronic Stethoscope Platform (RESP), is thinner than a smartphone. It houses a sensor that monitors the breathing of the patient. RESP is affixed to the patient’s chest with an adhesive patch. After putting it on, no further patient action is required. RESP listens to chest sounds and takes 30 second recordings every 15 minutes.
RESP employs noise-cancelling algorithms and filters to dampen speech and focus on the internal sounds of the lungs. The system includes a mobile app downloaded to the user’s smartphone; recorded data are sent to the phone via Bluetooth. Those data are uploaded securely to the cloud, where a physician can log in to review the recordings. Delmonico said the device can be used by patients who have any respiratory condition that causes coughing, wheezing, or shortness of breath.
Strados has raised slightly more than $6 million in its five year history. The company is now closing a $3.2 million Series A round of funding. That’s not a big amount, but the company has been generating revenue for some time. Application of the technology includes Covid-19. Strados already has partnerships with pharmaceutical companies that are using RESP as a way to monitor patients in clinical trials testing experimental Covid therapies. Delmonico said the device fits into the growing adoption of technologies that enable decentralized clinical trials, in which patients participate in drug studies from their homes rather than having to visit a clinical site.
“Resoundingly we hear, not just from one customer, but dozens, they want this,” he said. “Covid only made that accelerate faster but it’s something we’ve been looking at for a couple of years now.”
Strados is expanding RESP’s use beyond research settings. Late last year, the FDA granted RESP 510(k) clearance. Delmonico said RESP provides the same signal quality as an electronic stethoscope, which was used as the reference device in the company’s regulatory submission. The clearance covers use of RESP in all healthcare settings, including hospital-at-home uses. For in-home monitoring, in which the device would be shipped directly to the patient, Strados will need another regulatory clearance.
Electronic stethoscopes provide the capability to record breath sounds, but those medical devices stay with a physician. Delmonico said RESP’s advantage is the ability for the patient to return home and be monitored for an extended period of time. In addition to pharma companies, Strados’s customers include health systems.
Strados has a database of more than 150,000 different breath sounds. The company aims build that database to 1 million breath sounds in the next six months, making it the largest database of its kind. Delmonico said Strados will use that database to “pressure test” RESP in real-world settings, such as noisy hospital emergency rooms and intensive care units, outpatient clinics, and homes. The company also plans to publish data on the robustness of its algorithms.
RESP is covered by insurance, falling under telehealth reimbursement, Delmonico said. If the company can expand the claims for the device to include remote monitoring, the device would fall under those codes as well. That’s one of the next goals for Strados.
“The future for us is remote care,” Delmonico said. “This is going to go home with the patient.”
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