Patients with cystic fibrosis - many of whom are at high risk for other conditions including COVID-19 - can breathe easier, thanks to a Small Business Innovation Research grant from the National Heart, Lung and Blood Institute that enabled a healthcare start-up to repurpose an existing technology as an at-home diagnostic tool for measuring lung function.
Last year as the COVID-19 pandemic began to intensify, many patients with cystic fibrosis faced a difficult challenge. Because the disease damages the lungs and makes it hard to breathe, these patients needed in-hospital tests to measure how well their lungs were working. But many also were on drugs that reduce the strength of the immune system and leave them vulnerable to respiratory infections. That made venturing out of the house to visit a clinic a high-risk activity.
As patients began cancelling appointments and some medical offices closed, doctors needed a way to monitor those who could not be seen in person. And they needed to act fast.
Thomas Smith, MD, a pulmonary critical care physician at Albany Medical Center in New York, explained the problem to healthcare startup, ZEPHYRx. They were working with Smith on an NIH clinical trial involving a breath-activated video game for improving lung function in post-surgical patients. ZEPHYRx proposed that the therapeutic device be repurposed as an at-home diagnostic tool for measuring lung function remotely.
“When no one wants to come in the hospital, how do I assess my patients who have advancing lung disease?” Smith asked. “All of a sudden, telemedicine made sense.”
ZEPHYRx, the company behind the gaming device under study, quickly pivoted away from its original project to adapt its product for diagnostic testing. The company created a unique software program for at-home pulmonary function testing. In doing so, it joined a telemedicine market that has exploded nationwide during the coronavirus pandemic.
The ZEPHYRx system consists of an existing FDA-approved, handheld breathing device – about the size of a cell phone – and a newly created app called Breathe Easy (available for download). The company developed the innovative technology with funding support from the NHLBI through its Small Business Innovation Research (SBIR) Program with significant assistance from the NIH’s Concept to Clinic: Commercializing Innovation (C3i) Program.
The system functions much like a conventional spirometer, the device commonly used to measure lung function, in that it requires patients to blow into a tube to evaluate their breathing efficiency. But an office-based spirometer is relatively large and requires both the patient and technician to be present. The ZEPHYRx system is compact and allows patients to conduct pulmonary function tests at home on their own tablet or smartphone. It also has an in-app video call feature that allows the patients’ healthcare providers to communicate directly with them throughout the lung function test.
Dwight Cheu, CEO of ZEPHYRx, describes the system as a portable spirometry lab. “Our platform is able to extend a pulmonologist’s ability to treat patients wherever they are, whether they are four hours away or around the corner,” Cheu said. “We have the ability to treat people in this time of COVID and beyond COVID.” The device is easy to use, provides results in real-time, and works for a wide variety of different lung conditions, including COPD, ALS, asthma, as well as cystic fibrosis, he said. Based on the results, doctors can adjust medications and treatment accordingly.
Today, the ZEPHYRx Breathe Easy platform is used in more than 500 clinics across the country. Recently, the Cystic Fibrosis Foundation purchased a device for every patient with cystic fibrosis in the United States – at least 20,000 people. Demand for the device is expanding nationwide, Cheu said.
ZEPHYRx (operating as Jamboxx Inc.) first received an NHLBI SBIR award in 2016 for the development and testing of a breath-controlled video game for respiratory therapy. That system, which is set to resume clinical testing soon, uses the same Bluetooth spirometer and was the basis for the current Breathe Easy platform. By inhaling or exhaling, patients can activate the spirometer to play a suite of interactive games such as golf, fishing, car racing, and others. That device helps build lung muscle and improve lung function.
Since March 2020, ZEPHYRx has grown from a company of two full time employees to fifteen full-time employees. The company is in Troy, New York. Mike DiCesare, president of ZEPHYRx and the principal investigator of its clinical trials, says NHLBI SBIR funding has been critical to the company’s success.
“None of what we’ve accomplished would have been possible without getting an [SBIR] grant,” DiCesare said. “We never would have been able to expand into clinical trials, develop a product, develop software, and build the team out.”