Respiratory Therapy Magazine recently sat down with Nick Delmonico, CEO of Strados Labs, to discuss the RESP® Biosensor, an innovative wearable device designed to continuously capture lung sounds such as coughs, wheeze, and crackles. In this Q&A, Delmonico shares insights into the inspiration for the technology and the benefits of using a wearable device to remotely monitor respiratory patients.
Please tell us about your technology. What is the RESP® Biosensor?
The RESP® Biosensor is a first-of-its-kind wearable device we developed at Strados Labs to help respiratory therapists and clinicians better monitor patients with chronic respiratory diseases such as COPD and asthma.
The device, which is FDA 510(k) cleared, continuously captures lung sounds including cough, wheeze, and crackles similar to a digital stethoscope—lung sound data then gets transferred to the cloud where clinicians can observe the frequency of adventitious events (e.g. cough, wheeze) and understand how patients are doing remotely. It is often described as a Holter monitor for the lungs.
The goal of the technology is to allow clinicians to receive objective reports of patients’ lung events when they’re home (away from the clinician), offering greater diagnostic information and allowing for earlier insight into exacerbations.
What was the inspiration for developing this technology?
There were a few inspirations for developing this technology. I originally had the idea for our device based on my experience as an asthma patient not feeling adequately checked on and monitored after being discharged from the hospital. While I was asked by clinicians to watch and report on my symptoms, it was difficult for me to keep track and remember (especially as a kid). I learned that I was not alone in this, with most patients reporting that they have difficulty remembering their symptoms or identifying an acute event. This helps to explain the high re-admission rates for COPD and pediatric asthma. It seemed like there was a need to more effectively monitor at-risk pulmonary patients the way we do with cardiac patients.
Another inspiration for the technology was the limitations of auscultation with a stethoscope. While auscultation is considered to be one of the gold standards for diagnosing lung health, it is episodic, limited to in-person visits, and typically lasts only minutes. It is also prone to inter-observer variability; some clinicians may hear a wheeze while others might not. With the advent of wearables and also the pandemic, we saw an opportunity to extend the gold standard to patients remotely, offering clinicians greater and more objective insight into patient lung health while reducing the frequency that patients have to visit their clinician.
What benefits does this device offer clinicians and patients?
We designed the RESP Biosensor to improve care and outcomes for patients while also helping to increase clinician efficiency and effectiveness. The device combines lung sound events with other vitals like heart rate, respiratory rate, and activity levels (not yet FDA-cleared).
For patients, the device offers a way to feel safer and more secure especially after an acute event, with our studies so far showing promise that the device may help patients avoid a readmission that is both costly and unpleasant. It offers the convenience of being monitored or assessed in the comfort of patients’ homes rather than having to come into the office for a visit. This was especially important during the pandemic and is also helpful for patients who have issues with transportation, live in rural areas, or lack general mobility.
Additionally, it eliminates the burden of having to self-document, remember, and report symptoms back to clinicians. As for the clinician, it allows for the convenience of receiving reliable data, which can help create a more optimal treatment plan and decrease the number of appointments needed. Follow-up care can be done in an office or virtually.
The device allows for 24/7 monitoring of the patient’s day-to-day activities, enabling clinicians to detect if there are common factors to symptom onset. Often with asthmatic or pulmonary compromised patients, one will see that many triggers can affect a patient. Exercise can induce asthma symptoms; their environment can cause a flare-up or patients can experience nocturnal wheezing which may affect their quality of sleep. By pinpointing the trigger for the symptoms, the clinician can set up a treatment plan that is more suitable for the patient’s lifestyle.
How do you see the device being used in patient care?
While we hear new requests and applications from clinicians for the RESP Biosensor almost every day, we see the device mostly being used to help clinicians and patients better control and manage COPD and asthma from home and in inpatient settings.
As mentioned earlier, COPD is extremely difficult for clinicians and patients to manage, with 30-day readmissions often exceeding 20%. Similarly, pediatric asthma is also difficult to control and one of the most common reasons for pediatric ER visits in the US. Because of the urgent need for clinicians to prevent readmissions in both of these diseases and the burden placed on health systems, we see the device being used primarily to monitor at-risk patients in inpatient acute care, transitional care settings, outpatient settings, and at-home post-acute discharge.
Some additional use cases we see for the RESP Biosensor that we’re excited about include being used in pulmonary rehabilitation to reduce the need for patients to come to hospitals or clinics, in hospital-at-home programs, and in rural areas where patients often live hours from clinics.
What challenges have you faced in clinicians and RTs adopting the device?
One of the biggest challenges we’ve faced that has prevented clinicians from adopting the device right away is proving that our technology can accurately detect and measure changes in lung sound events including wheezing, crackles, and cough.
Fortunately, in the past few years, we have successfully proven the device is accurate through not only our 510(k) clearances but also through our scientific and clinical research efforts. In these studies, we have collected over thirty million breaths and five hundred thousand cough and lung sound events, which has allowed us to train our machine learning algorithms based on respiratory therapist and physician assessments of the sound files.
Another reality in healthcare is reimbursement and cost, which has been a barrier for widespread adoption despite the excitement we hear from clinicians. Currently we are relying on remote monitoring codes (RPM and RTM) for reimbursement, but we’re working towards achieving different pathways that can offer much greater reimbursement, making it more feasible for most patients and clinicians to use.
How do you see the RESP® technology offering an advantage over standard of care such as pulse oximetry and pulmonary function tests?
We see our technology as providing unique value and insight into patients’ lung health not offered by episodic pulmonary function tests (PFTs) and pulse oximetry. First, PFTs are typically not used to predict exacerbations like we anticipate our device will be able to do and are used more for diagnostic purposes. PFTs are a valuable diagnostic tool, but we think our device can offer clinicians additional diagnostic insight by measuring symptoms such as coughing, wheezing, and crackles, which directly impact patient’s quality of life and may be associated with disease severity.
Pulse oximetry has traditionally been used to predict exacerbations, similar to how we see our device being primarily used. However, drops in O2 saturation often occur once exacerbations are already moderate, and we see our device potentially offering clinicians a warning earlier than that. Pulse oximeters are also traditionally used during in-patient visits and less as a ‘continuous monitor’ in patients’ homes like our device was designed to do.
What results have you seen so far with patients wearing the device?
In our clinical trials with over six healthcare systems, we have seen some very promising initial results. As a patient myself, I’m personally thrilled by the amazing feedback we’ve received from patients, saying that they forget that it’s there and feel safer with the device on. We have demonstrated strong accuracy in the device detecting lung sound events compared to gold standards such as the Littman 3200 digital stethoscope, while also capturing significantly more events than episodic auscultation.
Most importantly, we have seen several cases where a spike in lung sound events (cough, wheeze, and crackles) precedes a patient’s readmission or exacerbation. Because our studies so far have been observational only, clinicians were unfortunately not allowed to act on the warnings or alerts, which may have led to better outcomes.
Where has the technology been used?
Our technology has been used in several patient populations including COPD, asthma, infectious disease, and heart failure as part of clinical trials to demonstrate the utility of our device.
Some of the hospitals and healthcare systems where these trials have taken place have included Einstein Health Network in Philadelphia, Mission Hospital, which is part of HCA Health System, Metropolitan Hospital which is part of NYC Health + Hospitals, and most recently Lurie Children’s in Chicago as part of a pediatric asthma validation study.
In addition to healthcare settings, we have found that drug developers have a strong need to collect objective data on lung sounds and have used our device in phase I-IV clinical trials to demonstrate treatment efficacy. The RESP Biosensor has been used in large pharmaceutical clinical trials in three continents and thirty languages.
What’s next for Strados Labs?
The next step that we’re currently focused on is starting a new COPD interventional study with the RESP Biosensor. As mentioned earlier, the device has so far only been used in non-interventional studies with COPD patients—this will be the first time where clinicians will be able to intervene based on data provided by our device which is a very big step.
We will be specifically measuring the device’s ability to improve outcomes compared to standard of care such as pulse oximetry. The results from the study will also help position us to receive broader insurance coverage, making it more available to patients and clinicians.
As I also mentioned, we recently finished a clinical trial with Lurie Children’s as part of a pediatric asthma validation study of our device. Results from this study will help us receive FDA 510(k) clearance for use in children (the device is currently only cleared for adult use). Because there’s such an urgent need for new solutions in pediatric asthma and my own experiences when I was younger, this is something I’m especially excited about.
Nick Delmonico is the CEO and Co-Founder of Strados Labs, a digital health company focused on improving respiratory care through leading remote patient monitoring technology. Nick is an asthma patient who developed the company’s technology based on his own healthcare experiences.