Respira Labs, a medtech company based in California, created the Sylvee sensor, an adhesive patch that the user wears on their lower rib cage, and which monitors respiratory health. The device works through acoustic resonance, whereby it emits sound into the chest cavity and analyzes the echoed vibrations.
The measured data provide information on lung air volume and correlate with the amount of air that is trapped in the lungs, which can offer a warning sign that a respiratory exacerbation is possible. With many COVID-19 patients experiencing impaired breathing for sustained periods after their initial infection has subsided, this type of technology could be very useful in monitoring respiratory health.
Medgadget had the opportunity to speak with Dr. Maria Artunduaga, Founder and CEO of Respira Labs, about the Sylvee sensor and how the technology is designed to be used.
Conn Hastings, Medgadget: Please give us an overview of respiratory disease and its incidence and consequences during the COVID-19 pandemic and beyond.
Maria Artunduaga, Respira Labs: Americans suffer an incredible burden with respiratory diseases. COPD (or Chronic Obstructive Pulmonary Disease) is the third leading cause of U.S. deaths, affecting 30 million Americans today and killing more than 150,000 people a year in the U.S., with a cost of $49 billion annually. Asthma affects 26 million Americans at an annual cost of more than $80 billion per year. Enter COVID-19, where an average single hospitalization costs $20,000. Infection from COVID-19 can also inflict long-term damage on lung function.
Up to 43% of hospitalized COVID-19 patients report persistent dyspnea (breathlessness) up to six months after discharge, and a substantial proportion of them continue to suffer from respiratory symptoms for much longer. As of today, up to 30% of COVID-19 survivors report long-term respiratory symptoms — about 11.5 million people to date in the U.S.
It’s clear from these statistics that left unchecked or untreated, respiratory symptoms can lead to permanent lung damage and progressive deterioration of lung function.
Medgadget: How are such patients currently monitored? Are existing techniques for monitoring effective at highlighting respiratory exacerbations?
Maria Artunduaga: Patients today are often monitored through PFTs (pulmonary function tests) performed in a specialist’s office, as well as other assessment tools and questionnaires that patients can use to monitor themselves.
There are many drawbacks. PFTs for example are difficult for the patient–requiring repetitive, forceful blowing or holding their breath–and can take as long as two hours to complete. Various accoutrements of the test, such as wearing a nose clip and sitting in a confined, air-sealed space can also cause patients discomfort.
Other lung assessment tools used by physicians include costly hospital-based machines including plethysmography ($60,000 per machine) and CT scans ($2 million for a new machine), or stethoscopes with a reported accuracy of 20 to 40 percent to detect respiratory diseases.
When it comes to self-monitoring, the simple in-home pulse oximetry is in fact not a suitable option as it only measures blood oxygen, which is informative but not conclusive. Although it’s true that FDA-cleared pulseox must have very good accuracy, many patients buy cheaper off-the-shelf devices making the numbers hard to trust. More importantly, the actual FDA indication is to measure O while still. The device accuracy is measured when people don’t move, but once you do, the noise to signal ratio changes dramatically and the numbers aren’t as good anymore.
As a result, today physicians have no options for real-time monitoring of the patient’s condition. They often revert to questionnaires to diagnose respiratory exacerbations, which miss up to 50% of the crises, driving hospitalizations and mortality up. In short, there’s not a single technology today that can diagnose exacerbations in real time with clinical-grade accuracy and that can demonstrate statistically significant results in a large population.
Medgadget: What consequences can respiratory exacerbations have for patients? Why is early diagnosis important?
Maria Artunduaga: Exacerbations (or flare ups) of COPD and other respiratory conditions can be deadly. An exacerbation is often caused by something the patient may be initially unaware of (such as an infection in the airways) which leads to swelling, mucus buildup, and inflammation, partially obstructing the airway. Symptoms of exacerbations include trouble sleeping, fatigue, headaches, and confusion, with high carbon dioxide and low oxygen levels.
Inhalers, steroids, and antibiotics can help initially, and medical providers agree that getting help early is essential. When an exacerbation becomes severe, hospitalization is needed. Recovery from an exacerbation can be long, and patients may never fully recover the abilities they had before the exacerbation took place. Also, patients who’ve had an exacerbation in the past are more likely to have one in the future; in fact 20% of people hospitalized for an exacerbation return to the hospital within the next month.
We now know that a large percentage of COVID-19 patients experience respiratory symptoms before and after their diagnosis. Moreover, patients hospitalized for COVID-19 are at six-fold higher risk of subsequently developing a new respiratory disease for which they must be re-hospitalized.
Conversely, people with pre-existing respiratory illnesses (such as COPD and asthma) are now at higher-than-average risk to exacerbate and receive inadequate treatment because the pandemic has forced hospitals to prioritize COVID-19 patients. As a result, the COVID-19 pandemic has increased the urgency for an inexpensive, reliable solution for large-scale remote lung-function monitoring.
Remote long-term monitoring will be key to (1) support the recovery of COVID-19 survivors, (2) alert those with chronic lung diseases to sudden deterioration (3) enable early intervention for both populations, and (4) assess the effect of therapeutic interventions.
From an epidemiological standpoint, such monitoring will also be crucial to predict, detect, prevent, or treat emerging infectious respiratory diseases and facilitate long-term public health planning.
From a scientific standpoint, patient monitoring will also provide insights into the basic biology of COVID-19 and the development of new therapeutics.
Medgadget: Please give us an overview of the Sylvee sensor and how it works.
Maria Artunduaga: Sylvee is an adhesive lung sensor worn on a patient’s lower ribcage. It uses speakers and microphones embedded in a wearable patch to measure changes in acoustic resonance as a proxy for changes in lung air volume, the basis of pulmonary function testing.
Air trapping is a central and early symptom of respiratory decline. From its position over the lungs, Sylvee actually ‘injects’ noise into the lung area and then measures the type of sound that is produced. Like a thump on a drum, if there is air trapped in the lung, the sound it makes differs from the resonance of sound produced when air is fully expelled from the lungs.
Coupled with an app, digital signal processing (DSP) and AI, the Sylvee delivers results that can be reviewed by pulmonologists.
Medgadget: What inspired you to develop this respiratory sensor?
Maria Artunduaga: My grandmother, Sylvia, suffered from COPD and had an exacerbation of her symptoms. She wasn’t very good at identifying that she was getting worse.
I come from a family of physicians, and we were living six hours away from her. Despite calling her daily, we couldn’t make the diagnosis on time, and when she got worse it was too late.
She had to be admitted to the ICU, and two weeks later died from complications, driven by invasive ventilation and the fact that because of her advanced age, she got infected in the hospital.
I left my medical career and devoted myself to devise Sylvee–which is named after my grandmother–so that no one else has to go through the same.
Medgadget: What parameters can the sensor measure, and how do these relate to respiratory health and clinical decisions?
Maria Artunduaga: Pulmonologists and primary care physicians base their diagnosis and management of respiratory conditions on lung volume, capacity, rates of flow and trapped air measured by plethysmography and CT scanning combined with patient information, symptoms and past medical history.
With Sylvee, we are currently completing clinical validation of our acoustic resonance signatures against the clinical standard. Research has demonstrated that expert panels could reach 77% accuracy when making a diagnosis based on pulmonary function testing (PFTs) and clinical history alone. This presents an opportunity for artificial intelligence, which could help decrease the time to final diagnosis, reduce the number of tests needed and decrease the number of false negatives in respiratory healthcare.
Medgadget: What are the next steps for the technology in its path to clinical adoption?
Maria Artunduaga: We know the road for clinical adoption of new technologies encompasses many challenges, but having identified a clear unmet need makes it easier for us to move forward. The goal for clinical adoption is to make Sylvee a standard monitoring technology for patients with lung distress, in the U.S. and abroad, preventing as many exacerbations as we can.
Our Team
I have been able to put together a team of 17 and forged three clinical research partnerships here and abroad. Doctors (including pulmonologists) have invested in the company and are actively helping us improve our solution. Patients are helping us too.
Financial Support
We have support from NSF and NIH, as well as Letters of Support valued at $25M in potential revenue from medical technology companies, remote monitoring/telehealth companies, pharma and providers. We’re also in conversation with a government agency to work on a pandemic response product.
Clinical Trials
Sylvee is currently in a prototype stage suitable for human testing, soon ready to be deployed in remote trials with more than 100 research subjects. Respira Labs has set a goal of achieving 90% accuracy in measuring air trapping by pursuing a large trial of more than 500 patients located both in the U.S. and internationally by the end of 2022.
FDA Clearance
We plan to get FDA clearance (expected within the next 18 months,) and produce strong clinical evidence to drive clinical adoption. We have already started conversations with the FDA and plan to submit for a Breakthrough Device Designation in 2022 which will allow us to accelerate our regulatory path and eventually allow us to get a new CPT code 3 for the predictive algorithms in three years. Luckily, there are Remote Patient Monitoring (RPM) codes (Medicare) that account for the hardware, remote data transmission and access to our analytics platform.
Market Launch
We anticipate early revenue in 2023 either through a standard 510(k) clearance for the device that would be sold to telemedicine and remote monitoring companies, or from pharma, medical technology companies or CROs that are conducting clinical trials with respiratory patients.
As a physician, I know patients and doctors are eager for a solution like ours; it’s just a matter of time, patience and funding to get to where we need to be.
Link: Respira Labs homepage…