Strados Labs RESP

Strados Labs has developed a Remote Electronic Stethoscope Platform (RESP) to address a critical need for high-quality respiratory monitoring inside and outside the hospital. The small wearable device is adhered to the patient's chest or back and can passively auscultate the lungs to acquire sounds of interest. The device is bluetooth enabled and the duration and frequency of data collection can be controlled using a mobile phone. The data can be immediately played back on a mobile phone and sent for storage to a secure cloud database. Strados Labs has also created accompanying machine learning algorithms to automatically classify lung sounds of interest such as coughs, wheezes, and markers of shortness of breath. This platform can be used to remotely monitor COVID-19 patients at home or in telecritical care units in the hospital to minimize healthcare worker exposure and to obtain an objective diary of pre-symptomatic and symptomatic respiratory signs.

The COVID-19 pandemic has illuminated an urgent need for remote respiratory monitoring technologies to evaluate patients in a variety of settings and to reduce healthcare worker exposure. Patients at risk for COVID-19 exposure may develop pre-symptomatic respiratory signs such as subtle increased work of breathing and increased cough frequency without being aware of disease development. A remote respiratory monitoring technology could quantify these changes and provide an objective diary to track potential COVID-19 development and progression of disease. Additionally, once patients are in the hospital, such a technology could also be used to continuously monitor a patient's respiratory status to guide management and limit healthcare worker exposure by reducing frequent bedside auscultation. There is currently a lack of understanding of the markers of COVID-19 disease progression, and a respiratory monitoring technology could help us to better determine the ideal timepoints for lifesaving and disease-alleviating interventions. Treatments such as convalescent plasma, cytokine inhibitors, and antiviral agents will function better if given early in the disease course, but an ideal time has not yet been determined. The RESP technology could therefore provide the capability to monitor adventitious lung sounds and markers of shortness of breath in COVID-19 clinical studies and trials.

Strados Labs has developed the Remote Electronic Stethoscope Platform (RESP) which consists of a small wearable device and accompanying software analytics platform. The wearable device consists of microphones and motion sensors that allow the hands-free acquisition of real-time, continuous lung sounds and chest wall motion. The device is controlled by a mobile phone through bluetooth connection, which allows the immediate playback of sounds and waveforms as well as user control over the length and frequency of data collection. The data is then sent to a secure cloud database for further analysis. Strados machine learning algorithms can identify lung sounds such as wheezes and coughs as well as respiratory rate and patterns to provide graphical trends in patients' physiological data over time. These trends can provide detailed information on a patient's respiratory status to help guide clinical management and decision-making both inside and outside traditional hospital and clinical settings.

The current target population for the technology are patients at risk for COVID-19 exposure including those with underlying cardiopulmonary disease, those who have COVID-19 positive contacts, and those hospitalized with COVID-19. Strados Labs has clinical contacts in inpatient and outpatient settings including in NY, PA, DE, VA, TN, and TX. We are in the process of sending test devices to have these contacts provide feedback on the platform and to troubleshoot the integration process with their own hospital and clinic systems. We have conducted preliminary studies of the device to test and acquire lung sound data for analysis in clinical settings. These studies were the basis of an FDA 510k application submitted back in April. The platform will also be targeted for use in patients with cardiopulmonary diseases such as heart failure, asthma, and COPD. We also collect feedback from patients and direct users of the device in addition to clinicians to better understand usability and feasibility of the platform from multiple perspectives.

The RESP technology directly responds to the challenge by providing a solution for prevention and rapid response to ongoing and emergent pandemics, such as COVID-19. The proposed platform has the ability to track and trend respiratory signs before patients become symptomatic and provides an avenue to isolate these individuals before infection spread. It allows improved telehealth offerings for clinicians to better take care of patients inside and outside the hospital, and provides crucial data that may otherwise be unattainable. This allows for both enhanced coordination of care as well as reduced exposure to contagious pathogens to vital front-line healthcare workers.

8 full-time employees, 3 part-time employees, 4 consultants

The RESP technology employs the use of powerful machine learning algorithms to improve our understanding of respiratory physiology and disease. We aim to eventually create a predictive analytics platform that can triage patients based on disease severity as well as to identify danger markers of eventual decompensation and respiratory system compromise. This goal will revolutionize the way we approach and treat respiratory disease with the potential to completely transform the field of pulmonology.

The RESP technology broadly impacts those with respiratory disease which is a significant cause of morbidity and mortality world-wide. It also addresses emerging respiratory pandemics which have impacted humanity on a global scale (ie: COVID-19). This innovative solution has the ability to truly impact and progress healthcare on a global scale, allowing for greater connectivity and greater health.