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Clario and Strados Labs partner to bring new pulmonary endpoints to respiratory clinical trials

Clario has partnered with Strados Labs to offer its customers the RESP Biosensor System, an advanced technological innovation for the at-home capture of lung sounds. The revolutionary device enables Clario to support the capture of additional clinical respiratory endpoints such as cough and wheeze, and it does so in a patient-friendly, streamlined way.

    • High-quality information about cough can be particularly difficult to assess as patient self-reporting is highly subjective and existing solutions are burdensome for both patients and researchers.
    • The RESP Biosensor is the only FDA-cleared pulmonary wearable device for use at home that allows researchers to objectively capture a variety of lung sounds such as cough, wheeze, rhonchi and crackles.
    • The Strados RESP Biosensor is a wireless, lightweight and patient-friendly device that records pulmonary sounds for 24 hours continuously without using bulky devices. Once recorded, patient data is transferred wirelessly via a provided mobile device for review by clinicians.

PHILADELPHIA, March 21, 2023 /PRNewswire/ — Clario, a healthcare research technology company that delivers leading endpoint technology solutions for clinical trials, today announced a partnership with Strados Labs  to provide the FDA-cleared RESP Biosensor for clinical trials. This innovative, wearable device is lightweight, comfortable and non-invasive, with capabilities that have not previously existed on the market, such as allowing for objective assessment of crackles, rhonchi, and wheeze events, as well as offering a streamlined approach for at-home cough monitoring in trial participants.

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The Strados RESP Biosensor is a refreshingly modern, patient-centered solution for Clario’s customers looking at additional respiratory data endpoints. The wireless device records pulmonary sounds for 24 uninterrupted hours and has the capacity to hold up to 220 hours (about one and a half weeks) of recordings on board. With the capabilities of a digital stethoscope, this device can capture lung sounds, enabling measurement of cough frequency, cough severity, cough type (e.g., dry, productive), and other adventitious events (e.g., wheeze, rhonchi, crackles).

“Clario has helped many sponsors to obtain high quality data supporting numerous drug approvals in respiratory clinical trials, and some of our customers are increasingly looking for robust and objective cough metrics – an endpoint that Strados Labs’ RESP Biosensor addresses fantastically. The RESP Biosensor’s capabilities eliminate the need for subjective self-reporting and introduce several new respiratory endpoints enabling sponsors to now demonstrate drug efficacy from different angles, enabling greater flexibility in protocol design while reducing the burden for clinical sites and patients.” Achim Schülke, Chief Innovation Officer at Clario.

The RESP Biosensor’s design reduces the burden placed on the patient in the at-home environment. Weighing only as much as a pen and less than half an inch thick, patients can discreetly wear the device on their chest under their clothes and carry on with their day as they ordinarily would. The device is wireless and rechargeable, so there is no need for messy cables or battery replacements.

After 24 hours of continuous recording, the patient docks the RESP Biosensor on the charger, and while it charges, the recorded audio is transferred to the Strados Clinician Portal for review via the Clario-supplied mobile device. This efficient data collection not only eliminates the need for patients to return to sites in person, but also allows clinicians to see patient data much sooner and make faster decisions, whether for patient screening or to support subjects in a study.

“Our goal is to provide clinical trials with much stronger respiratory data, allowing researchers to access lung sounds to determine when patients are coughing or wheezing, differentiate between cough type, and understand how symptoms progress over time in relation to medication use and other factors.” Said Nick Delmonico, CEO and Cofounder at Strados Labs. “We are extremely excited about this partnership with Clario and the potential to improve cough monitoring for many sponsors.”

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