Canary Speech Vocal Biomarker Model for Behavioral Health

o Designed to inform and augment (not replace) clinical management of adult patients at risk or being treated for behavioral health conditions such as Major Depressive Disorder and Generalized Anxiety Disorder in ambulatory, telehealth, acute, or remote monitoring settings. o Operates as a clinical decision support tool: clinicians collect ≥40 seconds of patient speech via app/device; AI analyzes speech for vocal biomarker patterns; clinician receives results in near real-time. o Requires human review and clinical correlation—clinicians maintain oversight.

Primary Care Providers, Psychiatrists, behavioral health professionals, credentialed telehealth clinicians. Requires basic digital literacy and familiarity with depression and anxiety screening.

All configuration settings are documented and designed specific to the customer use case. These settings are defined in the configuration file hosted in the secure Canary Speech cloud (Azure) environment.

Canary Speech’s vocal biomarker technology is designed to be used either in-person or remotely. In either setting, patient assessments require capturing at least 40 seconds of conversational speech in the system. o Clinician and patient meet in an environment that is quiet and where background noise is limited. o Clinician obtains informed consent from patient regarding the recording of their voice for purposes of conducting an assessment. o Clinician logs into the system via a Canary Speech-compatible audio capture device (such as a tablet, smartphone app, or telehealth software). o Clinician places the audio capture device in a location within 3 feet of the patient’s mouth ensuring that the device microphone is unobstructed, if in person, or conducts their usual telehealth visit with the patient remotely. o During the patient visit, once 40 seconds of the patient’s voice has been obtained Canary Speech will analyze the speech sample in real-time. o The analysis typically takes about 10-15 seconds and then the system returns a result to the clinician’s device. o The software will return results for Major Depressive Disorder and Generalized Anxiety Disorder.

Patients aged 18 or older