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Aural Analytics Launches Large-Scale Pivotal Study for Its Respiratory and Speech Motor Control Prediction Software Tools: Plans to Submit the Study to the FDA Late 2021

December 11, 2020

Aural Analytics announced today the initiation of a multi-product pivotal study to demonstrate the safety and efficacy of its speech-based tools for measuring pulmonary function and speech motor function in amyotrophic lateral sclerosis (ALS).

Aural Analytics anticipates submitting the results of this multi-site, multi-language, 280 participant, prospective, blinded study to the U.S. Food and Drug Administration (FDA) in late 2021. The study, conducted as part of the Target ALS Diagnosis Initiative, is one of several pivotal studies Aural Analytics is set to kick off in 2021 as it expands its suite of clinical-grade speech-based digital tools.

The Aural Analytics VCP™ software tool enables on-demand, real-time objective evaluation of pulmonary function by predicting forced vital capacity (FVC) and forced expiratory volume (FEV1) without the need for specialized hardware in-clinic and at-home. These measurements are commonly used in the assessment of airflow obstruction (COPD, asthma) and restrictive lung disease (ALS). The VCP™ software is currently being used as one approach to screen for eligibility in the Healey Center ALS platform trial at Massachusetts General Hospital. Aural Analytics will also use the study to further demonstrate the safety and efficacy of its speech-based assessment software that enables on-demand, real-time objective monitoring of symptoms and progression in diseases known to impact bulbar function (speech and swallowing).

“Aural Analytics is enabling clinical-grade speech analytics in areas of critical unmet patient and clinical need. This study will be the basis of multiple regulatory submissions for products that have broad clinical utility and commercial pathways,” said Daniel Jones, co-founder and CEO of Aural Analytics. “We continue to work closely with regulators at the FDA and key stakeholders across the healthcare industry to ensure safe, reliable, repeatable and transparent speech-based tools are brought to market.”

More about the Aural Analytics VCP™ Software in ALS

Respiratory failure is the leading cause of death in patients with ALS. As a result, regular assessment of respiratory function is the standard of care. People with ALS often have problems achieving valid measures on standard in-clinic or at-home spirometers. Lip weakness can prevent creation of a tight seal around the spirometer and some with ALS experience an involuntary slamming shut of their vocal cords when they exhale forcefully. Spirometers often induce bouts of coughing which, given the COVID-19 pandemic, has made it increasingly difficult to objectively measure respiratory function in-clinic.

“Our VCP software is designed to tap into both inspiratory and expiratory muscle strength, without requiring lip strength, and with far less chance of inducing laryngospasm or coughing,” said Dr. Julie Liss, co-founder and chief clinical officer at Aural Analytics. “Our application enables a patient to easily deliver pulmonary function data, remotely, with just a few short tasks. The outcome measures are clinically relevant, interpretable, reliable and highly repeatable.”

More about the Aural Analytics Speech Motor Control Software

Functional rating scales have been used historically to capture the impact of disease on a person’s daily life. These rating scales are often coarse, subjective, and can miss key information about how a patient is doing. “We have found that the information we extract from speech samples tracks well with a number of functional rating scales for different diseases,” said Dr. Liss. “Yet, more importantly, our speech metrics can detect changes in disease before they have functional consequences and in a far more frequent, objective way. We believe this tool will provide an opportunity for greater precision in clinical management.”

The Aural Analytics VCP and speech motor assessment applications further add to the company’s technology suite which includes mobile applications currently available for use in clinical research and clinical settings, an embeddable mobile and web SDK, web-progressive applications, and APIs, all with cloud-based computation that power disease-specific speech tasks and analytics.

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