BrainTale Unveils the New Version of Its Digital Biomarkers Platform brainTale-care CE-marked under the MDR 2017/745

STRASBOURG, France--(BUSINESS WIRE)--BrainTale, a medtech deciphering white matter to enable better brain care, spin-off of the Paris Region Greater Hospitals, announces the new release of its CE-marked version of the brainTale-care digital biomarker platform under European regulation MDR 2017/745. Now available to all users, this new release offers significant improvements with new features including new capabilities for patient monitoring, enhanced data and platform security, as well as optimized usage with automation and integration with integrated data flows.

Long underestimated in neuroscience, white matter, which represents 80% of the human brain, plays a key role in its proper functioning, development, and aging, whether normal or pathological. As a result, since its inception in 2018, BrainTale has been developing non-invasive, accessible, effective, and clinically validated measurement and prediction solutions for physicians treating patients with brain diseases.

Two modules are available on brainTale-care platform: brainQuant measuring quantitative, objective and reproducible white matter lesions non-invasively, and brainScore-coma dedicated to the prediction of coma recovery.

Three major features improvements are being available to customers:

1. Enhanced security of the software medical device: higher security of data, data flows and optimized cybersecurity.

2. Access to additional biomarkers targeting axons and myelin integrity for improved care in neurology, now available in clinical reports.

3. Improved usability: automation of data flows with the medical imaging management system (PACS)

Jean-Baptiste Martini, Chief Technical Director, comments "This new version of brainTale-care is an important improvement for all our users, with superior security and usability alongside additional available biomarkers. It is a significant enrichment of the platform's features, to allow its deployment to a growing number of customers, for the benefit of patients and industrial players".

Beyond the renewal of the ISO13485 certification obtained early 2023, this significant update of the brainTale-care platform supports the growth and development of BrainTale’s solutions of white matter biomarkers for drug development and real-life environments.

About BrainTale

BrainTale is an innovative medtech company deciphering white matter to enable better brain care with clinically validated prognostic solutions. With non-invasive, sensitive and reliable measurements of white matter microstructure alterations, BrainTale offers a digital biomarkers platform to support clinical decision-making. BrainTale enables the identification of patients at risk, early diagnosis and monitoring of disease progression and the effectiveness of treatments in neurology, in particular for demyelinating diseases, amyotrophic lateral sclerosis and neurodegenerative diseases. Based on more than 15 years of research and development, BrainTale's products are developed to meet the medical needs and expectations of healthcare professionals for the benefit of patients.

Since its inception in 2018, the company has implemented a comprehensive quality management system and is now ISO 13485:2016 certified, with a suite of products available on the European market under the European Medical Device Regulation (MDR).

For more information, please visit www.braintale.eu