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Braintale Cofounders Published the Multicentric Prognosis Clinical Validation of Its BrainScore Coma Solution for Severe Trauma Brain Injuries in Intensive Care Medicine

Braintale, an innovative company dedicated to deciphering white matter to enable better care in neurology and intensive care today announced that a leading journal, Intensive Care Medicine, published data from MRI-Coma and CENTER-TBI studies1 under Professor Louis Puybasset's supervision entitled: Prognostic value of global deep white matter DTI metrics for 1-year outcome prediction in ICU traumatic brain injury patients: an MRI-COMA and CENTER-TBI combined study.

The article is available via the following link: https://link.springer.com/article/10.1007/s00134-021-06583-z

The purpose of the multicentric studies focuses on the crucial need for a reliable solution for outcome prognostication in severe traumatic brain injury (TBI) patients. Led by Pr Louis Puybasset, cofounder and president of Braintale's Scientific Advisory Board, the combination study intends to contribute to improving intensive care unit (ICU) decision-making process by providing objective information to caregivers and families. The study aimed at designing a new classification score based on magnetic resonance (MR) diffusion metrics measured in the deep white matter between day 7 and day 35 after TBI to predict 1-year clinical outcome.

With a specificity compatible with a personalized decision-making process in ICU, the model successfully identified the patients with favourable and unfavourable outcomes.

This publication strengthens the clinical relevance of Braintale-care platform solutions, bringing personalized decision-making support in the clinic and real-life conditions. "After the first clinical validation of diffusion MRI markers for patients after cardiac arrest published in the Lancet Neurology in February 20182, the publication of this second etiology by founding members of Braintale anchors its value proposition in ICU environments" comments Vincent Perlbarg, study author and cofounder of Braintale. "it enables better care for severe patients and hard-to-live situations for families while assisting healthcare professionals in their decision-making."

"Clinical validation of AI-processed medical devices from multicentric studies is very often missing in the innovative landscape, and we are thrilled to complement our products portfolio in intensive care with this second indication" adds Julie Rachline, cofounder and CEO " It confirms Braintale's position as a white matter biomarkers platforms enabling identification of patients at risk, early diagnostics, monitoring of both disease progression and treatment efficacy while supporting decision-making in the clinic in neurology and intensive care".

Class I CE-marking of brainQuant, the first module of BrainTale care platform, was obtained in March 2020 according to the Medical Device Directive 93/42/CEE. Braintale has renewed its ISO 13485 certification and is expecting the finalization of its Class IIA CE-marking under the Medical Device Regulation (EU 2017/745) in the upcoming months.

About Braintale

Braintale is an innovative company dedicated to deciphering white matter to enable better care in neurology and intensive care with clinically validated prognostic solutions. Through sensitive and reliable measurements of brain white-matter microstructure alterations, Braintale offers a platform of digital biomarkers to assist decision-making in the clinic and enables identification of patients at risk, early diagnostics and monitoring of both disease progression and treatment efficacy. Building on more than 15 years in clinical development, Braintale's products are developed to address medical need and fulfill expectations of healthcare professionals and patients alike.

Since its inception in 2018, the company has set up a complete quality management system and is now ISO :13485 :2016 certified, with a suite of products available on the European market.

For more information, please visit www.braintale.eu

1 Puybasset L et al. Prognostic value of global deep white matter DTI metrics for 1-year outcome prediction in ICU traumatic brain injury patients: an MRI-COMA and CENTER-TBI combined study. Intensive Care Med. 2022 Dec 14. doi: 10.1007/s00134-021-06583-z. Epub ahead of print. PMID: 34904191.

2 Velly L, et al. Use of brain diffusion tensor imaging for the prediction of long-term neurological outcomes in patients after cardiac arrest: a multicenter, international, prospective, observational, cohort study. Lancet Neurol. 2018 Apr;17(4):317-326. doi: 10.1016/S1474-4422(18)30027-9. Epub 2018 Feb 27. PMID: 29500154.

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