STRASBOURG, France--(BUSINESS WIRE)--Braintale, the cerebral white matter specialist French medtech, announces today the launch of the brainTale-care platform with its modules brainQuant, dedicated to white matter quantification, and brainScore-coma, offering the prediction of coma recovery. Today, the company is taking a decisive step in its development by providing doctors and medical teams with an innovative decision support digital medical device in Europe. Braintale's ambition is to provide resuscitators and neurologists with innovative, non-invasive, clinically validated solutions to improve diagnosis, monitoring and prediction of neurological diseases and disorders evolution and thus contribute significantly in the decision-making process to optimize patient care.
White matter has been underestimated in neurosciences whereas it accounts for 80% of brain volume, playing a key role in its proper functioning, development and aging, whether normal or pathological. Thus, the vast majority of neurological and psychiatric diseases, such as Alzheimer's, Parkinson's multiple sclerosis or Charcot's disease are linked to direct or indirect alterations of the white matter. Importantly, the predictive score extracted from white matter in brain-damaged coma patients provides a precise prediction to guide doctors and families in their decision-making. A medical "frontier" that has never been explored before.
Since its creation in 2018, Braintale has been developing clinically accessible, effective and validated measurement and prediction digital platforms for physicians treating patients with brain injuries. Co-founded by Professors Louis Puybasset (Resuscitator, Pitié-Salpêtrière, Paris), Damien Galanaud (Neuroradiologist, Pitié-Salpêtrière, Paris), Lionel Velly (Resuscitator, Timone Hospital, Marseille), Didier Cassereau (Researcher, ESPCI) as well as Vincent Perlbarg, PhD in Medical Physics, and LallianSe, the life sciences integrator the company now brings together a dozen collaborators who develop innovative solutions, patented and protected on the basis of the work of the teams of clinicians of the PA-HP (Public Assistance - Hospitals of Paris).
After two major clinical validations published in The Lancet Neurology1 and Intensive Care Medicine2, Braintale, announces today the class IIa CE mark under the new European regulation MDR 2017/745 of the brainTale-care platform and its brainQuant and brainScore-coma modules, the latter being dedicated to the prediction of coma recovery. It follows the class I CE mark of brainQuant in March 2020, Braintale’s first medical device, which measures white matter in a truly quantitative way, under European directive 93/42/EEC on medical devices, and ISO 13485 certification:2016 of Braintale’s quality management system in 2020. This is the first class IIa CE mark according to the Medical Devices Regulation (MDR) in force since 2021 granted for a predictive solution in neuroimaging in Europe.
What is brainTale-care ?
Concretely, the company brings a complete novelty to the market: brainTale-care is a software medical device available in SaaS (Software as a Service) mode for any physician with access to a diffusion MRI. The platform, which identifies white matter alterations and provides customized prediction scores, today consists of two modules:
- The brainQuant module, which enables automatic processing and quality control of brain diffusion MRI [magnetic resonance imaging] data uploaded to the digital platform and the provision of global and regional standardized parameters. Results are designed to enable fast and efficient integration into current clinical workflow,
- The brainScore-coma module, which provides a clinically validated prediction score of coma recovery in two patient populations (comatose after cardiac arrest or trauma brain injuries to date) calculated from the brainQuant regional broadcast standard parameters.
Other modules are being developed.
Why is brainScore-coma revolutionary in coma management?
Until today, the prognosis of almost 25% of comatose patients after brain injuries remains significantly uncertain, leaving families and medical teams in indecision when it comes to deciding for a patient in a state of persistent impaired consciousness.
brainScore-coma is a software medical device designed to provide clinicians with reliable information to support intensive care decision-making by providing additional information, which was until today unavailable, to medical teams. The performance is compatible with the personalized decision-making process in intensive care. This reliable information complements the multimodal assessment of patients by promoting a serene decision of the medical teams to lead to an optimal management of the patient and his families.
"The availability in a clinical context of the Braintale care platform will allow better management of patients in coma with a clinically validated prospective prediction score and, ultimately, help to better manage terrible situations for the patient, their families and caregivers. " comments Vincent Perlbarg, co-founder and president.
"After 15 years of academic research and 3 years of investment to industrialize our approach, the launch of brainScore-coma responds to the universal medical need that has been the driving force behind this ambitious project since its inception" adds Prof. Louis Puybasset, President of the scientific advisory board and cofounder.
“This milestone is a turning point in the company's development, as our digital medical device platform is now available to better predict the clinical outcomes of brain-injured patients. In addition to being the result of considerable work on the part of all our team, this opens a new era in the monitoring and prediction of neurological diseases through the standardized measurement of white matter” adds Julie Rachline, co-founder and CEO through LallianSe.
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
About LallianSe
Pioneer and initiator of the concept of life sciences integrator, LallianSe transforms innovations into economic success through the co-construction and execution of convincing equity stories. LallianSe contributes to better health with its coworking spaces immerged in hospitals, its dedicated events, and its Experts and Entrepreneurs in residence, specifically mobilized for each company.
For more information, please visit www.lallianse.com
1 Velly et al., Use of brain diffusion tensor imaging for the prediction of long-term neurological outcomes in patients after cardiac arrest: a multicentre, international, prospective, observational, cohort study, The Lancet Neurology, 2018 Apr;17(4):317-32
2 Puybasset 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, 2021 Dec; 48:p 201–212
