BrainTale unveils the new version of its digital biomarkers platform brainTale-care CE-marked under the MDR 2017/745
Strasbourg, March 22nd 2023
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:
- Enhanced security of the software medical device: higher security of data, data flows and optimized cybersecurity.
- Access to additional biomarkers targeting axons and myelin integrity for improved care in neurology, now available in clinical reports.
- 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
BrainTale has presented the interest if its digital biomarkers platform in differential diagnosis during the 15th edition of Clinical Trials on Alzheimer’s Disease conference
BrainTale, a medtech deciphering white matter to enable better brain care, spin off from the Paris Region Greater Hospitals, has presented the “Evaluation of a clinically validated digital platform to provide Diffusion MRI biomarkers in Alzheimer’s disease” during the 15th edition of the Clinical Trials on Alzheimer’s Disease conference (CTAD 2022) held in San Francisco and online from November 29 to December 2, 2022.
The Clinical Trials on Alzheimer’s Disease conference is a meeting focused entirely on Alzheimer’s Disease Therapeutic Trials with key leaders in Alzheimer Disease research from Industry and Academia getting together and forming partnerships with the objective of speeding the development of effective treatments to fight the disease.
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.
Alzheimer’s disease affects about 10 million people per year worldwide and its incidence rate tends to increase year after year. The disease is often diagnosed too late to effectively slow its progression, although lesions are visible at an early stage, notably on the myelin sheath, axons, and oligodendrocyte cells.
Data of 113 subjects (66 healthy patients, 34 patients with mild cognitive impairment, 13 patients with dementia) from 5 centers were processed on the BrainTale platform. The multicentric study showed that the analysis resulting from the platform processing has demonstrated statistically different white matter assessments for the 3 subjects’ categories. Results show that BrainTale biomarkers are relevant biomarkers of disease severity, and that the platform has the potential for a differentiated diagnosis perspective.
BrainTale digital biomarkers platform offers the potential to diagnose Alzheimer’s patients at an early stage and monitor disease evolution, as well as drug efficacy as already demonstrated in other neurodegenerative conditions. This potential of impact for Alzheimer’s patients, community and stakeholders has already been awarded the Robert D. Zimmerman Scientific Award 2022 by the Eastern NeuroRadiology Society.
Vincent Perlbarg, cofounder, CSO and president comments: “This preliminary work shows the importance of integrating white matter biomarkers for neurodegenerative diseases. Our data suggest a very exciting complementary approach to existing initiatives to better diagnose, and ultimately better treat Alzheimer’s disease patients”. “Our approach enables non-invasive, sensitive and reliable assessments of white matter alterations that are both available in the clinic and implemented in clinical trials to improve success rates and support efficient clinical developments.” he adds.
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 diseas es. 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
Contacts
Braintale – Julie Rachline, CEO julie.rachline@braintale.eu +33 6 62 42 03 58
American Academy of Neurology (AAN 2022) – Braintale showcases together with Minoryx data from its biomarker platform for disease and treatment monitoring of X-linked Adrenoleukodystrophy and strengthens collaboration
Strasbourg, April 25th 2022
BrainTale, a medtech that is deciphering white matter, spin off from the Assistance Publique-Hôpitaux de Paris, showcases, with Minoryx, a biotechnology company developing a treatment for X-linked Adrenoleukodystrophy (X-ALD), the results of the multicentric ADVANCE sub study with Braintale biomarker platform on the occasion of the American Academy of Neurology (AAN). The data were presented digitally on April 24th, 2022. This has also been the occasion to deepen the collaboration between the two companies.
Long underestimated in neurosciences, white matter, which represents 80% of the human brain, plays a key role in its proper functioning, development, and aging, whether normal or pathological. Accordingly, Braintale has been developing, since its inception in 2018, non-invasive, accessible, effective and clinically validated measurement and prediction tools for physicians treating patients suffering from brain diseases.
The BrainTale platform includes AI-processed CE-marked digital solutions, deployed across three modules. BrainQuant enables white matter quantification, brainScore powers clinical prediction and MyelinDex, monitors myelin integrity. Beyond demyelinating conditions, the platform has also been successfully implemented to monitor patients with amyotrophic lateral sclerosis (ALS) and predict recovery for comatose patients after cardiac arrest or trauma brain injury.
X-ALD is an inherited orphan neurodegenerative disease. The most common form is adrenomyeloneuropathy (AMN), which is a highly debilitating chronic disease affecting male and female X-ALD patients reaching adulthood. There is currently no approved treatment for AMN patients. X-ALD male patients can also develop the acute cerebral form, cALD, in both pediatric age and adulthood. cALD results in aggressive brain inflammation leading to permanent disability and death within 2-4 years.
Leriglitazone, a novel brain penetrant PPAR gamma agonist, recently showed significant clinical benefit in Minoryx’s ADVANCE Phase II/III clinical trial in adult male patients with AMN. A separate phase II/III study in male pediatric patients with early stage cALD is ongoing (NEXUS).
On the occasion of the American Academy of Neurology, Braintale and Minoryx jointly presented additional results of a multicenter sub-study from the ADVANCE trial. The abstract is available online: https://index.mirasmart.com/aan2022/PDFfiles/AAN2022-002872.html
Beyond the characterization of MyelinDex as a relevant biomarker for monitoring disease progression and therapeutic efficacy, these data further support the efficacy of leriglitazone and its potential to improve myelin integrity in the brain of patients affected by AMN. These results pave the way to use of MyelinDex for disease and treatment monitoring in clinical trials as well as patient management in a hospital setting.
The collaboration between the two companies has expanded in order, notably, to implement the use of MyelinDex in additional clinical trials to further characterize beneficial impact of leriglitazone on myelin content, while contributing to a better understanding of X-ALD.
“We are very excited to see the potential of Braintale’s technology to deliver precise and longitudinal analysis of white matter” said Marc Martinell, CEO of Minoryx Therapeutics. “These results are aligned with preclinical data showing the impact of leriglitazone on myelination”.
“Pleased with the success of our collaboration to date, Minoryx and Braintale teams have decided to extend their partnership exploring the use of biomarkers developed with the Braintale platforms. Now, together, we are contributing to better understand and improve follow-up, treatment, and stratification of patients with this devastating orphan disease”, explains Julie Rachline, co-founder and CEO of Braintale through LallianSe.
About BrainTale
BrainTale is an innovative medtech company deciphering white matter to enable better care in neurology and intensive care with clinically validated prognostic solutions. With noninvasive, 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
Contacts
Braintale – Julie Rachline, CEO julie.rachline@braintale.eu +33 6 62 42 03 58
BRAINTALE, whose head office is 11 rue de l’Académie 67000 – STRASBOURG, is registered in the Trade and Companies Register under number 840 995 138 RCS STRASBOURG
Last update : 09/19/2022