neuroClues secures CE certification for its eye-tracking technology set to enhance neurologic care

Next step: bring neuroClues to the European market and become the “stethoscope of the brain”

In summary

• neuroClues achieves Medical Device Regulation (MDR) certification and is now allowed to issue the CE-mark on its Class IIa medical device designed to enhance neurologic care with eye movement biomarkers. 
• Its solution has been designed to bring to clinical practice a wealth of over 60 years of research. 
• The company is setting up strategic research partnerships and has ongoing discussions about its use in the French mega-cohort Constances. 
• The team positions itself for growth, with Bart Stulens appointed as Chief Commercial Officer, a former Medtronic executive bringing in over 25 years of experience. 
• It now plans to raise €10 million in Series A funding to support market expansion and build a European neurotech leader.

Paris, France – 7 January 2025 – neuroClues, a European MedTech company specializing in the diagnosis of neurodegenerative diseases, announced today it has received the MDR certificate for its groundbreaking eye-tracking device. 

Innovation in the EU remains achievable with proper support and the right team. In just 4 years, the company developed a complete hardware, software, and cloud system, from incorporation to EU market access. By integrating European Medical Device Regulation (MDR) requirements from initial product design, the company achieved certification within five months, showcasing its efficient and compliant innovation process. This achievement was made possible through collaboration with their notified body, whose clinical and AI expertise streamlined the review process. 

“This marks a major milestone for the millions of people affected by neurological disorders. neuroClues’ introduction to the EU market will improve diagnosis and care pathways for millions of EU patients, bringing objectivity to current clinical practice. This represents a significant value inflection point in our mission to improve neurodegenerative disease diagnosis,” said Antoine Pouppez, CEO and co-founder of neuroClues. “It demonstrates our team’s ability to deliver in a highly regulated environment with limited resources and proves that MedTech innovation remains possible in the EU.” 

This achievement was made possible thanks to the support from the board (Olivier Legrain & Diane Lejeune), the investors (White Fund, Graph Ventures, InvestBW, LeanSquare & WING), the Walloon Region and the European Innovation Council (EIC) Fund. 

neuroClues aims to address the pandemic of neurological disorders. 

Neurological disorders are a silent pandemic affecting 1 in 3 people over their lifetime. Diagnosis is complex and primarily relies on clinical observation, leading to a long diagnostic odyssey with an approximately 30% misdiagnosis rate. This prolonged journey has a profound impact on patients’ health and severely affects their neurological state. Studies show that Parkinson’s patients have lost 50-70% of their dopaminergic neurons by the time of diagnosis. 

neuroClues aims to transform years-long diagnostic wandering into rapid weeks-long processes in order to improve patient quality of life through proper care. The solution will initially target specialists like neurologists, movement disorder specialists, and neuro-ophthalmologists, before expanding to the 2.3 million physicians worldwide who currently assess brain health using the traditional “follow-my-finger” test. 

neuroClues: enhancing neurologic care through eye movement biomarkers 

The neuroClues device has built advanced eye-tracking technology using AI to analyze eye movements as biomarkers for neurological conditions. This portable, non-invasive and accurate solution complements existing diagnostic methods by extracting multiple biomarkers in 10 minutes while patients simply visually track a target on screen. 

“Our unique device aims at empowering healthcare professionals with an easy-to-use tool for early detection of complex conditions like Parkinson’s disease and other neurodegenerative disorders,” said Pouppez. 

neuroClues builds on 60+ years of eye movement research spanning 100,000+ publications from leading institutions worldwide. Gaining from its founding team’s expertise in neurology and with CE marking secured, neuroClues now bridges research insights and clinical needs, serving both daily practice and research applications. 

Strategic Partnerships to foster translational neurologic research 

neuroClues has established research partnerships with prominent studies across Europe and North America. In France, Professor Marie Vidailhet’s support allowed expanding subject enrollment using neuroClues within the Paris Brain Institute to dozens of participants per week. In the United States, studies are launching at two major institutions on hundreds of movement disorder patients.   

Additional research collaborations are in the making, such as one with Professor Bas Bloem, Director at the Center of Expertise for Parkinson & Movement Disorders at Radboud University Nijmegen (Netherlands) who shared : “We are thrilled by the perspective of using neuroClues’ automated eye movements examination to help us better distinguish patients with atypical parkinsonian syndromes when the clinical signs are not evident yet.” 

These collaborations demonstrate neuroClues’ dedication to driving evidence-based innovation and advancing the frontier of neurological research globally.  

neuroClues advances collaboration with Constances Mega-Cohort for eye movement biomarkers 

neuroClues is advancing discussions with the Constances cohort to integrate eye movement testing into their research for volunteers aged 55 and over. Constances, a renowned French epidemiological mega-cohort of 220,000 participants, offers a unique opportunity to collect data from 25,000 subjects. Supported by France 2030, this project would establish a comprehensive normative database of eye movement biomarkers. It aligns with neuroClues’ mission: leveraging eye movement analysis to revolutionize neurological care and enable earlier, more accurate diagnoses. 

Expanding Borders and Broadening Neurological Applications 

With its CE marking, neuroClues is prepared for deployment in hospitals and clinics across Europe, providing an innovative tool for neurologists and neuro-ophthalmologists. In Italy, Prof. Alessandra Rufa will lead efforts with neuroClues to develop normative databases for various neurological conditions, including Parkinson’s Disease, Alzheimer’s Disease, cerebellar syndromes, myasthenia, and myopathies. neuroClues goes beyond Parkinsonian syndromes, finding early adopters among dementia and sports medicine specialists, demonstrating its broad potential in diagnosing and managing neurological disorders across diverse fields. 

Shaping up the organisation for commercial success: strategic addition to the executive leadership 

neuroClues is delighted to announce the appointment of Bart Stulens as Chief Commercial Officer. With over 25 years of commercial and general management experience in the healthcare industry, including 16 years of senior leadership roles at Medtronic, Bart brings unparalleled expertise in implementing successful product launches and driving market expansion across multiple regions. His addition to the team underscores neuroClues commitment to enhancing its commercial capabilities and accelerating its growth trajectory. 

Bart Stulens: “I am thrilled to join neuroClues at this pivotal moment and work alongside this talented team. neuroClues’ mission to “develop the stethoscope of the brain” and revolutionize neurologic care through early diagnosis aligns perfectly with my passion for driving innovation in healthcare. I look forward to contributing to the company’s growth and introduce groundbreaking solutions that will make a real difference in people’s lives.”  

Now planning a new Series A to build a European neurotech champion  

Now that it has achieved market access, the company will be closing a Series A of 10 Million euros this half-year, 2/3 of which is already soft committed. With a proven track record of delivering on promises, the company aims to start growing the commercial team and bring its solution to the European market.  

About neuroClues 

neuroClues, formerly known as P3Lab, is a French Belgian startup founded in 2020. The company is developing a medical device based on eye-tracking to aid in the early diagnosis of neurological diseases. neuroClues is a partner of the Paris Brain Institute (France) and is incubated within the iPEPS-ICM, the Incubator of the Paris-Salpêtrière hospital. neuroClues has established a network of international collaborations in Europe and the United States. The company raised 4.7 million euros in 2021, received 2.5 million euros in grants from the European Innovation Council (EIC) Accelerator, and closed a 5 million euros Pre-Series A in 2024. neuroClues is now ambitioning to raise another 10 million euros, 2/3 of which is soft committed by existing investors, to develop this DeepTech innovation in the European and American markets. More information: https://neuroClues.com  

For more information, please contact

Antoine POUPPEZ, CEO
[email protected]
Louvain-la-Neuve
Belgium