CergenX

We’re beyond proud to share that CergenX has won the Irish Times Innovation Award in the Life Sciences & Healthcare category! Well done to our dedicated team members who made this achievement possible. This recognition reflects our ongoing commitment to advancing neonatal care through the CergenX Wave device and our scalable AI technology. The award highlights our progress and gives us the chance to share the real-world impact of our work with a wider audience. Our gratitude to The Irish Times for providing this platform. The award was presented by Dr Siobhan Roche from Research Ireland, alongside a panel discussion on the future of Irish innovation featuring Elaine C. (Atlantic Bridge), Sean Mitchell (Ubotica Technologies), and Karole Egan (Enterprise Ireland). The finals showcased truly inspiring innovations from across the country—we were blown away by all the nominees and winners. Watch out for more coverage in tomorrow's Irish Times. Huge thanks to everyone involved! #IrishTimesInnovationAwards #AiForGood #MedTechInnovation Sean Griffin Jason Mowles Geraldine Boylan INFANT Research Centre University College Cork UCC Innovation Enterprise Ireland Health Innovation Hub Ireland Photo credit: Conor McCabe

As we wrap up our final team meet-up of the year, we’ve taken a moment to reflect on our 2024 highlights: ⭐ First Clinical Trial: The moment we’d all been waiting for! This marked a huge moment for the team as the CergenX Wave device transitioned from research and development to real-world application, being used on newborns in hospital settings as part of a feasibility study. It represents a major milestone in neonatal care and underscores its tangible impact in clinical environments. ⭐ Events: We participated in key conferences and events throughout the year as attendees, sponsors, and presenters. We showcased our research at INBBC in Cork, brought Wave to AES2024 in Los Angeles for live demos, and engaged with global audiences from Italy to Illinois! ⭐ AI progress: Throughout the year, we advanced the capabilities of our AI-powered platform, achieving human expert-level seizure detection! These advancements are backed by groundbreaking research now under peer review, pending publication (watch this space!). John M. O'Toole presented our progress in three posters shared at INBBC and AES, with more in the pipeline for 2025. ⭐ Silverware: We won the Life Sciences & Healthcare category at the The Irish Times Innovation Awards and were named Spin-Out of the Year at the UCC Research & Innovation Awards while also being shortlisted for Irish Medtech Connect! ⭐ US Expansion: We launched a US entity and welcomed Oscar Gleeson full-time in Boston following his placement with us through the University of Notre Dame ESTEEM Graduate Program. ⭐ Team Growth: We welcomed Dan Egan (Data Strategy), Thaís Sala (Quality and Regulatory Affairs), and John Dennehy (Software Engineering). Our growing, multidisciplinary team reflects the momentum behind Wave as we head into our next phase of growth. ⭐ DTIF Kick-Off: In May, we officially launched our project funded by the Disruptive Technology Innovation Fund (DTIF), taking a significant step forward in advancing our vision. ⭐ ISO Certification & Regulatory Progress: We achieved ISO 13485:2016 certification for our Quality Management System, reaffirming our commitment to excellence and regulatory compliance. Key regulatory milestones include appointing BSI as our notified body, a successful pre-submission meeting with the FDA, and the submission of our application for FDA Breakthrough Designation Status, which is currently under review. Stay tuned for updates! ⭐ Global Recognition: CergenX was featured as a case study by Health Innovation Hub Ireland at the World Health Organization Europe Innovation Ecosystem for Public Health event in Copenhagen. Global leaders such as Sasha Rubel and Werner Vogels from Amazon highlighted our work at major tech events! We are very excited for 2025, which promises to be a huge year for the team and for Wave, our flagship device. Wishing everyone a joyful, relaxing holiday season from all of us at CergenX. INFANT Research Centre University College Cork Enterprise Ireland

Back to a wintery Ireland after a few days of glorious sunshine in California. 🌞 Wave made a splash at AES 2024 – a superb event driving collaboration and progress in MedTech and clinical innovation, held in LA. The momentum in this field was evident from the cutting-edge innovations and over 600 research posters on display, highlighting the active developments shaping the future of neonatal care. Dr. John M. O'Toole presented our work on the first neonatal seizure detection AI model that performs at human-expert-level, and we were buoyed by the incredibly positive feedback and discussions that followed. We also had the privilege of demo-ing the CergenX Wave device to medical, clinical, and MedTech professionals from all over the world, all committed to advancing innovative solutions. It’s a transformative time for the industry, and we're excited about the connections made and the opportunities ahead as we continue to push the boundaries of what’s possible. Our sincere thanks to the American Epilepsy Society for making it all possible. #AES2024 #MedTechInnovation #AiForGood

First baby steps in what I hope will be a very fertile research area of "#AI4Science" for Neonatal EEG. 🧪 🔬 🥼 This work with John M. O'Toole will be presented today at #AES2024 in LA. What did we do? - We built the first neonatal seizure detection AI model that performs at human expert level - We used the model to annotate EEG recordings from babies at an unprecedented scale - With this dataset, we were able to discover a novel insight enabling us to predict progression of seizures in newborns. - We found that babies with localised seizures had significantly lower seizure burden overall that those with generalized seizures, using just the first hour after seizure onset. Why is this important? - Because Neonatal EEG is highly specialised, there's still a lot we don't know. - Uncovering this difference improves our understanding of the different trajectories of newborn brain injury - Ultimately, this understanding could lead to more targeted treatments Why do we need AI? - This insight required large scale data annotated channel-by-channel - This is extraordinarily time consuming for experts whose time is very tight - As a result, these studies simply don't get done ... until now. What's next? - This is just one small example of what's possible - We have some additional promising results currently under review for upcoming conferences - We have big plans to look more deeply here, in collaboration with our friends at INFANT Research Centre - If this kind of research interests you and you want to take it to the next level, please reach out.

Day 2 of AES 2024 is here! 📌 Booth 2132: Meet the team behind innovative neonatal neurotechnology & experience a live demo of the CergenX Wave device. 📌 Poster 3.304: Explore our expert-level AI model in greater detail #AES2024 #NeonatalCare #AIInnovation #Neurotechnology

What a super day at MedTech Connect yesterday! Our CEO, Jason Mowles, presented the story of the CergenX Wave device and connected with an inspiring group of innovators. Events like this highlight the exciting work happening across the industry and the value of exchanging ideas with such a dynamic community. Our congratulations to the overall winners, Judi O' Malley and Spiorad Medical Limited , and well done to all the other presenters—AVeta Medical, Pumpinheart, Galenband, and Tympulse Medical. A huge thank you to the organisers for creating this platform—and in particular to Dr. Emer Sherry and Ciara Finlay. Irish Medtech Ibec #MedtechConnect #MedTechInnovation INFANT Research Centre University College Cork

As we gear up for #AES2024, let's introduce Dr. John M. O'Toole, Head of AI Research at CergenX, who will be presenting his poster on Monday 9th. 👋 About John With 20 years of experience in biomedical engineering and AI for neonatal neuromonitoring, John previously led an AI research team at the INFANT Research Centre, University College Cork. He now leads CergenX’s AI team, advancing neonatal care through cutting-edge technology. 📌 Don’t miss John’s poster at AES 2024!  Using CergenX’s expert-level AI model, we analysed 20,000+ hours of EEG data from 427 neonates, detecting more than 33,000 seizure events.  One of the key findings? Within the first hour of seizures, infants with seizure activity across more than two channels were more likely to experience a longer seizure burden over the first three days after birth. This suggests that the spatial distribution of seizures within the first hour could serve as a valuable predictive biomarker for future seizure burden over the first three days after birth. Stop by Booth 2132 to meet John and other key members of the CergenX team and experience a demo of the CergenX Wave device. #NeonatalCare #AIInnovation

Just wrapping up a fantastic couple of days at #IPA2024. Our thanks to the Irish Pediatric Association, IPA President Prof. Michael O'Grady, and Sinéad Cassidy for organising such a valuable event. The guest lectures from Pierre Gressens, Biba Stanton, Cilian Ó Maoldomhnaigh, and Mary T O'Mahony showcased the very latest research and developments, alongside nearly 50 oral presentations covering a wide range of paediatric and neonatal topics. It’s always energising to come together with such a remarkable community dedicated to advancing care and outcomes for children and newborns. Looking forward to the continued impact of these conversations! #Neonatology #HealthcareInnovation

The best part of this year’s Pediatric MedTech CEO Summit was engaging with companies dedicated exclusively to pediatric healthcare and hearing from experts with hands-on experience in bringing critical devices to market. In such a highly specialised space, it was invaluable to gather so many innovators in one room to share insights and challenges. Huge thanks to the founders, Impact1 at Stanford Biodesign, and a special shout-out to CobiCure for making this impactful event possible!

AES 2024 is shaping up to be an exciting opportunity to connect with the innovators behind the CergenX Wave device. First up, meet Sean Griffin—Co-founder and CTO. Sean is a trailblazing Irish tech entrepreneur with 35 years of experience in building cutting-edge enterprise solutions. Before founding CergenX, he led SAAS company Poppulo as CTO, helping transform it from a startup to an industry leader in internal communications. With extensive experience in developing large-scale, high-impact technology platforms, Sean’s vision and technical leadership are key to bringing the CergenX Wave to life. Stop by Booth 2132 to meet Sean, learn how his team are transforming neonatal care with AI-powered solutions, and experience a demo of Wave. #AES2024 #NeonatalCare #HealthcareInnovation #AIinHealthcare