Corify Care obtains CE Mark for ACORYS MAPPING SYSTEM

EIT Health-supported start-up Corify Care has recently obtained the CE Mark for its innovative cardiac mapping system ACORYS under the new Medical Device Regulation (MDR), which signifies it meets the high safety, health, and environmental protection standards required for medical devices in the European Union. The mark also means the ACORYS MAPPING SYSTEM is approved for commercial sale throughout the European Union, meaning that hospitals and cardiac care centres can now utilise this cutting-edge technology to provide patients with precise and rapid cardiac mapping, improving the diagnosis and treatment of various arrhythmias, including atrial fibrillation and ventricular tachycardia. 

On achieving the CE Mark, Andreu Climent, Co-Founder and CEO of Corify Care, said: “This is a significant milestone for Corify Care. It validates our commitment to providing innovative, non-invasive solutions for cardiac arrhythmias. We are excited to bring the ACORYS MAPPING SYSTEM to hospitals across Europe and improve patient outcomes.”  

What is the ACORYS MAPPING SYSTEM?

Cardiac arrhythmias, such as atrial fibrillation, affect millions of people worldwide, leading to significant health risks, including stroke and heart failure. It is estimated that 17.9 million people will suffer with atrial fibrillation, the most common type of arrhythmia, in Europe by 2060.[1] Traditional methods of cardiac mapping are often invasive, time-consuming, and uncomfortable for patients.  

The ACORYS MAPPING SYSTEM addresses these issues by providing a non-invasive, rapid, and accurate method for mapping the heart’s electrical activity, eliminating the need for CT or MRI scans. By utilising body surface potential measurements and a 3D torso model, ACORYS generates highly detailed electro-anatomical maps of the heart that enables clinicians to observe the heart’s electrical activity in real-time, enhancing their ability to diagnose and treat cardiac arrhythmias with unparalleled precision, speed, and safety. 

This innovative system offers several benefits: 

1. Speed and Precision: Produces detailed heart maps in real-time, facilitating quick and accurate clinical decision.
2. Non-Invasive: Allow the clinicians to see the electrical activity in the heart in those cases when invasive procedures are not an option (e.g., cardiac resynchronisation therapy, cardiac activity assessment in regular consultation, etc.). When invasive mapping is available, the intervention is much more efficient thanks to the combined used of invasive and non-invasive mapping.
3. Comprehensive Analysis: Capable of generating new maps with each heartbeat, allowing continuous monitoring and detailed analysis. 

Emphasising the clinical impact the ACORYS MAPPING SYSTEM has, Felipe Atienza, Co-founder and Chief Medical Officer, said: “For a clinician, being able to see what is happening in the heart before introducing catheters, and then guide those catheters during the procedure, allows us to be faster, more precise, and more effective. This capability significantly enhances our ability to treat cardiac arrhythmias efficiently and with greater accuracy.” 

How EIT Health helped Corify Care

EIT Health has played crucial role in Corify Care’s growth and development. In the early stages the start-up participated in two EIT Health accelerator programmes, aimed at helping start-ups realise their potential. In 2020, EIT Health recognised Corify’s technology as the most innovative in Europe. Following this recognition, in 2021, Corify took a significant leap forward with a €2.3 million investment round where Clave Capital and the Mondragón Group invested in their technology. 

Since 2022, EIT Health has continued to be an integral part of the Corify Care’s journey, funding the SAVE-COR project with over €2.5 million. Obtaining a CE Mark was a key objective of this project, which saw a consortium of partners come together to help Corify Care’s innovation enter the market and become a recommended solution within the European arrhythmia management guidelines. 

These strategic partnerships have been essential in driving Corify Care’s development and market readiness, ensuring that the ACORYS MAPPING SYSTEM can reach its full potential in improving cardiac care. Achieving the CE Mark certification is a key milestone in this journey, made possible by the evidence gathered in several clinical studies, conducted as part of the EIT Health SAVE-COR project in leading hospitals in Spain and Portugal. These studies, which enrolled more than 1,000 patients, demonstrated the critical need for this innovative technology. 

Next steps

Corify Care is committed to continuous innovation, and having received the CE Mark is set to expand its market presence across Europe. They are aiming to integrate the ACORYS MAPPING SYSTEM into clinical practice worldwide, with the next steps including obtaining FDA approval in the United States and expanding to other international markets 

They also have plans to develop ACORYS 2.0, incorporating digital twins and new clinical applications. 

María Guillem, Co-Founder and Chief Scientific Officer at Corify Care, reflects on the journey so far: “Fifteen years ago, this technology was little more than laboratory prototypes that required hours or even days to process a cardiac map. Today, thanks to relentless innovation and dedication, we have developed a device that can show clinicians real-time, non-invasive insights into cardiac activity. 

“Transforming such a complex technology into a practical, everyday tool for clinicians has been a remarkable achievement. Our team’s passion and commitment, and the support provided by EIT Health, have been essential in turning this vision into reality.”  

Helping start-ups navigate the regulatory pathway 

EIT Health’s innovation projects and programmes help start-ups like Corify Care to navigate the regulatory pathway and achieve key milestones which accelerate their journey to market access. Another example of an EIT Health supported start-up to earn a CE Mark this year is ABLE Human Motion. Learn about their story here.