Cerenion C-Trend® receives CE-mark for immediate sale in the European Union
In a landmark event for Cerenion, its core product Cerenion C-Trend® has now officially passed EC conformity assessment and has been CE-marked as a medical device for immediate sale in the European Union.
"Today represents a major milestone for our young company. We have been building towards this goal ever since starting work on the original Business Finland -project at the University of Oulu, where we had a novel scientific finding and wanted to find out whether it could be developed in to an actual product helping the patients and medical professionals in their work", exults Dr. Jukka Kortelainen, CEO and Co-founder at Cerenion. "Today is an exciting concrete step on our mission to improve monitoring of brain function during intensive care", he continues.
The Cerenion C-Trend® is a software device intended for the review and analysis of electroencephalogram (EEG) recordings made with a compatible EEG device to aid in the monitoring of the neurophysiological status of patients. The technology utilizes artificial intelligence (AI) in producing, from a complex EEG recording, an easy-to-understand set of parameters that can be used by medical professionals in clinical decision making. The indications for use of C-Trend® include monitoring of brain function in comatose cardiac arrest survivors as well as detecting epileptic seizure activity and brain hypoxia. The software will be available on select Cerenion C-Trend® -powered EEG devices released by our licensing partners.
A key factor in obtaining regulatory approval for C-Trend®, as any medical device, is convincing clinical evidence on the benefit and safety of the device. Cerenion’s clinical study program, originally started with a small pilot of 10 cardiac arrest patients measured at the Intensive Care Unit (ICU) of Oulu University Hospital, has since grown to a significant body of a few hundred patients measured across several sites in Finland. The substantial body of measurements provides clinical evidence on the Cerenion C-Trend® as a measure of brain condition and function for a number of different patient groups.
"Our patented technology represents a significant breakthrough in both the ease of use and the level of insight it offers on top of traditional EEG measurement", reports Dr. Eero Väyrynen, CTO and Co-founder at Cerenion. "We see a lot of potential, and a lot of interest in our patented technology", he continues.
The EC conformity assessment was conducted by SGS Fimko according to the Medical Device Directive (93/42/EEC) of the European Union. The assessment was preceded by ISO 13485:2016 certification of the Cerenion Quality Management System and a successful IEC 62304 conformance assessment of the Cerenion C-Trend® software.
"Our whole team has done a tremendous job to get us here today. We have met every challenge head on and developed our quality management system, our software development process and now also our first product in a way we can all be proud of", notes Dr. Ilkka Juuso, COO, Quality Manager and Co-founder at Cerenion.
The team behind the upward success of the company has largely come from the academic sphere, but always embraced the chance to affect real improvements in the everyday health and care of patients. Today, the company has two sites in Finland, one in Oulu near the university and another in the capital region of Helsinki.
"We have been fortunate in attracting a great team of talented and capable people to take this concept of a product and make it a reality. The entire team deserves credit for today", remarks Dr. Timo Koskela, CFO, head of human resources and Co-founder at Cerenion. "Our success, however, would not have been possible without the support from Butterfly Ventures, Icebreaker.vc and the hundreds of private investors believing in us in the funding round organized by Springvest", he acknowledges.
The now obtained CE-mark enables the immediate sale of Cerenion C-Trend® -powered medical device products in the European Union. The first products featuring C-Trend® are expected to be released shortly.
"The journey from a university spin-off with a fascinating innovation to an up-and-running medical device company is now complete, and it is time to appreciate the accomplishment. Our entire team has worked hard for this, and met all the demands and expectations with flying colors", remarks Dr. Kortelainen. "Yet, today only represents the beginning of the next phase as we can now ship C-Trend in Europe", he concludes.
Cerenion gratefully acknowledges support from the European Regional Development Fund of the European Union and the Centre for Economic Development, Transport and the Environment in North Ostrobothnia on the development of its quality management system and the related work in seeking the appropriate regulatory approvals and bringing the Cerenion C-Trend® to the international market. We would also like to thank all of our investors, Butterfly Ventures, Icebreaker.vc, Springvest, Business Finland, the Oulu Health Ecosystem, the University of Oulu, and our partner companies and hospitals.
For more information on Cerenion C-Trend® and its availability please contact Dr. Jukka Kortelainen, CEO of Cerenion.
Cerenion Oy has developed the world’s ﬁrst practical method for measuring the brain function of intensive care patients. Cerenion's patented C-Trend® technology reveals the status of the brain as one simple score – at the bed-side and without requiring any changes to the care of the patient. The solution works by combining standard EEG-measurement with advanced machine learning algorithms and artificial intelligence. The technology has the potential of improving both the quality and the cost of intensive care. http://www.cerenion.com
SGS is the world’s leading inspection, verification, testing and certification company. We are recognized as the global benchmark for quality and integrity. With more than 89,000 employees, we operate a network of more than 2,600 offices and laboratories around the world. https://www.sgs.com
Cerenion Oy has received support from the European Regional Development Fund of the European Union.
Cerenion Oy Elektroniikkatie 3 90590 Oulu FINLAND
Cerenion Oy Kyllikinportti 2 00240 Helsinki FINLAND