A Welsh startup developing a bionic pacemaker might be the best kept secret in medtech right now. It won't be a secret for much longer, however, as the company has secured a partnership that a more established medical device company.

Cardiff, Wales-based Ceryx Medical is now working with Berlin, Germany-based Osypka Medical to develop a bionic heart pacing device designed to pace the heart with real-time modulation. Unlike traditional pacemakers, this device, dubbed the Cysoni, is designed to prompt the heart to beat in line with the patient’s breathing. It means the device listens and responds to the body, rather than triggering the strict metronomic beats that current pacemakers do. The scientists behind the new technology say there are major advantages to this approach.

"It's a huge breakthrough in the treatment of people with even the most serious heart conditions," said Stuart Plant, CEO at Ceryx. "Our studies show that Cysoni increases cardiac output by at least 20% when compared with monotonic pacing while at the same time it enables heart cells to repair themselves. This is a ground-breaking development for patients with conditions such as heart failure, who will have the opportunity to live longer, fuller lives."

The partnership will see Ceryx’s Cysoni device combined with Osypka Medical’s pacemaker for the purpose of in-human testing. This clinical study is scheduled to take place in the third quarter of 2023 and will take Ceryx closer to commercialization.

"Osypka is a world leader in cardiac pacing technologies and is well-known for their innovation in the development and manufacturing of medical devices, it’s great that their team has shown such enthusiasm for our product. We’re hopeful that a longer-term partnership will emerge from this, which sees Cysoni becoming a standard part of pacemaking technology," Plant said.

Over the next few months, the teams at Ceryx and Osypka will work together to refine the device for clinical trials, which will take place in the United Kingdom and New Zealand. This will involve heart failure patients who have undergone a coronary artery bypass being fitted with this external device. These patients are usually paced for just a few hours after surgery, but the Ceryx team plans to extend this in order to build a full picture of Cysoni’s capabilities.

"We believe in hemodynamically optimized pacing therapy," said Markus Osypka, president and CEO at Osypka Medical. "Ceryx’s Cysoni technology has the potential to become another quantum leap in pacing therapy very much like A-V synchronous pacing is today, but without placing the additional burden on the operator."

Plant credits the ground-breaking research of scientists at the University of Bath and the University of Bristol for helping to lay the foundation for a new technology capable of doing things that no ohter pacing device has been able to do.

"The technology has also undergone five years of rigorous laboratory testing and pre-clinical evaluations as part of our collaboration with the University of Auckland in New Zealand," he said. "This next step, in partnership with Osypka, takes us within touching distance of making Cysoni available to the global healthcare community."