Ceryx Medical’s Pilot RSA-pace study Cysoni-XT Trial Approved

Ceryx Medical, an innovative medical technology company developing a revolutionary therapy for the treatment of heart failure, has announced trial approval for Cysoni-XT, a new temporary cardiac pacemaker aiming to boost recovery in heart failure.

 

The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has approved Ceryx Medical’s clinical trial authorization application for the pilot RSA-pace study of the Cysoni-XT system for post-cardiac surgery patients.

 

Cysoni-XT is a temporary cardiac pacemaker that aims to boost cardiac performance by resynchronization of the heart and lungs, a natural phenomenon known as Respiratory Sinus Arrythmia (RSA).  

 

The RSA-pace study will be the first time RSA therapy has been evaluated in patients.

 

Ceryx Medical’s Chief Executive Officer Dr Stuart Plant said:  “We believe Ceryx’s technology has the potential to transform the lives of patients with heart failure. This approval is a significant step on our journey towards a new therapy to support patients in their recovery and boost cardiac performance.”

 

The clinical trial is slated to begin in the UK later this year and will recruit patients from the University Hospital Wales, Cardiff; Morriston Hospital, Swansea; and the Bristol Heart Institute. 

 

The trial will enroll patients with heart failure with a reduced ejection fraction who have undergone a coronary artery bypass procedure. The trial’s primary objectives are to assess safety and feasibility, aiming to evaluate initial efficacy. The study will evaluate up to 10 days of therapeutic pacing in 32 participants in the UK.

 

Professor Zaheer Yousef, Consultant cardiologist at the University Hospital Wales and PI for the study, commented: “Patients with heart failure are at an increased risk of prolonged cardiac dysfunction following cardiac surgery. I am excited by the potential benefits of RSA pacing in post-surgical patients.”