IN Brief:
- Ceryx Medical has manufactured its first implantable bioelectronic pacemaker at King's College London's MAISI facility.
- The national manufacturing centre has two ISO-7 cleanrooms and was established with £5.2 million from Wellcome.
- Ceryx's completed RSA-Pace study used external pacing equipment; the newly manufactured implant is entering preclinical testing.
Ceryx Medical has manufactured its first implantable bioelectronic pacemaker at the MAISI facility operated by King’s College London. The device is also the first implantable product manufactured at the national facility for the Manufacture of Active Implants and Surgical Instruments since it opened in 2023. Designed for patients with heart failure, it is entering preclinical testing rather than being offered for routine clinical treatment.
The Cardiff company is developing a pacing system intended to restore the normal relationship between breathing and heart rhythm. In healthy physiology, the heart rate generally rises during inhalation and falls during exhalation, a pattern known as respiratory sinus arrhythmia. This variation is often reduced in people with heart failure. Ceryx aims to reproduce aspects of it through electrical pacing, rather than maintaining an unvarying programmed pacing interval.
Producing the implant represents a manufacturing milestone separate from the clinical evaluation of the therapy. A prototype that delivers the intended electrical pulses in a controlled research setting still requires materials, packaging and manufacturing controls suitable for implantation. The new device must also undergo testing to establish that its performance and construction remain appropriate for its intended environment.
MAISI is based at the St Thomas’ MedTech Hub in London and was established by King’s College London’s School of Biomedical Engineering and Imaging Sciences in partnership with UCL and Newcastle University. A £5.2 million grant from Wellcome supported its development. The facility operates two ISO-7 cleanrooms within a certified quality management system and provides regulatory expertise alongside small-batch production capabilities.
Specialised manufacturing is a constraint for developers of active implantable medical devices because relatively small clinical development programmes still require controlled processes and detailed records. Component traceability, inspection, assembly procedures and management of manufacturing changes all influence whether the finished product can support the intended regulatory pathway. The UK facility is designed to offer that capability without requiring companies to send every early-stage manufacturing project overseas.
The cleanroom classification describes the control of airborne particles in the specified manufacturing space; it does not by itself establish that a completed implant is sterile or clinically approved. A certified quality management system similarly supports documented production and control of processes, but it cannot substitute for evidence of a particular product’s safety, performance and suitability for implantation.
The centre supports manufacture of Class IIb and Class III medical devices, including active implants and complex surgical instruments for first-in-human research. Its public information sets out technical and regulatory services associated with that remit. The Ceryx announcement does not establish the final regulatory status of the new pacemaker, and its manufacture at MAISI should not be described as authorisation to treat patients with the implanted device.
Earlier clinical work has examined Ceryx’s biomimetic pacing approach using different equipment. Its RSA-Pace study, led by Professor Zaheer Yousef, delivered respiratory-linked pacing to patients through an external pacing system. Ceryx says that study has been completed and that full results will be reported separately. The company has not supplied detailed outcomes that would allow the benefit of the newly manufactured implant to be quantified.
Because the prior study used external pacing, its completion is not evidence that patients have already received the new MAISI-manufactured implant. Preclinical testing of the implant is the next step, followed by further studies intended to establish its clinical benefit. Any assessment will need to address the functioning of the device and the physiological response to its pacing approach, within the applicable regulatory and clinical requirements.
Dr Stuart Plant, chief executive of Ceryx Medical, said: “Seeing the first implantable device come off the line is a moment the whole team has worked towards for years.” He highlighted the opportunity to manufacture the equipment in the UK, with specialist quality and regulatory support available at the same facility.
Professor Anne Vanhoestenberghe, professor of active implantable medical devices at King’s College London and director of MAISI, said the centre was established to give developers a route from promising designs to devices manufactured under conditions appropriate for clinical translation. The Ceryx project demonstrates the centre’s ability to complete an implant manufacturing programme, while the device’s remaining development stages will determine its clinical future.
Ceryx originated from research at the Universities of Bristol, Bath and Auckland and has received investment from BGF, Parkwalk Advisors and the Development Bank of Wales. Professor Yousef has joined the company as chief medical officer. With the first implant produced, the programme will proceed through preclinical evaluation ahead of a future study involving the implanted technology; the timetable for those later trials has not been disclosed.
