Ceryx Medical
Ceryx Medical (Ceryx), a bioelectronic medtech company developing a new class of heart failure therapy, and King’s College London today announced that the first implantable device has been manufactured at MAISI, the national facility for the Manufacture of Active Implants and Surgical Instruments.
The device is Ceryx’s implantable bioelectronic pacemaker, designed to restore the natural coupling between breathing and heart rhythm in patients with heart failure. It is the first implantable device Ceryx has manufactured, and the first implantable device MAISI has produced since the facility opened.
Located at the St Thomas’ MedTech Hub in London, MAISI was established by King’s College London’s School of Biomedical Engineering & Imaging Sciences, in partnership with UCL and Newcastle University, with the support of a £5.2 million grant from Wellcome, and opened in 2023. It operates two ISO-7 cleanrooms within a certified quality management system, and exists to address a long-standing gap in the UK: the lack of specialized, regulated manufacturing capacity for complex active implants intended for human studies.
That gap has historically forced UK companies developing active implantable devices to look overseas for small-batch manufacture, adding cost and delay at the most fragile stage of a company’s development. Building the device at MAISI has allowed Ceryx to manufacture under a certified quality system in the UK, alongside the regulatory expertise needed to support the route to clinical use.
"Seeing the first implantable device come off the line is a moment the whole team has worked towards for years. It matters a great deal that we were able to do it here in the UK. MAISI is exactly the kind of infrastructure this country has been missing, and the fact that a Welsh company can build an active implantable device in London, under a certified quality system, with a regulatory team alongside, says something important about where UK medtech is heading," said Ceryx CEO Dr. Stuart Plant in a statement.
"MAISI was built for precisely this — to give UK innovators a route from a promising design to a device manufactured to the standards that clinical translation demands. Producing our first implantable device with Ceryx proves the facility works as it was intended to, and we are proud that the first one through is a device with the potential to change the outlook for people living with heart failure," said Professor Anne Vanhoestenberghe, professor of active implantable medical devices at King’s College London and Director of MAISI, in a statement.
The milestone follows the completion of Ceryx’s RSA-Pace clinical study, led by Professor Zaheer Yousef OBE, who has recently joined the company as Chief Medical Officer. In the study, Ceryx’s biomimetic pacing was delivered to patients via an external pacing system; full results will be reported in due course. The new implantable device now enters preclinical testing, ahead of a study to demonstrate its full benefit to patients.
Ceryx Medical said it has attracted interest from partners and investors in the UK and abroad, with backing from leading medtech investors including BGF, Parkwalk Advisors and the Development Bank of Wales.
