Six years after the first Stentrode was threaded into a blood vessel inside a human brain at the Royal Melbourne Hospital, Synchron is returning to Melbourne with a more advanced device and a broader trial. Surgery on the first patients in the FOCUS-AU study is scheduled for April, making it the first clinical trial anywhere in the world to test the company’s next-generation implant.
The trial will enrol ten patients with motor neurone disease across three hospitals: the Royal Melbourne Hospital and Alfred Hospital in Melbourne, and Liverpool Hospital in Sydney. Patients with other conditions, including spinal cord injury, may be considered in future phases.
Synchron’s approach remains distinct in the field. Where most brain-computer interface companies require a craniotomy to place electrodes directly on or into brain tissue, Synchron’s Stentrode reaches the motor cortex through the vascular system. A catheter is guided through a blood vessel in the neck and up into the brain, where a mesh of electrodes is deployed inside a vein adjacent to the motor cortex. The procedure is similar in technique to placing a cardiac stent and does not require open brain surgery.
The new device represents a significant step forward from the version used in Synchron’s earlier trials. According to Synchron chief executive Professor Tom Oxley, the updated Stentrode no longer requires an external module held near the skin and can recognise up to 16 different command outputs, compared with the two outputs available in the original device. That expanded command set allows for more granular control of digital devices, moving beyond simple click-and-cursor actions to a richer vocabulary of thought-driven inputs.
Professor Peter Mitchell, director of neurointervention services at the Royal Melbourne Hospital and the trial’s Melbourne site lead, will oversee the surgical procedures. Mitchell conducted the first-ever Stentrode implantation in a human patient during the SWITCH trial, which began at the hospital in 2020.
“Taking our thoughts and being able to do things to the external world just by thinking about it — I can’t think of anything quite that cutting-edge, leading-edge in neuroscience,” Mitchell told the Herald Sun in an exclusive report published on March 21. He described the electrodes as being arranged in a meshlike cylinder that opens to press against the wall of the vein, positioned within millimetres of the target area in the brain.
Dr Thanuja Dharmadasa, an RMH neurologist, Florey Institute researcher, and Melbourne site co-investigator, said the trial offered genuine hope to patients who have lost communication, independence, and autonomy to the disease.
The FOCUS-AU trial arrives at a moment of considerable momentum for Synchron. The company raised USD 200 million in a Series D round in November 2025, bringing total funding to USD 345 million. Australia’s National Reconstruction Fund Corporation took a separate AUD 54 million equity stake to support final clinical trials, US regulatory approval, and the establishment of a commercial hub in Australia. The company’s US-based COMMAND study, which implanted six patients with severe upper-limb paralysis at three American hospitals, reported positive 12-month safety and efficacy results at the Congress of Neurological Surgeons in September 2024, with no device-related serious adverse events resulting in death or permanent increased disability.
Synchron’s collaboration with Apple has also advanced the platform’s practical utility. In May 2025, Apple announced a new Brain-Computer Interface Human Interface Device protocol, formally recognising brain signals as a native input method alongside touch, keyboard, and voice. Synchron was the first company to achieve native BCI integration with iPhone, iPad, and Apple Vision Pro, and in August 2025 demonstrated thought-controlled iPad navigation for the first time. Oxley told the Herald Sun that patients in the new trial will be able to wake an Apple device, unlock it, and send messages entirely with their brain.
The human case for the technology is already well established. Rodney Gorham, a 65-year-old Melbourne man with MND, has lived with a first-generation Stentrode since the 2020 SWITCH trial. He uses two thought commands — one mapped to the intention to lift his foot, the other to hand movement — to operate a computer and iPad, allowing him to text, browse the internet, and check football scores. He has experimented with controlling smart home devices, including a pet feeder for his dog, using the implant alongside Apple VR goggles.
His wife Caroline described the trial as a saviour, noting that Gorham found the brain implant far more practical than eye-gaze tracking technology. Synchron engineer Zafahr Faraz, who has visited Gorham twice a week since 2020 for testing sessions, said the patient pushed the device’s limits, at one point running two iPads side by side — playing music on one while reading on the other.
Gorham’s MND has deteriorated significantly and he is now too fatigued to use the device outside testing sessions. But when asked by the Herald Sun whether he would do the trial again, he nodded several times.
Synchron was founded in Melbourne in 2012 by clinicians Tom Oxley, Nicholas Opie, and Rahul Sharma. Oxley, who conceived the idea while working as a doctor at the Alfred Hospital, now leads the company from New York. The return to Australian clinical sites for the FOCUS-AU trial brings the technology’s development full circle, from the laboratory benches of the University of Melbourne to what Synchron hopes will become a commercially approved product within the next few years.