Oxford Brain Diagnostics (OBD) is preparing to launch its groundbreaking technology for the early diagnosis of dementia across the UK and US healthcare markets, following a wave of key regulatory approvals that mark a major milestone in the company’s growth.
Backed by growth capital investor BGF, the Oxford-based medtech firm will begin commercial deployment of its patented Cortical Disarray Measurement (CDM) software — a novel tool that can objectively measure neurodegeneration using standard MRI scans. By enabling earlier and more accurate assessments of brain health, the technology is poised to transform how conditions like Alzheimer’s are diagnosed and monitored.
The roll-out follows successful FDA 510(k) clearance and UKCA self-certification, which together provide the regulatory green light for entry into two of the world’s most significant healthcare markets. The company now aims to expand into hospitals, clinics and clinical research organisations that urgently need non-invasive, precision diagnostic tools.
“Neurodegenerative diseases represent a growing public health challenge,” said Dr Steven Chance, CEO and co-founder of OBD. “The support from BGF and our other partners has been instrumental in taking CDM from the lab to the clinic. We’re now in a position to bring hope to millions seeking clarity on their brain health.”
OBD was co-founded in 2019 by Dr Chance, a former Associate Professor of Neuroscience at Oxford University, and Professor Mark Jenkinson, an expert in neuroimaging. The CDM platform builds on decades of scientific research into the structural changes in the brain associated with Alzheimer’s and other neurodegenerative conditions.
The company gained early validation in 2020 when the US Food and Drug Administration (FDA) granted CDM Breakthrough Device Designation, recognising the tool’s potential in identifying early-stage Alzheimer’s in adults.
OBD’s commercial progress has been powered by a multi-million pound funding round in 2023, led by BGF, the UK and Ireland’s most active growth capital investor. Continued support also came from existing backers, including the Oxford Technology & Innovations Fund (OTIF).
“OBD’s progress over the past two years has been remarkable,” said Maggy Lau, investor at BGF. “The technology is truly differentiated, and its recent regulatory achievements show just how close it is to making a major impact. We’re proud to back a company tackling one of the most urgent and important challenges in healthcare today.”
The company has already begun forging strategic partnerships with pharmaceutical firms, helping to support clinical trials and drug development by offering a reliable and scalable method for evaluating patients. As new Alzheimer’s treatments emerge, demand for accurate diagnostic tools is expected to surge — a gap OBD is now well placed to fill.
While CDM’s initial focus is on Alzheimer’s, its broader applications are already being explored. Early studies show potential in diagnosing and tracking other neurodegenerative diseases, including Parkinson’s Disease and Multiple Sclerosis.
With global dementia cases expected to double every 20 years, the need for early and accurate diagnostics has never been more pressing. OBD’s breakthrough signals a shift in how brain health can be evaluated, tracked and ultimately treated, moving beyond symptoms to deliver data-driven, proactive care.
As the UK and US roll-outs begin, OBD’s platform could soon become a central tool in both clinical settings and pharmaceutical pipelines, offering a new lens through which neurodegeneration can be understood — and tackled.