Key Highlights

• Ceretas enrolled its first patient in CERE-CALM at the end of October 2026.

• The study tests focused ultrasound for Alzheimer's.

• It is the company's first company-sponsored efficacy study.

• Ceretas is a medical technology company.

Ceretas (ASX:CTS) has moved from preparing to running its first company-sponsored efficacy study. At the end of October 2026 it announced that the first patient had been enrolled in CERE-CALM, a Phase 2 trial of its portable therapeutic ultrasound device in Alzheimer's disease.

What the device does

Ceretas (ASX:CTS) is a medical technology company, classified by the ASX under Health Care Equipment and Services. It is developing a non-invasive platform that sends low-intensity focused ultrasound through the skull.

The company points to two mechanisms: neuromodulation of circuits involved in memory, cognition and behaviour, and temporary opening of the blood-brain barrier, which might help clear disease-related proteins and assist drug delivery. Both remain subjects of clinical research rather than established treatment.

The trial

CERE-CALM is randomised, double-blind and sham-controlled, enrolling adults aged 50 and over with probable Alzheimer's disease and behavioural and psychological symptoms of dementia. The target is 66 participants, with a minimum of 60, split two to one between active treatment and sham.

Each participant receives six sessions over 12 weeks. The primary endpoint is the change in the Neuropsychiatric Inventory total score from baseline to week six.

Recruitment has begun at Cognivus Research in Sydney, with St Vincent's Hospital Sydney and the John Hunter Medical Research Institute expected to follow. Completion is expected in the first half of 2028, and Ceretas (ASX:CTS) says the trial is fully funded with A$3.4 million of IPO proceeds allocated to it.

Evidence so far

The only human data comes from a 2024 Phase 1 study of 12 Alzheimer's patients run by the Queensland Brain Institute, which found the treatment safe, fast and well tolerated with early signs of behavioural benefit. It was published in Brain Communications in December 2025.

That is a very small, uncontrolled sample, so Phase 2 is the first real test of whether any benefit exceeds the sham effect.

Separately, the Queensland Brain Institute is running its own Phase 2 study, AGIFUS, on Alzheimer's-related agitation with the same technology, funded by Queensland Health. Ceretas (ASX:CTS) does not sponsor that trial, but its results would add to the evidence base.

Money and milestones

Ceretas (ASX:CTS) listed on 23 July 2026 after raising A$8 million before costs from 32 million shares at A$0.25. For the year to 30 June 2026 it reported total income of A$1.28 million, mostly grants, a net loss of A$1.63 million and cash of A$1.19 million, before the float.

In the September 2026 quarter, cash at 30 September stood at A$7.05 million after a net operating outflow of A$1.31 million, which the company says equates to 5.4 quarters of funding. The final A$692,578 Tranche of a A$2.4 million CUREator+ grant arrived in October after the third milestone was completed.

That milestone delivered an in-house neuronavigation software prototype, which the company says reduces the operators needed from two to one, and a lift-assist device for positioning the probe, co-designed with Melbourne developer Planet Innovation. Development of the broader programme is described as on track for mid-2027.

The licensed intellectual property was assigned to Ceretas (ASX:CTS) by UniQuest on 16 July 2026 in return for one million shares and a nominal fee.

Risks

Most neurodegeneration trials Fail to confirm early signals, and a 66-person study may be too small to detect a modest effect. Behavioural symptoms are subjective to rate, which raises the importance of the sham comparison.

The directors' FY26 accounts said there is no material uncertainty about going concern, but the company has no product revenue, depends on grants and capital markets, and faces lengthy regulatory approval processes before any commercial sale could occur. Recruitment pace across several sites is another variable, and the trial is expected to run for more than a year.