First Patient Treated in MARGIN Clinical Study

Monday, 16 February 2026

From left to right: Natarsha Coghlan (FSHFHG Study Coordinator), Skandha Shanthakumar (OncoRes), Georgia Gould (OncoRes), Dr. Jose Fernandez (Breast Surgeon - Consultant), Dr. Fiona Bellamy (Breast Surgeon Fellow), Imogen Boman (OncoRes).

OncoRes Medical is pleased to announce that the first patient has been enrolled and treated in the Company’s MARGIN clinical trial.

The inaugural procedure was led by the team at Fiona Stanley Hospital, who have been long-standing collaborators of OncoRes. The case marks the first interventional use of our imaging technology, where surgeons may use the device’s outputs to guide decision-making during breast-conserving surgery.

This significant milestone advances the Company’s clinical program into the interventional evaluation phase, reflecting extensive work undertaken across OncoRes’ engineering, clinical and regulatory teams to prepare the technology and participating sites for trial commencement.

Breast cancer remains the most common cancer, the second most common cause of death from cancer in American women. In the U.S. alone, over 370,000 women and men will be diagnosed with breast cancer this year. Around two-thirds of those women will elect to undergo breast-conserving surgery in preference to mastectomy to surgically excise the tumour and preserve the appearance and function of their breast.

OncoRes CEO, Dr Katharine Giles, explains how 20 per cent of those women will require a second operation.

“Approximately one in five women who undergo BCS are required to return to theatre for a repeat operation to remove residual tumour. These repeat operations carry a higher risk of complications and create significant psychological, physical, and financial burdens for patients, their families and the healthcare system – this is something we are working hard to change,” said Dr Giles.

The MARGIN study will recruit more than 110 patients across six hospitals in Western Australia and Victoria. The trial is designed to evaluate the clinical utility of providing surgeons with additional intraoperative insight during breast-conserving surgery[ST1.1], with the goal of supporting surgical precision and improving patient outcomes.

With MARGIN now underway, the Company moves into its next phase of clinical execution - generating prospective interventional data to support our broader regulatory and commercial objectives.

We thank the team at Fiona Stanley team for their leadership in initiating the study and look forward to progressing enrolment across all participating sites in the months ahead.