Metro North breast scaffold research paves way for pivotal new trial
Prof Ung shares the results of the Phase 1 clinical trial.
A Metro North-led first-in-human safety study using bioresorbable breast scaffolds is paving the way for a pivotal new trial nationally, set to help more women sooner.
The joint initiative between Metro North Health’s Comprehensive Breast Cancer Institute and Herston Biofabrication Institute made history when it saw 19 patients undergo the Phase 1 clinical trial scaffold procedure using BellaSeno technology between 2021-2023, with no scaffold-related negative outcomes and high patient satisfaction reported.
The results of the study, presented internationally in 2026, demonstrated promise for further advancements with 83 per cent mean breast volume retention.
The 3D printed bioresorbable scaffolds, injected with the patient’s own fat cells, were proven to have provided a safe solution for those who had required breast reconstruction, with the end-goal of the research set to help women who have undergone mastectomy.
Now, BellaSeno has partnered with stakeholders including Macquarie University to commence its pivotal trial, set to advance the research so more women can benefit from the innovation.
Metro North Health breast surgeon and Director Comprehensive Breast Cancer Institute Professor Owen Ung, who led BellaSeno’s previous two-year first-in-human safety trial, said this month’s primary augmentation procedure was built on years of Australian-led clinical investigation and careful patient follow-up.
“The initial clinical investigation gave us important early evidence about the scaffold’s safety profile and patient outcomes, paving the way for this next phase and the possibility of helping more patients,” Professor Ung said.
“The next stage of this work is about continuing to build that evidence responsibly, with rigorous clinical oversight, longer-term follow-up and a clear focus on patient safety.
“Australia has played a central role in this research from the beginning, and this primary augmentation construction is a significant step in understanding how this technology may provide future options for people considering breast surgery.”
The current pivotal trial will further evaluate safety and performance of the scaffold, including its ability to provide temporary structural support, maintain space for tissue ingrowth over time, and longer-term patient outcomes.