World-first breast augmentation using absorbable 3D-printed scaffolds performed in Sydney

A landmark procedure at Macquarie University marks a major milestone in an Australian pivotal trial.

SYDNEY - Tuesday August 11, 2026

BellaSeno's absorbable 3D-printed scaffold technology has just been used in a world-first primary breast augmentation procedure at Macquarie University as part of a pivotal trial.

The landmark procedure was performed on Monday August 10 by Professor Anand Deva, Head of Plastic and Reconstructive Surgery at Macquarie University and the Director of the Integrated Specialist Healthcare Education & Research Foundation (ISHCERF).  

Professor Deva is Principal Investigator of the pivotal trial, which is being conducted by Macquarie University and ISHCERF using BellaSeno's absorbable 3D-printed scaffold technology.

The patient is the first participant treated in the planned 53-person primary augmentation component of the trial. The milestone extends the clinical investigation of BellaSeno's Breast Scaffold beyond women undergoing revision surgery after the removal of traditional breast implants and into women seeking breast augmentation for the first time.

The trial will evaluate the safety and performance of the scaffold, including its ability to provide temporary structural support, maintain space for tissue ingrowth over time, the developing tissue and longer-term patient outcomes.

The scaffold is manufactured from 100 per cent medical grade polycaprolactone, a material with a long history of use in absorbable medical devices.

Used in conjunction with the patient's own fat, the scaffold's open 3D architecture provides initial form and maintains space while the grafted fat integrates with surrounding tissue. The scaffold is designed to gradually resorb over time.  

Professor Deva said the trial reflected a growing need to provide women with options for breast augmentation that work naturally with the body.  

“What is exciting about this trial at Macquarie University and the technology, which was first developed in Australia 15 years ago, is that it could provide women with future options,” Professor Deva said.

“For decades, breast augmentation has relied on the same approach, a permanent implant to add volume.  

“Silicone implants have served women well and will remain an important option for many, and we are optimistic about the additional choices this new technology can offer.”  

Dr Mohit P. Chhaya, the Co-Founder and Chief Executive Officer of BellaSeno, described the procedure as a defining milestone in a journey that began with his PhD research in Queensland in 2011 and has since been advanced by engineers, scientists, surgeons and patients across Australia and Europe.

“For BellaSeno, this is the point at which 15 years of research, engineering and clinical collaboration enters an important new chapter,” Dr Chhaya said.

“Our Breast Scaffold was developed to provide temporary structure and work in conjunction with a patient's own tissue. Through this trial, we are now evaluating whether that approach may broaden the future choices available to women who want breast volume restoration or augmentation but may not want a permanent implant.

“This is BellaSeno's technology, but progress of this kind is only possible through close partnership with clinical investigators and research institutions. We are proud to be working with Macquarie University, ISHCERF and the Australian clinical community to build the evidence carefully and responsibly.”

‍Built on Australian first-in-human research

The primary augmentation procedure builds on BellaSeno's first-in-human safety investigation, led by Professor Owen Ung at Metro North Health's Comprehensive Breast Cancer Institute and the Herston Biofabrication Institute between 2021 and 2023.

This study involved 19 consecutive patients. Two-year results presented internationally in early 2026 reported no scaffold-related complications, high patient satisfaction and 83 per cent mean breast volume retention.  

The current pivotal trial, at Macquarie University, will continue to build on the clinical evidence across a broader patient population.

Metro North Health Professor Ung said this week’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.”

‍A collaborative clinical milestone

Walter Kmet, Chief Executive of Macquarie University Hospital, said the trial reflected the hospital’s role as a centre for clinical innovation backed by world-leading research.

“This first primary augmentation using an absorbable 3D-printed scaffold is an important milestone in the development of this promising technology,” Mr Kmet said.

“Supporting innovation through rigorous clinical research and patient-centred care is central to the ethos of Macquarie University Hospital, and we look forward to future trials on the path to developing this new technology.”

The primary augmentation component of the pivotal trial will continue to recruit eligible participants and follow outcomes over time.

For more information about the pivotal trial, including eligibility and participation details, visit bellaseno.com/breast-scaffold.

‍BellaSeno’s Breast Scaffold remains investigational and is being evaluated as part of a pivotal trial. Individual outcomes cannot be guaranteed.

About BellaSeno

BellaSeno GmbH is a clinical-stage medical technology company operating within the broader field of regenerative medicine. The company develops bioresorbable scaffold technologies for soft-tissue and structural tissue applications. Its proprietary platform combines established biomaterials, high-throughput additive manufacturing and advanced scaffold architecture to create temporary structural solutions that provide form, maintain space for tissue ingrowth and gradually resorb over time. BellaSeno is headquartered in Leipzig, Germany, with clinical and development activities across Europe and Australia.

About Macquarie University

Macquarie University is a leading Australian university built on collaboration between students, academics, industry and society. Since 1964, we have combined world-class research with practical innovation to help solve real-world challenges. Located on our Wallumattagal Campus in the heart of Australia’s largest hi-tech precinct, Macquarie is home to world-leading facilities including Australia’s only hospital on a university campus, the global headquarters of Cochlear and the Australian Genome Foundry. Our record of innovation spans wi-fi technology, synthetic funnel-web spider antivenom and agricultural sterilisation techniques, and today our researchers are advancing work in areas including motor neurone disease, Parkinson’s disease and dementia. Macquarie is ranked among the top one per cent of universities globally, with internationally recognised strengths in research, sustainability and student diversity.

Media contacts:

BellaSeno: Sarah Morgan, sarah.morgan@bespokenagency.com.au, 0421 664 969.
Macquarie University: Nicola Russell, Nicola.russell@mq.edu.au, 0478 263 504