MedTech company, BellaSeno, is accelerating human trials of its proprietary breast scaffolds as it moves regenerative breast surgery toward clinical adoption
LEIPZIG, Germany and SYDNEY, June 30, 2026 (GLOBE NEWSWIRE) -- Thirty Australian women have now undergone life-changing restorative breast surgery using new absorbable scaffold technology specifically designed to regenerate lost breast tissue.
Following successful world-first human safety trials of its proprietary breast scaffolds, BellaSeno - a leading regenerative medical technology company - is now well underway with its pivotal trial, aiming to bring the technology to women all over the world.
Patients seeking restoration or augmentation of breast volume, shape, or both have undergone surgery using absorbable scaffolds made from 100 per cent medical grade polycaprolactone, a material that has been safely used in absorbable sutures for decades.
The scaffolds are inserted into the breast and seeded with the patient's own fat, acting as a protective framework for tissue growth, gradually regenerating breast volume and shape over one to two years.
BellaSeno's clinical program is led by internationally recognized surgeons and Principal Investigators Professor Owen Ung and Professor Anand Deva, both based in Australia.
"Clinicians who are looking at MRI scans in these patients a few years after receiving these scaffolds would say they were simply looking at normal breast tissue," Professor Deva said.
The initial human clinical investigation was the first-in-human safety study involving 19 patients between 2021 and 2023, with Professor Deva presenting the two-year outcomes at The Aesthetic MEET 2026 in Boston last month.
The results showed no scaffold-related complications such as?capsular contracture, infection, necrosis, calcification, oil cysts or scaffold removals?in the study cohort.
They also demonstrated?high patient-reported satisfaction,?with 83 per cent mean breast volume retention, and?soft, natural-feeling tissue outcomes.
New trials underway
BellaSeno's active Pivotal Clinical Trial launched in January 2026 in Australia. So far 11 patients have undergone scaffold surgery in the current trial with dozens more enrolled.
"There are now 30 women walking around the world who have had breast scaffold surgery across both trials. By the end of August, we expect that number will more than double as we have many more patients scheduled for surgery.
"By the time we conclude this trial, we will have generated a robust scientific evidence base focused on efficacy, safety, and longer-term patient outcomes," Prof. Deva said.
"It is without a doubt the most significant advancement we have seen in the field of breast surgery for decades. We have now entered the era of medical regeneration."
From evidence base to clinical adoption
Dr Mohit P. Chhaya, Co-Founder and Chief Executive Officer of BellaSeno, said the company's focus had always been on building evidence through science.
"When BellaSeno was founded, the ambition was not simply to develop a product, but to help advance a new regenerative approach to soft tissue restoration," Dr Chhaya said.
"The progress achieved to date reflects years of collaboration between scientists, engineers, surgeons and patients who share a common belief that future healthcare will increasingly involve technologies designed to unlock the body's own regenerative capacity.
"However, we are now considering the pathway from clinical investigation toward future commercialization and broader clinical access.
"Regenerative soft tissue surgery is no longer a futuristic idea. Dozens of patients have had these procedures, and many more are going to as part of human clinical studies, which are happening inside operating theatres now."
For more information on the Breast Scaffold Clinical Trial go to: bellaseno.com/breast-scaffold
About BellaSeno
BellaSeno GmbH is a clinical-stage regenerative medicine company developing next-generation absorbable scaffold technologies for soft-tissue and structural tissue applications. The company's proprietary platform combines well-known biomaterials, high-throughput additive manufacturing and advanced proprietary scaffold design to support the body's own tissue formation over time. BellaSeno is headquartered in Leipzig, Germany, with clinical and development activities in Europe and Australia.
Media contacts:
Ash Moore - ash.moore@bespokenagency.com.au
Sarah Morgan - sarah.morgan@bespokenagency.com.au
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