Clinical-stage medtech BellaSeno, a company founded in Australia and now based in Germany, is ramping up human trials of its proprietary absorbable breast scaffolds, with 30 Australian women having undergone scaffold surgery across two clinical trials as the company pushes toward commercialisation of what it describes as a new approach to soft tissue restoration.
The announcement comes less than a month after BellaSeno revealed a worldwide collaboration with Mentor Worldwide LLC, part of Johnson & Johnson MedTech, signalling growing interest from major medtech players in scaffold-guided regeneration as an alternative to traditional inert silicone implants.
BellaSeno launched an active pivotal clinical trial in January this year that has enrolled 11 patients so far. The company expects the total number of patients across both trials to more than double by the end of next month.
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 recognised 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,” says Deva.
Results from BellaSeno's first-in-human safety study, which ran from 2021 to 2023 and involved 19 patients, showed no major scaffold-related complications and 83 per cent mean breast volume retention at two-year follow-up.
Typical scaffold-related complications can include capsular contracture, infection, necrosis, calcification and oil cysts.
“There are now 30 women walking around the world who have had breast scaffold surgery across both trials," says Deva.
"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.
“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.”
Research for BellaSeno's technology began at QUT in 2011 in collaboration with the Technical University in Germany.
The story is a personal one for BellaSeno co-founder and CEO Dr Mohit P. Chhaya, whose grandmother was diagnosed with breast cancer in the 1990s and went through a lumpectomy when reconstruction options were very limited.
That experience shaped the direction of his research, with his PhD focused on 3D printing and computer-aided design to engineer tissue for breast reconstruction.
"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," says Chhaya.
"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 commercialisation 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.”
BellaSeno is headquartered in Leipzig but also retains a strong presence in Australia.
The move to ramp up clinical trials comes on the heels of BellaSeno's global licensing and collaboration agreement with Johnson & Johnson subsidiary Mentor Worldwide announced in early June.
The partnership aims to advance regenerative soft-tissue reconstruction and bring these technologies closer to mainstream commercialisation.
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