Germany-based medtech company BellaSeno is developing solutions that could change the the standards for breast restoration and augmentation surgery. Using a combination of biomaterials, additive manufacturing, and a proprietary scaffold design, the company has created absorbable implants that promote the regeneration of breast tissue. While we’ve been following the company’s journey for several years now, its latest milestone suggests BellaSeno’s solution is nearing market readiness.

As part of ongoing clinical trials in Australia, 30 women have now successfully underdone restorative breast surgery using BellaSeno’s absorbable 3D printed scaffolds. 19 of these women were part of the company’s initial human clinical investigation, which took place between 2021 and 2023. The results of this trial, presented at an aesthetic surgery convention this past May by surgeon and principle investigator Professor Anand Deva, reportedly showed no scaffold-related complications and a high level of patient-reported satisfaction. In more measurable terms, this cohort had a 83% mean breast volume retention and natural-feeling tissue outcomes after two years.

“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.

Another 11 Australia patients received the 3D printed breast scaffolds as part of BellaSeno’s Pivotal Clinical Trial, which launched in January 2026. The company reports that dozens more women are also enrolled in this trial. “There are now 30 women walking around the world who have had breast scaffold surgery across both trials,” said Prof. 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.”

The scaffolds themselves are made entirely from a medical-grade polycaprolactone, a biodegradable polyester that already has medical applications, like absorbable sutures. Using a 3D printing technology the company can shape this material into complex scaffolds that have been engineered to “guide tissue formation”. In other words, the scaffolds are porous, which enables natural tissue to grow and eventually replace the printed structure in one to two years. In the surgical process, the 3D printed implant, which is tailored based on patient anatomy, is inserted into the body and seeded with fat cells from the patient. The fat protects the scaffold and facilitates tissue growth.

At this point, the company is continuing to build evidence for its innovative technology in clinical investigations while also starting to look to commercialization and broader clinical access. As Dr. Mohit P. Chhaya, co-founder and CEO of BellaSeno, said: “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.”