German medical startup BellaSeno has enrolled 30 patients across two Australian trials of a polycaprolactone breast scaffold designed to regenerate tissue without leaving a permanent foreign body.
The 30 patients are spread across a first-in-human safety study that ran from 2021 to 2023 and enrolled 19 patients, and a pivotal trial launched in January 2026 in which 11 patients have so far undergone surgery, with more enrolled. The company expects the total patient count to exceed 60 by the end of August.
“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 Anand Deva said.
Early Trial Shows Promising Results
The first clinical test of that approach involved 19 patients, and two-year outcomes were presented at The Aesthetic MEET 2026 in Boston in June by Professor Deva, one of two principal investigators on the program alongside Professor Owen Ung.
The results showed no scaffold-related complications across the cohort, including no cases of capsular contracture, infection, necrosis, calcification, oil cysts, or scaffold removals. Patient-reported satisfaction was high, and mean breast volume retention stood at 83%.
Those results come from a field where the breast implant industry, despite generating billions in annual revenue globally, has spent decades contending with well-documented complications from silicone and saline devices, including capsular contracture, implant rupture, and a rare associated lymphoma.
Instead, the scaffolds are made from medical-grade polycaprolactone, a biodegradable polymer used in absorbable sutures since the 1970s. Surgeons insert the scaffold and seed it with fat harvested from the patient. The structure acts as a temporary framework for tissue ingrowth and resorbs over one to two years, leaving behind regenerated soft tissue.
Those results, while encouraging, are early-stage evidence, and the pivotal trial is designed to generate the larger, longer-term dataset that regulators typically require before approving a device for broad clinical use.
Clinical Evidence Shapes Regulatory Outlook
A scaffold that fully resorbs removes the long-term liability carried by permanent implants, which is what the trial data will need to demonstrate at scale. If the pivotal trial confirms the safety and volume-retention results from the earlier cohort, BellaSeno would have the clinical evidence needed to support regulatory submissions in major markets.
Whether that translates into regulatory clearance and commercial viability depends on how the data holds up, and on how quickly the company can move through the approval process in its target markets.
How far that evidence base extends across the field becomes clear when looking at Conexeu Sciences, which listed on Nasdaq in May 2026 while still in the preclinical stage, meaning it has not yet generated human safety data.
Conexeu’s Nasdaq debut without human trial data illustrates how early the regenerative breast device field still is. BellaSeno’s two years of human outcomes data, however limited in scale, places it among the few regenerative breast scaffold developers with published human clinical outcomes.
Previously, France-based Lattice Medical completed its first-in-human implantation of the Mattisse device in October 2022 and is currently running the TIDE clinical study, which targets up to 50 patients. CE marking has not yet been granted. That timeline gives BellaSeno’s pivotal trial, which launched in January 2026, a concrete reference point for how long the regulatory path in this category can take.
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Featured image shows BellaSeno’s polycaprolactone breast scaffold shown in situ. Image via BellaSeno.
