BellaSeno Completes Two Clinical Trials with Its Resorbable Breast Implants

BellaSeno GmbH announced that all 19 breast scaffold patients enrolled in its 2022 Australian breast augmentation revision trial have completed a one-year follow-up without any major scaffold-related complications or scaffold removals.

The one-year assessment confirms a favorable safety profile of BellaSeno´s resorbable soft tissue implants. No major complications, such as capsular contracture, calcifications, oil cysts, infections, tissue necrosis, or wound healing issues, were observed. No scaffold removals or replacements were necessary, and no scaffold-related complications were observed in any patients six months post-surgery.

In a parallel Australian clinical trial, 7 pectus excavatum patients have successfully passed their one-year follow-up. The trials are the first-ever implant trials combining polycaprolactone (PCL) scaffolds, ultimately resulting in a fully resorbed implant and natural tissue. The data show that it is possible to replace silicone implants in breast augmentation with alternatives offering improved safety and quality of life.

“This is a very encouraging one-year clinical outcome,” said Mohit Chhaya, CEO of BellaSeno. “The data confirm that our resorbable scaffolds do not only meet the desired safety criteria but also show an improvement of patients´ quality of life. We now have a very strong clinical data set to initiate a pivotal study of our resorbable breast scaffolds in the U.S. and Europe. We will also expand the use of our scaffolds to primary breast augmentation and lumpectomy and also provide a final two-year follow-up next year.”

The trials are sponsored, single-arm, open, mono-centric, interventional, prospective clinical investigation studies in patients requiring breast augmentation revisions or surgical pectus excavatum correction. The primary endpoint is post-operative device safety, secondary endpoints are post-operative patient safety and post-operative device performance (QOL, volume replacement).

The one-year data review by the Independent Data Safety Monitoring Committee stated that all adverse events were within the expected range of complications for removal/replacement surgeries. There was high acceptability; patients were pain-free and did not report awareness of the scaffold in situ after twelve months. Identical findings were made in the one-year follow-up in pectus excavatum patients.