BellaSeno GmbH announced positive one-year follow-up data from two clinical trials evaluating its novel resorbable breast implants. The trials, conducted in Australia, assessed the safety and efficacy of polycaprolactone (PCL) scaffolds in breast augmentation revision and pectus excavatum correction. Results indicated a favorable safety profile and improved patient satisfaction compared to traditional silicone implants.
The trials represent a significant step forward in the field of reconstructive surgery, offering a potential alternative to silicone implants. The approach utilizes 3D-printed PCL scaffolds that are gradually resorbed by the body, leaving behind natural tissue. This eliminates the long-term risks associated with silicone implants, such as capsular contracture and implant rupture.
Clinical Trial Details
The clinical trials were single-arm, open, mono-centric, interventional, prospective clinical investigation studies. Nineteen patients undergoing breast augmentation revision and seven patients undergoing pectus excavatum correction were enrolled. The primary endpoint was post-operative device safety, while secondary endpoints included post-operative patient safety and device performance, measured by quality of life (QOL) and volume replacement.
Key Findings
The one-year assessment revealed no major complications related to the scaffolds, such as capsular contracture, calcifications, oil cysts, infections, tissue necrosis, or wound healing issues. No scaffold removals or replacements were necessary. An Independent Data Safety Monitoring Committee confirmed that all adverse events were within the expected range for removal/replacement surgeries.
Clinical investigators reported higher patient satisfaction with their breasts and improved quality of life compared to baseline (silicone implants). Patients reported being pain-free and unaware of the scaffold's presence after twelve months. Similar findings were observed in the pectus excavatum patients.
Future Directions
"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."
BellaSeno plans to expand the use of its resorbable scaffolds to primary breast augmentation and lumpectomy procedures. The company is also planning a pivotal study in the U.S. and Europe to further evaluate the safety and efficacy of its technology.
