- One-year follow-up data show BellaSeno’s scaffolds have a favorable safety profile compared to silicone implants.
- The company plans to expand use of its scaffolds to primary breast augmentation and lumpectomy procedures.
Leipzig, Germany/ Brisbane, Australia, January 14, 2025 – BellaSeno GmbH, an ISO 13485-certified medical technology company specializing in resorbable scaffolds produced via additive manufacturing, today announced the successful completion of a one-year follow-up for all 19 patients in an Australian breast augmentation revision trial. No major scaffold-related complications or removals were reported. A parallel Australian clinical trial involving 7 pectus excavatum patients also showed successful one-year results. These trials mark the first use of a novel polycaprolactone (PCL) scaffold approach, leading to complete resorption and natural tissue regeneration. The results demonstrate a safe and effective silicone implant alternative, improving patient safety and quality of life.
The trials were single-arm, open-label, prospective studies focused on patients needing breast augmentation revisions or pectus excavatum correction. The primary endpoint was post-operative device safety; secondary endpoints included overall patient safety and device performance (quality of life and volume replacement).
The one-year assessment revealed a highly favorable safety profile for BellaSeno’s resorbable soft tissue implants. No significant complications, such as capsular contracture, calcifications, oil cysts, infections, tissue necrosis, or wound healing problems, were observed. No scaffold removals or replacements were needed, and no scaffold-related issues occurred six months post-surgery.
The Independent Data Safety Monitoring Committee’s one-year data review indicated that all adverse events fell within the expected range for removal/replacement surgeries. Clinical investigators reported higher patient satisfaction and improved quality of life with BellaSeno’s scaffolds than with silicone implants. Patient acceptance was high, with individuals reporting pain-free experiences and no awareness of the scaffold after twelve months. Similar results were seen in the pectus excavatum patient group.
“These encouraging one-year clinical results,” stated Mohit Chhaya, BellaSeno’s CEO, “demonstrate that our resorbable scaffolds not only meet safety standards but also enhance patients’ quality of life. This robust clinical data set allows us to initiate a pivotal study in the U.S. and Europe. We will also expand our scaffold application to primary breast augmentation and lumpectomy and provide a complete two-year follow-up next year.”
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About BellaSeno
Founded in 2015, BellaSeno GmbH is based at BioCity Leipzig, Germany, with a subsidiary in Brisbane, Australia. The ISO 13485-certified company develops innovative resorbable soft tissue and bone reconstruction implants using additive manufacturing (3D-printing). BellaSeno has received significant funding from private investors, the Saxony Development Bank (SAB), the European Fund for Regional Development (EFRE), Germany’s Federal Ministry of Education and Research (BMBF), and the Australian government. Funding includes tax resources approved by the Saxony State Parliament.
Contact BellaSeno
BellaSeno GmbH
Dr. Mohit Chhaya
mohit.chhaya@bellaseno.com
Tel.: +49 176 2283 9583
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