Revolutionary Data from BellaSeno's Clinical Trials
At the 93rd Annual Plastic Surgery Meeting, BellaSeno GmbH presented promising data from their landmark study on scaffold-guided breast regeneration. This innovative approach showcases a statistically significant advantage over traditional fat grafting methods, boasting twice as high breast volume retention.
Study Overview: Safety and Performance
The clinical trial, spearheaded by Principal Investigator Professor Owen Ung, focused on the application of BellaSeno's 3D-printed resorbable breast scaffolds. The research, currently registered under ClinicalTrials.gov ID NCT05437757, aligns with BellaSeno's mission to enhance safety in breast reconstructive procedures. Results revealed that the company's scaffolds not only proved safe but also boosted patient satisfaction and overall well-being.
Significant Findings and Patient Outcomes
In this open-label, single-arm trial, 19 participants underwent breast implant revision surgery, where existing silicone implants were replaced with biodegradable scaffolds. Approximately half of the volume was filled with the patient’s own fat graft. Initial outcomes looked promising, as thirteen patients completed a 12-month follow-up and demonstrated no complications like explantation or infections, which are often associated with silicone implants.
Enhanced Volume Retention
One of the key findings from the first set of results indicated that the BellaSeno mPCL scaffolds allowed for 80% volume retention compared to only 60% from standard autologous fat grafts. Additionally, MRI imaging 12 months post-surgery confirmed excellent soft tissue retention, while patients reported substantial improvements in breast satisfaction and well-being.
Potential for Future Trials
Professor Owen Ung expressed enthusiasm regarding the results, highlighting the prospect of protected autologous reconstruction (PAR) as a revolutionary procedure for women seeking breast implant revision or reconstruction. The goal is to expand this study phase into an international multi-center trial, offering the transformative benefits of this innovative technology to a broader patient population worldwide.
Addressing Challenges of Traditional Procedures
Traditional breast augmentation and reconstruction rely heavily on silicone implants, which may lead to complications, including capsular contracture and ruptures. BellaSeno's approach using their resorbable scaffold, coupled with an autologous fat graft, provides a strategic alternative. Over time, these scaffolds naturally assimilate into bodily tissue, promoting safer outcomes while potentially catering to a wide array of applications, from aesthetic surgeries to interventions following mastectomy.
Building on Previous Research
This clinical trial is an extension of BellaSeno's prior successful studies, including the first-in-human trial for correcting pectus excavatum, based on the same scaffold technology—a study that received EU Market Authorization in the previous year. The ongoing research aims to thoroughly assess the long-term safety and efficacy of the mPCL scaffolds ahead of the anticipated conclusion results in the years to come.
About BellaSeno
BellaSeno GmbH is an innovative leader in the development of resorbable soft tissue and bone reconstruction implants utilizing advanced additive manufacturing techniques. Founded in 2015 and situated on the BioCity campus in Leipzig, Germany, the company holds ISO 13485 certification and has established a subsidiary in Australia. BellaSeno has garnered significant support from various investors, including governmental entities, facilitating their groundbreaking work in tissue engineering.
Contact Information
BellaSeno GmbH
Dr. Mohit Chhaya
Email: mohit.chhaya@bellaseno.com
Phone: +49 176 2283 9583
Media Inquiries
akampion
Dr. Ludger Wess / Ines-Regina Buth
Managing Partners
Email: info@akampion.com
Tel: +49 40 88 16 59 64
Tel: +49 30 23 63 27 68
Frequently Asked Questions
What is the primary focus of BellaSeno's clinical trial?
The clinical trial primarily focuses on assessing the safety and performance of BellaSeno's resorbable breast scaffolds in patients undergoing breast implant revision.
How does BellaSeno's technology compare to traditional methods?
BellaSeno's technology offers significantly better volume retention and reduced complication rates compared to traditional silicone implants and fat grafting methods.
What are the expected outcomes from the ongoing study?
The expected outcomes include long-term data on the safety, performance, and patient satisfaction relating to the use of mPCL scaffolds in breast surgeries.
Who leads the clinical trial?
Professor Owen Ung serves as the principal investigator, guiding the study aimed at breast reconstruction techniques.
What future plans does BellaSeno have for its research?
BellaSeno aims to expand its clinical trials into international multi-center studies to further validate the effectiveness of their innovative technology.
