BellaSeno GmbH, an ISO 13485-certified medtech company with a cutting-edge approach to additive manufacturing technologies, has just reported highly encouraging interim results from two clinical trials of its products sponsored by its Australian arm, BellaSeno Pty.
The groundbreaking findings were delivered at the 91st Annual Scientific Congress 2023 of the Royal Australasian College of Surgeons (RACS), sparking excitement amongst the medical fraternity and beyond.
Principal Investigator of the first clinical trial evaluating BellaSeno’s implant with autologous fat grafting for pectus excavatum camouflage, Michael Wagels, presented exciting 3-year data from the first in-human case, confirming the safety and well-tolerance of the implant.
Further, histologic studies demonstrated tissue growth and vascularization within the implant scaffold. Wagels also reported animal data from large 450 ccm scaffolds, showing full regeneration of tissue without the development of necrosis – a major breakthrough!
At a recent clinical trial update, Professor Owen Ung, M.D., presented promising initial data on the use of BellaSeno’s breast scaffold implantation with autogenous fat grafting for breast implant revision and congenital defect surgery. This clinical trial, which is enrolling up to 20 patients, has the potential to revolutionize the field of breast augmentation and reconstruction.
Professor Ung’s presentation highlighted the safety, efficacy, and comfort of using BellaSeno’s innovative approach, which has the potential to drastically improve outcomes for patients undergoing breast implant revision or congenital breast defect surgery.
Patients who received large implant scaffolds of up to 200 ccm were among the first to experience the positive benefits of this innovative procedure. Not only were impressive tissue retention results observed as soon as two months after surgery, but patient satisfaction was also evident in the marked improvement in quality of life scores.
At BellaSeno, our team is thrilled to report the successful results of our tissue implant studies. Not only were the implants found to be safe, but they also resulted in the development of tissue within the scaffolds, including vascularization. Most importantly, our patients have expressed that the implants have positively impacted their quality of life. We are delighted to have achieved such positive results.
Dr. med. Tobias Grossner, CMO of BellaSeno, expressed his excitement at the groundbreaking results of both animal studies and patient data, which show that the implantation of resorbable scaffolds is not only safe and well tolerated, but also yields results that closely resemble natural tissue. He eagerly awaits further results from BellaSeno’s ongoing studies.
For the first time ever, it has been proven that large volumes of clinically relevant tissue can be regenerated without the risk of necrosis, thanks to the technology developed by BellaSeno. This impressive breakthrough, achieved by Dr. Michael Wagels of the Herston Biofabrication Institute (HBI), Consultant Plastic and Reconstructive Surgeon at Princess Alexandra Hospital, Director of the Australian Centre for Complex Integrated Surgical Solutions (ACCISS) and Senior Lecturer at the University of Queensland, has opened up a world of possibilities when it comes to reconstructing large defects.
The current solutions for breast reconstruction come with a host of risks and complexities, making them costly and only suitable for small volumes. But BellaSeno’s implants offer a safer, simpler, and more cost-efficient alternative. Not only can they replace large volumes of tissue, but they also support cell attachment, migration, and proliferation.
What’s more, implantation can be completed in only one to two hours and patients can be discharged from the hospital the very next day. According to Prof. Owen Ung, Director of the Centre for Breast Health, Head of Breast and Endocrine Surgery at the Royal Brisbane and Women’s Hospital and Professor of Surgery at the University of Queensland Medical School, BellaSeno’s implants offer a superior solution to traditional breast reconstruction.
BellaSeno provides a revolutionary approach to breast augmentation, using AI-driven, no-touch additive manufacturing to create porous polycaprolactone scaffolds for implantation. These scaffolds are then grafted with the patient’s own fat tissue obtained through liposuction, allowing for the gradual and complete resorption of the scaffold and replacement with the patient’s own vascularized tissue. The result is a natural, long-lasting enhancement with no permanent foreign material in the body.
About BellaSeno
BellaSeno GmbH, a pioneering company specializing in the development of novel resorbable soft tissue and bone reconstruction implants created through additive manufacturing (3D-printing), was founded in 2015 and is headquartered at the BioCity campus in Leipzig, Germany.
With the support of private investors and governmental organizations such as 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, the Company has been able to establish a subsidiary in Brisbane, Australia and is certified under ISO 13485. With the support of these tax resources, BellaSeno GmbH is well-positioned to continue to push the boundaries of 3D-printing technology.
About Senella®
Senella®, a patented PCL scaffold, is designed to revolutionize the world of breast reconstruction and augmentation. By providing a safe and stable platform for fat tissue harvested through liposuction, this innovative implant is designed to get absorbed over a span of up to five years, resulting in a natural soft tissue with no foreign material residue. Senella® provides an opportunity to avoid the complications found with traditional methods, while delivering beautiful and lasting results.