BellaSeno GmbH, an ISO 13485-certified medtech company developing resorbable scaffolds using additive manufacturing technologies, has reported encouraging one-year follow-up data of its 3D printed breast and pectus excavatum scaffolds.
Both pectus and breast implants demonstrated a very good safety profile, were very well accepted by the surgeons, and patients expressed high satisfaction and reported an improvement in quality of life. A significant improvement in pain scores was observed in breast reconstruction patients with prior silicone implants. All patients’ breasts maintained their shape and volume after surgery.
The majority of patients enrolled in the trial have been treated already (13 of 20 breast, and 9 of 10 pectus reconstruction patients, respectively) and it is expected that all patients will undergo surgery by the end of this year. BellaSeno is therefore planning an expansion of the trial into a multi-center study with several trial sites in Europe and Australia.
With its resorbable breast and pectus excavatum scaffolds, BellaSeno has developed leading-edge 3D printed products for plastic and reconstructive surgeries. The company has already demonstrated superior properties of its medical scaffolds and reported the data at scientific meetings and in peer-reviewed publications.
“The positive one-year follow-up is a key milestone for our breast and pectus excavatum scaffolds,” said Mohit Chhaya, CEO of BellaSeno. “The data brings us closer to realizing our vision of providing breakthrough innovations in the world of breast surgery by offering personalized care options. First-in-human data have been very promising so far, demonstrating excellent safety of the scaffolds and high acceptance of the products among surgeons and patients. Moreover, patient recruitment is going well, which confirms that there is a significant need for alternatives to silicone implants.”
BellaSeno’s ISO 13485-certified manufacturing platform is designed to meet the requirements of medical scaffolds ranging from soft tissue to bone and enables the production of both custom-made and off-the-shelf sterile medical implants.