BellaSeno Moves into Trauma Care with 3D Printed Patient-specific Bone Scaffold

BellaSeno, already exploring significant opportunities with its custom resorbable breast implants entering clinical trials, is expanding its scope. The company has received market approval for its bone scaffold product and is venturing beyond its initial focus. It highlights a case where its resorbable scaffolds were utilized in a trauma situation, specifically for a patient with an infected radial shaft resulting from a bullet wound. This case has been documented in the Journal of Personalized Medicine, indicating the company’s commitment to diversifying its applications in medical treatments.

A team at Hannover Medical School‘s Clinic for Trauma Surgery created a custom scaffold to aid in the healing of a patient’s arm. This patient had previously undergone over six surgeries to repair the trauma and promote wound healing. In this instance, Professor Philipp Mommsen and his team harvested a bone graft from the patient’s femur and combined it with an Evonik Resomer scaffold. This composite was used to repair a 14-centimeter section of the bone. The scaffold, optimized for vascularization, was automatically constructed from polycaprolactone.

“As the example of the 46-year-old patients demonstrates, sophisticated solutions to treat large bone defects are scarce. BellaSeno’s scaffold enabled us to conduct a new surgical technique for graft vascularization by embedding a vascular muscle arcade directly into a patient-specific, 3D-printed bioresorbable scaffold. This surgical procedure represents an innovative and promising approach for the restoration of extensive bone defects. As we see an increasing number of such catastrophic and very difficult to treat defects we are facing a rapidly growing medical need to reconstruct such injuries,” said Professor Philipp Mommsen of the Clinic for Trauma Surgery at Hannover Medical School.

“The sheer size of such defects and the lack of vascularization have limited the optimal treatment of large-volume bone defects. Using one of our scaffolds, the outstanding team at Hannover Medical School was able to perform the reconstruction of such an extensive radial shaft bone while ensuring immediate vascularization. This demonstrates the power of our technology to improve the surgical treatment of large bone defects, individually customized to the specific anatomy of the patient and the design preferences of the surgeon,” BellaSeno CMO Tobias Grossner stated.

Dr. Mohit Chhaya the CEO of BellaSeno said,

“The open structure of the scaffold enables vascularization which is crucial not only for proper bone healing but also to allow access of immune cells and anti-microbial drugs to prevent surgical site infections. We are currently working on next-generation bone scaffolds made of a composite of PCL and bio-active glass with anti-infective properties.”

The skepticism regarding personalized and customized medicine is understandable, especially when considering the logistical and safety concerns associated with producing nearly infinite variations in medical treatments or implants. Standardizing to a set range of sizes can indeed seem safer and more practical in many medical contexts. However, in specialized fields like trauma, wound care, and oncology surgery, the unique nature of each patient’s condition can make standardized solutions insufficient. In these cases, customized components can provide tailored solutions that significantly improve outcomes.

The concern about long-term presence of polymers or metals in the body is valid, given the potential risks and side effects, many of which may not be fully understood. Resorbable implants, such as those made from Evonik materials, offer a safer alternative as they are designed to dissolve into the body over time, reducing the risk of long-term complications.

Polycaprolactone is particularly notable for its flexibility, safety, and compatibility with the human body, making it an excellent material for medical applications. Your enthusiasm for the advancements in customized polycaprolactone implants and medical devices is well-founded. These innovations, led by companies like BellaSeno, represent a significant area of interest for the future of medical treatment and have the potential to transform patient care, particularly in areas where traditional solutions fall short.