BellaSeno Gets European Approval for 3D-Printed Bone and Chest Wall Implants

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BellaSeno Receives European Authorization/ Source: Medical Plastic News

German medical technology firm BellaSeno GmbH, founded in 2015, creates unique resorbable 3D printed soft tissue and bone reconstruction implants. This summer, the business said it will conduct two clinical studies in Australia on its 3D printed breast and chest implant solutions. The European Union recently authorized the use of the ISO 13485-certified clinical stage medical device company’s individualized 3D printed bone and pectus excavatum scaffolds in accordance with EU medical device standards. With access to the European market, BellaSeno will be able to commercialize its 3D-printed regenerative medicine solutions.

The company’s custom scaffolds for pectus excavatum, a common congenital deformity of the chest wall in which the breastbone is sunken into the chest, are among the first 3D printed regenerative medicine products that can be used in reconstructive and plastic surgeries. These unique scaffolds are 3D printed from a completely resorbable PCL material, and are used by expert engineers and treating surgeons to produce a camouflage for these intricate problems. In time, the patient’s own tissue will have grown into and replaced the scaffold, and no foreign materials will have been left behind.

BellaSeno Receives European Authorization

BellaSeno Receives European Authorization
BellaSeno’ 3D Printed Bone and Chest Wall Implants/ Source: Design news

Our resorbable implants are safe, well tolerated, and expand the possibilities of autologous tissue transplants, as shown by the early findings from the first patients. According to Dr. med. Tobias Grossner, the Chief Medical Officer of BellaSeno, “we are convinced that our approach bears the potential for a paradigm change in regenerative surgery, a field that is in need of innovation to restore complex three-dimensional structures.”

The company’s proprietary AM technology platform satisfies the requirements of medical scaffolds for both soft tissue and bone, and its AI-driven, no-touch manufacturing process enables the automated production of medical devices and products with personalized characteristics, high patient safety, and scalability. BellaSeno utilizes this system to create a variety of standard and personalized sterile medical implants and scaffolds.

Also read: First Private 3D-Printed Residential Villa Construction in Dubai

BellaSeno’s proprietary design software makes it possible for the company to create 3D unit-cell based designs that maximize both strength and adaptability. The website claims that the implant’s open porosity architecture allows for vascularization at the regeneration site and complete integration into the body (i.e., no encapsulation).

For complex, massive bone deformities, the company’s 3D-printed PCL scaffolds are not only resorbable and adaptable, but also possess “dynamic mechanical compressability.” In order to “securely retain” autologous and allogenic bone transplants within the segmental defects and voids of a bone, the scaffolds serve as cages for the grafts. When compared to the conventional autograft strategy for bone regeneration, which is unstable and cannot be packed into voids under precise control, this method represents an improvement.

BellaSeno isn’t just talking the talk, either; the company has shown that its 3D printed medical scaffolds have superior mechanical properties, withstanding more stress cycles and more weight than rivals at the European Federation of National Associations of Orthopaedics and Traumatology (EFORT) Congress. In addition, 3D printed resorbable bone scaffolds fabricated from Evonik’s Resomer polymers were granted FDA clearance earlier this year.

We are pleased to announce that our specialized bone and pectus excavatum scaffolds will soon be available in the European market. To yet, clinical data from patients who have received the scaffolds has been quite positive,” stated Mohit Chhaya, CEO of BellaSeno. Our off-the-shelf breast implants are ideal for both breast reconstruction and cosmetic surgery, and we are currently applying for market authorizations in other locations and for more items. Our flexible and cutting-edge production infrastructure positions us favorably to become a diverse portfolio firm.

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