Objective:

1. Bellaseno is developing resorbable scaffolds for soft tissue reconstruction.
2. Improvement of patient’s experience by using biodegradable scaffolds as soft tissue implants instead of silicone implants.
3. Bellaseno is aiming to design and develop a market-ready product for soft tissue regeneration following the ISO 13485 guidelines.

Alignment within M3D Innovation:

1. This project utilises additive manufactured scaffolds (multiscale manufacturing) and the development of a new manufacturing method.
2. Overlap with project P5-1: QA of 3D printed soft tissue scaffolds.

Approach:

1. Multiscale analysis and characterisation of soft tissue implants.
2. Scaffold development and validation for clinical studies.
3. Multiscale imaging (CT, MRI, Histological Imaging Analysis).
4. Design requirement analysis.
5. Product verification and regulatory development.

Key Milestones:

1. Product – Proof of Concept.
2. Product – Beta Prototypes, verification, patents filed.
3. Surgeon validation.
4. Manufacturing SOP.