Develops and manufactures bioresorbable 3D-printed PCL scaffolds for soft tissue regeneration, with a focus on breast surgery
BellaSeno GmbH
Deutscher Platz 5A, 04103 Leipzig, Germany · 4 Starling Street, Burleigh Heads QLD 4220, AustraliaNew on Amplifa
BellaSeno – Regenerative Soft Tissue Scaffolds from Leipzig
BellaSeno GmbH is a clinically focused medical technology company founded in 2017, based at its headquarters in Leipzig (BioCity) and in Brisbane, Australia. The company develops and manufactures bioresorbable scaffolds made of polycaprolactone (PCL) using proprietary high-speed additive manufacturing. The scaffolds feature interconnected porosity that supports cell infiltration, vascularization and tissue growth, and are progressively resorbed over time. The clinical focus is on breast surgery (primary and revision augmentation); further platform applications include chest wall reconstruction, bone regeneration and other soft tissue indications. Manufacturing is being scaled up using proprietary MagLev technology. BellaSeno is certified to ISO 13485 and EU MDR 2017/745 and is conducting, among other things, the BRV-004 feasibility study (19 patients, 83% volume retention after two years) as well as the ongoing BRV-005 pivotal study. An exclusive global license agreement with Mentor Worldwide LLC (Johnson & Johnson) supports further development and subsequent market launch.
- Site
- Leipzig
- Processes
- 3D-printed bioresorbable scaffolds (proprietary high-throughput additive manufacturing), Scaffold design and development of structured scaffolds for tissue regeneration (tissue engineering), Manufacture of bioresorbable breast scaffolds with interconnected porosity, Custom scaffolds for chest wall reconstruction (anatomically adapted implants), Resorbable bone scaffolds for stabilization of bone graft material, Scalable manufacturing using proprietary MagLev technology (manufacturing scale-up), Additive manufacturing (production of bioresorbable PCL scaffolds), MagLev technology for manufacturing scale-up
- Materials
- PCL (polycaprolactone), Absorbable/bioresorbable polymers (clinically established), Polycaprolactone, Absorbable Polymers, Additive Manufacturing (3D Printing), MagLev Manufacturing Technology
- Certificates
- ISO 13485, EU MDR 2017/745
- Founded
- 2017
- Industries
- Medical technology, Regenerative medicine, Plastic and aesthetic surgery, Breast surgery, Soft tissue / bone reconstruction
- 01
Scaffold design and engineering
- 02
Additive manufacturing (3D printing) of PCL scaffolds
- 03
Scale-up using MagLev technology
- 04
Regulatory development (CE, FDA)
- 05
Clinical studies and distribution partnerships
Materials and Manufacturing Processes
Polycaprolactone
Clinically established bioresorbable polymer for scaffolds with interconnected porosity that is gradually resorbed by the body.
Absorbable Polymers
Clinically established bioabsorbable polymers that provide temporary structure and guide the body's own tissue formation.
Additive Manufacturing (3D Printing)
Proprietary high-throughput 3D printing process for reproducible and scalable scaffold manufacturing.
MagLev Manufacturing Technology
Magnetic levitation-based technology for manufacturing scale-up to serve the global market.
Sites
Leipzig
DEHeadquarters, manufacturing and development center
- Lot size
- Prototype to clinical series
- Materials
- PCL
- Proprietary high-speed additive manufacturing system
- MagLev technology
Brisbane (Burleigh Heads)
AUSite, clinical and regional activities
- Materials
- PCL
Components and Scaffolds
Inside the production
Industries
Processes & technical limits
| Processes | Tolerance | Max. part | Weight | Lot size | Materials |
|---|---|---|---|---|---|
| 3D-printed bioresorbable scaffolds (proprietary high-throughput additive manufacturing)Additive | – | – | – | – | PCL (polycaprolactone) |
| Scaffold design and development of structured scaffolds for tissue regeneration (tissue engineering)Engineering | – | – | – | – | PCL, absorbable polymers |
| Manufacture of bioresorbable breast scaffolds with interconnected porosityAdditive | – | – | – | – | PCL |
| Custom scaffolds for chest wall reconstruction (anatomically adapted implants)Additive | – | – | – | – | PCL |
| Resorbable bone scaffolds for stabilization of bone graft materialAdditive | – | – | – | – | PCL |
| Scalable manufacturing using proprietary MagLev technology (manufacturing scale-up)Additive | – | – | – | – | PCL |
2 Anlagen & Maschinen
| Machine | Manufacturer / model | Quantity | Working area | Year built | Site |
|---|---|---|---|---|---|
| Proprietary high-speed additive manufacturing system | – | – | – | – | Leipzig / Brisbane |
| MagLev manufacturing technology (magnetic levitation-based manufacturing) | – | – | – | – | – |
Additional services
Reference customers
Quality and Certification
BellaSeno is certified to ISO 13485 and EU MDR 2017/745 and accompanies product development through clinical studies with long-term follow-up of up to three years. The ongoing Notified Body and FDA interaction secures a regulatory development pathway.
| Evidence | Leipzig |
|---|---|
| ISO 13485 | |
| EU MDR 2017/745 |
History and Milestones
- 2017
Foundation of BellaSeno in Leipzig.
- 2025
Exclusive global distribution and partnership pathways established.
- 2026
Exclusive global license agreement with Mentor Worldwide LLC (Johnson & Johnson); positive two-year results of the BRV-004 study (19 patients, 83% volume retention); world's first breast augmentation with a resorbable 3D-printed scaffold in Sydney; start of the BRV-005 pivotal study.
- 2026
Manufacturing scale-up through proprietary MagLev technology for global supply.
- 2028
Goal: CE marking for resorbable breast scaffolds.
- 2030
Goal: FDA approval for primary/revision augmentation.