Develops 3D-printed, resorbable bone substitute (RePore 3D) and digital surgical planning with anatomical 3D models.
Agensmed GmbH
BayreuthNew on Amplifa
About Agensmed
Agensmed is a spin-off founded in 2023 from the BioMed Center Innovation Institute, based in Bayreuth. The company develops additively manufactured, resorbable bone substitute based on an HA/β-TCP material system (hydroxyapatite and β-tricalcium phosphate) with dual porosity: micropores for biological integration and 3D-printed channels for vascularization and controlled remodeling into natural bone. The veterinary variant Cystblox® is already in use via the distribution partner Pferd Dental; clinical studies for RePore 3D are planned for the end of 2026. In addition, Agensmed offers digital surgical planning with Boneplan® based on CT, MRI or DICOM data, including artifact correction and haptic 1:1 planning models. Production preparation is being aligned with ISO 13485 and ISO/ASTM 52920, supported by LIMS documentation and the partner Qualified AM; Agensmed is also involved in the EU project InkjetBioAM (15 partners, 36 months) on additive biomanufacturing.
- Site
- Bayreuth
- Processes
- 3D printing of resorbable bone substitute (RePore 3D, dual porosity: micropores + channels), Additive manufacturing of bioscaffolds (aligned with ISO/ASTM 52920,, 3D printing of block geometries / prospectively patient-specific shapes (Cystblox®,, Sterilization by autoclaving, Digital surgical planning: CT/MRI/DICOM data conversion, anatomically correct segmentation and, 3D printing of haptic 1:1 planning models (gypsum-based polymer composite, bone-like feel, for, 3D printing of patient-specific subperiosteal implant, two-piece (concept, transfer from, Additive biomanufacturing / bioscaffold pilot line (EU project InkjetBioAM)
- Materials
- Hydroxyapatite (HA), β-Tricalcium phosphate (β-TCP), HA/β-TCP material system (RePore 3D), Zirconia ceramic, Gypsum-based polymer composite (Boneplan® models), Hydroxyapatite, β-Tricalcium Phosphate, Gypsum-based polymer composite (Boneplan®)
- Certificates
- ISO 13485 (in preparation/orientation), ISO/ASTM 52920 (alignment), ISO 13485 (implementation/orientation), LIMS documentation
- Founded
- 2023
- Industries
- Medical technology / regenerative medicine, Dental and cranio-maxillofacial surgery, Veterinary medicine, Additive manufacturing / biomanufacturing, Veterinary medicine (equine dental, maxillofacial)
- 01
Digital data preparation (CT/MRI/DICOM, segmentation, artifact correction)
- 02
Digital design and model approval
- 03
3D printing of the structure (dual porosity)
- 04
Sterilization by autoclaving
- 05
LIMS documentation and release
- 06
Training and process introduction at clinical partners
Materials & Processes
Hydroxyapatite
Component of the resorbable RePore 3D material system with controlled resorption and remodeling into natural bone.
β-Tricalcium Phosphate
Combined with hydroxyapatite to balance stability, resorption and biological remodeling.
HA/β-TCP material system (RePore 3D)
Synthetic, storable bone substitute material with dual porosity for ingrowth and vascularization.
Zirconia ceramic
Material for the 3D-printed, two-piece patient-specific subperiosteal implant (concept, MDR preparation).
Gypsum-based polymer composite (Boneplan®)
Material for haptic 1:1 planning models with bone-like feel for cutting, drilling and screwing.
Locations
Bayreuth
DEHeadquarters, development and additive manufacturing
- Lot size
- Prototype to small series (clinical/application quantities)
- Materials
- HA, β-TCP, zirconia ceramic, gypsum-based polymer composite
- 3D printing (development machines, transfer to qualified production environment planned)
- LIMS documentation
Products & Components
Inside the production
Industries
Processes & technical limits
| Processes | Tolerance | Max. part | Weight | Lot size | Materials |
|---|---|---|---|---|---|
| 3D printing of resorbable bone substitute (RePore 3D, dual porosity: micropores + channels)Additive | – | – | – | – | Hydroxyapatite (HA), β-Tricalcium phosphate (β-TCP), HA/β-TCP material system |
| Additive manufacturing of bioscaffolds (aligned with ISO/ASTM 52920,Additive | – | – | – | – | Hydroxyapatite, β-Tricalcium phosphate |
| 3D printing of block geometries / prospectively patient-specific shapes (Cystblox®,Additive | – | – | – | – | HA/β-TCP material system |
| Sterilization by autoclavingTesting | – | – | – | – | Hydroxyapatite, β-Tricalcium phosphate |
| Digital surgical planning: CT/MRI/DICOM data conversion, anatomically correct segmentation andEngineering | – | – | – | – | – |
| 3D printing of haptic 1:1 planning models (gypsum-based polymer composite, bone-like feel, forAdditive | – | – | – | – | gypsum-based polymer composite |
| 3D printing of patient-specific subperiosteal implant, two-piece (concept, transfer fromAdditive | – | – | – | – | Zirconia ceramic |
| Additive biomanufacturing / bioscaffold pilot line (EU project InkjetBioAM)Additive | – | – | – | – | biomaterial-based scaffold materials |
Additional services
Reference customers
Quality & Documentation
Development and production preparation are documented digitally via LIMS; the processes are being aligned with ISO 13485 and ISO/ASTM 52920, supported by the partner Qualified AM.
| Evidence | Bayreuth |
|---|---|
| ISO 13485 (implementation/orientation) | |
| ISO/ASTM 52920 (alignment) | |
| LIMS documentation |
History
- 2023
Agensmed founded at the end of 2023 as a spin-off from the BioMed Center Innovation Institute
- 2024
Registered in the Commercial Register Bayreuth in early 2024
- 2026
Clinical studies for RePore 3D planned for the end of 2026