Swiss biotech company: development and manufacturing of bone substitute materials and patient-specific bone grafts (SmartBone®)
Industrie Biomediche Insubri SA (IBI SA)
Mezzovico-Vira (Ticino, CH) · Milano (IT)New on Amplifa
An innovative Swiss high-tech company in biomedicine
IBI SA (Industrie Biomediche Insubri SA) is a Swiss high-tech company in the field of biomedicine headquartered in Mezzovico-Vira (Ticino) with a European branch in Milan. The company develops and produces medical devices for tissue engineering and regenerative medicine: bone substitute materials, grafts, 3D matrix structures and 2D scaffolds. Core products are SmartBone®, SmartBone® ORTHO, SmartBone® On Demand™ (CAD/CAM-manufactured patient-specific bone grafts) and SwissBone®. The technology combines a deproteinized, trabecular bovine bone matrix (hydroxylapatite) with bioresorbable polymers (PLCL) and RGD-bearing collagen fragments in a thin-film coating process. Since 2017, the entire production process has been insourced; material cleaning is carried out at low temperature and in multiple chemical stages. Fields of application are dental/craniomaxillofacial reconstructions, orthopedics, traumatology, spine surgery and oncological reconstruction. Products are manufactured in accordance with ISO 13485:2016, subject to CE marking (Class III) and since 2021 certified under the MDR.
- Site
- CH-6805 Mezzovico-Vira (Ticino), Switzerland
- Processes
- Manufacturing of bone substitute materials (bone substitutes, grafts, 3D matrixes, 2D scaffolds) for, Cleaning process: low-temperature washing and multi-stage chemical cleaning of bovine bone, Reinforcement treatment: thin-film deposition of bioresorbable, Sterilization with ethylene oxide (EtO) for medical devices packaged in pouches, Sterilization by beta radiation (E-Beam irradiation) for medical devices packaged in vials, CAD/CAM manufacturing of patient-specific bone grafts (SmartBone® On Demand™) based on, Microextrusion of polymers (polymer processing for medical devices), Testing and characterization: ESEM, micro-computed tomography, compression testing, cell tests
- Materials
- Bovine bone / hydroxylapatite (xenograft, deproteinized), Poly(L-lactide-co-ε-caprolactone) (PLCL), GMP-grade block copolymer of L-lactide and ε-caprolactone, Collagen fragments (gelatin-based, MedellaPro from Gelita AG), Calcium phosphosilicate, Intrinsically disordered proteins (IDPs) for SmartBonePep®, Deproteinized bovine bone matrix (hydroxylapatite), Poly(L-lactide-co-ε-caprolactone) (PLCL), GMP grade, Intrinsically disordered proteins (IDPs)
- Certificates
- ISO 13485:2016 & EN ISO 13485:2016, ISO 9001, CE mark (93/42/EEC MDD, class III), ISO 13485:2016, CE 93/42/EEC (Class III), MDR
- Founded
- 2008
- Industries
- Medical technology / biomedicine, Dental oral and maxillofacial surgery, Orthopedics, Traumatology, Oncological reconstructive surgery, Spine surgery
- 01
BSE-free bovine bone raw material sourcing
- 02
Low-temperature washing and multi-stage chemical cleaning (removal of
- 03
Reinforcement by thin-film deposition of PLCL polymer and collagen fragments
- 04
Shaping or CAD/CAM manufacturing of patient-specific grafts based on
- 05
Validated sterilization (EtO for pouches, E-Beam for vials)
- 06
Testing and release (ISO 13485)
Materials and processes
Deproteinized bovine bone matrix (hydroxylapatite)
Natural trabecular mineral structure as the scaffold of the bone substitute products, from BSE-free breeding, cleaned through a multi-stage chemical low-temperature process.
Poly(L-lactide-co-ε-caprolactone) (PLCL), GMP grade
Bioresorbable block copolymer for mechanical reinforcement of the bone matrix by means of thin-film deposition.
Collagen fragments (gelatin-based, MedellaPro from Gelita AG)
RGD-exposing fragments to promote cell adhesion and cell colonization of the scaffold.
Calcium phosphosilicate
Synthetic biomaterial, clinically used in dental bone regeneration.
Intrinsically disordered proteins (IDPs)
Biomimetic biomolecules for SmartBonePep®, which promote cell proliferation and differentiation of bone cells.
Microextrusion (polymer processing)
Process for processing bioresorbable polymers while preserving their molecular properties.
Locations
Mezzovico-Vira (Ticino)
CHHeadquarters and production
- Lot size
- Prototype to series (patient-specific one-off pieces)
- Materials
- Bovine bone xenograft, PLCL, collagen
Products and components
Inside the production
Industries
Processes & technical limits
| Processes | Tolerance | Max. part | Weight | Lot size | Materials |
|---|---|---|---|---|---|
| Manufacturing of bone substitute materials (bone substitutes, grafts, 3D matrixes, 2D scaffolds) forEngineering | – | – | – | – | Bovine bone xenograft (hydroxylapatite), Bioresorbable polymers (poly(L-lactide-co-ε-caprolactone), Collagen fragments (gelatin) |
| Cleaning process: low-temperature washing and multi-stage chemical cleaning of bovine boneSurface | – | – | – | – | Bovine bone |
| Reinforcement treatment: thin-film deposition of bioresorbableSurface | – | – | – | – | Poly(L-lactide-co-ε-caprolactone) (PLCL), Collagen fragments (MedellaPro, Gelita AG), Bovine bone matrix |
| Sterilization with ethylene oxide (EtO) for medical devices packaged in pouchesTesting | – | – | – | – | SmartBone® / SwissBone® medical devices |
| Sterilization by beta radiation (E-Beam irradiation) for medical devices packaged in vialsTesting | – | – | – | – | SmartBone® / SwissBone® medical devices |
| CAD/CAM manufacturing of patient-specific bone grafts (SmartBone® On Demand™) based onEngineering | – | – | – | – | Deproteinized bovine bone (xeno-hybrid composite bone), Bioresorbable polymers, Collagen |
| Microextrusion of polymers (polymer processing for medical devices)Plastics | – | – | – | – | Bioresorbable polymers (e.g. PLCL) |
| Testing and characterization: ESEM, micro-computed tomography, compression testing, cell testsTesting | – | – | – | – | SmartBone® Scaffold |
Additional services
Quality and certification
The quality system is certified according to ISO 13485:2016 & EN ISO 13485:2016; SmartBone® products are subject to CE marking under Directive 93/42/EEC (Class III), and SmartBone® On Demand™ has been certified under the MDR since 2021 by the Notified Body BSI. Characterization includes ESEM, micro-computed tomography, compression testing, cell tests (SAOS-2, MG-63) and ISO biocompatibility studies.
| Evidence | Mezzovico-Vira |
|---|---|
| ISO 13485:2016 | |
| ISO 9001 | |
| CE 93/42/EEC (Class III) | |
| MDR |
Company history
- 2008
IBI founded as a privately managed company under Swiss federal law.
- 2009
Partner in the Italian-Swiss Interreg project Clu.B.; distribution of SmartBone for laboratory purposes in cell therapies.
- 2011
Opening of the European branch; approval for clinical studies on SmartBone®.
- 2012
ISO 13485 and ISO 9001 certification; CE marking for SmartBone® by DNV; Agire Invest SA joins as an investor.
- 2014
Compagnie Financiere St. Exupéry SA becomes an investor.
- 2015
Eurostars grant with Corticalis AS (Norway) for next-generation bone substitutes (SmartBonePep®).
- 2016
Entry into the orthopedic business (oncology, traumatology, craniofacial, spine).
- 2017
Complete insourcing of the entire production process.
- 2018
Start of publications on clinical outcomes with SmartBone®; presentation at the MSE in Darmstadt.
- 2019
CE marking renewed (BSI); certification according to ISO 13485:2016; investor syndicate including VitaTech (Luxembourg SICAV).
- 2020
CE marking for SmartBone® ORTHO (orthopedic indications) by BSI.
- 2021
MDR certification for SmartBone® On Demand™ by Notified Body BSI.