The evidence base behind our implants.
A growing body of clinical evidence across multiple study designs, indications, and follow-up windows. Below is the public summary; the full clinical evidence dossier is available to qualified clinical and commercial partners under NDA.
Large-cohort prospective clinical study.
The pivotal evidence supporting the Patient-Matched Skull Reconstruction System.
Patient-Matched 3D-Printed Titanium Cranial Implant — Multi-Centre Prospective Study
Multi-centre, prospective, with active follow-up
Patients with cranial defects from TBI, stroke, tumour, congenital deformity
50+ clinical partner sites, China
Ongoing; full-cohort analysis published
Key results
- Total complication rate < 2% (vs. 12–18% for mesh / PEEK literature controls)
- Infection rate < 1.7% (vs. 6–8% literature controls)
- Re-operation for critical failure: none observed
- Implant-related serious adverse events: none observed
- Patient-reported aesthetic and quality-of-life outcomes: consistently positive
Full study report and post-market clinical follow-up (PMCF) data available under NDA.
Where the evidence is generated.
Our clinical research spans 50+ sites across China, with growing engagement in Europe and the United States.
- Fourth Military Medical University (Xi'an)
- Southern Medical University Affiliated Hospitals (Guangzhou)
- Shenzhen Second People's Hospital
- Beijing Tiantan Hospital
- Huashan Hospital (Shanghai)
- Xuanwu Hospital (Beijing)
- Charité Berlin (Germany)
- Medizinische Hochschule Hannover (Germany)
- Ludwig-Maximilians-Universität München (Germany)
- AP-HP Pitié-Salpêtrière (France)
- Niguarda Hospital (Italy)
- Vall d'Hebron (Spain)
- Addenbrooke's, Cambridge (UK)
- King's College Hospital (UK)
- Queen's Square, UCL (UK)
- Oslo University Hospital, Rikshospitalet (Norway)
- Karolinska Institute (Sweden)
The evidence doesn't stop at approval.
Under our PMCF programme, we continuously collect real-world outcomes data and feed it back into product and process improvements.
Real-world data
Continuous outcomes tracking across the 500+ hospital clinical partner network.
Patient-reported outcomes
Aesthetic, functional, and quality-of-life patient-reported outcomes tracked longitudinally.
Registries
Cooperation with national and international CMF implant registries for benchmarking.
Peer-reviewed work from the team.
A selection of peer-reviewed publications from the Excellent MedTech team and our clinical collaborators. For the full publication list, please contact our team.
Gradient porous titanium for cranial reconstruction
Bobyn-window pore size and Klawitter-Hulbert interconnectivity thresholds in EBM-built Ti-6Al-4V ELI.
Materials Science and Engineering: C, 2024.
Multi-centre prospective study of 3D-printed cranial implants
Total complication rate < 2% across 5,000+ patient-matched cranioplasties.
Neurosurgery, 2025.
FEA-based design acceptance for patient-specific cranial implants
Patient-specific FEA with peak von Mises < 440 MPa, micromotion < 50 µm, stress-shielding 0.7–1.3.
Journal of the Mechanical Behavior of Biomedical Materials, 2024.
Native TiO₂ and protein adsorption in patient-matched titanium
Ti-OH groups and Ti-O-R covalent bonds as the molecular basis for titanium biocompatibility.
Biomaterials, 2023.