Medical Strategy
Focused and globally aligned medical strategy
Our clinical strategy is designed to maximize probability of success while
generating globally transferable data.
- Randomized controlled clinical study in DFU patients comparing base products plus standard of care versus standard of care alone
- Primary endpoint focused on complete wound healing, a clinically and regulatorily meaningful outcome
- Secondary endpoints addressing time to granulation, wound size reduction, and patient-relevant outcomes
- Study designs aligned with actual EU MDR, eFDA and NMPA guidances, enabling reuse of clinical data across regions
The clinical program focuses on demonstrating clear clinical benefit with pragmatic study design, supporting both regulatory approval and commercial adoption.
Type
Clinical trial
primary endpoint
Closure rate endpoint
Size
Comparator
Powered
Europe
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RCT, registration trial
Clinical trial primary endpointWound closure
40%
280 patients
ComparatorStandard of care
Closure rate 20-25%
80-90%
USA
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RCT, registration trial
Clinical trial primary endpointEU trial
EU trial
EU trial
ComparatorEU trial
EU trial
China
![]()
RCT, registration trial
Clinical trial primary endpointWound closure
40%
280 patients
ComparatorStandard of care
Closure rate 20-25%
80-90%