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

Type

RCT, registration trial

Clinical trial primary endpoint

Wound closure
 

Closure rate endpoint

40%
 

Size

280 patients

Comparator

Standard of care
Closure rate 20-25%

Powered

80-90%

USA

Type

RCT, registration trial

Clinical trial primary endpoint

EU trial
 

Closure rate endpoint

EU trial​​​​​​
 

Size

EU trial​​​​​​

Comparator

EU trial
 

Powered

EU trial

China

Type

RCT, registration trial

Clinical trial primary endpoint

Wound closure
 

Closure rate endpoint

40%
 

Size

280 patients

Comparator

Standard of care
Closure rate 20-25%

Powered

80-90%