Regulatory strategy
Designed for speed, predictability, and transferability
Cutempa Medical Ltd. follows a globally aligned regulatory strategy focused on early de-risking and
data reuse across regions:
Europe
Primary development path
Curi01 developed as a Class IIb medical device under EU MDR
Randomized controlled clinical study designed to demonstrate superiority vs standard of care (SoC)
Early implementation of ISO 13485 quality management system
European clinical data structured to support globalisation
USA
The FDA 513 (g) process has been initiated already for final classification of device
EU clinical data designed to be to the basis for the US submission
Focus on accelerated market access
China
Registration planned as Class III medical device via innovation pathway
Local clinical study based on experience and results from clinical test in China and taking into account the EU study design
Product localization (Curi02) and local manufacturing to support pricing, access, and protection of core markets
This approach creates clean, well-documented regulatory assets, highly attractive for strategic partners and acquirers.