What has been done:
1. The project was initiated under a humanitarian program.
2. A two-week setup process was completed, which included document preparation, engagement with English-speaking doctors, obtaining authorities' permissions, and establishing a MSA.
3. Creation of a secured data transmission option for data collection occurred within one month, carried out in parallel with other preparations.
4. The device was delivered from the USA to hospitals on the battlefields in
Ukraine within one week.
5. Surgeons received training.
6. Immediate patient enrollment, given the urgency of the war situation, and due to the high number of patients in need.
7. The product's real effectiveness was tested.
8. Data management was implemented.
9. The results were transmitted to the client for further promotional activities, emphasizing that the product has been tested in war zones.
The collected data has been accepted by the FDA and will enable the Sponsor to proceed with the market authorization submission.
