Key technical focus of the first reporting period was to deliver WP2 (Manufacturing Process Optimisation), progress the ongoing Clinical Trials (WP3), strengthen the Regulatory Approvals (WP4) pathways and undertake communication and dissemination activities (WP5).
During WP2, we have developed a new cleaning room at our new facilities in Netanaya, Israel. This room has met all production and regulatory requirements and has also gained DEKRA approval.
- Developed and implemented a new robotic balloon-folding process, replacing two production technicians. This custom-built machine folds balloons into a precise s-shape at controlled temperatures, achieving a high throughput of over 10 balloons per hour with consistent performance.
- Designed and deployed a second-generation dipping system, increasing yield and throughput by expanding chamber capacity, integrating actuating motors, and optimizing the dipping solution. This setup enables multiple balloon molds per cycle, boosting production efficiency.
- Validated the updated manufacturing process, ensuring compliance with regulatory standards. We produced and approved 200 complete device sets (balloon, dilators, and Ecognic needle) for clinical trials.
Completed product validation, including biocompatibility, safety, packaging, and compatibility testing, in accordance with MDR and FDA requirements.
During WP3, we have;
- Prepared an investigator brochure for ethics committee submission
- A total of 100 patients were recruited from five centers for the study. Patients were recruited Poland (EC number: 98/2021), Rabin Hospital in Israel (EC number: 0773-21-RMC), Assuta Hospital in Israel (EC number: AAA-0001-22), MAASTRO Hospital in the Netherlands (EC number: 2022-3111), and Dublin (EC number: 19-38).
During WP4, we have;
- Received the new European certification from MDR.
- Received FDA approval and certification.
- Received Product validation (safety, packaging and compatibility testing as per MDR and FDA requirements).
- Completed clinical trials
During WP5, we have published three articles.
During WP1, we have undertaken weekly review meetings to ensure timely delivery of the deliverables and milestones. We have doubled our human resources to 83 (50 in Israel and 33 in the USA) during the project duration.
