Our Progress

Tri.O Medical has been awarded a third-year grant from the Israel Innovation Authority, supporting our POC and pivotal clinical trials, model development, and regulatory certification. This milestone reflects the dedication and professionalism of our team. We look forward to advancing toward market entry and commercialization.

Tri.O Medical has successfully achieved ISO 13485 certification by SII, a key step toward Israeli Ministry of Health approval and upcoming CE mark submission. This milestone reflects the dedication of our Engineering and QARA teams. We look forward to continuing our journey of innovation and excellence.

The FITT system has passed EMC and safety testing, a major step forward in its development. Thanks to our R&D team's dedication, we continue to uphold the highest standards. Next, we move closer to bringing this breakthrough to patients.

Tri.O Medical has signed an agreement with Medimor to begin device production, marking a key step in moving from development to manufacturing. This partnership ensures high-quality execution as the FITT system advances toward market readiness.

Tri.O Medical has completed the Verification & Validation (V&V) phase for the FITT system, marking the final and most rigorous step in its development. This milestone brings the company significantly closer to CE certification and market readiness.

We are pleased to share that we have passed the ISO 13485 Stage 1 audit by TÜV SÜD, marking another step toward achieving the CE mark. We appreciate the flexibility and support shown by the TÜV SÜD team throughout this process.

We successfully completed the first clinical trial at Hillel Yaffe Medical Center, working closely with a dedicated clinical team. The initial results were highly encouraging and mark an important step forward in validating the technology.

We are pleased to share that we have successfully passed the ISO 13485 Stage 2 certification audit by TÜV SÜD. This milestone brings us one step closer to securing CE certification for the FITT system and advancing our mission to deliver a safe, validated medical solution for diabetic wound care.