Chase Nicheboker's questions to Mediwound Ltd (MDWD) leadership • Q2 2025
Question
Chase Nicheboker from Craig-Hallum Capital Group asked about the timeline for FDA feedback on the DFU trial, the status of VLU site activation and patient competition, and the potential impact of proposed reimbursement changes for skin substitutes on EscharEx utilization.
Answer
CEO Ofer Gonen confirmed they are approaching the FDA in H2 2025 for DFU protocol feedback and that most U.S. VLU sites are active, with European sites catching up. He sees minimal impact from competing CTP trials. EVP Barry Wolfferson opined that the proposed reimbursement changes, which require proper wound bed preparation, are a 'huge win' for EscharEx, positioning it as a critical precursor to CTP application.