"We are thrilled to now have a clear regulatory pathway to possible approval of D-PLEX100 in the U.S. following confirmation from the FDA that the ongoing SHIELD II trial can potentially be used to complete our clinical testing," stated Dikla Czaczkes Akselbrad, PolyPid’s CEO. "Importantly, the ability to leverage the SHIELD II study will significantly reduce the time and resources needed to finalize the clinical study as compared to having to initiate a new trial. We look forward to resuming patient recruitment in the second quarter. We view SHIELD II as a de-risked Phase 3 trial given the more focused patient population with large incisions in which we have already generated highly positive data in SHIELD I, and the fact that it will not be conducted within tight COVID-19 related restrictions. The recruitment of the additional 550 patients into SHIELD II is expected to take approximately 12 months and the top-line results are anticipated in mid-2024."
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