Microbot Medical completes discussions with FDA for Self-Cleaning Shunt

Microbot Medical announced the completion of discussions with the U.S. Food and Drug Administration for its Self-Cleaning Shunt. After review of the Company's existing pre-clinical data, the FDA's feedback will allow the Company to apply for a limited clinical investigation known as an Early Feasibility Study, which is designed for novel technologies such as the SCS. Consequently, the Company reiterates its timeline for the First-in-Human clinical trial under the EFS, expected to commence in the third quarter of 2022. As anticipated, the FDA review focused on product-specific, regulatory and scientific topics related to the SCS, and included in the pre-submission were pre-clinical study data conducted by leading U.S. academic institutions. The Company expects to continue to work with the FDA towards finalizing the SCS device design, and to incorporate their feedback prior to submitting the Investigational Device Exemption to seek authorization to begin the EFS clinical trial. While there can be no assurance that the FDA will approve the EFS study, the agency's recent feedback indicates that the agency will be receptive to allowing this FIH study to proceed based on existing data. After completing the EFS, the Company would then seek FDA input on the device design as finalized through the EFS process in a subsequent IDE filing for approval of a clinical study proposal. The Company's innovative SCS is designed to be a transformative device which prevents obstruction in the cerebrospinal fluid catheters implanted in the ventricle of the brain of patients who suffer from hydrocephalus or Normal Pressure Hydrocephalus.