Microbot says activities continue without interruption amid geopolitical events

Microbot Medical shared that despite the unprecedented events in Israel yesterday, which are a continuation to the situation in Israel since October 7th, 2023, the Company’s activities both in Israel, USA and other parts of the globe continue without interruption and it believes that current planned timelines and milestones will be met. From a regulatory perspective, the Company has been working with the FDA on its recent IDE submission and believes that those efforts will result in commencing its pivotal study in humans as planned. In addition, as part of its efforts to gain regulatory approval in Europe, the Company successfully completed an internal audit in preparation for ISO 13485 certification audits, which are expected this year, to ensure the Company continues to meet its timeline toward CE approval. From an operational perspective, the Company has established sufficient inventory of the LIBERTY Endovascular Robotic Surgical System to support its pivotal study and other ongoing activities. In addition to focusing on gaining regulatory approval for the current LIBERTY Endovascular Robotic Surgical System in both the USA and Europe, the Company already executed an initial phase partnership with one clinical partner and is in advanced discussions with additional clinical partners to develop the future potential capabilities of the LIBERTY Endovascular Robotic Surgical System, such as remote operations, imaging integration and AI capabilities. With its pre-commercial activities, the Company is already in discussions with multiple strategic partners, both in the USA and globally, to allow the Company to evaluate the most efficient commercialization channels once the product would be approved for sale in the USA and globally.