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All Regulatory, Clinical, Operational and Pre-Commercial Activities Continue to Stay on Track Despite the On-going Situation in Israel
Company Believes that Both Regulatory and Commercial Milestones to be Achieved in Accordance with the Company's Current Timeline
BRAINTREE, Mass., April 15, 2024 (GLOBE NEWSWIRE) -- Microbot Medical Inc. (NASDAQ:MBOT), developer of the LIBERTY® Endovascular Robotic Surgical System, today 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.
"Overcoming multiple challenges over the past 4 years, starting with COVID-19 and continuing with the war in Israel since October 7th which reached new heights yesterday, we have been successful in establishing our infrastructure and meeting meaningful milestones such as the successful completion of the GLP study and the IDE submission to the FDA," said Harel Gadot, CEO, President and Chairman of Microbot Medical. "With the infrastructure we have both in Israel and the USA, together with the milestones we already achieved and believe that we will achieve over the next few months, we are confident we can continue to execute against our regulatory milestones and to position us to commercialize the LIBERTY® System in both the USA and Europe as planned."
Posted In: MBOT
