Microbot Medical Gets FDA Clearance for LIBERTY® Robot
Accelerated Launch Readiness Plans Position Company for Commercialization throughout This autumn 2025
The Company’s Initial Addressable Market Includes Approximately 2.5 Million Peripheral Endovascular Procedures within the U.S. Annually
CEO, President & Chairman to Present Live Webcast on the H.C. Wainwright Annual Investor Conference on September 9, 2025, at 9 AM ET.
Microbot Medical Inc. (Nasdaq: MBOT), developer and producer of the modern LIBERTY® Endovascular Robotic System, in the present day introduced that the U.S. Food and Drug Administration (FDA) has granted 510(okay) clearance for the LIBERTY® System, the primary FDA cleared single-use, remotely operated robotic system for peripheral endovascular procedures. The FDA clearance positions the Company to commercialize LIBERTY® within the U.S., with the purpose of reworking the sector to allow accessibility to superior robotics with out the normal constraints of capital tools and a devoted infrastructure.
“Obtaining FDA 510(okay) clearance for LIBERTY® marks a defining second for Microbot Medical and, we imagine, for the way forward for endovascular robotics. This achievement validates our mission to broaden entry to superior robotic applied sciences whereas addressing crucial unmet wants and supporting cost-effective healthcare,” commented Harel Gadot, Chairman, CEO & President. “With our business readiness technique being developed and executed since Q2 this yr, we imagine we’re nicely positioned to speed up market entry. With FDA clearance, we will now full the ultimate business actions that had been contingent on advertising clearance, positioning us to start commercialization, penetrate the roughly 2.5 million annual U.S. peripheral vascular procedures, and pursue entry into world markets.”
The LIBERTY® pivotal research confirmed 100% success within the robotic navigation to focus on, and nil system associated adversarial occasions. The research additionally confirmed a 92% relative discount in radiation publicity for physicians. Its distant design is anticipated to enhance ergonomics, which might assist in lowering the bodily pressure on healthcare suppliers. The Company believes that LIBERTY® has the potential to boost process effectivity, decrease process prices, and enhance the general high quality of care. The Company plans to proceed scientific knowledge assortment for LIBERTY® in the course of the business launch.
The Company will attend the H.C. Wainwright Annual Investor Conference held in NYC from September 8-10, 2025. Mr. Gadot will current reside on Tuesday, September ninth at 9:00am ET, and a reside webcast could also be accessed by way of the ‘Events’ part of the Company’s web site at www.microbotmedical.com. Investors ought to attain out to their H.C. Wainwright gross sales representatives or contact [email protected] to schedule a one-on-one assembly with Microbot Medical’s administration crew.
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