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HINGHAM, Mass. - Microbot Medical Inc. (NASDAQ:MBOT), whose stock has surged over 226% year-to-date according to InvestingPro data, announced Monday that the U.S. Food and Drug Administration has granted 510(k) clearance for its LIBERTY Endovascular Robotic System, described as the first FDA-cleared single-use, remotely operated robotic system for peripheral endovascular procedures.
The regulatory clearance positions the company to begin commercialization in the U.S. market during the fourth quarter of 2025. With a strong financial health score and current ratio of 12.06, Microbot Medical appears well-positioned to execute its commercialization strategy. According to the company’s press release statement, the initial addressable market includes approximately 2.5 million peripheral endovascular procedures performed annually in the United States. (InvestingPro subscribers have access to 8 additional key financial insights about MBOT’s growth potential.)
"Obtaining FDA 510(k) clearance for LIBERTY marks a defining moment for Microbot Medical," said Harel Gadot, Chairman, CEO and President of the company.
The LIBERTY system demonstrated 100% success in robotic navigation to target during its pivotal study, with zero device-related adverse events, according to the company. The study also showed a 92% relative reduction in radiation exposure for physicians.
The single-use robotic system is designed to operate remotely, potentially improving ergonomics and reducing physical strain on healthcare providers. The company has been developing its commercial readiness strategy since the second quarter of this year.
Microbot Medical will present at the H.C. Wainwright Annual Investor Conference in New York City on Tuesday, September 9, with CEO Gadot scheduled to speak at 9:00 AM ET.
The company focuses on developing medical device technology for endovascular procedures, with the LIBERTY system representing its flagship product aimed at improving precision and provider safety during these interventions. With a market capitalization of $166.7 million and holding more cash than debt on its balance sheet, Microbot Medical shows promising financial fundamentals despite current unprofitability, according to InvestingPro analysis.
In other recent news, Microbot Medical Inc. has raised approximately $5.9 million through the issuance of nearly 3 million shares of its common stock. This capital increase resulted from the exercise of various series of preferred investment options, with the majority being Series H options. Additionally, H.C. Wainwright maintained its Buy rating for Microbot Medical, setting a price target of $9.00, following a new patent grant for its LIBERTY endovascular robotic system. The patent, granted by the United States Patent and Trademark Office, covers a modular robotic surgical system.
Furthermore, Microbot Medical has appointed Christina Bailey as its new Vice President of Sales. Bailey brings 20 years of medical device sales experience and is a two-time U.S. Olympian. Meanwhile, Brenmiller Energy Ltd. has announced the appointment of Harel Gadot, Microbot Medical’s CEO, as an independent director to its board. Gadot is noted for his extensive leadership experience in the healthcare sector. These developments reflect ongoing strategic moves by both companies.
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