Microbot Medical Inc. MBOT recently announced that it has submitted a 510(k) premarket notification to the FDA for its LIBERTY system. The 510(k) submission follows the successful completion of its multi-center, single-arm trial to evaluate the performance and safety of LIBERTY in human subjects undergoing Peripheral Vascular Interventions.
The company anticipates FDA marketing clearance during the second quarter of 2025, with U.S. commercialization activities expected to commence after the clearance.
Following the announcement, shares of the company moved 2% north and closed at $1.02 on Wednesday. In the year-to-date period, MBOT shares have lost 37.8% against the industry’s 6.5% growth. The S&P 500 increased 27.3% in the same time frame.
Meanwhile, MBOT currently has a market capitalization of $16.9 million.
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The LIBERTYEndovascular Robotic Surgical System by Microbot Medical is an innovative robotic solution for endovascular procedures. It is notable for being the first single-use robotic system to address significant barriers in vascular interventions. Unlike traditional robotic systems that require large capital investment and infrastructure, LIBERTY is designed for efficiency, mobility, and ease of use. The system aims to increase procedural efficiency and expand access to robotic-assisted surgeries. In October, MBOT completed a pivotal clinical trial (ACCESS-PVI) evaluating LIBERTY’s safety and effectiveness in peripheral vascular interventions.
The successful completion of the ACCESS-PVI trial marked a significant milestone for Microbot Medical, demonstrating the effectiveness of the LIBERTY system in clinical settings. This accomplishment not only strengthened the company’s position in the healthcare market but also supported the 510(k) submission to the FDA, which has now set the stage for future commercialization efforts. The encouraging results from the trial, along with positive feedback from physicians, signify strong prospects for Microbot Medical and its innovative robotic surgical technologies.
In August, Microbot Medical entered a Phase 2 collaboration agreement with Corewell Health to advance remote telesurgery for endovascular procedures using its LIBERTY Endovascular Robotic System. Following positive results from Phase 1, which demonstrated LIBERTY's technical capabilities and potential applications, the new phase will focus on developing the system's ability to perform simulated cardiovascular interventional procedures across two Corewell Health sites located five miles apart.
The same month, Microbot Medical agreed with Emory University to explore the potential for collaboration on autonomous robotics in endovascular procedures. Under this agreement, Emory University will investigate the feasibility of integrating the LIBERTY Endovascular Robotic Surgical System with an imaging system to create an autonomous robotic system for these procedures.
Per a report in Grand View Research, the global peripheral vascular devices market size is estimated to be worth $10.4 billion in 2024 and is anticipated to reach $14.8 billion by 2030 at a CAGR of 5.9%.
The robust growth is likely to be driven by the increasing incidence of cardiac diseases, the rising global geriatric population base triggering incidence rates of target diseases, novel product launches and an increase in collaboration and mergers by key players.
MBOT carries a Zacks Rank #3 (Hold) at present.
Some better-ranked stocks from the medical industry are Masimo MASI, AngioDynamics ANGO and Globus Medical GMED.
Masimo, sporting a Zacks Rank #1 (Strong Buy) at present, has an estimated growth rate of 10.4% for 2025. You can see the complete list of today’s Zacks #1 Rank stocks here.
MASI’s earnings surpassed estimates in each of the trailing four quarters, delivering an average surprise of 17.10%. Masimo’s shares have risen 37.2% year to date compared with the industry’s 6.7% growth.
AngioDynamics, carrying a Zacks Rank #2 (Buy) at present, has an estimated growth rate of 38.2% for 2025. ANGO’s earnings surpassed estimates in three of the trailing four quarters and missed once, delivering an average surprise of 31.71%.
AngioDynamics’ shares have lost 8.9% year to date against the industry’s 6.7% growth.
Globus Medical, carrying a Zacks Rank of 2 at present, has an estimated long-term growth rate of 12.7%. GMED’s earnings surpassed estimates in each of the trailing four quarters, delivering an average surprise of 12.1%. Its shares have risen 56.5% year to date compared with the industry’s 6.7% growth.
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