Microbot Medical Inc. MBOT recently announced the receipt of ISO 13485:2016 certification for its quality management system. This certification underscores the company’s commitment to excellence in the development and manufacturing of its LIBERTY Endovascular Robotic Surgical System, marking an essential step toward commercialization and regulatory compliance in both the European Union and the United States.
With this certification, Microbot Medical is well-positioned to advance toward CE mark approval and streamline its transition to the updated FDA regulations, paving the way for future growth and commercialization in key markets.
Microbot Medical is a clinical-stage medical device company focused on developing innovative micro-robotic technologies to enhance patient outcomes and improve access to minimally invasive procedures. The Investigational LIBERTY Endovascular Robotic Surgical System is designed to revolutionize endovascular procedures by eliminating the need for large, costly equipment, reducing radiation exposure and minimizing physician strain. With its potential for remote operation, the LIBERTY system aims to democratize endovascular interventions, making them more accessible and efficient.
Implications of the Certification
The ISO 13485 certification validates the strength of the company’s quality management system. Achieving ISO 13485:2016 certification is a critical milestone for Microbot Medical, as it signifies that the company has implemented a rigorous quality management system tailored to the medical device industry. This certification not only validates the company’s dedication to maintaining high standards in product development and manufacturing but also aligns Microbot Medical with the stringent regulatory requirements of the European Union’s Medical Device Regulation and the FDA’s revised Quality System Management Regulation.
Industry Growth Forecast
As reported by Future Market Insights, the robotic-assisted endovascular systems market size was worth $94 million in 2023 and is projected to reach $214.7 million by 2033, showing a Compound Annual Growth Rate (CAGR) of 8.6%.
The anticipated growth is driven by the increasing adoption of advanced systems that enhance efficiency and precision during procedures, as well as the surging demand for innovative, minimally invasive surgeries that minimize patient trauma and recovery time.
Latest Developments Regarding the LIBERTY System
Recently, Microbot Medical and Emory University initiated discussions on potential collaboration in autonomous robotics for endovascular procedures. Emory will lead a feasibility study to integrate the LIBERTY Endovascular Robotic Surgical System with an imaging system to create an autonomous robotic system, leveraging CT guidance, artificial intelligence, and medical robotics to enhance procedural standardization, efficiency, and patient access.
In July, MBOT received Institutional Review Board approval and established a clinical trial agreement with Memorial Sloan Kettering Cancer Center (MSKCC) for its LIBERTY Endovascular Robotic Surgical System under an Investigational Device Exemption, enabling future FDA submissions and commercialization. The trial, which includes Brigham and Women’s Hospital and Baptist Hospital of Miami, aims to yield results supporting future regulatory processes and commercial rollout.
In the same month, Microbot Medical announced that Baptist Hospital of Miami conducted its first clinical procedure using the LIBERTY Endovascular Robotic Surgical System. This follows Baptist Hospital’s enrollment as a clinical trial site and marks the second institution, after Brigham & Women’s Hospital, to perform such a procedure. Anticipated results from this trial could bolster future FDA submissions and commercialization efforts.
Stock Performance Overview
Shares of Microbot Medical have declined by 37.8% year-to-date, contrasting with a 7.2% industry rise and a 16.4% increase in the S&P 500 during the same period.
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Zacks Rank & Top Picks
Presently, Microbot Medical holds a Zacks Rank #3 (Hold).
Some notable stocks in the broader medical sector include Universal Health Services, Quest Diagnostics, and ABM Industries. Universal Health Services boasts a Zacks Rank #1 (Strong Buy), while Quest Diagnostics and ABM Industries carry a Zacks Rank #2 (Buy) each.
Universal Health Services has an estimated long-term growth rate of 19% and consistently surpassed earnings estimates in the past four quarters, with an average beat of 14.58%.
Compared to the industry’s 34.8% rise, Universal Health Services has surged by 41.1% this year.
Quest Diagnostics holds an estimated long-term growth rate of 6.20% and has exceeded earnings expectations in the trailing four quarters, with an average surprise of 3.31%.
Quest Diagnostics shares have climbed 3.7% year-to-date, contrasting with the industry’s 10.2% upturn.
ABM Industries outperformed earnings estimates in the past four quarters, delivering an average surprise of 7.34%.
ABM’s shares have risen by 24.1% year-to-date, surpassing the industry’s 11.9% increase.