Microbot Medical Gets Quality Certification for its System

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.

Significance 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 Prospects

Per a report in Future Market Insights, the robotic-assisted endovascular systems market size was worth $94 million in 2023. It is anticipated to reach $214.7 million by 2033 at a CAGR of 8.6%.

The robust growth will be primarily driven by the increasing adoption of advanced systems that enhance efficiency and precision during procedures, along with the rising demand for innovative, minimally invasive surgeries that reduce patient trauma and recovery time.

Recent LIBERTY Endovascular Robotic Surgical System Developments

This month,Microbot Medical and Emory University agreed to explore potential collaboration on autonomous robotics in endovascular procedures. Emory will lead the feasibility study of integrating the LIBERTY Endovascular Robotic Surgical System with an imaging system to develop an autonomous robotic system. The project aims to combine CT guidance, artificial intelligence, and medical robotics to enhance procedural standardization, efficiency and patient access.

In July, MBOT secured Institutional Review Board approval and signed a clinical trial agreement with Memorial Sloan Kettering Cancer Center (MSKCC) in New York City for its LIBERTY Endovascular Robotic Surgical System. MSKCC will conduct the clinical trial under an Investigational Device Exemption to support future FDA marketing submissions and commercialization.The trial also includes Brigham and Women's Hospital and Baptist Hospital of Miami, which are already enrolled and conducting clinical cases.

In the same month,Microbot Medical announced that the Baptist Hospital of Miami, including Miami Cardiac & Vascular Institute and Miami Cancer Institute, has successfully conducted its first clinical procedure using the LIBERTY Endovascular Robotic Surgical System. This follows the recent inclusion of Baptist Hospital as a clinical trial site and marks the second site to perform such a procedure after Brigham & Women's Hospital. This trial is part of the Investigational Device Exemption for LIBERTY, with results anticipated to support future FDA submissions and commercialization.

Price Performance

Shares of Microbot Medical have decreased 37.8% so far this year against a 7.2% rise in the industry. The S&P 500 has witnessed a 16.4% rise in the same time frame.

Image Source: Zacks Investment Research

Zacks Rank & Key Picks

Currently, Microbot Medical carries a Zacks Rank #3 (Hold).

Some top-ranked stocks in the broader medical space are Universal Health Services, Quest Diagnostics and ABM Industries. While Universal Health Services sports a Zacks Rank #1 (Strong Buy), Quest Diagnostics and ABM Industries carry a Zacks Rank #2 (Buy) each.

Universal Health Services has an estimated long-term growth rate of 19%. UHS' earnings surpassed estimates in each of the trailing four quarters, with the average being 14.58%.

Universal Health Services has gained 41.1% compared with the industry's 34.8% rise so far this year.

Quest Diagnostics has an estimated long-term growth rate of 6.20%. DGX's earnings surpassed estimates in each of the trailing four quarters, with the average surprise being 3.31%.

Quest Diagnostics shares have gained 3.7% so far this year compared with the industry's 10.2% rise.

ABM Industries' earnings surpassed estimates in each of the trailing four quarters, delivering an average surprise of 7.34%.

ABM's shares have risen 24.1% so far this year compared with the industry's 11.9% increase.

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