Microbot Medical Inc. MBOT has recently achieved the prestigious ISO 13485:2016 certification for its quality management system. This recognition highlights the company’s unwavering dedication to excellence in developing and manufacturing its LIBERTY Endovascular Robotic Surgical System, a significant milestone that enhances its path to commercialization and regulatory adherence in key markets such as the European Union and the United States.
The attainment of this certification not only elevates Microbot Medical’s position for securing CE mark approval but also serves as a strategic move to align with the updated FDA regulations. These developments are pivotal as the company aims for sustained growth and expansion in crucial markets.
Microbot Medical is a forward-thinking medical device company in the clinical stage, specializing in pioneering micro-robotic technologies to advance patient outcomes and access to minimally invasive procedures. The revolutionary Investigational LIBERTY Endovascular Robotic Surgical System is crafted to transform endovascular procedures by eliminating the need for bulky, expensive equipment, reducing radiation exposure, and lessening strain on physicians. With its potential for remote operation, the LIBERTY system seeks to democratize endovascular interventions, improving accessibility and efficiency.
Validation of Quality Standards
The ISO 13485 certification serves as an affirmation of Microbot Medical’s robust quality management system, showcasing the company’s meticulous adherence to high standards in product development and manufacturing processes. This milestone signifies the company’s commitment to meeting the stringent regulatory guidelines set forth by the European Union’s Medical Device Regulation and the FDA’s updated Quality System Management Regulation.
Market Growth Prospects
According to a report by Future Market Insights, the robotic-assisted endovascular systems market was valued at $94 million in 2023 and is projected to reach $214.7 million by 2033, boasting a Compound Annual Growth Rate (CAGR) of 8.6%.
This upward trajectory is fueled by the increasing adoption of advanced systems that enhance procedural efficiency and precision while meeting the growing demand for innovative, minimally invasive surgeries that reduce patient trauma and expedite recovery periods.
Recent Developments in LIBERTY System
Recent events have seen Microbot Medical forging a collaboration with Emory University to explore the potential integration of autonomous robotics in endovascular procedures. This partnership will see Emory spearheading a feasibility study to merge the LIBERTY Endovascular Robotic Surgical System with an imaging system to create an autonomous robotic platform, leveraging CT guidance, artificial intelligence, and medical robotics to improve procedural standardization, efficiency, and patient accessibility.
In a separate development, Microbot Medical received approval from the Institutional Review Board and clinched a clinical trial agreement with Memorial Sloan Kettering Cancer Center (MSKCC) in New York City for its LIBERTY Endovascular Robotic Surgical System. The clinical trial, operating under an Investigational Device Exemption, involves Brigham and Women’s Hospital and Baptist Hospital of Miami, both of which are actively conducting clinical cases.
Furthermore, Baptist Hospital of Miami, inclusive of Miami Cardiac & Vascular Institute and Miami Cancer Institute, successfully executed its initial clinical procedure using the LIBERTY Endovascular Robotic Surgical System. This achievement follows Baptist Hospital’s inclusion as a clinical trial site, with additional procedures being conducted at Brigham & Women’s Hospital. The results of this trial under the Investigational Device Exemption are anticipated to bolster future FDA submissions and commercialization efforts.
Stock Performance
Microbot Medical’s shares have dipped by 37.8% since the beginning of the year, in contrast to a 7.2% upsurge in the industry. Meanwhile, the S&P 500 index has observed a 16.4% increment over the same period.
Image Source: Zacks Investment Research
Zacks Rank & Key Selections
Presently, Microbot Medical holds a Zacks Rank #3 (Hold).
Noteworthy stocks in the broader medical sector include Universal Health Services, Quest Diagnostics, and ABM Industries. Universal Health Services is recognized with a Zacks Rank #1 (Strong Buy), while Quest Diagnostics and ABM Industries both carry a Zacks Rank #2 (Buy).
Universal Health Services boasts an estimated long-term growth rate of 19%, surpassing earnings predictions in the past four quarters with an average outperformance of 14.58%.
Year-to-date, Universal Health Services has seen a 41.1% growth, outstripping the industry’s 34.8% surge.
Quest Diagnostics, with an expected long-term growth rate of 6.20%, has exceeded earnings forecasts in the previous four quarters, averaging a 3.31% surprise.
Comparatively, Quest Diagnostics’ shares have risen by 3.7% this year against the industry’s 10.2% climb.
ABM Industries has consistently outperformed earnings expectations over the trailing four quarters, delivering an average surprise of 7.34%.
Year-to-date, ABM Industries’ shares have surged by 24.1%, surpassing the industry’s 11.9% increase.