Clinical advancements are driving the future of medical technology, and Microbot Medical is at the forefront with its innovative endovascular surgical robot, Liberty. The company has recently completed the enrollment of clinical trial sites for its first-in-human study, a significant milestone that includes the addition of New York’s Memorial Sloan Kettering Cancer Center. This trial is conducted under an investigational device exemption (IDE) awarded by the US Food and Drug Administration (FDA) in early June.
Results from Microbot’s trial will be used to support future marketing submissions to the FDA, marking a pivotal step in bringing Liberty to the market. With this study, Microbot aims to demonstrate the efficacy and safety of its single-use endovascular surgical robot, which eliminates the need for large and expensive capital equipment traditionally associated with such procedures.
Clinical Success Boosts Microbot’s Shares and Market Confidence
Microbot’s shares have seen a 10% increase since late May, reflecting growing investor confidence. The company currently boasts a market cap of $17.2 million. The trial will evaluate the Liberty system, which successfully completed over 100 catheterizations during pre-clinical studies in May 2023, achieving a 95% success rate in meeting predetermined vascular targets. Microbot believes that Liberty has the potential to democratize endovascular interventional procedures, making them more accessible and affordable.
Endovascular surgery, a minimally invasive technique that uses catheters to treat vascular diseases, stands to benefit significantly from Liberty’s advancements. Additionally, Microbot is developing remote capabilities for the Liberty system, enabling surgical procedures to be performed without the surgeon’s physical presence. This remote functionality is being developed in partnership with Corewell Health, enhancing the versatility and reach of the Liberty system.
The Memorial Sloan Kettering Cancer Center joins Boston’s Brigham and Women’s Hospital and Miami’s Baptist Hospital as clinical sites for the LIBERTY trial. The robotic surgical systems market is projected to grow from $3.3 billion in 2023 to $7.2 billion by 2033, with a compound annual growth rate (CAGR) of 15.7%, driven by the demand for less-invasive procedures and an aging population.
Clinical Trial Advancements: New Entrants and Innovations in Surgical Robotics
The clinical trial space for surgical robots is seeing significant advancements. For instance, J&J MedTech is preparing to enter this space with plans to submit an investigational device exemption application to the FDA in the second half of 2024. This approval would enable their robotic system to be used in clinical trials later this year. Similarly, Netherlands-based Vitestro reported positive results from its trial of an autonomous blood-drawing device in May 2024.
Dr. Francois Cornelis, the principal investigator of the LIBERTY trial, expressed his optimism about the future of robotics in interventional procedures. He stated, “I’m a great believer in the future of robotics for interventional procedures and the value robotics can bring to physicians and our patients. I am excited to participate in the LIBERTY clinical trial.”
Despite the rapid growth and potential of the robotics sector, several challenges remain in the long-term implementation of these technologies. Issues such as regulatory hurdles, cost, and the integration of new technologies into existing medical practices need to be addressed to ensure widespread adoption and success.
In conclusion, Microbot’s successful enrollment of clinical sites for the LIBERTY trial represents a significant achievement in the journey towards advancing robotic-assisted endovascular surgery. As the trial progresses, the data collected will be crucial in supporting future FDA marketing submissions, potentially transforming the landscape of minimally invasive surgical procedures and expanding access to cutting-edge medical technology.
Clinical advancements are driving the future of medical technology, and Microbot Medical is at the forefront with its innovative endovascular surgical robot, Liberty. The company has recently completed the enrollment of clinical trial sites for its first-in-human study, a significant milestone that includes the addition of New York’s Memorial Sloan Kettering Cancer Center. This trial is conducted under an investigational device exemption (IDE) awarded by the US Food and Drug Administration (FDA) in early June.
Resource: Medical Device Netwok, July 19, 2024
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