Microbot Medical Inc. MBOT has recently secured the prestigious ISO 13485:2016 certification, a testament to its commitment to upholding excellence in the development and manufacturing of the acclaimed LIBERTY Endovascular Robotic Surgical System. This achievement marks a pivotal moment for the company, setting the stage for enhanced commercialization efforts and regulatory compliance across the European Union and the United States.
With this quality certification in place, Microbot Medical is primed to progress towards obtaining CE mark approval and navigating the revised FDA regulations seamlessly, signaling a promising trajectory for future expansion and market penetration in key regions.
As a pioneering clinical-stage medical device enterprise, Microbot Medical is dedicated to pioneering cutting-edge micro-robotic technologies that can elevate patient outcomes and facilitate access to minimally invasive procedures. The LIBERTY Endovascular Robotic Surgical System, currently under investigation, is engineered to redefine endovascular interventions by obviating the need for bulky, expensive equipment, mitigating radiation exposure, and reducing strain on physicians. By offering the potential for remote operation, the innovative LIBERTY system aims to democratize endovascular treatments, rendering them more accessible and efficient.
The Significance of the ISO 13485 Certification
The attainment of the ISO 13485 certification is a resounding endorsement of the robustness of Microbot Medical’s quality management system. Securing the ISO 13485:2016 certification constitutes a pivotal milestone for the company, as it underscores that Microbot Medical has implemented a stringent quality management framework tailored for the exacting standards of the medical device realm. This certification not only corroborates the company’s unwavering commitment to upholding superior benchmarks in product development and manufacturing but also aligns Microbot Medical with the stringent regulatory requisites outlined in the European Union’s Medical Device Regulation and the FDA’s revised Quality System Management Regulation.
Promising Prospects in the Medical Device Industry
According to a report by Future Market Insights, the market size of robotic-assisted endovascular systems stood at $94 million in 2023, with expectations to soar to $214.7 million by 2033 at a compelling CAGR of 8.6%.
This robust growth trajectory will be chiefly propelled by the escalating adoption of sophisticated systems that enhance procedural efficiency and precision, alongside the mounting demand for innovative, minimally invasive procedures that curtail patient trauma and expedite recovery.
Recent Developments in the LIBERTY Endovascular Robotic Surgical System
Noteworthy engagements this month include Microbot Medical’s collaboration with Emory University to explore potential synergies in autonomous robotics for endovascular procedures. Emory University will spearhead a feasibility study aimed at integrating the LIBERTY Endovascular Robotic Surgical System with an advanced imaging platform to realize an autonomous robotic system. This transformative project seeks to amalgamate CT guidance, artificial intelligence, and medical robotics to amplify procedural standardization, efficiency, and patient accessibility.
In another significant development, Microbot Medical recently secured Institutional Review Board approval and finalized a clinical trial agreement with Memorial Sloan Kettering Cancer Center (MSKCC) in New York City for its LIBERTY Endovascular Robotic Surgical System. MSKCC will lead the clinical trial under an Investigational Device Exemption to bolster forthcoming FDA marketing submissions and commercialization efforts. Moreover, Brigham and Women’s Hospital and Baptist Hospital of Miami are actively enrolled in the trial and conducting clinical cases.
Furthermore, Microbot Medical disclosed that the Baptist Hospital of Miami, encompassing Miami Cardiac & Vascular Institute and Miami Cancer Institute, successfully executed its inaugural clinical procedure using the LIBERTY Endovascular Robotic Surgical System. This significant milestone follows Baptist Hospital’s recent inclusion as a clinical trial site and marks the second institution to undertake such a procedure subsequent to Brigham & Women’s Hospital. The ongoing trial, conducted under the Investigational Device Exemption for LIBERTY, is poised to yield valuable insights that will bolster future FDA submissions and commercialization endeavors.
Price Performance Overview
Despite posting a decline of 37.8% year-to-date, Microbot Medical’s shares have demonstrated resilience amidst industry fluctuations, which have witnessed a modest 7.2% uptick. In contrast, the S&P 500 index has registered a commendable 16.4% increase during the same period.
Image Source: Zacks Investment Research
Zacks Rank Insights and Notable Selections
Presently, Microbot Medical holds a Zacks Rank #3 (Hold).
Within the expansive medical landscape, key stellar performers include Universal Health Services, Quest Diagnostics, and ABM Industries. While Universal Health Services commands a Zacks Rank #1 (Strong Buy), Quest Diagnostics and ABM Industries boast a Zacks Rank #2 (Buy) each.
Universal Health Services is projected to exhibit a commendable long-term growth rate of 19%. Having surpassed earnings estimates in all the preceding four quarters, with an average beat of 14.58%, UHS has witnessed a robust 41.1% surge year-to-date compared to the industry’s 34.8% rise.
Quest Diagnostics is anticipated to deliver a notable long-term growth rate of 6.20%. With earnings outperforming expectations consistently in the last four quarters, registering an average surprise of 3.31%, DGX’s shares have ascended 3.7% thus far this year, in contrast to the industry’s 10.2% ascent.
Additionally, ABM Industries has exceeded earnings projections in the consecutive four quarters, showcasing an average surprise of 7.34%. Noteworthy share price growth of 24.1% year-to-date, against the industry’s 11.9% incline, underscores ABM’s sound market performance.
