The Path to Quality: Microbot Medical’s Recent ISO 13485 Certification
Microbot Medical Inc. MBOT recently secured the ISO 13485:2016 quality management system certification. This achievement signals the company’s relentless pursuit of excellence in crafting its LIBERTY Endovascular Robotic Surgical System. The certification acts as a crucial gateway towards both commercialization and regulatory adherence in the European Union and the United States.
With this significant milestone, Microbot Medical propels itself forward in the journey towards obtaining CE mark approval and aligning with the revised FDA regulations. This progress sets the stage for substantial advancements and market penetrations in key regions.
Microbot Medical, a pioneer in developing innovative micro-robotic technologies, aims to elevate patient outcomes and enhance the accessibility of minimally invasive procedures. The LIBERTY Endovascular Robotic Surgical System, currently in its investigational stage, is engineered to transform endovascular interventions by eliminating bulky equipment, lowering radiation exposure, and lessening the physical strain on physicians. This system’s potential for remote operation seeks to democratize endovascular procedures, making them more efficient and readily available.
The Implications of Achieving ISO 13485 Certification
The ISO 13485 certification serves as a testament to the robustness of Microbot Medical’s quality management framework. By attaining ISO 13485:2016 certification, the company showcases its adherence to a stringent quality management system meticulously designed for the medical device sphere. This certification not only validates the company’s unwavering commitment to maintaining superior standards in product development and manufacturing but also positions Microbot Medical in harmony with the rigorous regulatory standards of the EU Medical Device Regulation and the FDA’s updated Quality System Management Regulation.
Navigating the Promising Industry Landscape
According to a report by Future Market Insights, the market size of robotic-assisted endovascular systems was valued at $94 million in 2023 and is projected to reach $214.7 million by 2033, reflecting a compound annual growth rate of 8.6%.
This remarkable growth trajectory stems from the escalating adoption of advanced systems that bolster procedural efficiency and accuracy, coupled with the surging demand for innovative, minimally invasive surgeries that reduce patient trauma and recovery durations.
Recent Strides with the LIBERTY Endovascular Robotic Surgical System
In a recent development, Microbot Medical initiated discussions with Emory University to explore potential collaboration on autonomous robotics within endovascular procedures. Emory will spearhead a feasibility study to integrate the LIBERTY Endovascular Robotic Surgical System with an imaging solution in crafting an autonomous robotic platform. This collaborative effort aims to fuse CT guidance, artificial intelligence, and medical robotics to elevate procedural standardization, efficacy, and patient accessibility.
Furthermore, in July, MBOT garnered Institutional Review Board approval and penned a clinical trial agreement with Memorial Sloan Kettering Cancer Center (MSKCC) based in New York City for the LIBERTY Endovascular Robotic Surgical System. The clinical trial, conducted under an Investigational Device Exemption, will support future FDA marketing submissions and commercialization endeavors. Additionally, Brigham and Women’s Hospital and Baptist Hospital of Miami have already commenced clinical trials as part of this program.
Notably, Microbot Medical announced that the Baptist Hospital of Miami, encompassing Miami Cardiac & Vascular Institute and Miami Cancer Institute, successfully executed its inaugural clinical procedure utilizing the LIBERTY Endovascular Robotic Surgical System in July. This achievement follows Baptist Hospital’s inclusion as a clinical trial location, marking it as the second site after Brigham & Women’s Hospital to conduct such procedures. The results of this trial, conducted under an Investigational Device Exemption for LIBERTY, are poised to bolster future FDA submissions and commercialization prospects.
Stock Performance Review
Year-to-date, Microbot Medical’s shares have experienced a 37.8% dip, juxtaposed against a 7.2% uptick in the industry and a 16.4% rise in the S&P 500 during the same period.
Image Source: Zacks Investment Research
Analyzing Zacks Rank & Key Selections
At present, Microbot Medical holds a Zacks Rank #3 (Hold).
Some noteworthy stocks within the broader medical landscape include Universal Health Services, Quest Diagnostics, and ABM Industries. While Universal Health Services boasts a Zacks Rank #1 (Strong Buy), Quest Diagnostics and ABM Industries carry a Zacks Rank #2 (Buy) each.
Universal Health Services exhibits an estimated long-term growth rate of 19%, with a trend of outperforming earnings estimates in the past four quarters, averaging 14.58%.
Year-to-date, Universal Health Services has seen a 41.1% surge, surpassing the industry’s 34.8% upswing.
Quest Diagnostics projects a long-term growth rate of 6.20%, showcasing consistent earnings beats in the last four quarters, yielding an average positive surprise of 3.31%.
Quest Diagnostics shares have risen by 3.7% thus far this year, relative to the industry’s 10.2% incline.
ABM Industries also exceeded earnings estimates in the last four quarters, delivering an average earnings surprise of 7.34%.
ABM’s shares have ascended by 24.1% year-to-date, outshining the industry’s 11.9% growth.