Microbot Medical Inc. Reports Financial Losses and Regulatory Challenges in Latest 10-K Filing

Microbot Medical Inc. reported significant financial challenges in its latest 10-K filing, revealing that the company has not generated any revenue since its inception and has incurred substantial operating losses, totaling approximately $90.9 million. For the fiscal year ending December 31, 2024, Microbot's net loss increased to $6.6 million, up from $5.7 million in 2023. The company’s research and development expenses rose by approximately $906,000, primarily due to increased headcount and regulatory expenses associated with its Investigational Device Exemption (IDE) and 510(k) submission processes. General and administrative expenses also saw a rise of about $864,000, reflecting costs related to management and compliance.

In terms of operational developments, Microbot is focused on advancing its LIBERTY® Endovascular Robotic Surgical System, which is designed for minimally invasive surgeries. The company has made progress in its preclinical studies, achieving a 95% success rate in catheterizations and recently completing a pivotal preclinical study with 100% usability and technical success. However, the company continues to face uncertainties regarding regulatory approvals, as it awaits FDA clearance for its 510(k) application, which is anticipated in the second quarter of 2025. Additionally, Microbot has received ISO 13485:2016 certification for its quality management system, which is crucial for future CE Mark approval in Europe.

Microbot's strategic initiatives include the acquisition of assets from Nitiloop Ltd. in 2022, which has expanded its product offerings in the intraluminal revascularization space. The company is also exploring partnerships with institutions like Emory University to enhance its technological capabilities in autonomous robotics for endovascular procedures. As of March 2025, Microbot has a workforce of 21 employees, with plans to expand its commercialization and sales team in anticipation of regulatory approvals.

Despite these developments, Microbot's future remains uncertain, as it continues to rely on external funding to support its operations. The company reported a net working capital of approximately $3.4 million as of December 31, 2024, down from $4.1 million the previous year. It has raised approximately $30.6 million since the end of 2024 through various financing activities, including equity offerings and institutional investments. However, the company acknowledges the need for additional capital to sustain its research and development efforts and to navigate the complexities of regulatory compliance and commercialization.

Looking ahead, Microbot's management has indicated that it expects to continue incurring losses as it ramps up its commercialization efforts. The company is closely monitoring geopolitical risks, particularly the ongoing military actions in Israel, which could impact its operations and supply chain. As it moves forward, Microbot aims to establish its LIBERTY® system as a standard of care in the medical community, contingent upon successful regulatory approvals and market acceptance.