Microbot Medical (NASDAQ: MBOT) stock soared during intraday trading Monday after the company gained FDA approval to advance its human clinical trial.
Microbot Medical has achieved a significant milestone with the receipt of approval from the U.S. Food and Drug Administration (FDA) to proceed with its human clinical trial as part of its Investigational Device Exemption (IDE) application for the LIBERTY® Endovascular Robotic Surgical System.
The approved study, set to be conducted in the United States, marks a pivotal step forward for Microbot Medical. The company has already secured a clinical trial service agreement with a leading academic medical center, positioning it for the commencement of the trial. Concurrently, Microbot Medical is diligently completing biocompatibility tests as mandated by its IDE application.
Harel Gadot, CEO, President, and Chairman of Microbot Medical, expressed enthusiasm regarding the FDA’s authorization, stating,
“The recent authorization by the FDA to commence our pivotal clinical study, following submission of the results of our extensive pre-clinical studies and tests, reinforces our confidence in our innovative technology.”
He emphasized that this development underscores the company’s commitment to achieving significant milestones as it progresses toward potential regulatory clearance and subsequent commercialization in the United States and other global markets.
Microbot Medical (NASDAQ: MBOT) Stock Reaction
On Monday, MBOT stock surged 38%, closing at $1.38, marking a 35.29% increase for the week. The trading volume was 151,008,528 shares, significantly higher than the average daily volume of 2.45 million.
