BRAINTREE, Mass. - Microbot Medical Inc. (NASDAQ:MBOT) has announced FDA approval to proceed with its pivotal clinical trial for the LIBERTY® Endovascular Robotic Surgical System. This development follows the Company's submission of preclinical study results and is a significant step toward a potential 510(k) submission.
The trial, which will take place in the U.S., is part of the Investigational Device Exemption (IDE) application process. Microbot Medical has already entered into a service agreement with a leading academic medical center and is engaging additional top centers for the trial.
Parallel to the upcoming human trials, the Company is finalizing biocompatibility testing as required by the IDE application. CEO Harel Gadot expressed confidence in their technology and its path toward regulatory clearance and commercialization.
Microbot Medical specializes in micro-robotic technologies aimed at enhancing clinical outcomes and accessibility for endovascular procedures. The LIBERTY® system is designed to eliminate the need for large, traditional surgical equipment, potentially reducing radiation exposure and physician strain while allowing remote operation.
The information is based on a press release statement from Microbot Medical. The Company cautions that forward-looking statements involve risks and uncertainties, including the successful completion of clinical trials and regulatory approvals. Additional information on risks is available in the Company's SEC filings.
InvestingPro Insights
As Microbot Medical Inc. (NASDAQ:MBOT) strides towards a pivotal moment with their LIBERTY® Endovascular Robotic Surgical System, the financial landscape of the company showcases a mixture of strengths and challenges. With a market capitalization of $14.4 million, the company's financial health is under scrutiny by investors tracking its progress. According to InvestingPro data, MBOT is currently operating at a loss, with an adjusted operating income of -$9.32 million over the last twelve months as of Q1 2024. This is reflected in their negative P/E ratio of -1.55, indicating that the market expects future losses.
An InvestingPro Tip highlights that MBOT holds more cash than debt on its balance sheet, which is a positive sign of liquidity. Additionally, the company's liquid assets exceed short-term obligations, suggesting that MBOT is well-positioned to handle its immediate financial responsibilities. However, analysts do not anticipate the company will be profitable this year, and the firm has been quickly burning through cash. This is further compounded by weak gross profit margins and the fact that the company has not been profitable over the last twelve months.
Investors interested in the detailed financial outlook for MBOT, including additional InvestingPro Tips, can find more information by visiting https://www.investing.com/pro/MBOT. There are currently six additional tips listed in InvestingPro, which could provide deeper insights into the company's financial health and future prospects. For those considering a longer-term commitment to the InvestingPro platform, make sure to use the coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription.
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