BRAINTREE, Mass. - Microbot Medical Inc. (NASDAQ:MBOT), a clinical-stage medical device company, has reported significant progress in its ACCESS-PVI clinical trial for the LIBERTY® Endovascular Robotic Surgical System. The trial has seen an accelerated rate of patient enrollment, with 80% of participants having completed the follow-up period. This advancement puts the company on a fast track to potentially complete the trial earlier than expected.
The ACCESS-PVI trial, a prospective, multi-center, single-arm study, is designed to evaluate the performance and safety of the LIBERTY® system in peripheral vascular interventions. The positive enrollment pace has bolstered the company's confidence in meeting its goal to submit a 510(k) application to the U.S. Food and Drug Administration (FDA) by the end of 2024.
Microbot Medical's Chairman, CEO, and President, Harel Gadot, expressed satisfaction with the trial's progress and anticipated the timely completion of the study and subsequent FDA submission. Chief Medical Officer Juan Diaz-Cartelle also commended the dedication of the Microbot team and participating physicians.
In addition to the clinical trial, Microbot Medical has completed all biocompatibility tests required by the Investigational Device Exemption (IDE) application and has received final IDE approval from the FDA.
The LIBERTY® Endovascular Robotic Surgical System is a micro-robotic technology aiming to revolutionize endovascular procedures by eliminating the need for large equipment, reducing radiation exposure, and lessening physician strain. The system's remote operation feature is expected to democratize endovascular interventional procedures.
The company is concurrently performing customary bench testing, the results of which will be included in the 510(k) submission. These developments are based on a press release statement by Microbot Medical.
In other recent news, Microbot Medical has made significant advancements in its operations. The clinical-stage medical device company has announced a Phase 2 collaboration with Corewell Health to further develop its LIBERTY Endovascular Robotic System for remote telesurgery, following the successful completion of Phase 1. In other developments, Microbot Medical expanded its pivotal human clinical trial for the LIBERTY system to include Baptist Hospital of Miami, following FDA approval.
Microbot Medical also amended its existing At the Market Offering Agreement with H.C. Wainwright & Co., LLC, allowing it to offer and sell shares of its common stock with an aggregate offering price of up to $4,819,905. Concurrently, the company secured approximately $2.35 million in gross proceeds from a stock sale and investment options, with H.C. Wainwright & Co. serving as the exclusive placement agent.
H.C. Wainwright adjusted its outlook on Microbot Medical, reducing the price target to $7.00 while maintaining a Buy rating. Despite recent tensions in Israel, Microbot Medical confirmed that its operations remain on track, continuing to meet its regulatory objectives and positioning the LIBERTY system for market entry in the USA and Europe. These are the recent developments for Microbot Medical.
InvestingPro Insights
As Microbot Medical Inc. (NASDAQ:MBOT) progresses with its ACCESS-PVI clinical trial, investors should consider some key financial metrics and insights from InvestingPro. The company's market capitalization stands at a modest $14.21 million, reflecting its status as a clinical-stage medical device company.
InvestingPro data reveals that Microbot Medical's stock is currently trading near its 52-week low, with a price that is only 36.64% of its 52-week high. This could be of interest to value investors, especially considering the company's recent clinical trial progress. However, it's important to note that the stock has seen a year-to-date price total return of -47.49%, indicating significant volatility.
Two relevant InvestingPro Tips highlight that Microbot Medical holds more cash than debt on its balance sheet and that its liquid assets exceed short-term obligations. These factors could provide the company with financial flexibility as it moves towards completing its clinical trial and pursuing FDA submission.
It's worth noting that InvestingPro offers 8 additional tips for Microbot Medical, which could provide further insights for investors interested in a deeper analysis of the company's financial health and market position.
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