BRAINTREE, Mass. – Microbot Medical Inc. (NASDAQ:MBOT), a clinical-stage medical device company, has announced the completion of patient enrollment and follow-up for its ACCESS-PVI clinical trial. The trial is a significant step toward the company's goal to submit a 510(k) application to the U.S. Food and Drug Administration (FDA) by the end of 2024.
The ACCESS-PVI trial is a prospective, multi-center, single-arm study designed to evaluate the performance and safety of the company's LIBERTY® Endovascular Robotic Surgical System in peripheral vascular interventions. The successful conclusion of the trial is poised to support the FDA submission and future commercialization efforts.
Microbot Medical is also advancing its go-to-market strategy, planning to establish commercial infrastructure and hire a healthcare executive to lead sales following anticipated FDA clearance, expected in the second quarter of 2025.
Juan Diaz-Cartelle, MD, Chief Medical Officer, expressed gratitude to the investigators for their commitment and indicated that the results of the clinical trial would be presented to the medical community in early 2025. Harel Gadot, the company's Chairman, CEO, and President, described the trial's completion as a "monumental moment" and emphasized the immediate focus on preparing the FDA submission package.
The LIBERTY® Endovascular Robotic Surgical System is designed to enhance the current use of surgical robotics in endovascular procedures, aiming to reduce the need for large equipment, minimize radiation exposure, and alleviate physician strain. The system's remote operation could democratize endovascular interventional procedures.
This announcement is based on a press release statement from Microbot Medical. The company has cautioned that forward-looking statements involve risks and uncertainties, including market conditions, clinical development, regulatory approvals, and the need for future capital. These factors could influence the successful commercialization of the LIBERTY® Endovascular Robotic Surgical System. The company's periodic reports filed with the Securities and Exchange Commission, which include risk factors, are available for further details.
In other recent news, Microbot Medical Inc. has made significant strides in its ACCESS-PVI clinical trial for the LIBERTY® Endovascular Robotic Surgical System, with accelerated patient enrollment and 80% of participants completing the follow-up period. Concurrently, the company has expanded its pivotal human clinical trial for the LIBERTY system to include Baptist Hospital of Miami, following FDA approval. Microbot Medical has also received final Investigational Device Exemption (IDE) approval from the FDA, having completed all required biocompatibility tests. In collaboration with Corewell Health, Microbot Medical has launched Phase 2 development of its LIBERTY system for remote telesurgery, following a successful Phase 1.
Financially, Microbot Medical has 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. The company also 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 has adjusted its outlook on Microbot Medical, reducing the price target to $7.00 while maintaining a Buy rating.
Finally, Microbot Medical has been notified by Nasdaq that its stock does not meet the minimum bid price requirement for continued listing on the Nasdaq Capital Market, with a compliance deadline set for April 7, 2025. These are the recent developments for Microbot Medical.
InvestingPro Insights
As Microbot Medical Inc. (NASDAQ:MBOT) advances towards its FDA submission for the LIBERTY® Endovascular Robotic Surgical System, investors should consider some key financial metrics and insights from InvestingPro.
According to InvestingPro data, Microbot Medical has a market capitalization of $15.87 million, reflecting its status as a small-cap company in the medical device sector. The company's stock has experienced significant volatility, with a year-to-date price total return of -41.38% as of the latest data. This volatility aligns with an InvestingPro Tip indicating that "stock price movements are quite volatile," which is not uncommon for clinical-stage biotech companies awaiting regulatory approvals.
Despite the promising developments in its clinical trials, Microbot Medical faces financial challenges. An InvestingPro Tip notes that the company is "quickly burning through cash," which is critical information for investors considering the capital-intensive nature of medical device development and the upcoming commercialization efforts. Additionally, the company "does not pay a dividend to shareholders," focusing instead on reinvesting in its product development.
On a positive note, Microbot Medical "holds more cash than debt on its balance sheet," which could provide some financial flexibility as it moves towards potential FDA clearance and commercialization in 2025. However, investors should be aware that analysts "do not anticipate the company will be profitable this year," underscoring the speculative nature of investing in pre-revenue medical device companies.
For those interested in a deeper dive into Microbot Medical's financial health and prospects, InvestingPro offers additional tips and metrics. In fact, there are 8 more InvestingPro Tips available for MBOT, providing a comprehensive view of the company's financial situation and market position.
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