BRAINTREE, Mass. – Microbot Medical Inc. (NASDAQ: NASDAQ:MBOT), a clinical-stage medical device company, has announced the addition of Baptist Hospital of Miami as a new participant in its pivotal human clinical trial for the LIBERTY Endovascular Robotic Surgical System. This follows the recent approval from the Food and Drug Administration (FDA) to begin the trial, marking Baptist Hospital as the second site to enroll in the study.
The trial, which is part of the company's Investigational Device Exemption (IDE), will also include Miami Cardiac & Vascular Institute and Miami Cancer Institute. Brigham and Women’s Hospital was previously named as another participating site.
The principal investigator at Baptist Hospital of Miami is Dr. Ripal Gandhi, MD, FSVM, who expressed enthusiasm for the technology's potential to revolutionize endovascular procedures.
Harel Gadot, CEO, President, and Chairman of Microbot Medical, highlighted the swift progress in enrolling and activating leading clinical sites for the trial and praised the partnership with Baptist Hospital of Miami, recognized as one of the nation's top hospitals.
Microbot Medical specializes in micro-robotic technologies aimed at enhancing clinical outcomes and accessibility for patients undergoing endovascular procedures. The LIBERTY system is designed to be operated remotely, potentially democratizing endovascular interventional procedures by eliminating the need for large and expensive equipment while also reducing radiation exposure and physician strain.
The company's forward-looking statements, as included in their press release, indicate their belief in the system's potential and outline the risks involved in the development and commercialization process. These statements are subject to various uncertainties, including market conditions, regulatory approvals, and the outcome of clinical trials.
This expansion into Baptist Hospital of Miami represents a significant step for Microbot Medical as it continues to evaluate the LIBERTY system's effectiveness and safety. The information reported here is based on a press release statement from Microbot Medical.
In other recent news, Microbot Medical has seen significant developments in its operations. The medical device company 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.
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.
Microbot Medical has also been advancing with its LIBERTY® Endovascular Robotic Surgical System. The company received FDA approval to proceed with a pivotal clinical trial for the LIBERTY® system, marking a significant step towards a potential 510(k) submission.
Moreover, the first phase of its collaboration with Corewell Health, assessing the technical capabilities of the LIBERTY system for endovascular interventions, has been completed.
In terms of analyst notes, 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 latest developments for Microbot Medical.
InvestingPro Insights
As Microbot Medical Inc. (NASDAQ: MBOT) embarks on its pivotal human clinical trial for the LIBERTY Endovascular Robotic Surgical System, the financial health and market performance of the company are instrumental for potential investors and stakeholders. According to InvestingPro data, Microbot Medical currently holds a market capitalization of 15.81 million USD, reflecting its size and market value.
InvestingPro Tips suggest that Microbot Medical has more cash than debt on its balance sheet, which could provide the company with a degree of financial flexibility as it progresses through the clinical trial phase. Still, it is also important to note that the company is quickly burning through cash and suffers from weak gross profit margins, which could present challenges in sustaining operations without generating additional funding or revenue.
InvestingPro metrics show that the company's stock price has experienced considerable volatility, with a 1-month price total return of -28.26% and a 1-year price total return of -66.33%. This level of fluctuation may be a point of consideration for investors looking at the short-term performance of the company's stock.
For those interested in a deeper dive into the financials and prospects of Microbot Medical, there are additional InvestingPro Tips available at InvestingPro. Subscribers can use the coupon code PRONEWS24 to get up to 10% off a yearly Pro and a yearly or biyearly Pro+ subscription, unlocking further insights into the company's performance and potential. With a total of 9 InvestingPro Tips available, subscribers can gain a comprehensive understanding of the company's financial and operational status.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.