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Overview
Microbot Medical Inc is a pre-clinical medical device company dedicated to developing next-generation micro-robotic technologies aimed at transforming surgical procedures. The company is at the intersection of advanced robotics and healthcare innovation, focusing on minimally invasive surgery to reduce the trauma associated with traditional surgical access. By integrating state-of-the-art micro-robotic systems with precise automated instruments, Microbot Medical is addressing one of the largest unmet medical needs: minimizing procedural invasiveness while maintaining surgical efficacy.
Technological Innovation
At the core of its operations, Microbot Medical Inc specializes in micro-robotic platforms that enhance surgical precision. Its innovative approach leverages autonomous micro-robot systems, designed to navigate and operate within extremely confined anatomical spaces, thus ensuring a reduction in surgical morbidity. The LIBERTY platform and Self-Cleaning Shunt (SCS) exemplify the integration of robotics and automation, offering advanced solutions across multiple surgical disciplines. With a strong intellectual property portfolio, the company secures its competitive advantage through domestic and global patents.
Industry Context and Market Position
The company operates within the burgeoning field of minimally invasive surgery, a sector characterized by its continuous evolution and robust demand driven by patient and physician preferences for procedures that limit trauma and promote swift recoveries. As healthcare systems increasingly adopt technologies that promise reduced surgical risks and improved precision, Microbot Medical Inc positions itself as a key innovator. The market benefits from the company’s commitment to addressing complex challenges in endovascular robotics and other surgical applications, setting a clear benchmark for precision and disrupting traditional surgical methods.
Operational Approach and Business Model
Microbot Medical Inc generates its potential revenue streams by developing platforms that can be adapted and applied to a range of surgical specialties. The company’s business model is underpinned by extensive R&D, strategic partnerships, and a focus on securing robust patent protection, all of which minimize competitive risks. By targeting procedures where access-induced trauma has historically compromised outcomes, the company has created a niche that leverages technological precision to improve overall surgical safety.
Competitive Advantages and Future Considerations
Within the competitive landscape of medical device innovations, Microbot Medical Inc distinguishes itself through its commitment to blending robotics with minimally invasive techniques. This intersection of fields allows the company to deliver unique value propositions to healthcare providers by reducing the invasiveness inherent in many traditional surgical procedures. The firm’s ongoing focus on research and development, coupled with its strategic intellectual property positioning, underscores its dedication to advancing surgical care without relying on speculative performance projections.
Commitment to Quality and Innovation
Quality, precision, and innovation are the hallmarks of Microbot Medical Inc's approach. The company’s platforms are engineered to assist physicians in targeting disease sites with remarkable precision, significantly lowering the risk of collateral trauma. By consistently pushing the boundaries of micro-robotic applications in surgery, Microbot Medical Inc continues to build a foundation based on expertise and proven technological advancements that support improved surgical outcomes.
Microbot Medical (MBOT) has announced a registered direct offering priced at-the-market, selling 3,788,550 shares of common stock at $2.27 per share. The company will also issue unregistered short-term series H preferred investment options in a concurrent private placement, allowing the purchase of up to 7,577,100 shares at $2.10 per share, exercisable for two years.
The offerings, expected to close around January 9, 2025, will generate approximately $8.6 million in gross proceeds. H.C. Wainwright & Co. serves as the exclusive placement agent. The net proceeds will fund the development and commercialization of the LIBERTY® Robotic System, expand applications from existing IP portfolio, and provide working capital for general corporate purposes.
Microbot Medical (Nasdaq: MBOT) has successfully raised approximately $11.8 million in gross proceeds through multiple offerings. The company completed a registered direct offering of 4,000,001 shares at $1.75 per share, generating about $7 million. Additionally, they issued unregistered short-term series G preferred investment options for up to 8,000,002 shares with an exercise price of $1.75, exercisable for two years.
The company also raised approximately $4.8 million through their at-the-market facility through January 2025. H.C. Wainwright & Co. served as the exclusive placement agent. The proceeds will fund the development and commercialization of the LIBERTY® Robotic System, expand applications from their IP portfolio, and provide working capital for general corporate purposes.
Microbot Medical (Nasdaq: MBOT) has announced a $7 million registered direct offering priced at-the-market under Nasdaq rules. The company will sell 4,000,002 shares of common stock at $1.75 per share. Additionally, in a concurrent private placement, Microbot will issue unregistered short-term series G preferred investment options to purchase up to 8,000,004 shares of common stock at an exercise price of $1.75 per share, exercisable for two years.
The closing is expected around January 7, 2025, with H.C. Wainwright & Co. acting as the exclusive placement agent. The proceeds will fund the development and commercialization of the LIBERTY® Robotic System, expand applications from existing IP portfolio, and provide working capital for general corporate purposes.
Microbot Medical (Nasdaq: MBOT) has concluded 2024 with significant achievements, including the FDA 510(k) submission for its LIBERTY® Endovascular Robotic System. Key milestones include receiving IDE approval, completing the ACCESS-PVI pivotal human clinical trial across three major US medical centers, and obtaining ISO 13485 certification. The company has initiated inventory build-up and completed two phases of telesurgery collaboration with Corewell Health. Additionally, Microbot entered an agreement with Emory University for autonomous robotics development. The company anticipates launching LIBERTY in Q2 2025 in the U.S., with plans for international expansion.
Microbot Medical announces CEO Harel Gadot's upcoming interview on Benzinga All Access on December 10, 2024, at 10:50am ET. The discussion will focus on the company's LIBERTY® Endovascular Robotic System and the growing surgical robotics market.
The company has submitted an FDA 510(k) application for the LIBERTY® system, which is the world's first single-use, fully disposable endovascular robotic system. The technology eliminates the need for expensive capital equipment while offering benefits such as reduced radiation exposure for medical staff, improved ergonomics, potential cost savings, increased procedure efficiency, and enhanced quality of care.
Microbot Medical (Nasdaq: MBOT) has submitted a 510(k) premarket notification to the FDA for its LIBERTY® Endovascular Robotic System, following successful completion of a multi-center clinical trial. LIBERTY® is the world's first single-use, fully disposable robotic system for endovascular procedures.
The company anticipates FDA marketing clearance during Q2 2025, targeting over 2 million annual peripheral vascular procedures in the U.S. The system eliminates the need for expensive capital equipment, reduces radiation exposure to medical staff, improves ergonomics, and aims to lower procedure costs while increasing efficiency.
Microbot Medical Inc. (Nasdaq: MBOT) has successfully completed enrollment and follow-up for all patients in its ACCESS-PVI human clinical trial for the LIBERTY® Endovascular Robotic Surgical System. The company is on track to file its 510(k) submission with the FDA by the end of 2024, with expected clearance during Q2 2025. Microbot Medical is accelerating its go-to-market strategy, planning to build commercial infrastructure upon FDA clearance.
The clinical trial results will be shared at a medical conference in early 2025. The company's Chief Medical Officer, Juan Diaz-Cartelle, MD, expressed satisfaction with LIBERTY®'s performance throughout the study. CEO Harel Gadot described the trial's conclusion as a monumental moment for Microbot Medical.
Microbot Medical Inc. (Nasdaq: MBOT) has announced an acceleration in patient enrollment for its ACCESS-PVI human clinical trial of the LIBERTY® Endovascular Robotic Surgical System. With 80% of patients having completed the follow-up period, the company expects to finish the trial earlier than anticipated. Microbot remains on track to file its 510(k) submission with the FDA by the end of 2024.
The company has successfully completed all biocompatibility tests required by its Investigational Device Exemption (IDE) application and received full approval for the IDE study from the FDA. ACCESS-PVI is a prospective, multi-center, single-arm trial evaluating the performance and safety of LIBERTY® in peripheral vascular interventions. Microbot is also conducting additional bench testing, with results to be included in the 510(k) submission.
Microbot Medical Inc. (Nasdaq: MBOT) has reached a significant milestone in its pivotal human clinical trial for the LIBERTY® Endovascular Robotic Surgical System. The company has successfully enrolled and completed follow-up for 50% of the patients in the ACCESS-PVI trial, which aims to evaluate the system's performance and safety in peripheral vascular interventions. Microbot Medical expects to:
1. Complete enrollment and follow-up in Q4 2024
2. File a 510(k) submission with the FDA by the end of 2024
3. Proceed with commercialization upon FDA approval
Dr. Dmitry Rabkin from Brigham and Women's Hospital praised the system's ease of use and quick set-up, noting a short learning curve. The company's Chief Medical Officer, Dr. Juan Diaz-Cartelle, expressed excitement about the milestone and physician feedback, confirming they remain on track for trial completion and FDA submission.
Microbot Medical Inc. (Nasdaq: MBOT) has entered a Phase 2 collaboration agreement with Corewell Health to advance remote telesurgery using the LIBERTY® Endovascular Robotic System. This follows the successful completion of Phase 1, which demonstrated LIBERTY's technical capabilities for endovascular interventions. The objective of Phase 2 is to develop and demonstrate new telesurgery capabilities by performing simulated cardiovascular interventional procedures across two Corewell Health facilities located 5 miles apart.
The project is led by Dr. Ryan Madder, who recently published a manuscript highlighting the technical success of coronary guidewire and stent delivery using LIBERTY in a pre-clinical study. Microbot Medical's CEO, Harel Gadot, emphasized that incorporating telesurgery capabilities is important to their long-term strategy for LIBERTY, aiming to increase access to care for patients in remote locations.