Ankündigung • Jun 23
Microbot Medical Announces First Health System in Pennsylvania to Adopt the Liberty Endovascular Robotic System Microbot Medical Inc. announced that a globally recognized academic center headquartered in Pennsylvania is the first in the state to adopt the LIBERTY System, allowing the Company to further expand its presence in the Northeast U.S., joining other health systems in New York City and Boston that have also adopted the LIBERTY System. This latest customer operates multiple hospitals and multispecialty centers serving patients in the highly concentrated Pennsylvania and New Jersey regions and is the second customer with hospitals and medical facilities spanning two states, with the NYC-based customer also having medical facilities in New Jersey. The Company now has accounts in seven states across the Eastern U.S., with multiple hospitals across their health systems, having already adopted the LIBERTY System. The LIBERTY Endovascular Robotic System is the first single-use, remotely operated robotic solution designed for precision, efficiency and safety. The Company is planning to expand its sales territory to the West Coast. The recent agreement to expand access to the LIBERTY System across certain U.S. federal healthcare systems, including those serving veterans and military patient populations, is further strengthening the Company’s confidence in accelerating adoption of the LIBERTY System within existing and new accounts. Price Target Changed • Jun 03
Price target decreased by 22% to US$7.00 Down from US$9.00, the current price target is an average from 3 analysts. New target price is 255% above last closing price of US$1.97. Stock is down 29% over the past year. The company is forecast to post a net loss per share of US$0.30 next year compared to a net loss per share of US$0.29 last year. Ankündigung • May 26
Microbot Medical Inc. Receives Its First International Regulatory Approval for the Commercialization of the LIBERTY Endovascular Robotic System Microbot Medical Inc. announced that it has achieved a significant regulatory milestone as Israel becomes the second jurisdiction — and the first outside of the U.S.— to grant marketing clearance for the LIBERTY System. The regulatory approval from the Israeli Ministry of Health's AMAR Division, the authority responsible for medical device regulation in Israel, allows the Company to market and commercialize the LIBERTY System in Israel, which also enables the Company to obtain a Free Sale Certificate to support submissions and commercial activities in additional jurisdictions. The Company continues to pursue CE Mark certification and is working toward completion by the end of 2026, in preparation for the next phase of commercial expansion into the EU market. The expansion into international markets follows the successful launch of the LIBERTY System in the U.S. which continues to be the focused territory for the Company. Multiple accounts and hospitals in Georgia, Florida, New York, Massachusetts, Michigan, and North Carolina have already adopted the LIBERTY System. LIBERTY is the only FDA-cleared, single-use, remotely operated robotic system for peripheral endovascular procedures, and it is designed for precise vascular navigation while aiming to reduce radiation exposure and physical strain. Major Estimate Revision • May 20
Consensus revenue estimates decrease by 50%, EPS upgraded The consensus outlook for fiscal year 2026 has been updated. 2026 revenue forecast fell from US$6.80m to US$3.40m. EPS estimate increased from -US$0.32 to -US$0.31 per share. Medical Equipment industry in the US expected to see average net income growth of 13% next year. Consensus price target of US$8.50 unchanged from last update. Share price fell 21% to US$1.73 over the past week. Ankündigung • Apr 13
Microbot Medical Inc. Commences Full Market Release Of Liberty Endovascular Robotic System In The U.S Microbot Medical Inc. announced that it has successfully executed its limited market release (LMR) and will commence its full market release (FMR) in the U.S. as planned. To date, LIBERTY has been adopted by multiple healthcare systems with dozens of hospitals in their networks, including globally recognized hospitals such as Emory Healthcare and Tampa General Hospital. The LIBERTY system is creating an entirely new category as the only FDA-cleared, single-use, remotely operated robotic system. It has been successfully used commercially across a variety of procedures, including Prostate Artery Embolization (PAE), Uterine Fibroid Embolization (UFE), Genicular Artery Embolization (GAE), Y90 mapping, Y90 deliveries, and peripheral arterial interventions. Physicians have highlighted LIBERTY’s precision, short learning curve, fast setup, the ability to use their preferred wires and catheters, as well as the potential to improve efficiency by reducing procedure time and number of instruments used to perform such procedures. In preparation for the FMR, the Company has further enhanced its commercial team core capabilities by adding salespeople in key locations and broadening its sales footprint from four to eight sales territories, with a goal of having 12 territories across the U.S. by the end of 2026. SIR, along with the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) have recently adopted new guidelines, which were published in CardioVascular and Interventional Radiology (CVIR), and endorsed by at least eight other medical societies. These guidelines cover updated evidence, address new exposure sources such as CT-guided procedures and radioembolization, and radiation protection during pregnancy for female practitioners, as well as addresses musculoskeletal risks for interventional radiology staff. This follows a recent American Medical Association policy adopted late last year to strengthen protections for health care professionals from occupational exposure to ionizing radiation. The Company plans to meet with physicians and other stakeholders, to showcase the LIBERTY system at booth #423, and to further educate physicians on the system’s full capabilities to accelerate market adoption in the U.S. LIBERTY is the only FDA cleared, single-use, remotely operated robotic system for peripheral endovascular procedures. It is designed for precise vascular navigation while aiming to reduce radiation exposure and physical strain, addressing key clinical and operational challenges faced by interventional radiology teams. Ankündigung • Mar 25
Microbot Medical Inc. Strengthens Liberty Endovascular Robotic System Position with Publication of Access Pvi Pivotal Study Microbot Medical Inc. announced the publication of an article in the Journal of Vascular and Interventional Radiology (JVIR), titled “In Vivo Evaluation of a Disposable Endovascular Robotic System for Arterial Peripheral Vascular Interventions: A Multicenter Feasibility Study.” The article’s first author, Dr. Francois Cornelis, is a leading interventional radiologist specializing in neurointerventions and image-guided, minimally invasive therapies. He has a keen interest in robotics, AI, and advanced imaging, and served as the Lead Principal Investigator for the LIBERTY ACCESS PVI Pivotal Study. The Journal of Vascular and Interventional Radiology, published continuously since 1990, is the premier peer-reviewed journal serving the global interventional radiologist community. Publication in a peer-reviewed journal is a significant milestone, signifying that the study’s methodology and data have been rigorously vetted by independent experts, ensuring a fair and balanced evaluation of the results. This article provides a comprehensive, evidence-based analysis of the Company’s ACCESS-PVI study, which was completed in 2025 and presented at the Society of Interventional Radiology (SIR) annual meeting in April 2025. The study has now undergone rigorous independent peer review, which is considered the gold standard for clinical validation. The LIBERTY system received U.S. Food and Drug Administration (FDA) clearance in September 2025 for peripheral endovascular procedures. LIBERTY is the only FDA cleared, single-use, remotely operated robotic system for peripheral endovascular procedures, and it is designed for precise vascular navigation while aiming to reduce radiation exposure and physical strain. The Company commenced the limited market release of the LIBERTY system in late 2025 and plans for a full market release at the Society of Interventional Radiology (SIR) conference in April 2026, allowing the Company to showcase LIBERTY with the goal to deepen market adoption. Price Target Changed • Feb 10
Price target decreased by 17% to US$7.50 Down from US$9.00, the current price target is an average from 3 analysts. New target price is 266% above last closing price of US$2.05. Stock is up 1.0% over the past year. The company is forecast to post a net loss per share of US$0.29 next year compared to a net loss per share of US$0.73 last year. Ankündigung • Nov 06
Microbot Medical Inc. Commences the Limited Market Release of its LIBERTY® Endovascular Robotic System in the U.S Microbot Medical Inc. announced that its LIBERTY® System, the first FDA cleared single-use, remotely operated robotic system for peripheral endovascular procedures, is now commercially available in the U.S. The Limited Market Release (LMR) will introduce LIBERTY® to selected high procedure volume regions where the Company already experienced preliminary demand for LIBERTY®. The LMR will focus on collecting real-world insights from potential high-volume users to guide responsible growth and ensure consistent quality and performance, leading to the expected Full Market Release (FMR) during the Society of Interventional Radiology (SIR), the largest U.S. medical conference for Interventional Radiology, in April 2026. Since receiving the FDA 510(k) clearance for the LIBERTY® System in September, the Company has advanced its commercial readiness by securing a third-party logistics partner and expanding its commercial leadership team to ensure a fully supported and successful limited market release. Ankündigung • Oct 16
Microbot Medical Inc. Announces Management Appointments Microbot Medical Inc. recently completed the hiring and on-boarding of its entire commercial leadership team. Justin Bourne, with 20 years of sales leadership and commercial experience in the healthcare industry, joined as Regional Sales Director. Mr. Bourne has a strong track record of driving growth, building high-performing teams, and launching disruptive technologies. Most recently, he served as Regional Sales Director at Boston Scientific, where he led multiple new product launches. In this newly created role, he will report directly to Christina Bailey, Vice President of Sales, and will be instrumental in supporting the commercial team sales strategy and strengthening customer partnerships. Dani Kulp joined as Sales Training Director and will be instrumental in shaping the Company’s sales training strategy and equipping the sales team with the tools, knowledge, and confidence to meet sales objectives. Ms. Kulp brings over 15 years of experience in medical education, sales training, and clinical program development, with a strong focus in endovascular, vascular surgery, and peripheral vascular therapies. She has built her career leading high-impact training programs that empower both sales teams and healthcare providers—driving product launches, clinical adoption, and professional growth across the globe. Most recently, she served as Director of Commercial Excellence at Endologix, where she led field sales training, physician education programs, and product launch initiatives. Ankündigung • Oct 01
Microbot Medical®? Receives First Patent in Japan as It Continues to Broaden Its Global Intellectual Property Portfolio Microbot Medical Inc. announced that the Japanese Patent Office has granted the Company its first patent in Japan, covering the core LIBERTY®? System technology, such as a compact robotic device for driving and manipulating movement of at least one elongate surgical tool. In addition to today's news, the Company has also received patents in the U.S., China and Israel over the past 90 days. The Company announced marketing clearance for the LIBERTY®? System by the U.S. Food and Drug Administration (FDA) on September 8, 2025, and has accelerated its commercial launch plans as it targets an estimated 2.5 million peripheral endovascular procedures performed in the U.S., annually. As the Company evaluates other future global markets that have historically accepted FDA cleared devices, the successful implementation of its global IP strategy is expected to protect and allow it to monetize its innovative technology. Ankündigung • Sep 09
Microbot Medical Inc. Receives FDA 510(K) Clearance for its LIBERTY Endovascular Robotic System Microbot Medical Inc. announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the LIBERTY®? System, the first FDA cleared single-use, remotely operated robotic system for peripheral endovascular procedures. The FDA clearance positions the Company to commercialize LIBERTY®? in the U.S., with the goal of transforming the field to enable accessibility to advanced robotics without the traditional constraints of capital equipment and a dedicated infrastructure. The LIBERTY®? pivotal study showed 100% success in the robotic navigation to target, and zero device related adverse events. The study also showed a 92% relative reduction in radiation exposure for physicians. Its remote design is expected to improve ergonomics, which would aid in reducing the physical strain on healthcare providers. The Company believes that LIBERTY®? has the potential to enhance procedure efficiency, lower procedure costs, and improve the overall quality of care. The Company plans to continue clinical data collection for LIBERTY®? during the commercial launch. The Company will attend the H.C. Wainwright Annual Investor Conference held in NYC from September 8-10, 2025. New Risk • Sep 06
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of American stocks, typically moving 11% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risks Earnings have declined by 4.8% per year over the past 5 years. Shareholders have been substantially diluted in the past year (176% increase in shares outstanding). Revenue is less than US$1m. Minor Risk Share price has been volatile over the past 3 months (11% average weekly change). Ankündigung • Aug 20
Microbot Medical Inc. Receives U.S. Patent That Significantly Expands Potential Market Applications Microbot Medical Inc. announced that the United States Patent and Trademark Office (USPTO) has granted the Company a patent, covering a modular robotic surgical system which includes a base and a plurality of tool-receiver units arranged as separate units and independently and interchangeably attachable to the base. The Company considers the issuance of this patent to be significant, as it will potentially enable LIBERTY to be adapted in the future for a wider range of endovascular procedures, which would increase substantially the Total Addressable Market (TAM) the Company is aiming to penetrate. The patent supports innovation and customization for different clinical needs that would allow the Company to address other indications and significantly increase its potential customer base. The Company now has the flexibility and protection to continue building additional capabilities and features to enhance the LIBERTY®? System, with the potential to eventually expand well beyond the estimated 2.5 million peripheral endovascular procedures performed in the U.S. annually. Ankündigung • Aug 05
Microbot Medical® Receives Non-Dilutive Grant to Enhance Operational Capabilities from the Israel Innovation Authority Microbot Medical Inc. announced it has been approved to receive a non-dilutive grant from the Israel Innovation Authority ("IIA”) in the amount of NIS 2.15 Million (approximately $630,000 at a recent exchange rate). The funding will further strengthen the Company’s manufacturing capabilities, positioning it to successfully implement the commercialization of the LIBERTY® System, pending marketing clearance by the U.S. Food and Drug Administration (FDA). In addition to recognizing the Company’s recent milestone achievements, the IIA acknowledged several other factors in its final decision, including the size and characteristics of the target market, the competitive advantages of a single-use, disposable robot, the regulatory status of the LIBERTY® System and the overall benefits it is expected to deliver to the end user and healthcare system. The Company believes that the grant validates its technology and reflects the rigorous, independent due diligence conducted by the IIA. LIBERTY® is an investigational device pending FDA 510(k) clearance, and is currently not available for sale in the U.S. Ankündigung • Jun 18
Microbot Medical Strengthens Global Ip Portfolio with Newly Granted Patent in China Microbot Medical Inc. announced that it has been granted a critical patent in China by the China National Intellectual Property Administration (CNIPA), a key step in the Company's global IP expansion strategy. The patent, which covers the robotic manipulation of a surgical tool handle, further validates the Company's technological innovation and expands its intellectual property (IP) portfolio. This milestone demonstrates Microbot's continued commitment to protect its proprietary technology as it builds a broader global commercialization strategy. This growing portfolio with respect to LIBERTY, which includes nine patents granted globally and 59 patent applications pending, helps ensure the Company maintains a competitive advantage while protecting the unique capabilities of the LIBERTY System. The Company's primary objective remains focused on the U.S. market and preparing for the anticipated Third Quarter 2025 commercial launch of the LIBERTY Endovascular Robotic System, upon planned FDA clearance. Preparations for the anticipated U.S. launch are underway with regulatory, operational and commercial activities accelerating. In parallel, Microbot is laying the groundwork to enter international markets and maximize the long-term potential of the LIBERTY system. Ankündigung • Jun 10
Microbot Medical Inc. Announces Addition of Michael Lytle as the Head of Sales Operations & Analytics As part of Microbot Medical Inc.’s ongoing launch preparation, it recently expanded its commercial team with the addition of Michael Lytle as the head of Sales Operations & Analytics. Mr. Lytle brings deep experience in sales support, data analysis, and operational excellence. He is expected to play a key role in shaping market intelligence tools and processes to optimize the sales cycle and drive strategic growth. Prior to joining Microbot, Mr. Lytle held increasing leadership roles at ZOLL Cardiac Management Solutions (CMS), a division of ZOLL Medical Corporation, where he supported the rollout of innovative cardiac care technologies. Ankündigung • Apr 26
Microbot Medical Inc. Appoints Lisa Dobbins as Director, Human Resources Microbot Medical Inc. announced Lisa Dobbins, an experienced and versatile human resources executive with hands-on MedTech experience, has joined Microbot Medical as Director, Human Resources, a newly created role reporting to Naama Moav, Vice President, Human Resources. Lisa will play an instrumental role as the Company continues to establish its commercial infrastructure and expands its U.S. commercial team. Previously, she was the HR Business Partner, Global Operations and Quality (Boston and Mansfield, MA) for Integra LifeSciences, a global medical technology company. Additionally, Ms. Dobbins has worked for other cutting-edge medical technology companies, utilizing her experience to hire and build high-performing teams that execute long-term growth objectives. Ankündigung • Apr 17
Microbot Medical Inc., Annual General Meeting, Jun 10, 2025 Microbot Medical Inc., Annual General Meeting, Jun 10, 2025. Ankündigung • Apr 09
Microbot Medical Shares Results from Its Pivotal Clinical Trial, Achieving 100% Robotic Navigation Success for the Liberty® Endovascular Robotic System Microbot Medical Inc. presented for the first time the data from its ACCESS-PVI pivotal trial at the Society of Interventional Radiology (SIR) annual meeting. The study was performed at three leading medical centers in the U.S.; Memorial Sloan Kettering Cancer Center (New York, NY), Baptist Hospital of Miami (Miami, FL) and Brigham and Women's Hospital (Boston, MA). The late-breaking podium presentation was given by Francois Cornelis, M.D., PhD, Director of the Neuro Vascular Interventional Radiology Program at Memorial Sloan Kettering Cancer Center. The data presented concluded that robotic endovascular procedures using LIBERTY are feasible and significantly minimize radiation exposure. Significant Highlights of the ACCESS-PVI Study: Successful robotic navigation was achieved in every case (N=20), yielding a success rate of 100%, meeting the primary endpoint of the study. No Adverse Device Events (ADE=0%) were reported through the duration of follow-up. Mean difference in radiation exposure between operator and control was (-)29.8 uS, resulting in a mean 92% relative reduction in radiation exposure. New Risk • Feb 16
New major risk - Shareholder dilution The company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 159% This is considered a major risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (32% average weekly change). Earnings have declined by 8.3% per year over the past 5 years. Shareholders have been substantially diluted in the past year (159% increase in shares outstanding). Revenue is less than US$1m. Minor Risk Market cap is less than US$100m (US$69.1m market cap). Ankündigung • Feb 12
Microbot Medical Inc. has completed a Follow-on Equity Offering in the amount of $13.000006 million. Microbot Medical Inc. has completed a Follow-on Equity Offering in the amount of $13.000006 million.
Security Name: Common Stock
Security Type: Common Stock
Securities Offered: 6,103,289
Price\Range: $2.13
Discount Per Security: $0.1491
Transaction Features: Registered Direct Offering Ankündigung • Feb 11
Microbot Medical Inc. has filed a Follow-on Equity Offering in the amount of $13.000006 million. Microbot Medical Inc. has filed a Follow-on Equity Offering in the amount of $13.000006 million.
Security Name: Common Stock
Security Type: Common Stock
Securities Offered: 6,103,289
Price\Range: $2.13
Discount Per Security: $0.1491
Transaction Features: Registered Direct Offering Board Change • Feb 02
Insufficient new directors No new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 8 experienced directors. 4 highly experienced directors. Member of Scientific Advisory Board Ajay Wakhloo was the last director to join the board, commencing their role in 2022. The following issues are considered to be risks according to the Simply Wall St Risk Model: Insufficient board refreshment. Ankündigung • Jan 21
Microbot Medical Inc. Appoints Ms. Michal Ahuvia to the Newly Created Role of Director of Operations Microbot Medical Inc. announced the appointment of Ms. Michal Ahuvia, to the newly created role of Director of Operations. In this role, Ms. Ahuvia will assume responsibility to ramp-up production and improve production efficiencies as the Company prepares for the planned commercial launch of LIBERTY, which is anticipated in the second quarter of 2025. Ms. Ahuvia will report to Simon Sharon, the Company’s General Manager and Chief Technology Officer, and her addition is expected to play a crucial role in strengthening the Company’s manufacturing and operations processes. Ms. Ahuvia brings over 20 years of experience in operations with track records in process transformation, performance improvement, material planning, production, logistics, and supply chain management. Prior to joining Microbot Medical, Ms. Ahuvia held operational and supply chain positions at Philips Healthcare, Nanomotion, XACT Robotics and Jordan Valley. Michal holds a B.Sc. in Industrial Engineering and Management from Ben-Gurion University. Ankündigung • Jan 09
Microbot Medical Inc. has completed a Follow-on Equity Offering in the amount of $7.000002 million. Microbot Medical Inc. has completed a Follow-on Equity Offering in the amount of $7.000002 million.
Security Name: Common Stock
Security Type: Common Stock
Securities Offered: 4,000,001
Price\Range: $1.75
Discount Per Security: $0.1225
Transaction Features: Registered Direct Offering Ankündigung • Jan 08
Microbot Medical Inc. has filed a Follow-on Equity Offering in the amount of $8.600009 million. Microbot Medical Inc. has filed a Follow-on Equity Offering in the amount of $8.600009 million.
Security Name: Common Stock
Security Type: Common Stock
Securities Offered: 3,788,550
Price\Range: $2.27
Transaction Features: Registered Direct Offering Ankündigung • Jan 07
Microbot Medical Inc. has filed a Follow-on Equity Offering in the amount of $7.000002 million. Microbot Medical Inc. has filed a Follow-on Equity Offering in the amount of $7.000002 million.
Security Name: Common Stock
Security Type: Common Stock
Securities Offered: 4,000,001
Price\Range: $1.75
Discount Per Security: $0.1225
Transaction Features: Registered Direct Offering New Risk • Jan 04
New major risk - Share price stability The company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of American stocks, typically moving 26% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$9.0m free cash flow). Share price has been highly volatile over the past 3 months (26% average weekly change). Earnings have declined by 8.3% per year over the past 5 years. Revenue is less than US$1m. Minor Risks Shareholders have been diluted in the past year (45% increase in shares outstanding). Market cap is less than US$100m (US$19.3m market cap). Ankündigung • Dec 30
Microbot Medical Inc. Concludes 2024 by Achieving Key Milestones Culminating in FDA Submission for the Commercialization of LIBERTY Microbot Medical Inc. concludes 2024 with the achievement of several key milestones, including the recent FDA 510(k) submission for FDA commercial approval of LIBERTY, which the company believes will position the Company for continued success in 2025. The following are the key milestones the Company has reported achieving during the past 12 months: Complete FDA 510(k) submission; received Investigational Drug Exemption (IDE) approval from the FDA to initiate the ACCESS-PVI pivotal human clinical trial. Successfully completed the ACCESS-PVI crucial human clinical trial in three leading medical centers in the USA: Miami Baptist (Miami, FL), Memorial Sloan Kettering (NYC, NY) and Brigham & Women's (Boston, MA). Successfully completed the substantial R&D testing required for FDA's 510(k) submission, including biocompatibility, transportation validation, and usability testing, among others. Submitted 510(k) file to FDA for the commercialization of the LIBERTY Endovascular Robotic System. Establish pre-commercial infrastructures; received ISO 13485 certification for quality management system to support commercialization. Initiated inventory build-up while improving operational infrastructure; Submitted the ACCESS-PVI key human clinical trial results to conferences in anticipation of sharing them publicly by leveraging these professional channels; Attended several endovascular medical conferences, including the Society of Interventional Radiology (SIR) and Cardiovascular and Interventional Radiological Society of Europe (CIRSE). Execute strategic initiatives to support future growth; Completed Phase 1 and Phase 2 of the telesurgery collaboration with Corewell Health, culminating in a simulated procedure between two facilities located 5 miles apart; entered into an agreement with Emory University to collaborate on the development of autonomous robotics. Based on these achievements, the Company believes it has laid the necessary groundwork to support its commercial objectives in 2025. The Company is anticipating the launch of LIBERTY in Second Quarter 2025 in the U.S. and continuing its efforts to receive additional regulatory approval outside the U.S. to support future growth. Ankündigung • Dec 11
Microbot Medical Inc. Announces FDA Submission for the Commercialization of the LIBERTY Endovascular Robotic System Microbot Medical Inc. announced that it has submitted a 510(k) premium notification to the U.S. Food and Drug Administration (FDA) for LIBERTY. LIBERTY is the world's first single-use, fully disposable robotic system for endovascular procedures. The 510(k) submission follows the successful completion of its multi-center, single-arm, trial to evaluate the performance and safety of LIBERTY in human subjects undergoing Peripheral Vascular Interventions. The Company anticipates FDA marketing clearance during the second quarter of 2025, with U.S. commercialization activities expected to commence after the clearance. As the world's first single- use, fully disposable endovascular robotic system, LIBERTY eliminates the need for large and expensive capital equipment and streamlines customers' access to robotics. With its remote control, LIBERTY is designed to significantly reduce radiation exposure to physicians and staff, and improve ergonomics, which has the potential to reduce the physical strain on healthcare providers. The Company also believes that LIBERTY has the potential to lower procedure costs, increase procedure efficiency and improve the overall quality of care. New Risk • Nov 15
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -US$9.0m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$9.0m free cash flow). Earnings have declined by 8.3% per year over the past 5 years. Revenue is less than US$1m. Minor Risks Shareholders have been diluted in the past year (41% increase in shares outstanding). Market cap is less than US$100m (US$15.7m market cap). Ankündigung • Nov 07
Microbot Medical Inc., Annual General Meeting, Dec 17, 2024 Microbot Medical Inc., Annual General Meeting, Dec 17, 2024. Location: offices of mintz, levin, cohn, ferris, glovsky and, popeo, p.c, one financial center, ma 02111, boston United States Ankündigung • Oct 15
Microbot Medical Inc. Announces Successful Completion of Its Pivotal Human Clinical Trial Microbot Medical Inc. announced that it has successfully completed enrollment and follow up for all patients in its ACCESS-PVI human clinical trial. The Company remains on track to file its 510(k) submission with the U.S. Food and Drug Administration (FDA) by of the end of 2024. The Company also announced that it is accelerating its go-to-market strategy. It expects to begin building out the commercial infrastructure, including the hiring of a seasoned healthcare executive to lead its sales efforts, upon the FDA clearance, which is expected during second quarter 2025. ACCESS-PVI is a prospective, multi-center, single-arm, trial to evaluate the performance and safety of LIBERTY in human subjects undergoing Peripheral Vascular Interventions. The trial will support the 510(k) submission to the FDA and subsequent commercialization. The Company wants to thank the patients, physicians and clinical sites for their participation in the trial. Ankündigung • Oct 14
Microbot Medical Receives a Deficiency Letter from the Nasdaq Listing Qualifications Department of the Nasdaq Stock Market On October 9, 2024, Microbot Medical Inc. received a deficiency letter from the Nasdaq Listing Qualifications department of The Nasdaq Stock Market, LLC (“Nasdaq”), notifying the Company that it is not in compliance with Nasdaq Listing Rule 5550(a)(2) (the “Minimum Bid Price Requirement”) for continued listing on the Nasdaq Capital Market, as the minimum bid price of the Company’s common stock on the Nasdaq Capital Market was below $1.00 for 30 consecutive business days, from August 26, 2024 to October 7, 2024. In accordance with Nasdaq Listing Rule 5810(c)(3)(A), the Company has a period of 180 calendar days, or until April 7, 2025, to regain compliance with the Minimum Bid Price Requirement. If, at any time before the Compliance Date, the closing bid price of the Company’s common stock is at least $1.00 for a minimum of ten consecutive business days, the Staff will provide a written confirmation to the Company that it has regained compliance with the Minimum Bid Price Requirement. If the Company does not regain compliance with the Minimum Bid Price Requirement by the Compliance Date, the Company may be eligible for additional time. To qualify, the Company will be required to meet the continued listing requirement for market value of publicly held shares and all other initial listing standards for The Nasdaq Capital Market, with the exception of the Minimum Bid Price Requirement, and will need to provide written notice of its intention to cure the deficiency during the second compliance period, by effecting a reverse stock split, if necessary. If the Company meets these requirements, Nasdaq will inform the Company that it has been granted an additional 180 calendar days. However, if it appears to Nasdaq that the Company will not be able to cure the deficiency, or if the Company is otherwise not eligible, Nasdaq will provide notice that its securities will be subject to delisting. At that time, the Company may appeal the Staff’s delisting determination to a Nasdaq Listing Qualifications Panel (the “Panel”) pursuant to the procedures set in the applicable Nasdaq Listing Rules. However, there can be no assurance that, if the Company receives a delisting notice and appeals the delisting determination by the Staff to the Panel, such appeal would be successful. Additionally, there can be no assurance that the Company will be able to regain compliance with the Minimum Bid Price Requirement, or will otherwise be compliant with other Nasdaq Listing Rules. Ankündigung • Sep 17
Microbot Medical Inc. Announces the Successful Enrollment of 50% of the Patients in its Pivotal Human Clinical Trial for the LIBERTY Endovascular Robotic Surgical System Microbot Medical Inc. announced that it has successfully reached the midpoint of the ACCESS-PVI pivotal human clinical trial, enrolling and completing the follow up of 50% of the patients participating in the trial to evaluate the LIBERTY® Endovascular Robotic Surgical System. The Company expects to complete enrollment and follow up in the fourth quarter of 2024 and file its 510(k) submission with the U.S. Food and Drug Administration (FDA) by the end of 2024. ACCESS-PVI is a prospective, multi-center, single-arm, clinical trial designed to evaluate the performance and safety of LIBERTY® in human subjects undergoing Peripheral Vascular Interventions. The trial is expected to support the future 510(k) submission to the FDA and, when approved, subsequent commercialization. Ankündigung • Jul 18
Microbot Medical Inc. Completes the Enrollment of Clinical Sites in Its Pivotal Human Clinical Trial with the Addition of Memorial Sloan Kettering Cancer Center Microbot Medical Inc. announced it has received Institutional Review Board (IRB) approval and signed a clinical trial agreement with Memorial Sloan Kettering Cancer Center, located in New York City, New York. Memorial Sloan Kettering Cancer Center will conduct the clinical trial as part of the Investigational Device Exemption (“IDE”) for LIBERTY®, and the Company expects its results will support the future marketing submission to the FDA and subsequent commercialization. The clinical trial at Memorial Sloan Kettering Cancer Center will be led by Francois Cornelis, MD, PhD. “I’m a great believer in the future of robotics for interventional procedures and the value robotics can bring to physicians and patients. Ankündigung • Jul 08
Microbot Medical Enrolled the First Patient in Its Pivotal Human Clinical Trial Microbot Medical Inc. announced the completion of the first procedure in a patient utilizing its LIBERTY® Endovascular Robotic Surgical System. The procedure took place at Brigham and Women’s Hospital (BWH), a leading academic medical center located in Boston, Massachusetts, as part of the Company’s pivotal human clinical trial. The clinical trial at BWH is led by Dr. Dmitry Rabkin, MD, PhD, Assistant Chief, Division of Angiography & Interventional Radiology, who also performed this first human case. The trial is part of the Investigational Device Exemption (“IDE”) for LIBERTY®, and the Company expects its results will support the future submission to the FDA and subsequent commercialization. Ankündigung • Jul 02
Microbot Medical Inc. has filed a Follow-on Equity Offering in the amount of $4.819905 million. Microbot Medical Inc. has filed a Follow-on Equity Offering in the amount of $4.819905 million.
Security Name: Common Stock
Security Type: Common Stock
Transaction Features: At the Market Offering Ankündigung • Jun 21
Microbot Medical Inc. announced that it has received $1.762502 million in funding On June 20, 2024, Microbot Medical Inc. closed the transaction. The transaction included participation from three investors. The company paid $164,500 as sales commissions in the transaction. The placement agent received an aggregate cash fee equal to 7.0% of the gross proceeds, a management fee equal to 1.0% of the gross proceeds. New Risk • Jun 06
New major risk - Shareholder dilution The company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 53% This is considered a major risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Earnings have declined by 11% per year over the past 5 years. Shareholders have been substantially diluted in the past year (53% increase in shares outstanding). Revenue is less than US$1m. Minor Risks Share price has been volatile over the past 3 months (14% average weekly change). Market cap is less than US$100m (US$18.5m market cap). Ankündigung • Jun 06
Microbot Medical Inc. has completed a Follow-on Equity Offering in the amount of $2.350004 million. Microbot Medical Inc. has completed a Follow-on Equity Offering in the amount of $2.350004 million.
Security Name: Common Stock
Security Type: Common Stock
Securities Offered: 1,566,669
Price\Range: $1.5
Discount Per Security: $0.105
Transaction Features: Registered Direct Offering New Risk • Jun 03
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of American stocks, typically moving 14% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$7.8m free cash flow). Earnings have declined by 11% per year over the past 5 years. Revenue is less than US$1m. Minor Risks Share price has been volatile over the past 3 months (14% average weekly change). Shareholders have been diluted in the past year (48% increase in shares outstanding). Market cap is less than US$100m (US$14.4m market cap). Ankündigung • Apr 30
Microbot Medical Announces Positive Results from the First Phase of Its Collaboration with Corewell Health Microbot Medical Inc. reported that the first phase of the previously announced collaboration with Corewell Health has been completed, which demonstrated the LIBERTY System's technical capabilities and outlines potential future applications in a range of endovascular interventions. The objective of the collaboration, which will take place in multiple phases, is to enable telerobotics between remote centers by utilizing the LIBERTY System. The agreement with Corewell Health includes the right to mutually evaluate the LIBERTY System for remote procedures and it is being led by Ryan Madder, M.D., Section Chief of Interventional Cardiology and Director of the Cardiac Cath Lab at Corewell Health in Grand Rapids, Michigan. Ankündigung • Feb 06
Microbot Medical Submits an IDE Application to Gain FDA Approval to Commence Its Pivotal Clinical Trial in the US Microbot Medical Inc. announced that it has filed an Investigational Device Exemption (IDE) application with the US Food and Drug Administration (FDA). The IDE application follows the completion of multiple preclinical activities performed to provide preliminary safety and effectiveness information, and its approval by the FDA would allow the company to commence its pivotal human clinical trial in the United States. Ankündigung • Jan 30
Microbot Medical Announces Settlement and Release Agreement, Effectively Resolving All Associated Legal Matters Microbot Medical Inc. announced it has signed a Settlement Agreement and Release with Empery Asset Master Ltd., Empery Tax Efficient, LP, Empery Tax Efficient II, LP, Hudson Bay Master Fund Ltd. that resolves all claims asserted against the Company by these entities in a lawsuit filed in 2020 relating to a June 2017 securities purchase agreement. All of the cash payable to the plaintiffs in the settlement, representing over half of the settlement amount, will be covered by Microbot's insurance carrier. This arrangement ensures that the settlement will not impact the company's cash position or its balance sheet. New Risk • Jan 24
New major risk - Shareholder dilution The company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 70% This is considered a major risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$9.2m free cash flow). Share price has been highly volatile over the past 3 months (20% average weekly change). Earnings have declined by 14% per year over the past 5 years. Shareholders have been substantially diluted in the past year (70% increase in shares outstanding). Revenue is less than US$1m. Minor Risk Market cap is less than US$100m (US$17.3m market cap). Ankündigung • Jan 19
Microbot Medical Expands US Clinical Infrastructure in Support of the Upcoming IDE Submission to Commence its First in Human Clinical Study Microbot Medical Inc. announced that following the recent positive results of its pivotal GLP Pre-Clinical Study, and to support its anticipated IDE submission to commence its first in human clinical trial, the Company added a US- based Clinical Research Associate (CRA). The CRA will join the already established clinical team in the USA, led by Dr. Juan Diaz-Cartelle, the Company's Chief Medical Officer. Ankündigung • Dec 29
Microbot Medical Announces Positive Results of Its GLP Pivotal Pre-Clinical Study Where All Study Objectives Met Microbot Medical Inc. announced the successful completion of its GLP pivotal pre-clinical study, done under the guidelines of FDA-required levels of planning, controlling, monitoring, and reporting, using a porcine model. As previously announced on December 7, 2023, the study was conducted by three leading interventional radiologists that utilized the LIBERTY Endovascular Robotic Surgical System to perform a total of 96 robotic navigations. Target vessels with surrounding tissue were examined and evaluated microscopically after they were subjected to procedures using a range of commercially available intravascular catheterization devices controlled and manipulated via the LIBERTY Endov vascular Robotic Surgical System. Ankündigung • Dec 07
Microbot Medical Announces the Successful Completion of its GLP Pivotal Pre-Clinical Study Microbot Medical Inc. announced the successful completion of its GLP pivotal pre-clinical study, done under the guidelines of FDA-required levels of planning, controlling, monitoring, and reporting, using a porcine model. The study was conducted by three leading interventional radiologists that utilized the LIBERTY Endovascular Robotic Surgical System to perform a total of 96 robotic navigations. Target vessels with surrounding tissue were examined and evaluated microscopically after they were subjected to procedures using a range of commercially available intravascular catheterization devices controlled and manipulated via the LIBERTY Endov vascular Robotic Surgical System. Ankündigung • Nov 22
Microbot Medical Inc. Announces Executive Changes Microbot Medical Inc. announced the appointment of Dr. Juan Diaz-Cartelle as its new Chief Medical Officer (CMO), effective December 1, 2023. The hiring of Dr. Diaz-Cartelle, a U.S.-based physician, coincides with the transition of the Company focusing mainly on research and development in Israel to the Company increasing its U.S.-based activities, which includes its planned clinical trials for the LIBERTY® Endovascular Robotic Surgical System in the U.S., the regulatory process with the FDA and establishing the commercial foundations to enter the U.S market. Dr. Diaz-Cartelle brings to Microbot a wealth of experience in the endovascular and interventional space, along with an impressive track record in clinical research. Before joining the Company, Dr. Diaz-Cartelle served for 14 years as the Senior Medical Director for the Peripheral Interventional Division (Endovascular and Interventional Oncology) at Boston Scientific Corporation. In this role, he played a pivotal part in the development of global clinical strategy and study oversight, supporting commercial activities and future pipeline development. Most recently he served as the Executive Medical Director at Haemonetics Corporation, where he advised the company on new investments in the cardiovascular space, among other responsibilities. Before joining the corporate life, he worked at NYU as a research scientist. Dr. Diaz-Cartelle succeeds Dr. Eyal Morag, the company's previous CMO, who was based out of Israel and played an integral part of the development and testing of the LIBERTY Endovascular Robotic System from its inception phase. The Company is grateful for Dr. Morag's vast contribution to the Company over the years and wishes him success in his next ventures. Ankündigung • Nov 15
Microbot Medical Inc. Successfully Completed Integral Part of the Verification and Validation Process Microbot Medical Inc. announced it had successfully completed the Electromagnetic compatibility (EMC) testing section of the Verification and Validation (V&V) process. V&V are distinct procedures employed to ensure that a product, service, or system, aligns with specified requirements and effectively serves its intended purpose. The V&V, together with the pre-clinical pivotal study Microbot recently completed, are essential elements to an Investigational Device Exemption (IDE) submission for the FDA to commence clinical trials as part of the pathway for and receiving the required regulatory clearance. Ankündigung • Nov 01
Microbot Medical Reveals Successful Short Term Follow Up Outcomes from Its Pivotal Pre-Clinical Study Microbot Medical Inc. announced additional updates regarding positive outcomes of its previously announced pivotal pre-clinical study using the LIBERTY Robotic Surgical System. The pivotal study was conducted by three leading interventional radiologists that utilized the LIBERTY RoboticSurgical System to reach a total of 48 animal targets. In a series of visual testing, preformed 72 hours following each procedure, examination of the animals treated with the LIBERTYRobotic Surgical System showed no visual evidence of vascular injury or any other visual adverse event. This new data follows the recently announced successful initial outcomes from the pivotal pre-clinical study. A total of 6 LIBERTY Systems were used in the study, each was used to reach a total of 8 targets. All 6 LIBERTY Systems performed flawlessly based on the initial outcomes, with 100% usability and technical success. No acute adverse events or complications were visually observed intra-operative. The Company expects to receive the comprehensive final report later this quarter. Subject to the final report, and the completion of the verification and validation (V&V) process, the Company plans on submitting the Investigational Device Exemption (IDE) application to the FDA, in order to commence its pivotal clinical trial in humans. Ankündigung • Oct 20
Microbot Medical Inc. Announces Grant of Summary Judgment in its Favor and Dismissal of Counterclaim Against Company Microbot Medical Inc. announced that the United States District Court for the Southern District of New York, approved Microbot’s motion for summary judgment and dismissed with prejudice the previously announced Section 10(b) counterclaim brought by defendant as against Microbot in the action titled Microbot Medical Inc., Plaintiff v. Joseph Mona, Defendant. In its Memorandum Decision and Order, the Court adopted in full the Magistrate Judge’s Report and Recommendation, which had recommended that the Court grant Microbot’s motion for summary judgment and dismiss defendant’s counterclaim with prejudice. In its ruling, in part, the Court held that the defendant failed to raise a triable issue of fact in support of his claim. Microbot previously announced that a judgment in the action against defendant and in favor of Microbot in the amount of $484,614.30 was entered, and no appeal was filed. As the counterclaim has now been dismissed, the Company is now seeking to enforce the judgment as against defendant. Ankündigung • Oct 18
Microbot Medical Inc. Announces Successful Initial Outcomes from its Pivotal Pre-Clinical Study with the LIBERTY Robotic Surgical System Microbot Medical Inc. announced the successful initial outcomes of using the LIBERTY Robotic Surgical System in its pivotal pre-clinical study. The pivotal study was conducted by three leading interventional radiologists that utilized the LIBERTY RoboticSurgical System to reach a total of 48 animal targets. A total of 6 LIBERTY Systems were used in the study, each was used to reach a total of 8 targets. All 6 LIBERTY Systems performed flawlessly, with 100% usability and technical success. No acute adverse events or complications were visually observed intra-operative. The company expects to receive the comprehensive final report later this quarter. Subject to the final report, and the completion of the verification and validation (V&V) process, the Company plans on submitting the Investigational Device Exemption (IDE) application to the FDA, in order to commence its pivotal clinical trial in humans. Ankündigung • Sep 06
Microbot Medical Inc., Annual General Meeting, Nov 02, 2023 Microbot Medical Inc., Annual General Meeting, Nov 02, 2023. Price Target Changed • Aug 16
Price target decreased by 60% to US$8.00 Down from US$20.00, the current price target is provided by 1 analyst. New target price is 276% above last closing price of US$2.13. Stock is down 59% over the past year. The company posted a net loss per share of US$1.81 last year. Ankündigung • Aug 11
Microbot Medical Inc. Appoints Francois H. Cornelis to its Scientific Advisory Board Microbot Medical Inc. announced the expansion of its global team of experts supporting the Company as scientific advisory board members ("SAB"), with Francois H. Cornelis, MD, PhD joining company's Scientific Advisory Board (SAB). Professor Cornelis is an interventional radiologist who specializes in neuro interventions and image-guided minimally invasive therapies that allow for pain palliation and tumor control in the bones and spine. Professor Cornelis uses a variety of technologies to treat tumors and cancer-related pain, such as radiofrequency and microwave energy, cryotherapy, focused ultrasound, and electroporation, as well as image-guided modalities, including navigation software, MRI, robotics, and PET-CT-guided procedures. He is pursuing research, mainly into intra-arterial therapies for brain tumors and in the fields of mentoplasty, osteoplasty, and fixation - which help reinforce bones to reduce pain. Professor Cornelis received his MD in 2003 and completed his radiology training and his fellowship in 2008 and 2010, respectively, at the University of Bordeaux in France. He stayed on the faculty, with appointments in Radiology at the Bergoni Institute (2010) and the University of Bordeaux (2012). He was appointed as a tenured professor of radiology in France in 2017 and served as Chief of the Department of Interventional Radiology and Oncology at the Sorbonne University in Paris before heading to New York. The support and endorsement of a global leader such as Professor Cornelis is a vote of confidence and a great honor for the company. Professor Cornelis joins a team of global leaders in their fields that are already serving as members of SAB, said Dr. Eyal Morag, Chief Medical Officer of Microbot Medical. The significant contributions of SAB members to the company, including their participation in pre-clinical studies, is expected to greatly support forthcoming plans, including clinical trials and collaborations with leading medical centers worldwide.. Ankündigung • Jun 23
Microbot Medical Inc. Announces the Expansion of its Global IP Portfolio by Receiving a Grant of Protection from the Japan Patent Office Microbot Medical Inc. announced the expansion of its global IP portfolio by receiving a Grant of Protection from the Japan Patent Office for a Design Patent covering the innovative industrial design of the robotic drive of the LIBERTY Robotic Surgical System. Microbot's IP portfolio for LIBERTY and its related technologies includes 19 patents issued/allowed and 41 applications pending. This Design Patent complements previously received protection in Japan covering the unique design of the LIBERTY Robosis System remote controller. Similar Design Patents were granted in the U.S., Europe, and Israel. New Risk • Jun 09
New major risk - Shareholder dilution The company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 50% This is considered a major risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$12m free cash flow). Share price has been highly volatile over the past 3 months (48% average weekly change). Earnings have declined by 16% per year over the past 5 years. Shareholders have been substantially diluted in the past year (50% increase in shares outstanding). Revenue is less than US$1m. Minor Risk Market cap is less than US$100m (US$28.5m market cap). Ankündigung • Jun 03
Microbot Medical Receives Non-Dilutive Grant from the Israel Innovation Authority Supporting the Development of the Manufacturing Process for Its Endovascular Surgical Robotic System Microbot Medical Inc. announced it has received a grant from the Israel Innovation Authority ("IIA”) in the amount of ILS 1.62 million, which based on a recent exchange rate to the U.S. dollar, would be approximately $440,000, to further support the development of the Company’s manufacturing process of its robotic surgical system, the LIBERTY. This is the first time Microbot has received approval for a grant for "transition from development to manufacturing" program, which the Company believe is a reflection of the recent activities and milestones the LIBERTY achieved as it progresses in its path toward its regulatory and commercialization activities. In relation to the IIA grant, Microbot is obligated to pay royalties amounting to between 3%-5% of its future sales of the LIBERTY product up to the grant amount plus interest. The grant is linked to the U.S. dollar and bears interest at Libor per annum. The grant monies will be paid over time based on the terms of the grant, and the U.S. dollar amount actually received will be based on the exchange rate of the U.S. dollar to the New Israeli Shekel at the time of payment. Ankündigung • Jun 01
LIBERTY Robotic Surgical System Achieved Additional Milestone in its Path to First in Human and Regulatory Process Microbot Medical Inc. announces that an additional milestone was achieved when medical professionals experienced the Company's LIBERTY Robotic Surgical System as part of a formative study. The study was designed to enable medical professionals, including physicians and Cath-lab technicians, to use and experience LIBERTY in a real-use simulated environment. The study was performed and managed by experts from a company specializing in conducting Human Factors and Usability Engineering tests of medical devices. The study included five teams, each consisting of an interventional radiologist and a Cath-Lab technician and simulated the expected clinical setup and use of the LIBERTY® Robotic Surgical System. All participants were successfully trained on the system prior to their participation and the study validated that the LIBERTY Robotic Surgical System operation and setup are intuitive. Analysis and data from the study exhibited high subjective grading both by the physicians and the technicians, with no comments made on the designed operative flow. Ankündigung • May 17
Microbot Medical Inc. announced delayed 10-Q filing On 05/16/2023, Microbot Medical Inc. announced that they will be unable to file their next 10-Q by the deadline required by the SEC. Ankündigung • May 10
Microbot Medical Initiates Preparations for First-In-Human (Fih) Cases in Brazil for the Liberty® Robotic System Microbot Medical Inc. announced that it has initiated preparations for potential First-In-Human cases in Brazil, by engaging with distinguished publisher and lecturer interventional radiologist Prof. Francisco Cesar Carnevale. The engagement with Prof. Carnevale, from the prestigious University of Sao Paulo Medical School Hospital, is expected to support the Company's intention to conduct a FIH clinical trial in Brazil as part of its ongoing clinical and regulatory efforts. The potential clinical cases are expected to commence upon completion of the verification & validation process of the LIBERTY Robotic system, as well as obtaining the necessary regulatory approvals to perform those cases. Price Target Changed • May 10
Price target decreased by 58% to US$8.00 Down from US$19.00, the current price target is provided by 1 analyst. New target price is 627% above last closing price of US$1.10. Stock is down 78% over the past year. The company posted a net loss per share of US$1.81 last year. Ankündigung • May 06
Microbot Medical Inc. Announces Final Data from Its Recent Animal Study Microbot Medical Inc. has received the histopathology report from the European-based MedTech research laboratory that performed the animal study for the LIBERTY Robotic System in October 2022. During the animal study, the physicians conducted 63 navigations to the targeted sites using the investigational LIBERTY Robotic System and performed an equal number of procedures manually. The LIBERTY Robotic System received overwhelmingly positive feedback from participating physicians, and there were no observable immediate intraoperative adverse events, or harm, to the test subjects. The new data from the report, which included histopathology data (the microscopic examination of tissue to study the manifestations of disease), exhibited equivocal results which were identified as related to unusual physiological animal responses in both manual and robotic test groups. The Company believes the results of the study allow it to move forward and focus on the next phases to ultimately include a U.S.-based pivotal pre-clinical study. The Company, together with its regulatory experts and consultants, believe a larger sample size and robust data generated by this study will advance the company's efforts towards the submission of Investigational Device Exemption (IDE) with U.S. Food and Drug Administration (FDA). Ankündigung • May 04
Microbot Medical Inc. Announces Liberty Robotic System Surpasses 100Th Catheterization Microbot Medical Inc. announced the system has surpassed its 100th catheterization during multiple pre-clinical studies, with a 95% success rate of reaching pre-determined vascular targets, such as distal branches of hepatic, gastric, splenic, mesenteric, renal, hypogastric arteries. Moreover, all of the procedures were completed without notable signs of intraoperative injury. The LIBERTY Robotic System performed safely, consistently and reliably, regardless of the operator. Preponderance of data being generated from pre-clinical studies and feedback generates increased physician interest as the company advances towards commercialization objectives. The LIBERTY Robotic System aims to improve the way surgical robotics are being used in endovascular procedures, by eliminating the need for large, cumbersome, and expensive capital equipment, while reducing radiation exposure and physician strain. The Company believes the LIBERTY Robotic System’s remote operation has the potential to be the first system to democratize endovascular interventional procedures. Board Change • Nov 16
High number of new directors There are 5 new directors who have joined the board in the last 3 years. Member of Scientific Advisory Board Ajay Wakhloo was the last director to join the board, commencing their role in 2022. The company’s lack of board continuity is considered a risk according to the Simply Wall St Risk Model. Board Change • Apr 27
High number of new directors There are 5 new directors who have joined the board in the last 3 years. Member of Scientific Advisory Board Ajay Wakhloo was the last director to join the board, commencing their role in 2022. The company’s lack of board continuity is considered a risk according to the Simply Wall St Risk Model. Board Change • Apr 15
High number of new directors There are 5 new directors who have joined the board in the last 3 years. Member of Scientific Advisory Board Ajay Wakhloo was the last director to join the board, commencing their role in 2022. The company’s lack of board continuity is considered a risk according to the Simply Wall St Risk Model.