Microbot Medical Stock

Microbot Medical Inc. (Microbot), a pre-clinical medical device company, specializes in the research, design, and development of next generation robotic endoluminal surgery devices targeting the minimally invasive surgery space. Microbot is primarily focuses on leveraging its robotic technologies with the goal of redefining surgical robotics while improving surgical outcomes for patients.

Microbot's technological platforms, LIBERTY, NovaCross, One & Done, ViRob and TipCAT, are consists of proprietary innovative technologies. Utilizing the LIBERTY and One & Done platforms, Microbot is developing the first ever fully disposable robot for various endovascular interventional procedures. In addition, the company focuses on the development of a Multi Generation Pipeline Portfolio utilizing all of its proprietary technologies.

Microbot has a patent portfolio of 58 issued/allowed patents and 51 patent applications pending worldwide, of which 6 issued/allowed patents and 34 patent applications relate to the LIBERTY device.

Technological Platforms and Product Pipeline

LIBERTY

The LIBERTY robotic system features a unique compact design with the capability to be operated remotely, reduce radiation exposure and physical strain to the physician, reduce the risk of cross contamination, as well as the potential to eliminate the use of multiple consumables when used with its One & Done capabilities, which would be based in part on the company's One & Done and NovaCross platforms or possibly other guidewire/microcatheter technologies.

LIBERTY is designed to maneuver guidewires and over-the-wire devices (such as microcatheters) within the body's vasculature. In addition, when combined with the company's One & Done technology or possibly other guidewire/microcatheter technologies, it is being designed to streamline Cath-lab procedures with tools that combines guidewire and microcatheter into a single device.

LIBERTY's addressable markets are the Interventional Cardiology, Interventional Radiology and Interventional Neuroradiology markets.

On August 17, 2020, Microbot announced the successful conclusion of its feasibility animal study using the LIBERTY robotic system. On December 22, 2021, the company entered into a strategic collaboration agreement for technology co-development with Stryker Corporation, acting through its Neurovascular Division. The company is still determining scheduling to move the collaboration forward.

In 2022, the company filed its pre-submission package for the LIBERTY Robotic System with the FDA, addressing the regulatory pathway for the LIBERTY Robotic System.

On October 13, 2022, the company announced the completion of a pre-clinical animal study that was conducted in September 2022. The study was performed by a team of Key Opinion Leaders (KOLs) in the endovascular space at a research laboratory with FDA-required levels of planning, controlling, monitoring, and reporting (GLP standards), using a porcine model.

In October 2022, the company submitted a follow-up pre-submission package for the LIBERTY Robotic System to ensure that it remains aligned with the FDA as it prepares for its Investigational Device Exemption (IDE) submission and first-in-human clinical trial with the system, expected in 2023.

The company is continuously exploring and evaluating additional innovative guidewire/microcatheter technologies to be integrated and combined with the LIBERTY robotic platform.

One & Done Technology

On April 8, 2018, the company acquired a patent-protected technology from CardioSert Ltd., a privately-held medical device company based in Israel that was part of a technological incubator supported by the Israel Innovation Authorities. The CardioSert technology contemplates a combination of a guidewire and microcatheter, technologies that are broadly used for surgery within a tubular organ or structure, such as a blood vessel or duct. The CardioSert technology features a unique guidewire delivery system with steering and stiffness control capabilities which when developed is expected to give the physician the ability to control the tip curvature, to adjust tip load to varying degrees of stiffness in a gradually continuous manner. The technology was originally developed to support interventional cardiologists in crossing chronic total occlusions (CTO) during percutaneous coronary intervention (PCI) procedures and has the potential to be used in other spaces and applications, such as peripheral intervention, and neurosurgery. The company's CardioSert tool is trademarked as One & DoneTM.

Microbot is exploring the integration of the One & Done technology into the LIBERTY endovascular robotic system for a range of potential applications in the cardiovascular, peripheral vascular and neurovascular spaces.

NovaCross

On October 6, 2022, the company purchased substantially all of the assets, including intellectual property, devices, components and product related materials of Nitiloop Ltd., an Israeli limited liability company. The assets include intellectual property and technology in the field of intraluminal revascularization devices with anchoring mechanism and integrated microcatheter, and the products or potential products incorporating the technology owned by Nitiloop and designated by Nitiloop as NovaCross, NovaCross Xtreme and NovaCross BTK and any enhancements, modifications and improvements.

ViRob

The ViRob is an autonomous crawling micro-robot which can be controlled remotely or within the body. Its miniature dimensions are expected to allow it to navigate and crawl in different natural spaces within the human body, including blood vessels, the digestive tract and the respiratory system, as well as artificial spaces, such as shunts, catheters, ports, etc. Its unique structure is expected to give it the ability to move in tight spaces and curved passages, as well as the ability to remain within the human body for prolonged time. The SCS product was developed using the ViRob technology.

On October 11, 2022, the company announced that it is planning to focus its strategic efforts on the growing endovascular space and advancing the LIBERTY Robotic System to achieve its regulatory and commercial milestones, as well as expanding the LIBERTY ecosystem, and made a strategic decision to suspend the continued research and development of the SCS project, effective at that date.

TipCAT

The TipCAT is a disposable self-propelled locomotive device that is specially designed to advance in tubular anatomies. The TipCAT is a mechanism comprising a series of interconnected balloons at the device's tip that provides the TipCAT with its forward locomotion capability. The device can self-propel within natural tubular lumens, such as the blood vessels, respiratory and the urinary and GI tracts. A single channel of air/fluid supply sequentially inflates and deflates a series of balloons creating an inchworm like forward motion. The TipCAT maintains a standard working channel for treatments. Unlike standard access devices such as guidewires, catheters for vascular access and endoscopes, the TipCAT does not need to be pushed into the patient's lumen using external pressure; rather, it will gently advance itself through the organ's anatomy.

Strategy

The key elements of the company's strategy are to continue to refine existing product candidates and develop additional surgical robotic solutions; establish and leverage relationships with key institutions and leading clinicians; continuously invest in research and development; explore partnerships for the introduction of Microbot's products; and seek additional IP and technologies to complement and strengthen Microbot's IP portfolio.

Intellectual Property

The SCS and TipCAT are based on technological platforms licensed from The Technion Research and Development Foundation Ltd., or TRDF. The LIBERTY platform core technology is co-owned by Microbot and TRDF. The One & Done device is based on technologies acquired by Microbot from CardioSert. The NovaCross device is based on technologies acquired by Microbot from Nitiloop Ltd. Microbot plans to develop other medical-robotic solutions through internal research and development, to strengthen its intellectual property position, and to continue exploring strategic collaborations and accretive acquisition opportunities. Microbot holds an intellectual property portfolio of 58 patents issued/allowed and 48 patent applications pending worldwide. Microbot also holds 5 design patents issued/allowed and 6 design patents pending worldwide. It also has registered trademarks in Israel, Europe and the U.S. relating to its LIBERTY platform, and also has trademarks relating to its proprietary Microbot Medical tradename and logo registered in Israel, Europe, and the U.K., and pending in the U.S. and China, in addition to having registered trademarks for the One & Done name in Israel, Europe and Japan, and pending in the U.S., the U.K., China, and Japan. Microbot also has a registered trademark in the U.S. for the newly acquired NovaCross trademark.

Microbot's issued U.S. patents, which cover Microbot's product candidates, will expire between 2026 and 2040, not including any patent term adjustments that may be available. Issued patents outside of the United States directed to Microbot's product candidates will expire between 2026 and 2040.

License Agreement with the Technion

In June 2012, Microbot entered into a license agreement with TRDF, the technology transfer subsidiary of The Technion Institute of Technology, pursuant to which it obtained an exclusive, worldwide, royalty-bearing, sub-licensable license to certain patents and inventions relating to the SCS and TipCAT technology platforms invented by Professor Moshe Shoham, a former director of and an advisor to the company, and in certain circumstances other TRDF-related persons.

Research and Development

For the fiscal year ended December 31, 2022, Microbot incurred research and development expenses of approximately $7,736,000.

Strategic collaboration agreement with Stryker

On December 22, 2021, the company entered into a strategic collaboration agreement for technology co-development with Stryker Corporation (Stryker), acting through its Neurovascular Division. Pursuant to the agreement, the collaborative development program between the company and Stryker aims to integrate certain of Stryker's instruments with its LIBERTY Robotic System to address certain neurovascular procedures.

LIBERTY

The LIBERTY prototype system was tested at the company's laboratories in an in-vitro silicone model, using off-the-shelf guidewires and microcatheters, and showing an ability to successfully provide linear and rotational movements of the guidewires and linear motion of the microcatheters. During 2022, the company conducted several simulated trials using silicone models, as well as animal trials to validate the design and obtain valuable feedback.

The LIBERTY prototype is designed to control the One & Done tool. Future versions are expected to control the NovaCross products that were acquired by the company in 2022. Additionally, the company is exploring and evaluating additional innovative guidewire/microcatheter technologies to be integrated and combined with the LIBERTY robotic platform to further enhance the performance of the system.

Since the One & Done tool was originally designed for chronic total occlusion, the company is working with subcontractors and guidewire design-houses to perfect the performance of the One & Done tool to the indication that will be selected for the LIBERTY platform. These may include procedures in the peripheral, coronary or neurovascular spaces.

Government Regulation

To obtain 510(k) clearance, Microbot must submit a notification to the FDA demonstrating that its proposed device is substantially equivalent to a predicate device (i.e., a device that was in commercial distribution before May 28, 1976, a device that has been reclassified from Class III to Class I or Class II, or a 510(k)-cleared device).

History

Microbot Medical Inc. was incorporated in 1988.