NASDAQ: MBOT

We
believe the addressable markets for the LIBERTY® Endovascular Robotic Surgical System in its current version includes
the peripheral interventional radiology market, with future versions expected to include the Interventional Cardiology and Interventional
Neuroradiology markets.

The
unique characteristics of the LIBERTY® Endovascular Robotic Surgical System - compact, mobile, disposable and remotely
controlled – also may open the opportunity of expanding telerobotic interventions to patients with limited access to life-saving
procedures.

The
LIBERTY® Endovascular Robotic Surgical System is being designed to have the following attributes:

●
Compact
size - Eliminates the need for large capital equipment in dedicated cath-lab rooms with dedicated staff.

●
Fully
disposable - To our knowledge, the first fully disposable robotic system for endovascular procedures.

●
One
& Done® - Has the potential to be compatible with our NovaCross® products or possibly other instruments
that combines guidewire and microcatheter into a single device. We are currently evaluating this combination in different applications.

●
State
of the art maneuverability - Provides linear and rotational control of its guidewire, as well as linear and rotational control of
a guide catheter, and the linear motion for an additional microcatheter (“over the wire”) device.

●
Compatibility
with a wide range of commercially-available guidewires, microcatheters and guide-catheters.

●
Enhanced
operator safety and comfort - Aims to reduce exposure to ionizing radiation and reduce physical strain due to the need for heavy
lead vests otherwise to be worn during procedures.

●
Ease
of use - A remote control designed to be intuitive aims to simplify advanced procedures while shortening the physician’s learning
curve.

●
Telemedicine
capability – May serve as a platform for supporting tele-catheterization, carried out remotely by highly trained specialists.
The Company’s research collaboration with Corewell Health™ has demonstrated the feasibility of using the LIBERTY®
Endovascular Robotic System between separate and remote facilities in a coronary simulation model. The project assesses the feasibility
of using LIBERTY® to perform simulated cardiovascular interventional procedures across two sites within the Corewell
Health™ system located 5 miles apart. The telesurgery feature of LIBERTY® is still being evaluated and is not
covered under the Company’s 510(k) clearance with the U.S. Food and Drug Administration (“FDA”).

1

On
August 13, 2024, we announced that we received ISO 13485:2016 certification for our quality management system. Receiving ISO 13485 certification
indicates that a company has developed and implemented robust policies and procedures for the development and manufacture of regulated
medical products. This is a certification ensuring compliance with the Quality Management System (QMS) requirements of the EU Medical
Devices Regulation (MDR 2017/745) and supporting our future CE Mark approval, and ultimately allowing us to market the LIBERTY®
Endovascular Robotic Surgical System in Europe as well as other regions who accept the CE Mark. We anticipate CE Mark approval in the
second half of 2026. However, we can give no assurance that we will meet this or any other projected milestones, if ever. In addition,
in view of recent FDA quality system management regulations and its incorporation by reference of the ISO 13485 standard, we believe
it will help streamline our transition into this revised FDA regulation.

On
September 8, 2025, we announced that the FDA has granted 510(k) clearance for the LIBERTY® Endovascular Robotic Surgical
System, and in November 2025, we announced the limited market release of LIBERTY® to selected high procedure volume regions
where we already experienced preliminary demand for the product. The Company is planning for its full market release at the Society of
Interventional Radiology conference in April 2026.

The
Company entered into an agreement with Emory University, which will allow the parties to evaluate and explore the potential for a future
collaboration in connection with autonomous robotics in endovascular procedures. Under the terms of the agreement, Emory University will
assume the responsibility of exploring the feasibility of integrating the LIBERTY® Endovascular Robotic Surgical System
with an imaging system to create an autonomous robotic system for endovascular procedures. In November 2025, we announced that Emory
University Hospital adopted LIBERTY® for patient care, and that we are collaborating with it to establish an Endovascular
Robotics Program in interventional radiology.

NovaCross®

On
October 6, 2022, we 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.

Industry
Overview

Minimally
Invasive Robot-Assisted Endovascular Interventions

Minimally
Invasive Surgery, or MIS, refers to surgical procedures performed through tiny incisions instead of a single large opening. Because the
incisions are small, patients tend to have quicker recovery times and experience less trauma than with conventional surgery. The global
MIS surgery is expected to grow from $24 billion in 2020 to $42 billion in 2026, representing a CAGR of 9.85%. MIS involves three major
categories of devices: surgical, monitoring and visualization, and endoscopy. The market for surgical devices, including ablation, electrosurgery
and medical robotic systems, accounts for the largest share of revenue and is also expected to show the highest rate of growth. According
to Precedence Research, the global market for robotic surgery is projected to continue its growth with a CAGR of 15.6% from 2025 to 2034.

2

Vascular
disease is the most common precursor to ischemic heart disease and stroke, which are two of the leading causes of death worldwide. Advances
in endovascular intervention in recent years have transformed patient survival rates and post-surgical quality of life. It is estimated
that more than three million percutaneous coronary interventions (PCI) and over two million of peripheral vascular interventions are
performed annually worldwide. The incidence of stroke in the U.S. alone is estimated at 900,000 cases annually. Compared to open surgery,
it has the advantages of faster recovery, reduced need for general anesthesia, reduced blood loss and significantly lower mortality.
However, the current practice of endovascular procedures, which virtually has remained unchanged since the introduction of Intervention
four decades ago, is limited by a number of factors, including physical strain and exposure to X-Ray radiation of the operator, and involves
complex maneuvering of intervention tools, such as guidewires and catheters, to reach target areas in the vasculature. Despite recent
advancements in technology and devices, manual procedures are still highly dependent on the technical skills and training of the operator,
which makes the access to expert medical centers and advanced emergent treatments, such as endovascular thrombectomy for acute ischemic
stroke, geographically limited. In addition, we believe that demand for physicians continues to grow faster than supply.

Endovascular
robotic systems are aimed to increase the stability and precision of guidewires and catheters, protecting the physicians from ionizing
radiation and physical strain by removing them from the radiation source, helping in closing shortages of skilled physicians and skill
gaps and enable tele-interventions (e.g. the Hub & Spoke hospital model).

Today,
there are only a few commercially available robotic systems for endovascular interventions. We believe these systems have major drawbacks,
such as limited maneuverability, the requirement to exchange and use multiple expensive surgical tools, being cumbersome to set-up and
operate, and requiring significant up-front capital expenditures.

Microbot
believes that with the LIBERTY® Endovascular Robotic System, it is well-positioned to deliver a value-added endovascular
robotic system, with a focus on improving the ease and access and enhancing the safety of endovascular interventions.

Strategy

Microbot’s
goal is to establish the LIBERTY® Endovascular Robotic System as the standard-of-care in the eyes of medical practitioners,
patients and medical facilities, as well as getting the support of payors and insurance companies. Microbot believes that it can achieve
this objective by working with health care providers and systems to demonstrate the key benefits of its products. Microbot’s strategy
includes the following key elements:

●
Expand
our global commercial footprint to establish LIBERTY® as the standard of care for robotic endovascular procedures
in targeted accounts. We seek to partner with Key Opinion Leaders (KOLs) to conduct post-market clinical research and develop centers
of excellence that are capable of educating and training future users.

●
Continue
to refine LIBERTY® and develop additional surgical robotic solutions. Microbot also expects to continue to innovate
in the surgical robotics field by continuing to find ways of using its core technology to solve unmet needs, with the overarching
goal of providing a safer, more effective and more efficient surgical environment for patients and physicians.

●
Continuously
invest in research and development. Microbot’s most significant expense has historically been research and development, and
Microbot expects to continue investing in research and development activities, including expenses it expects to incur to improve
LIBERTY® and any other prototype products it may have from time to time in order to respond to clinical data, to develop
additional applications using its technologies and to develop future product candidates.

●
Explore
partnerships for the introduction of Microbot’s products. In parallel to its efforts to establish direct sales and marketing
capabilities, Microbot intends to continue its efforts on pursuing collaborations with global medical device companies that have
established sales and distribution networks. Microbot will seek to enter collaborations and partnerships with strategic players that
offer synergies with Microbot’s product candidates and expertise.

●
Seek
additional IP and technologies to complement and strengthen Microbot’s current IP portfolio. Microbot intends to continue exploring
new technologies, IP and know-how to add to its current portfolio through licensing, mergers and/or acquisitions and to allow Microbot
to enter new spaces and strengthen its overall product portfolio.

3

Competition

LIBERTY®
Competitive Landscape

We
believe the main competitor to the LIBERTY® Endovascular Robotic Surgical System is the CorPath GRX vascular robotics
system by Corindus Vascular Robotics, a Siemens Healthineers company. To our knowledge, CorPath GRX system is FDA-approved and CE-marked
for percutaneous coronary and vascular procedures, and is CE-marked for neurovascular interventions. Another competitor is R-One+ by
Robocath (CE Marked, NMPA, South Africa for PCI only), and we believe there are many other competitors in the endovascular robotics space
that are current in development. We believe these systems of our competitors that we have identified have drawbacks, such as limited
maneuverability, the requirement to exchange and use multiple expensive surgical tools, requiring a larger space to operate, being cumbersome
to set-up and operate, and/or requiring significant upfront capital expenditures. We also expect that we could be competing with other
technologies that are in different stages of development, including preclinical, clinical and without CE/FDA approvals, such as LN Robotics
(approved in Korea for coronary interventions) Nanoflex Robotics, UAB Inovatyvi medicina and Endoways, of which additional competitive
data will be required to better determine their respective positioning in the competitive landscape.

Microbot’s
existing and planned products could also be rendered obsolete or uneconomical by technological advances developed in the future by existing
or new competitors. Some of Microbot’s competitors currently have significantly greater resources than Microbot does; have established
relationships with healthcare professionals, customers and third-party payors; and have long-term contracts with group purchasing organizations
in the United States. In addition, some of Microbot’s competitors have established distributor networks, greater resources for
product development, sales and marketing, additional lines of products and the ability to offer financial incentives such as rebates,
bundled products or discounts on other product lines that Microbot cannot provide.

Intellectual
Property

General

The
LIBERTY® Endovascular Robotic Surgical System’s core technology is co-owned by Microbot Medical®
and The Technion Research and Development Foundation Ltd., or TRDF. The NovaCross® device is based on technologies acquired
by Microbot from Nitiloop Ltd. Microbot may 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
currently holds an intellectual property portfolio of 29 patents issued/allowed and 52 patent applications pending worldwide. Microbot
also holds 14 design patents issued/allowed worldwide. It also has registered trademarks in Israel, Europe, UK and the U.S. relating
to the LIBERTY® Endovascular Robotic Surgical System, and also has trademarks relating to its proprietary Microbot Medical®
wordmark registered in the U.S., Israel, Europe, and UK, and Microbot Medical logo registered in Israel, Europe, and UK. Microbot also
has a trademark relating to the Liberty Endovascular Robotic Surgical System logo registered in Israel and pending in the U.S., Europe,
UK, and Japan. In addition to having registered trademarks for the “One & Done” wordmark in Israel, Europe, the U.S.,
UK, and Japan. Microbot also has a registered trademark in the U.S. for the NovaCross trademark.

Microbot
relies or intends to rely on intellectual property licensed or developed, including patents, trade secrets, trademarks, technical innovations,
laws of unfair competition and various licensing agreements, to provide its future growth, to build its competitive position and to protect
its technology. As Microbot continues to expand its intellectual property portfolio, it is critical for Microbot to continue to invest
in filing patent applications to protect its technology, inventions, and improvements.

Microbot
requires its employees and consultants to execute confidentiality agreements in connection with their employment or consulting relationships
with Microbot. Microbot also requires its employees and consultants who work on its product candidates to agree to disclose and assign
to Microbot all inventions conceived during the term of their service, while using Microbot property, or which relate to Microbot’s
business.

Patent
applications in the United States and in foreign countries are maintained in secrecy for a period of time after filing, which results
in a delay between the filing date of the patent applications and the time when they are published. Patents issued and patent applications
filed relating to medical devices are numerous, and there can be no assurance that current and potential competitors and other third
parties have not filed or in the future will not file applications for, or have not received or in the future will not receive, patents
or obtain additional proprietary rights relating to product candidates, products, devices or processes used or proposed to be used by
Microbot. Microbot believes that the technologies it employs in its products and systems do not infringe the valid claims of any third-party
patents. There can be no assurance, however, that third parties will not seek to assert that Microbot devices and systems infringe their
patents or seek to expand their patent claims to cover aspects of Microbot’s products and systems.

4

The
medical device industry in general has been characterized by substantial litigation regarding patents and other intellectual property
rights. Any such claims, regardless of their merit, could be time-consuming and expensive to respond to and could divert Microbot’s
technical and management personnel. Microbot may be involved in litigation to defend against claims of infringement by other patent holders,
to enforce patents issued to Microbot, or to protect Microbot’s trade secrets. If any relevant claims of third-party patents are
upheld as valid and enforceable in any litigation or administrative proceeding, Microbot could be prevented from practicing the subject
matter claimed in such patents, or would be required to obtain licenses from the patent owners of each such patent, or to redesign Microbot’s
products, devices or processes to avoid infringement. There can be no assurance that such licenses would be available or, if available,
would be available on terms acceptable to Microbot or that Microbot would be successful in any attempt to redesign products or processes
to avoid infringement. Accordingly, an adverse determination in a judicial or administrative proceeding or failure to obtain necessary
licenses, could potentially prevent Microbot from manufacturing and selling its products.

Microbot’s
issued U.S. patents, which cover Microbot’s product candidates, will expire between 2032 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 2032 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. During the second and third quarters of 2023, as a result of our core-business focus
program and related cost reductions, we ceased research and development activities relating to the SCS and TipCat platforms. As a result,
we returned intellectual property relating to the SCS (ViRob) and TipCat to TRDF.

The
LIBERTY® Endovascular Robotic Surgical System, which was invented by employees of Microbot together with Professor Moshe
Shoham of the Technion, in his capacity as a consultant to Microbot, is co-owned by Microbot and TRDF, and the parties established the
LIBERTY® Endovascular Robotic Surgical System as a “Joint Invention” in accordance with the terms of the License
Agreement. Once the Joint Invention is established pursuant to the terms of the License Agreement, Microbot will have to pay TRDF royalties
of between 1.5% and 3.0% of net sales of products covered by this Joint Invention.

Research
and Development

Microbot’s
research and development programs are generally pursued by engineers and scientists employed by Microbot in its offices in Israel on
a full-time or hourly basis or as consultants, or through partnerships with industry leaders in manufacturing and design and
researchers in academia. Microbot also works with subcontractors in developing specific components of its technologies.

The
primary objectives of Microbot’s research and development efforts are to continue to introduce incremental enhancements to the
capabilities of its candidate products and to advance the development of proposed products.

Microbot
Israel has received grants from the Israeli Innovation Authority (“IIA”) for participation in research and development since
2013 through December 31, 2025 totaling approximately $2.5 million. This includes amounts received of approximately $518,000, which is
a portion of an additional grant from the IIA in the amount of approximately NIS 2,153,000 (approximately $673,000) approved by the IIA
on July 15, 2025, to further finance the development of the manufacturing process of the LIBERTY® Endovascular Robotic
Surgical System.

As
a result of the agreement with Nitiloop, on October 6, 2022, Microbot Israel took over the liability to repay Nitiloop’s IIA grants
in the aggregate amount of approximately $925,000.

In
relation to the IIA grants described above, the Company is obligated to pay royalties amounting to 3%-5% of its future sales of the products
relating to such grants.

The
grants are linked to the exchange rate of the dollar to the New Israeli Shekel and bears interest of SOFR per year (SOFR is a benchmark
interest rate which replaced LIBOR).

5

The
repayment of the grants is contingent upon the successful completion of the Company’s research and development programs and generating
sales. The Company has no obligation to repay these grants, if the project fails, is unsuccessful or aborted or if no sales are generated.
The financial risk is assumed completely by the Government of Israel. The grants are received from the Government on a project-by-project
basis.

As of December 31, 2025 the Company received grants
from the Ministry of Economy of the State of Israel in the amount of approximately $50,000, to further finance the marketing activities
of the LIBERTY® Endovascular Robotic Surgical System in the U.S. market.

In
relation with the Ministry of Economy grant, the Company is obligated to pay royalties amounting to 3% of future sales of the LIBERTY®
Endovascular Robotic Surgical System up to the grant amount plus interest.

Microbot
expects to continue to access government funding in the future to the extent available.

For
the fiscal years ended December 31, 2025 and 2024, respectively, Microbot incurred research and development expenses, net of approximately
$6,283,000 and 6,630,000.

Manufacturing

Microbot
does not have any manufacturing facilities. Microbot currently relies, and expects to continue to rely, on third parties for the manufacturing
of its product candidates for preclinical and clinical testing, as well as for commercial manufacturing if its product candidates receive
marketing approval.

During
2022 Microbot initiated the transfer to production by means of designing and building molds for plastic injection of parts which is a
more cost-effective method for producing high quantities compared to conventional machined production of these parts. Some molds are
already operative while others are being designed and built. We expect completion of all molds during 2026.

On
August 4, 2023, we signed a Turn-Key Manufacturing Agreement with a subcontractor that is suited to assemble and test our products under
applicable regulatory requirements and regulations. As of the filing date of this Annual Report on Form 10-K, we are working with the
subcontractor to increase its production capacity, as we plan for the full market release of LIBERTY® expected in April
2026.

Commercialization

In
2025, Microbot established a sales, marketing and product distribution infrastructure for the LIBERTY® Endovascular Robotic
System in the U.S.

In
November 2025, we announced the limited market release of LIBERTY® to selected high procedure volume regions where we
already experienced preliminary demand for the product. Since then, we have announced that Emory University Hospital and Tampa General Hospital have adopted LIBERTY for
patient care. The Company is planning for its full market release at the Society of Interventional
Radiology conference in April 2026.

Microbot
has not yet developed a commercial strategy outside of the United States, but it most likely would utilize distributors and strategic
partnerships.

Middle
East Conflict

Subsequent
to the reporting period, on February 28, 2026, an Israeli military operation referred to as “Epic-Fury”
commenced with a large-scale attack on Iran carried out in coordination with the United States. In response, Iran launched a
counterattack that included the firing of ballistic missiles and unmanned aerial vehicles toward military and civilian targets in
Israel. Additionally, Hezbollah, a terrorist organization in Lebanon, joined the
attacks against Israel and Israel has started military operations in Lebanon.

As
a result, a special state of emergency was declared in Israel, which included, among other things, the closure of Israel’s airspace,
restrictions on public gatherings, temporary closures and/or reduced operating hours of businesses, and the mobilization of military
reservists, which have resulted in reduced economic activity.

6

We
have considered various ongoing risks relating to these and other Israeli military operations and related matters, including:

●
That
some of our Israeli subcontractors, vendors, suppliers and other companies in which the Company relies, may not be fully active and
operational, as instructed by the relevant authorities;

●
A
slowdown in the number of international flights in and out of Israel;

●
The
decreasing international regard for Israeli-based companies in certain quarters, including as a result of the Israeli government’s
policies in Gaza and the West Bank in particular, and the Middle East in general; and

●
Possible
and actual boycotts of Israel and Israeli-based companies, which may adversely affect our ability to do business in certain jurisdictions
or with certain industry groups or potential customers, among others.

We
closely monitor how these and other Israeli military operations and related activities could adversely affect our anticipated
milestones and our Israel-based activities to support future commercial, clinical and regulatory milestones, including our ability
to import materials that are required to construct our LIBERTY® devices and to ship them outside of Israel. In
addition, we are also monitoring how negative international reaction to the events in Gaza, the West Bank, Iran and elsewhere in the
Middle East could create a corresponding negative perception of companies with Israeli operations, which if broad enough, could
negatively impact our business. As of the filing date of this Annual Report on Form 10-K, we have determined that there have not
been any materially adverse effects on our business or operations, but we continue to monitor the situation, as in the event that
the situation escalates into an even greater regional conflict or our Israeli facilities are damaged as a result of hostile actions,
or hostilities otherwise disrupt our Israeli office’s support of our commercial, clinical and regulatory activities, our
Israeli operations could be materially and adversely affected. We do not have any specific contingency plans in the event of any
such escalation or change.

Government
Regulation

General

Microbot’s
medical technology products and operations are subject to extensive regulation in the United States and other countries. Most notably,
Microbot’s products sold in the United States will be subject to the Federal Food, Drug, and Cosmetic Act (FDCA) as implemented
and enforced by the U.S. Food and Drug Administration. The FDA regulates the development, bench and clinical testing, manufacturing,
labeling, storage, record-keeping, promotion, marketing, sales, distribution and post-market support and reporting of medical devices
in the United States to ensure that medical products distributed domestically are safe and effective for their intended uses. Regulatory
policy affecting its products can change at any time.

Advertising
and promotion of medical devices in the United States, in addition to being regulated by the FDA, are also regulated by the Federal Trade
Commission and by state regulatory and enforcement authorities. Recently, promotional activities for FDA-regulated products of other
companies have been the subject of enforcement action brought under healthcare reimbursement laws and consumer protection statutes. In
addition, under the federal Lanham Act and similar state laws, competitors and others can initiate litigation relating to advertising
claims.

Foreign
countries where Microbot wishes to sell its products may require similar or more onerous approvals to manufacture or market its products.
Government agencies in those countries also enforce laws and regulations that govern the development, testing, manufacturing, labeling,
advertising, marketing and distribution, and market surveillance of medical device products. These regulatory requirements can change
rapidly with relatively short notice.

Other
regulations Microbot encounters in the United States and in other jurisdictions are the regulations that are common to all businesses,
such as employment legislation, implied warranty laws, and environmental, health and safety standards, to the extent applicable. In the
future, Microbot will also encounter industry-specific government regulations that would govern its products, if and when they are developed
for commercial use.

U.S.
Regulation

The
FDA governs the following activities that Microbot performs, or that are performed on its behalf, to ensure that medical products distributed
domestically or exported internationally are safe and effective for their intended uses:

●
product
design, and development;

●
product
safety, testing, labeling and storage;

●
record
keeping procedures; and

●
product
marketing.

7

There
are numerous FDA regulatory requirements governing the approval or clearance and subsequent commercial marketing of Microbot’s
products. These include:

●
the
timely submission of product listing and establishment registration information, along with associated establishment user fees;

●
continued
compliance with the Quality Management System Regulation, or QMSR, which require specification developers and manufacturers, including
third-party manufacturers, to follow stringent design, testing, control, documentation and other quality assurance procedures during
all aspects of the manufacturing process, and incorporates as a reference the ISO 13485 standard for medical device;

●
labeling
regulations and FDA prohibitions against the promotion of products for uncleared, unapproved or off-label use or indication;

●
clearance
or approval of product modifications that could significantly affect the safety or effectiveness of the device or that would constitute
a major change in intended use;

●
Medical
Device Reporting regulations (MDR), which require that manufacturers keep detailed records of investigations or complaints against
their devices and to report to the FDA if their device may have caused or contributed to a death or serious injury or malfunctioned
in a way that would likely cause or contribute to a death or serious injury if it were to recur;

●
adequate
use of the Corrective and Preventive Actions process to identify and correct or prevent significant systemic failures of products
or processes or in trends which suggest same;

●
post-approval
restrictions or conditions, including post-approval study commitments;

●
post-market
surveillance regulations, which apply when necessary to protect the public health or to provide additional safety and effectiveness
data for the device; and

●
notices
of correction or removal and recall regulations.

Unless
an exemption applies, before Microbot can commercially distribute medical devices in the United States, Microbot must obtain, depending
on the classification of the device, either prior 510(k) clearance, 510(k) de-novo clearance or premarket approval (PMA), from the FDA.
The FDA classifies medical devices into one of three classes based on the degree of risk associated with each medical device and the
extent of regulatory controls needed to ensure the device’s safety and effectiveness:

●
Class
I devices, which are low risk and subject to only general controls (e.g., registration and listing, medical device labeling compliance,
MDRs, Quality System Regulations, and prohibitions against adulteration and misbranding) and, in some cases, to the 510(k) premarket
clearance requirements;

●
Class
II devices, which are moderate risk and generally require 510(k) or 510(k) de-novo premarket clearance before they may be commercially
marketed in the United States as well as general controls and potentially special controls like performance standards or specific
labeling requirements; and

●
Class
III devices, which are devices deemed by the FDA to pose the greatest risk, such as life-sustaining, life-supporting or implantable
devices, or devices deemed not substantially equivalent to a predicate device. Class III devices generally require the submission
and approval of a PMA supported by clinical trial data.

The
LIBERTY device is a classified as Class II, and received 510(k) premarket clearance in 2025. Microbot expects future medical products
in its pipeline currently to be classified as Class II or possibly Class III. Class II devices are those for which general controls alone
are insufficient to provide reasonable assurance of safety and effectiveness and there is sufficient information to establish special
controls. Special controls can include performance standards, post-market surveillance, patient histories and FDA guidance documents.
Premarket review and clearance by the FDA for these devices is generally accomplished through the 510(k) or 510(k) de-novo premarket
notification process. As part of the 510(k) or 510(k) de-novo notification process, FDA may require the following:

●
Development
of comprehensive product description and indications for use;

●
Comprehensive
review of predicate devices and development of data supporting the new product’s substantial equivalence to one or more predicate
devices; and

●
If
appropriate and required, certain types of clinical trials (IDE submission and approval may be required for conducting a clinical
trial in the U.S.).

8

Clinical
trials involve use of the medical device on human subjects under the supervision of qualified investigators in accordance with current
Good Clinical Practices (GCPs), including the requirement that all research subjects provide informed consent for their participation
in the clinical study. A written protocol with predefined end points, an appropriate sample size and pre-determined patient inclusion
and exclusion criteria, is required before initiating and conducting a clinical trial. All clinical investigations of devices to determine
safety and effectiveness must be conducted in accordance with the FDA’s Investigational device Exemption, or IDE, regulations that
among other things, govern investigational device labeling, prohibit promotion of the investigational device, and specify recordkeeping,
reporting and monitoring responsibilities of study sponsors and study investigators. If the device presents a “significant risk,”
as defined by the FDA, the agency requires the device sponsor to submit an IDE application, which must become effective prior to commencing
human clinical trials.

Description
of the IDE process. The IDE will become effective 30 days after receipt by the FDA, unless the FDA otherwise informs the sponsor prior
to the 30-day period that the IDE is approved, approved with conditions, or disapproved. If the FDA determines that additional information
is required, the FDA may permit a clinical trial to proceed under a conditional approval. In case of disapproval, the Company can continue
its existing IDE process interaction with the FDA, and supply FDA with additional information to obtain approval or conditional approval.
In addition, the study must be approved by, and conducted under the oversight of, an Institutional Review Board (IRB) for each clinical
site. If the device presents a non-significant risk to the patient, a sponsor may begin the clinical trial after obtaining approval for
the trial by one or more IRBs without separate approval from the FDA, but it must still follow abbreviated IDE requirements, such as
monitoring the investigation, ensuring that the investigators obtain informed consent, and labeling and record-keeping requirements.
See “-Recent Developments-FDA Approval to Proceed with Pivotal Human Clinical Trial” above.

510(k)
clearance typically involves the following:

●
Assuming
successful completion of all required testing, a detailed 510(k) premarket notification or 510(k) de-novo is submitted to the FDA
requesting clearance to market the product. The notification includes all relevant data from pertinent preclinical and clinical trials,
together with detailed information relating to the product’s manufacturing controls and proposed labeling, and other relevant
documentation.

●
A
510(k) clearance letter from the FDA will authorize commercial marketing of the device for one or more specific indications for use.

●
After
510(k) clearance, Microbot will be required to comply with a number of post-clearance requirements, including, but not limited to,
Medical Device Reporting and complaint handling, and, if applicable, reporting of corrective actions. Also, quality control and manufacturing
procedures must continue to conform to QMSRs. The FDA periodically inspects manufacturing facilities to assess compliance with QMSRs,
which impose extensive procedural, substantive, and record keeping requirements on medical device manufacturers. In addition, changes
to the manufacturing process are strictly regulated, and, depending on the change, validation activities may need to be performed.
Accordingly, manufacturers must continue to expend time, money and effort in the area of production and quality control to maintain
compliance with QMSRs and other types of regulatory controls.

●
After
a device receives 510(k) clearance from the FDA, any modification that could significantly affect its safety or effectiveness, or
that would constitute a major change in its intended use or technological characteristics, requires a new 510(k) clearance or could
require a PMA. The FDA requires each manufacturer to make the determination of whether a modification requires a new 510(k) notification
or PMA in the first instance, but the FDA can review any such decision. If the FDA disagrees with a manufacturer’s decision
not to seek a new 510(k) clearance or PMA for a particular change, the FDA may retroactively require the manufacturer to seek 510(k)
clearance or PMA. The FDA can also require the manufacturer to cease U.S. marketing and/or recall the modified device until additional
510(k) clearance or PMA approval is obtained.

●
The
FDA and the Federal Trade Commission, or FTC, will also regulate the advertising claims of Microbot’s products to ensure that
the claims Microbot makes are consistent with its regulatory clearances, that there is scientific data to substantiate the claims
and that product advertising is neither false nor misleading.

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). The FDA’s 510(k) clearance process generally takes from three to
12 months from the date the application is submitted but also can take significantly longer. If the FDA determines that the device or
its intended use is not substantially equivalent to a predicate device, the device is automatically placed into Class III, requiring
the submission of a PMA.

9

There
is no guarantee that the FDA will grant Microbot 510(k) clearance for its pipeline medical device products, and failure to obtain the
necessary clearances for its products would adversely affect Microbot’s ability to grow its business. Delays in receipt or failure
to receive the necessary clearances, or the failure to comply with existing or future regulatory requirements, could reduce its business
prospects.

Devices
that cannot be cleared through the 510(k) process due to lack of a predicate device but would be considered low or moderate risk may
be eligible for the 510(k) de-novo process. In 1997, the Food and Drug Administration Modernization Act, or FDAMA added the de novo classification
pathway now codified in section 513(f)(2) of the FD&C Act. This law established an alternate pathway to classify new devices into
Class I or II that had automatically been placed in Class III after receiving a Not Substantially Equivalent, or NSE, determination in
response to a 510(k) submission. Through this regulatory process, a sponsor who receives an NSE determination may, within 30 days of
receipt, request FDA to make a risk-based classification of the device through what is called a “de novo request.” In 2012,
section 513(f)(2) of the FD&C Act was amended by section 607 of the Food and Drug Administration Safety and Innovation Act (FDASIA),
in order to provide a second option for de novo classification. Under this second pathway, a sponsor who determines that there is no
legally marketed device upon which to base a determination of substantial equivalence can submit a de novo request to FDA without first
submitting a 510(k).

In
the event that Microbot receives a Not Substantially Equivalent determination for any future device candidates in response to a 510(k)
submission, the Microbot device may still be eligible for the 510(k) de-novo classification process.

Devices
that cannot be cleared through the 510(k) or 510(k) de-novo classification process require the submission of a PMA. The PMA process is
much more time consuming and demanding than the 510(k) notification process. A PMA must be supported by extensive data, including but
not limited to data obtained from preclinical and/or clinical studies and data relating to manufacturing and labeling, to demonstrate
to the FDA’s satisfaction the safety and effectiveness of the device. After a PMA application is submitted, the FDA’s in-depth
review of the information generally takes between one and three years and may take significantly longer. If the FDA does not grant 510(k)
clearance to its products, there is no guarantee that Microbot will submit a PMA or that if Microbot does, that the FDA would grant a
PMA approval of Microbot’s products, either of which would adversely affect Microbot’s business.

Foreign
Regulation

In
addition to regulations in the United States, Microbot will be subject to a variety of foreign regulations governing clinical trials,
marketing authorization and commercial sales and distribution of its products in foreign countries. The approval process varies from
country to country, and the time may be longer or shorter than that required for FDA approval or clearance. The requirements governing
the conduct of clinical trials, product licensing, pricing and reimbursement vary greatly from country to country.

International
sales of medical devices are subject to foreign governmental regulations which vary substantially from country to country. Whether or
not Microbot obtains FDA approval or clearance for its products, Microbot will be required to make new regulatory submissions to the
comparable regulatory authorities of foreign countries before Microbot can commence clinical trials or marketing of the product in such
countries. The time required to obtain certification or approval by a foreign country may be longer or shorter than that required for
FDA clearance or approval, and the requirements may differ. Below are summaries of the regulatory systems for medical devices in Europe
and Israel, where Microbot currently anticipates marketing its products. However, its products may also be marketed in other countries
that have different systems or minimal requirements for medical devices.

Europe.
The primary regulatory body in Europe is the European Union, or E.U., which consists of 27 member states and has a coordinated system
for the authorization of medical devices.

The
E.U. has adopted regulations concerning the regulation of medical devices within the European Union. The regulations include, among others,
the Medical Device Regulation, or MDR, that establishes certain requirements with which medical devices must comply before they can be
commercialized in the European Economic Area, or EEA (which comprises the member states of the E.U. plus Norway, Liechtenstein and Iceland).
Under the MDR, medical devices are classified into four Classes, I, IIa, IIb, and III, with Class I being the lowest risk and Class III
being the highest risk.

10

In
order to commercialize medical devices in the European Union, a CE Mark certificate is needed. This certification verifies that a device
meets all regulatory requirements for medical devices under the new Medical Devices Regulation (MDR 2017/745). The CE approval process
in Europe is summarized below:

1.
To obtain CE Marking certification, comply with European Commission Regulation (EU) No. 2017/745, commonly known as the Medical Device
Regulation (MDR).

2.
Appoint a Person Responsible for Regulatory Compliance (PRRC). Determine classification of device - Class I (self-certified); Class I
(sterile, measuring or reusable surgical instrument); Class IIa (which LIBERTY is considered), Class IIb, or Class III.

3.
For all devices, implement a Quality Management System (QMS) in accordance with the MDR. Companies usually apply the EN ISO 13485 standard
to achieve initial compliance. The QMS must include Clinical Evaluation, Post-Market Surveillance (PMS) and Post Market Clinical Follow-up
(PMCF) plans. Make arrangements with suppliers about unannounced Notified Body audits. For Class I (self-certified), implement a QMS
though Notified Body intervention is not required.

4.
Prepare a CE Technical Documentation or Design Dossier (Class III) providing information about the device and its intended use plus testing
reports, Clinical Evaluation Report (CER), risk management file, Instruction For Use (IFU), labeling and more. Obtain a Unique Device
Identifier (UDI) for the device. All devices, even legacy products in use for decades, will require clinical data. Most of these data
should refer to the subject device. Clinical studies are generally required for implantable and Class III devices. Existing clinical
data may be acceptable. Clinical trials in Europe must be pre-approved by a European Competent Authority.

5.
If the company does not have a location in Europe, appoint an Authorized Representative (EC REP) located in the EU who is qualified to
handle regulatory issues. Place the EC REP name and address on device label. Obtain a Single Registration Number from the regulators.

6.
For all devices except Class I (self-certified), the QMS and Technical Documentation or Design Dossier must be audited by a Notified
Body, a third-party accredited by European authorities to audit medical device companies and products.

7.
For all devices except Class I (self-certified), the company will be issued a European CE Marking Certificate for the device and an ISO
13485 certificate for the company’s facility following successful completion of the Notified Body audit. ISO 13485 certification
must be renewed every year. CE Marking certificates are typically valid for a maximum of 5 years, but are typically reviewed during the
annual surveillance audit.

8.
Prepare a Declaration of Conformity, a legally binding document prepared by the manufacturer stating that the device is in compliance
with the applicable European requirements. At this time, the CE Marking may be affixed.

9.
Register the device and its Unique Device Identifier (UDI) in the EUDAMED database. UDI must be on label and associated with the regulatory
documents.

10.
For Class I (self-certified), annual NB audits are not required. However, CER, Technical File, and PMS activities must be kept updated.
For all other classes, the company will be audited each year by a Notified Body to ensure ongoing compliance with the MDR. Failure to
pass the audit will invalidate the CE Marking certificate. The company must perform Clinical Evaluation, PMS, and PMCF.

Microbot
applied for the CE Mark for LIBERTY. There is no guarantee that Microbot will be granted a CE Mark for LIBERTY or all or any of its future
potential pipeline products. Failure to obtain the CE Mark would likely adversely affect Microbot’s ability to grow its business.

On
October 24, 2023, we announced that we received confirmation for the commencement of the process to support our future CE Mark approval,
and to ultimately allow us to market the LIBERTY® Endovascular Robotic Surgical System in Europe as well as other regions
who accept the CE Mark. In 2025, we engaged with a leading Notified Body and commenced audits for ISO 13485 certification to ensure basic
compliance with the Quality Management System (QMS) requirements of the EU Medical Devices Regulation (MDR 2017/745).

Israel.
Israel’s Medical Devices Law generally requires the registration of all medical products with the Ministry of Health, or MOH, Registrar
as a precondition for production and distribution in Israel. Special exemptions may apply under limited circumstances and for purposes
such as the provision of essential medical treatment, research and development of the medical device, and personal use, among others.

11

Registration
of medical devices requires the submission of an application to the Ministry of Health Medical Institutions and Devices Licensing Department,
or AMAR. An application for the registration of a medical device includes the following:

●
Name
and address of the manufacturer, and of the importer as applicable;

●
Description
of the intended use of the medical device and of its medical indications;

●
Technical
details of the medical device and of its components, and in the event that the device or the components are not new, information
should be provided on the date or renovation;

●
Certificate
attesting to the safety of the device, issued by a competent authority of one of the following countries: Australia, Canada, European
Community (EC), Member States (MSs), Israel, Japan, or the United States;

●
Information
on any risk which may be associated with the use of the device (including precautionary measures to be taken);

●
Instructions
for use of the device in Hebrew; the MOH may allow the instructions to be in English for certain devices;

●
Details
of the standards to which the device complies;

●
Description
of the technical and maintenance services, including periodic checks and inspections; and

●
Declaration,
as appropriate: of the local manufacturer/importer, and of the foreign manufacturer.

If
the application includes a certificate issued by a competent authority of one of the following “recognized” countries: Australia,
Canada, European Community (CE) Member States (MSs), Japan, or the United States, the registration process is generally expedited, but
could still take 6-9 months for approval. If such certificate is not available, the registration process will take significantly longer
and a license is rarely issued. Furthermore, the MOH will determine what type of testing is needed. In general, in the case of Israeli
manufactured devices that are not registered or authorized in any “recognized” country, the application requires presentation
of a risk analysis, a clinical evaluation, a summary of the clinical trials, and expert opinions regarding the device’s safety
and effectiveness. Additional requirements may apply during the registration period, including follow-up reviews, to improve the quality
and safety of the devices.

According
to regulations issued by Israel’s Minister of Health in June 2013, a decision on a request to register a medical device must be
delivered by AMAR within 120 days from the date of the request, although this rarely occurs. The current rules for the registration of
medical devices do not provide for an expedited approval process.

Once
granted by the MOH, a license (marketing authorization) for a medical device is valid for five years from the date of registration of
the device, except for implants with a life-supporting function, for which the validity is for only two years from the date of registration.
Furthermore, the holder of the license, the Israeli Registration Holder, or IRH, must do the following to maintain its license:

●
Reside
and maintain a place of business in Israel and serve as the regulatory representative.

●
Respond
to questions from AMAR concerning the registered products.

●
Report
adverse events to AMAR.

●
Renew
the registration on time to keep the market approval active.

Comply
with post-marketing requirements, including reporting of adverse and unexpected events occurring in Israel or in other countries where
the device is in use.

Getting
a device listed on Israel’s four major Sick Funds (health insurance entities) is also necessary in order for Israeli hospitals
and health care providers to order such products.

Microbot
has applied for a license from the MOH for the LIBERTY device, and it is awaiting the outcome of the registration process. There is no
guarantee that Microbot will be granted licenses for the LIBERTY device or any future pipeline products and failure to obtain such licenses
would adversely affect its ability to grow its business.

12

Human
Capital

Employees

As
of March 24, 2026, we have 43 employees (including full-time and hourly employees).

Microbot’s
Chief Executive Officer, President and Chairman, Harel Gadot, along with 23 other full-time employees, are based in the United
States. These employees include executive, management and commercial operations of the Company. Additionally, Microbot has 18
full-time employees and 1 hourly employee based in its office located in Yokneam, Israel. These employees oversee day-to-day
operations of the Company and leading engineering, manufacturing, intellectual property and administration functions of the Company.
The Company expects to continue to increase hirings for its U.S.-based commercial team and other aspects of its U.S. and global
operations. As required, Microbot also engages consultants to provide services to the Company, including regulatory, legal and
corporate services. We are subject to labor laws and regulations within our locations in the U.S. and Israel. These laws and
regulations principally concern matters such as pensions, paid annual vacation, paid sick days, length of the workday and work week,
minimum wages, overtime pay, insurance for work-related accidents, severance pay and other conditions of employment. Microbot has no
unionized employees.

We
have historically been able to attract and retain top talent by creating a culture that challenges and engages our employees, offering
them opportunities to learn, grow and achieve their career goals.

Compensation,
Benefits and Wellbeing

We
believe that we provide competitive compensation for our employees. We offer annual bonuses and stock-based compensation for eligible
employees, along with other benefits customary in the locations at which the employees are based.

Leadership,
Training and Development

We
aim to provide our employees with advanced professional and development skills, so that they can perform effectively in their roles and
build their capabilities and career prospects for the future.

Diversity,
Equity and Inclusion

We
strive to encourage a diversity of views and to create an equal opportunity workplace. During the past three years, we have increased
the total number of women in management positions.