NSPR US Equity☆

Item 7. Management’s Discussion and Analysis of Financial Condition 73

Item 7A. Quantitative and Qualitative Disclosures About Market Risk. 78

Item 8. Financial Statements and Supplementary Data. 79

Item 9A. Controls and Procedures. 79

Item 9B. Other Information. 79

Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections 79

PART III

Item 10. Directors, Executive Officers and Corporate Governance. 80

Item 11. Executive Compensation. 80

Item 14. Principal Accounting Fees and Services. 80

PART IV

Item 15. Exhibits and Financial Statement Schedules. 81

INTRODUCTION

“InspireMD,”

the “InspireMD” logo, “CGuard,” “CGuard Prime,” “MicroNet,” “SwitchGuard,”

and our other registered or common law trade names, trademarks or service marks appearing in this Annual Report on Form 10-K are our

property. Trade names, trademarks and service marks of other companies appearing in this Annual Report on Form 10-K are the property

of their respective owners. We do not intend our use or display of other companies’ trade names, trademarks or service marks to

imply a relationship with, or endorsement or sponsorship of us by, these other companies unless otherwise stated. Solely for convenience,

the trademarks and tradenames referred to in this Annual Report on Form 10-K appear without the ® and TM symbols, but those

references are not intended to indicate, in any way, that we will not assert, to the fullest extent under applicable law, our rights,

or the right of the applicable licensor to these trademarks and tradenames.

CAUTIONARY

NOTE REGARDING FORWARD-LOOKING STATEMENTS

This

Annual Report on Form 10-K contains “forward-looking statements,” which include information relating to future events, future

financial performance, strategies, expectations, competitive environment and regulation, including, expected revenue growth. Words such

as “may,” “will,” “should,” “could,” “would,” “predicts,” “potential,”

“continue,” “expects,” “anticipates,” “future,” “intends,” “plans,”

“believes,” “estimates,” and similar expressions, as well as statements in future tense, identify forward-looking

statements. Forward-looking statements should not be read as a guarantee of future performance or results and will probably not be accurate

indications of when such performance or results will be achieved. Forward-looking statements are based on information we have when those

statements are made or our management’s good faith belief as of that time with respect to future events and are subject to risks

and uncertainties that could cause actual performance or results to differ materially from those expressed in or suggested by the forward-looking

statements. Important factors that could cause such differences include, but are not limited to:

● negative clinical trial results or lengthy product delays in key markets;

● our ability to maintain compliance with the Nasdaq listing standards;

● our ability to generate significant revenues from our products;

● inability to carry out research, development and commercialization plans;

● loss of a key customer or supplier;

● product malfunctions;

● price increases for supplies and components;

The

foregoing does not represent an exhaustive list of matters that may be covered by the forward-looking statements contained herein or

risk factors that we are faced with that may cause our actual results to differ from those anticipated in our forward-looking statements.

You should review carefully the risks and uncertainties described under the heading “Item 1A. Risk Factors” in this Annual

Report on Form 10-K for a discussion of these and other risks that relate to our business and investing in shares of our common stock.

Moreover, new risks regularly emerge, and it is not possible for our management to predict or articulate all the risks we face, nor can

we assess the impact of all risks on our business or the extent to which any risk, or combination of risks, may cause actual results

to differ from those contained in any forward-looking statements. All forward-looking statements included in this Annual Report are based

on information available to us on the date of this Annual Report. Except to the extent required by applicable laws or rules, we undertake

no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.

All subsequent written and oral forward-looking statements attributable to us or persons acting on our behalf are expressly qualified

in their entirety by the cautionary statements contained above and throughout this Annual Report.

The

forward-looking statements contained in this Annual Report on Form 10-K are expressly qualified in their entirety by this cautionary

statement. We do not undertake any obligation to publicly update any forward-looking statement to reflect events or circumstances after

the date on which any such statement is made or to reflect the occurrence of unanticipated events.

PART

I

Item

1. Business.

Overview

We

are a medical device company specializing in the development and commercialization of products for the treatment of carotid artery disease

and other vascular conditions. Our portfolio includes two commercial products based on our proprietary CGuard carotid stent technology,

designed to provide market-leading embolic protection during and after stenting procedures. A stent is an expandable scaffold-like metallic

device placed in an artery to widen the lumen and restore blood flow.

Our

first product, the CGuard Carotid Embolic Prevention System (“CGuard EPS”), integrates a self-expanding nitinol stent with

a MicroNet mesh sleeve as a single device for carotid artery revascularization. In January 2024, we received CE Mark recertification

for CGuard EPS under the EU Medical Device Regulation (“MDR”). Our CGuard EPS previously held CE Mark approval under the

former Medical Device Directive (“MDD”). CGuard EPS is marketed in over 30 countries outside the United States through a

network of distributors.

Our

second product, the CGuard Prime Carotid Stent System (“CGuard Prime”), uses the same stent and MicroNet mesh as the CGuard

EPS with a differentiated deployment mechanism. CGuard Prime received premarket approval (“PMA”) by the U.S. Food and Drug

Administration (“FDA”) on June 23, 2025, and is marketed exclusively in the United States through our direct salesforce.

It also received MDR CE Mark approval on June 12, 2025.

In

October 2024, the FDA approved the Company’s IDE to initiate the CGUARDIANS II pivotal study of its CGuard Prime 80 cm carotid

stent system during transcarotid revascularization (“TCAR”) procedures. In the first quarter of 2026, we completed enrollment in the CGUARDIANS II pivotal study.

In

October 2023, the Centers for Medicare & Medicaid Services (“CMS”) issued its final National Coverage Determination (“NCD”),

expanding coverage for both carotid artery stenting (“CAS”) and TCAR procedures to include both asymptomatic and standard

risk patients, significantly expanding and supporting the future growth of the U.S. addressable market for CAS.

In

November 2025, the results of the CREST-2 study were released, which showed that CAS combined with medical therapy demonstrated a significantly

lower stroke risk as compared to intensive medical management alone in patients with severe asymptomatic carotid stenosis. CREST-2 was

an independent study sponsored by the National Institute of Health (NIH) with a set of two parallel, observer-blinded clinical trials

across 155 centers globally. CREST-2 showed that, among patients with high-grade carotid stenosis without recent neurological symptoms,

the addition of stenting led to significantly better outcomes than intensive medical management alone, as measured by a decreased risk

of the composite of perioperative stroke or death or ipsilateral stroke within four years. In a separate arm of the same trial, carotid

endarterectomy (“CEA”) did not achieve a significant benefit for these patients as compared to intensive medical management

alone.

We

continue to invest in new product generations and potential new clinical indications for the CGuard platform with a strategy of focusing

on advancing a “stent-first” approach to carotid revascularization. As part of this strategy, we are evaluating CGuard Prime

in TCAR-based clinical programs, including the CGUARDIANS II pivotal trial, which studies the use of the CGuard Prime 80 cm carotid

stent system in conjunction with an established neuroprotection device, and the CGUARDIANS III pivotal trial, which evaluates our proprietary

SwitchGuard neuroprotection system (“SwitchGuard NPS”) paired with CGuard Prime to enable flow-reversal neuroprotection during

TCAR. In parallel, we are pursuing new clinical applications outside TCAR, including the treatment of acute ischemic stroke with tandem

lesions, which is currently being studied in an early feasibility study conducted with the Jacobs Institute. In this acute-stroke setting,

the flexible, low-metal-burden design and MicroNet mesh of CGuard Prime may offer advantages where traditional embolic-protection devices

cannot be used.

We

consider our current addressable market for our CGuard EPS, CGuard Prime, and SwitchGuard NPS to be both symptomatic and asymptomatic

individuals with diagnosed high-grade carotid artery stenosis for whom intervention is preferable to medical (drug) therapy. This group

includes not only patients eligible for either CAS or TCAR procedures, but also individuals who are candidates for CEA, as all three

approaches can be options to treat these patients. Assuming full penetration of the intervention caseload, we estimate that the addressable

market for CGuard EPS, CGuard Prime, and SwitchGuard NPS is approximately $1.3 billion (source: Health Research International Personal

Medical Systems, Inc. September 13, 2021 Results of Update Report on Global Carotid Stenting Procedures and Markets by Major Geography

and Addressable Markets and internal estimates). According to this same report and internal estimates, assuming full penetration of treatment

for all individuals diagnosed with high-grade carotid artery stenosis, we estimate the total available market for CGuard EPS, CGuard

Prime, and SwitchGuard NPS to be approximately $9.3 billion, which may grow over time if expanded treatment options such as our products

lead to increased patient screening for carotid artery disease.

We

were organized in the State of Delaware on February 29, 2008. In October 2024, we established our global headquarters in Miami, Florida

to support the U.S. launch and commercialization of CGuard Prime.

Business

Strategy

Our

business strategy is focused on establishing the CGuard carotid stent system as global leader in carotid revascularization. Our business

strategy includes:

Our

Industry

Carotid

Arteries

Carotid

arteries are located on each side of the neck and provide the primary blood supply to the brain. Carotid artery disease, also called

carotid artery stenosis, is a type of atherosclerosis (hardening of the arteries) that is one of the major risk factors for ischemic

stroke. In carotid artery disease, plaque accumulates in the artery walls, narrowing the artery and disrupting the blood supply to the

brain. This disruption in blood supply, together with plaque debris breaking off the artery walls and traveling to the brain, are significant

causes of stroke. According to the World Health Organization, every year, 15 million people worldwide suffer a stroke, and nearly six

million die and another five million are left permanently disabled. According to the same source, stroke is the second leading cause

of disability, after dementia.

In

2022, three million people between the age of 50 and 89 years old were estimated to be diagnosed with high grade carotid artery disease,

of which, approximately 394,000 of those received intervention, according to a September 2021 report from Health Research International

Personal Medical Systems, Inc. entitled Update Report on Global Carotid Stenting Procedures and Markets by Major Geography and Addressable

Markets.

There

are three current interventional treatments used to treat carotid artery disease. The first is CEA, in which a surgeon accesses the blocked

carotid artery though an incision in the neck and then surgically removes the plaque. The second treatment is TCAR, a minimally invasive

procedure in which a surgeon places a stent in the blocked carotid artery though a small incision in the neck while temporarily reversing

blood flow to protect the brain from stroke during the procedure. The third treatment is CAS, a minimally invasive procedure in which

a surgeon places a stent in the blocked carotid artery through access of the femoral, radial, or brachial arteries. We believe that the

availability of minimally invasive treatment options like TCAR and CAS should increase the number of patients being treated since they

avoid the need for complex surgery.

Our

Products

MicroNet

Mesh Platform Technology

MicroNet

is our proprietary biocompatible polymer mesh material woven from a single strand of 23 μm polyethylene terephthalate (“PET”),

a material widely used in medical implants. We apply the sleeve to our proprietary self-expanding stent to provide additional protection

to patients from plaque prolapse and embolization following deployment of the stent in the patient’s artery. The size, or aperture,

of the MicroNet “pore” is only 150-180 microns, designed to maximize protection against the release of potentially dangerous

plaque and thrombus by significantly limiting the size of any embolic debris that can dislodge from the diseased carotid artery and pass

through the MicroNet mesh. The MicroNet mesh is the core technology around which we have developed our proprietary CGuard carotid stent

technology.

CGuard

EPS – Carotid Artery Applications

Our

CGuard EPS combines our MicroNet mesh and a self- expanding nitinol stent (a stent that expands without balloon dilation pressure or

need of an inflation balloon) in a single device for use in carotid artery applications. MicroNet is placed over and attached to the

outside of an open cell nitinol stent, forming a highly flexible implant that conforms to the carotid anatomy designed to trap debris

and emboli that can dislodge from the diseased carotid artery and potentially travel to the brain and cause a stroke. This danger is

one of the greatest limitations of carotid artery stenting with conventional, non-mesh covered carotid stents.

We

believe that our CGuard EPS design provides advantages over existing therapies in treating carotid artery stenosis, such as conventional

carotid stenting and surgical CEA, given the superior embolic prevention characteristics provided by the MicroNet. We believe the MicroNet

provides acute embolic protection at the time of the procedure, but more importantly, provides post-procedure protection against embolic

dislodgement. According to an article published in the Journal of American College of Cardiology Cardiovascular Interventions entitled

Late cerebral embolization after emboli-protected carotid artery stenting assessed by sequential diffusion-weighted magnetic resonance

imaging, it is in this post-procedure time frame that embolization is the source of post-procedural strokes in the brain, which have

shown that the majority of the incidents of embolic showers associated with carotid stenting occur post-procedure.

Our

CGuard EPS originally received CE mark approval in the EU in March 2013 and was fully launched in Europe in September 2015. Subsequently,

we launched CGuard EPS in over 30 countries through a network of distributors. In January 2024, we received CE mark recertification under

the EU’s MDR regulatory framework.

CGuard

Prime Stent System

Our

CGuard Prime also combines our MicroNet mesh and a self-expanding nitinol stent, but with a differentiated deployment system as compared

to the CGuard EPS. The CGuard Prime Carotid Stent is available in diameters ranging from 6mm to 10mm and in lengths of 20, 30, 40 and

60mm. The CGuard Prime delivery system is a rapid exchange (Rx), delivery system with a 6Fr profile that can accommodate all stent sizes

from 6mm to 10mm. In the U.S., PMA approval was received for stent sizes in 8-, 9- and 10-mm diameters with lengths of 30 and 40 mm.

CGuard

Prime advances the first generation CGuard transfemoral delivery system with a new handle design for ease of deployment and a new catheter

design for more flexible navigation of tortuous anatomy. The CGuard Prime product was used in 32 patients out of 316 patients in the

C-GUARDIANS study, since April 2023. In October 2024, the FDA approved the Company’s IDE to initiate the CGUARDIANS II study of

its CGuard Prime 80 cm carotid stent system for use in TCAR procedures. In the first quarter of 2026, we completed enrollment in the CGUARDIANS II pivotal study.

On

June 23, 2025, the FDA approved our PMA for CGuard Prime. The approval was supported by data from our C-GUARDIANS pivotal trial, a prospective

multicenter study that enrolled 316 patients in the U.S. and Europe . The trial demonstrated low rates of death, stroke, and myocardial

infarction at 30 days (0.95%) and low rates of 30-day DSMI or ipsilateral stroke through one year (1.93%). For additional information,

see “Item 1 – Business – Completed Clinical Trials for CGuard EPS – C-GUARDIANS.”

On

June 12, 2025, CGuard Prime stent system received MDR CE Mark approval.

SwitchGuard

NPS

SwitchGuard

NPS is a Class II neuroprotection system (“NPS”) that we have developed and that is subject to regulatory approval, composed

of medical grade tubing with male Luer lock connectors at each end and an in-line 200-micron blood filter. When connected to the included

arterial and venous sheaths, the system is intended as an external arterial-venous (A-V) shunt, allowing arterial blood to flow into

the venous system, while filtering particulate before returning blood to the patient on the venous side.

SwitchGuard

NPS is being developed to provide flow reversal for cerebral protection in carotid interventions utilizing the TCAR procedure since symptomatic

distal embolization, caused by the release of material (thrombotic, necrotic, or atherosclerotic) from the site of the lesion during

the intervention, is the most frequent and important complication of CAS. Reversing blood flow has been shown to reduce stroke risk during

carotid artery procedures.

We

submitted an IDE to the FDA for the C-GUARDIANS III clinical trial in December 2024, which was approved in June 2025. This approval allows

us to initiate a clinical trial to support the clearance of the SwitchGuard NPS coupled with CGuard Prime.

Acute

Stroke with Tandem Lesions

It

is estimated that 20-30% of acute ischemic strokes that are caused by large vessel occlusion involve tandem lesions- high grade stenosis/occlusion

of the internal carotid artery plus thrombotic occlusion of an intracranial vessel. Currently there is no indicated use of CAS for these

lesions during stroke treatment when the placement of an embolic protection device is not possible. We believe CGuard Prime is optimally

suited for intervention in this acute setting by its design (flexible / low metal structure) as well as MicroNet mesh offering embolic

protection both during and post procedure. Our goal is to develop CGuard Prime to mitigate strokes in this acute setting.

In

November 2023, we announced a strategic agreement with Jacobs Institute to execute an early feasibility study of CGuard Prime for the

treatment of acute stroke patients with tandem lesions. The study is expected to enroll 15 acute stroke patients across three U.S. sites

to explore the safety and feasibility of using CGuard Prime in this setting.

Completed

Clinical Trials for CGuard EPS

CARENET

The

CARENET trial was the first multi-center study of CGuard EPS following the receipt of CE mark of this device in March 2013. The CARENET

trial was designed to evaluate feasibility and safety of CGuard EPS in treatment of carotid lesions in consecutive patients suitable

for CAS in a multi-operator, real-life setting. The acute, 30-day, magnetic resonance imaging (“MRI”), ultrasound and six-month

clinical event results were presented at the LINC conference in Leipzig, Germany in February 2015. In the third quarter of 2015, the

results of the CGuard CARENET trial were published in the Journal of the American College of Cardiology. In November 2015, positive twelve-month

follow-up data from the CGuard CARENET trial was presented at the 42nd Annual Symposium on Vascular and Endovascular Issues, documenting

the benefits of the CGuard MicroNet technology as well as the patency benefits (maintaining the artery open) of the internal and external

carotid arteries at twelve months. In September 2022, the results of the CGuard CARENET trial five year follow up were published in the

Journal of the American College of Cardiology: Cardiovascular Interventions Vol. 15, No 18, 2022 September 26, 2022:1883-1891. There

was no ipsilateral stroke or ipsilateral stroke-related death which occurred throughout the five years. In addition, no stent restenosis

or external carotid artery occlusion occurred in CARENET within five years, indicating normal healing and uncompromised side-branch patency.

MACCE

(myocardial infarction (“MI”), stroke or death) rate was 0.0% at 30 days. At six months, there was one death, which was not

device or procedure-related but did result in a MACCE rate of 3.6% at six months. At twelve months there were two additional deaths,

which were not device or procedure-related resulting in a MACCE rate of 10.7% at one year.

MACCE (MI, stroke, death) (0) 0.0 % (1) 3.6 % (3) 10.7 %

CAS

carries the risk of cerebral embolization during and following the procedure, leading to life-threatening complications, mainly cerebral

ischemic events. Diffusion-weighted magnetic resonance imaging (DW-MRI) is a sensitive tool used to identify cerebral emboli during CAS

by measuring “lesions” within the brain which are areas that are ischemic and do not receive oxygenated blood due to cerebral

emboli. In the CARENET trial, 37.0% of patients treated with CGuard EPS had new ischemic lesions at 48 hours after the procedure, with

an average volume of 0.039 cm3. Of these lesions, there was only one that remained at 30 days following the procedure and all others

had resolved. Complete details appear in the following table. Where there is a second number shown below after a ± symbol, it

indicates the potential error in the measurement.

Subjects with new Acute Ischemic Lesions (“AIL”) 10 1

Incidence of new lesions 37.0 % 4.0 %

Total number new AIL 83 1

Permanent AIL at 30 days — 1

The

healing process of the tissue and in-stent restenosis can be measured by a non-invasive form of ultrasound called duplex ultrasound.

This type of ultrasound measures the velocity of the blood that flows within the carotid arteries, which increases exponentially as the

lumen of the internal carotid artery narrows and the percent stenosis increases. One of the measurements is called PSV (peak systolic

velocity) and is known to be highly correlated to the degree of in-stent restenosis; PSV values higher than 300 cm/sec are indicative

of >70% stenosis, while PSV values lower than 104 cm/sec are indicative of <30% restenosis and healthy healing. In the CARENET

trial, duplex ultrasound measurements done at 30 days, 6 months and 12 months following the stenting procedure all attest to healthy

normal healing without restenosis concerns, as the PSV values were 60.96 cm/sec ± 22.31, 85.24 cm/sec ± 39.56, and 90.22

cm/sec ± 37.72 respectively. The internal carotid artery was patent in all patients (100%).

The

conclusions of the CARENET trial were:

● All but one lesion had resolved completely by 30 days;

Physician-Sponsored

Clinical Trials for CGuard—PARADIGM-101 and PARADIGM -500 Studies

PARADIGM-101

(Prospective evaluation of All-comer peRcutaneous cArotiD revascularization

In symptomatic and increased-risk asymptomatic carotid artery stenosis, using CGuard Mesh-covered

embolic prevention stent system-101) was an investigator-led, single center study with the objective of evaluating feasibility and outcome

of routine use of CGuard EPS in 101 consecutive unselected all-comer patients referred for carotid revascularization, initiated in 2015.

In May 2016, the 30-day results were presented at the EuroPCR 2016 Late-Breaking Clinical Trial Session in Paris, and in the Journal

of EuroIntervention. In Dec 2020, the 12-month results were presented in the Official Journal of the EuroPCR and the European Association

of Percutaneous Coronary Interventions, EuroIntervention 2020;16:e950-e952. DOI: 10.4244/EIJ-D-19-01014) Key findings from the PARADIGM-101

study and the follow-up data are as follows:

The

results of the PARADIGM-101 study demonstrated that CGuard EPS can safely be used in a high risk, all-comer population of patients with

carotid artery stenosis and indicated that routine use of CGuard EPS may prevent cerebral events, such as strokes, by holding plaque

against the vessel wall, preventing emboli from being released into the blood stream. The PARADIGM-101 study found that CGuard EPS is

applicable in up to 90% of all-comer patients with carotid stenosis.

PARADIGM-500

(Prospective evaluation of All-comer peRcutaneous cArotiD revascularization

In symptomatic and increased-risk asymptomatic carotid artery stenosis, using CGuard Mesh-covered

embolic prevention stent system-500) is an investigator-initiated, single center study designed to evaluate the outcomes of routine CGuard

EPS in consecutive all-comer patients accepted by a multidisciplinary committee for carotid revascularisation. The PARADIGM-500 study

is an extension of the PARADIGM-101 study, which was initiated in 2015.

An

update of the PARADIGM-500 study was presented at the Veith 2024 conference in New York, held from November 19-23, 2024. Key findings

were:

● 30-day death or stroke rate of 0.75%;

● 30-day death, stroke and myocardial infarction (DSMI) rate of 0.94%;

The

Paradigm-500 study confirms that CAS with the CGuard EPS stent delivers reliable and low rates of 30-day composite DSMI, 12-month ipsilateral

stroke, ISR and no instances of stent thrombosis in a wide range of patients at standard and high risk for CEA.

Clinical

Results and Mechanical Properties of the Carotid CGUARD Double-Layered Embolic Prevention Stent Study

“Clinical

Results and Mechanical Properties of the Carotid CGUARD Double-Layered Embolic Prevention Stent Study” was an investigator-led,

prospective single-center study which evaluated CGuard EPS in 30 consecutive patients with internal carotid artery stenosis disease with

the objective of reporting early clinical outcomes with a novel MicroNet covered stent for the internal carotid artery and the in vitro

investigation of the device’s mechanical properties. In October 2016, the 30-day positive results were published online-ahead-of-print

in the Journal of Endovascular Therapy.

Key

findings from the study were as follows:

● 100% success in implanting CGuard EPS without residual stenosis;

● No peri- or post-procedural complications;

● All vessels treated with CGuard EPS remained patent (open) at six months; and

Additionally,

based on engineering evaluations, the study concluded that CGuard EPS provides a high radial force and strong support in stenotic lesions.

The stent is easy to use and safe to implant because it does not foreshorten and its structure adapts well to changes in diameter and

direction of tortuous vascular anatomies. The MicroNet mesh did not cause any changes to specific mechanical parameters of the underlying

stent.

Safety

and Efficacy of the New Micromesh-Covered Stent CGuard in Patients Undergoing Carotid Artery Stenting: Early Experience From a Single

Center

“Safety

and Efficacy of the New Micromesh-Covered Stent CGuard in Patients Undergoing Carotid Artery Stenting: Early Experience From a Single

Center” was an investigator-led, single-center study which evaluated CGuard EPS in 82 consecutive patients. The aim of the study

was to evaluate the safety (technical success) and efficacy (clinical success) of the CGuard stent system – a new nitinol stent

covered by a closed-cell polyethylene and terephthalate mesh designed to prevent embolic events. In 2017, the 30-day positive results

were published online-ahead-of-print in the European Journal of Vascular and Endovascular Surgery (2017), https://doi.org/10.1016/j.ejvs.2017.09.015.

Key

findings from the study were as follows:

● 100% success in implanting CGuard EPS;

● One case of acute stent thrombosis occurred within 4 hours of the procedure;

CGUARD

Mesh-Covered Stent in Real World: The IRON-Guard Registry

“CGUARD

Mesh-Covered Stent in Real World: The IRON-Guard Registry using CGuard EPS” was a physician initiated prospective multi-center

registry that included 200 patients from 12 medical centers in Italy. The objective of the study was to report 30-day outcomes (including

MACCE) in a prospective series of patients who were treated with CGuard EPS between April 2015 and June 2016. In January 2017, 30-day

results were presented at the Leipzig Interventional Course (LINC) 2017 and published in the Journal of EuroIntervention in May 2017.

The 12-month follow-up was published in the Journal of EuroIntevention in October 2018.

Key

30-day results presented were:

● 100% success in implanting CGuard EPS;

● No MI, major stroke or death at 30 days;

● Total elimination of post-procedural neurologic complications by 30 days;

● One myocardial infarction occurred at 12 months.

Initial

Clinical Study of the New CGuard EPS MicroNet Covered Carotid Stent: “One Size Fits All”

“Initial

Clinical Study of the New CGuard EPS MicroNet Covered Carotid Stent: ‘One Size Fits All’” was an investigator-led,

single-center study, which evaluated CGuard EPS in 30 consecutive patients with symptomatic stenosis of the internal carotid artery with

the objective of evaluating the CGuard EPS MicroNet-covered stent for its ability to adjust to different vessel diameters. The results

of the study were published in the Journal of Endovascular Therapy in May 2019. The conclusion of the study as reported was that CGuard

EPS has high conformability combined with an almost equivalent outward radial force at expansion diameters ranging from 5.5 to 9.0 mm.

The first clinical results demonstrate the “One Size Fits All” stent can be implanted in internal carotid arteries with reference

diameters within this range.

Key

findings from the study were as follows:

● 100% technical success in implanting CGuard EPS;

● No neurological events within 30 days;

Preliminary

Results from a Prospective Real-World Multicenter Clinical Practice of Carotid Artery Stenting Using the CGuard Embolic Prevention System:

The IRONGUARD 2 Study

“Preliminary

Results From a Prospective Real-World Multicenter Clinical Practice of Carotid Artery Stenting Using the CGuard Embolic Prevention System:

The IRONGUARD 2 Study” is a physician initiated prospective multi-center registry enrolling 733 patients from 20 medical centers

in Italy, from January 2017 to June 2019. The objective of the study is to evaluate periprocedural (24 hours), post-procedural (up to

30 days), and 12-month outcomes in a largest, prospective, multicenter series of patients submitted for protected carotid artery stenting

with the CGuard EPS. The 24-hour, 30-day and 12-month preliminary results (data available on 726 patients out of the 733 treated) were

presented at the Leipzig Interventional Course (LINC) in January 2021. The study’s preliminary results from the IRONGUAURD 2 study

suggested in a real-world evaluation of carotid artery stenting, CGuard EPS can be safely used for treatment of extracranial carotid

artery stenosis, allowing a low rate of post procedural adverse events by 12 months.

Key

findings from the study were as follows:

● 100% procedural success in implanting CGuard EPS;

Thirty-Day

Results of the Novel CGuard-Covered Stent in Patients Undergoing Carotid Artery Stenting

“Thirty-Day

Results of the Novel CGuard-Covered Stent in Patients Undergoing Carotid Artery Stenting” was an investigator-led, prospective

single-center study which evaluated CGuard EPS in 103 patients that underwent carotid artery stenting procedures. The aim of the study

was to provide early-term evaluation, safety, and efficacy of the novel CGuard micromesh self-expanding stent with embolic protection

system (EPS). In April 2021, the 30-day positive results were published in the Journal of Endovascular Therapy, DOI: 10.1177/15266028211007466.

Key

findings from the study were as follows:

● 100% technical success was achieved in all patients:

● No major adverse events (death, stroke, or myocardial infarction) at 30 days.

The

SIBERIA Trial for Carotid Artery Stenosis: A Randomized Controlled Trial of Conventional Versus Micronet-Covered Stent Use in Percutaneous

Neuroprotected Carotid Artery Revascularization: Peri-procedural and 30-day Diffusion-Weighted Magnetic Resonance Imaging and Clinical

Outcomes (RCT trial)

“The

SIBERIA Trial for Carotid Artery Stenosis: A Randomized Controlled Trial of Conventional Versus Micronet-Covered Stent Use in Percutaneous

Neuroprotected Carotid Artery Revascularization: Peri-procedural and 30-day Diffusion-Weighted Magnetic Resonance Imaging and Clinical

Outcomes” was an investigator-initiated randomized clinical trial, single-center study, which evaluated one hundred patients who

qualified for carotid revascularization with high risk for surgery and were randomized 1:1 to either CGuard EPS or AcculinkTM.

The primary endpoints were incidence and volume of new cerebral embolic post-procedural lesions (24-48 hours) as determined by diffusion

weighted magnetic resonance imaging (DW-MRI). The principal secondary endpoints included incidence of periprocedural or postprocedural

stroke, myocardial infarction and death at 30 days. The 30-day results of the study were presented in a late-breaking session at the

EuroPCR in June 2020 and published (Randomized Controlled Trial of Conventional Versus MicroNet-Covered Stent in Carotid Artery Revascularization,

JACC Cardiovascular Interventions, Vol. 14, November 21, 2021). The conclusion of the study was that the use of CGuard EPS in consecutive

unselected patients subjected to neuroprotected carotid artery stenting was associated with a greater than three-fold reduction in the

procedure-generated mean cerebral lesion volume, and with zero post-procedural cerebral embolisms observed. The MicroNet covered stent

significantly reduced periprocedural and abolished post procedural cerebral embolism in relation to a conventional carotid stent. This

is consistent with the MicroNet covered stent’s sustained embolism prevention, translating into cerebral protection not only during

but after carotid artery stenting. The incidence of restenosis and vessel occlusion according to the ICA (internal carotid artery) ultrasound

and the incidence of strokes, myocardial infarctions or deaths between the study arms at 365 days were presented at the LINC conference

in Leipzig, Germany in June, 2022. The 12-month outcomes demonstrated a significantly higher prevalence of the combined endpoint of death,

stroke or myocardial infarctions and in-stent restenosis and vessel occlusion rate in the first generation (single layer) carotid stent,

AcculinkTM, versus the MicroNet-Covered Stent, CGuard.

Key

findings from the study were as follows:

C-GUARDIANS

C-GUARDIANS

was a multicenter, single-arm, pivotal study to evaluate the safety and efficacy of the CGuard carotid stent system when used to treat

symptomatic and asymptomatic carotid artery stenosis in patients undergoing carotid artery stenting.

The

study completed enrollment in June 2023. The primary endpoint was a composite of: (1) incidence of major adverse events including Death

(all-cause mortality), any Stroke, and Myocardial Infarction (DSMI) through 30-days post index procedure, or (2) ipsilateral stroke from

day 31 to day 365 post-procedure. All events were adjudicated by an independent clinical events committee. The composite index was compared

to a performance goal based on the observed rate of the two components of the primary endpoint from previous pivotal stent trials which

were considered industry standard. The performance goal was considered met if the upper bound of the two-sided 95% confidence interval

calculated from the observed primary endpoint rate is < 11.6% and the p-value is less than 0.025.

From

July 2021 to June 2023, 316 patients were prospectively enrolled at 24 sites in the US and the EU and from April 2023 included deployment

of the CGuard stent using CGuard Prime. All CAS procedures were performed utilizing the CGuard MicroNet mesh covered stent and cleared

intra-procedural cerebral protection distal embolic filters or proximal embolic protection with flow cessation, or both. At 30 days,

the hierarchical DSMI rate was 0.95% in the intent to treat (ITT) analysis and 0.63% in the per- protocol (PP) analysis. Three patients

experienced major adverse cardiovascular events by 30-days: one patient who did not take dual antiplatelet therapy (protocol violation)

had a major stroke and died and two other patients had a stroke. There was no myocardial infarction (MI). These results support a potential

“neuroprotective” effect of the CGuard stent from the procedure to 30 days follow-up.

On

May 28, 2024, we announced positive one-year follow up results from the C-GUARDIANS trial of the CGuard carotid stent system in which

stenting with the CGuard carotid stent system in patients with carotid artery stenosis and at high risk for CEA had a 30-day DSMI and

Ipsilateral stroke between 31 and 365 days rate of 1.95%, measured from procedure to 1-year follow-up in the ITT analysis, using Kaplan-Meier

method. The primary endpoint rate was 1.71% in the per-protocol population.

On

June 23, 2025, the FDA granted PMA approval of CGuard Prime in the U.S. with the following indication for use:

On-going

and Planned Clinical Trials

C-GUARDIANS

Post-Market Approval Study

The

C-GUARDIANS Post-Market Approval Study was a condition of PMA approval for CGuard Prime in the U.S. The C-GUARDIANS Post-Market Approval

Study is a prospective, multicenter follow-up of the C-GUARDIANS pivotal study. It will evaluate the long-term safety and effectiveness

of CGuard Prime. All 303 remaining subjects active at the end of the 12-month evaluation will continue to be followed annually through

36 months.

Early

Feasibility Study of CGuard EPS for Acute Stroke Patients with Tandem Lesions

In

November 2023, we announced the entry into a strategic agreement with the Jacobs Institute at the State University of New York at Buffalo

to execute an early feasibility study of CGuard carotid stent system for the treatment of acute stroke patients with tandem lesions.

The study, a prospective, single-arm, open label, non-blinded study is expected to enroll 15 acute stroke patients across three U.S.

sites to assess the safety and feasibility of using CGuard carotid stent system to treat acute ischemic stroke patients with tandem lesions.

of Dr. Adnan Siddiqui, Vice-Chairman and Professor of Neurosurgery at the State University of New York at Buffalo, CEO of the Jacobs

Institute, is the Principal Investigator for the study. The trial began enrolling in the first quarter of 2025.

C-GUARDIANS

II for TCAR procedures

On

October 3, 2024, the FDA approved our IDE for CGUARDIANS II, a multicenter, single-arm, pivotal study to evaluate the safety and efficacy

of the CGuard Prime 80 cm carotid stent system used in conjunction with the ENROUTE NPS during TCAR procedures. Patrick Geraghty, M.D.,

professor of surgery and radiology, section of vascular surgery at Washington University School of Medicine in St. Louis, MO, and Patrick

Muck, M.D., program director and chief of vascular surgery at Good Samaritan Hospital in Cincinnati, OH, are lead principal investigators

for the trial. In the first quarter of 2026, we completed enrollment of 50 patients in our

CGUARDIANS II pivotal study.

C-GUARDIANS

III for TCAR procedures using SwitchGuard NPS

The

SwitchGuard NPS is designed to allow the treating physician to reverse cerebral blood flow during a TCAR procedure. SwitchGuard is intended

to prevent embolic debris generated during the procedure from traveling to the brain, passing the blood through the filter before returning

it to the patient to minimize blood loss.

On

December 30, 2024, we submitted an IDE to the FDA for CGUARDIANS III, a multicenter, single-arm, pivotal study to evaluate the safety

and efficacy of the SwitchGuard NPS used in conjunction with the CGuard Prime 80 cm carotid stent system for providing cerebral embolic

protection during carotid artery stenting via the TCAR procedure. The IDE submission was approved on June 6, 2025 by the FDA. The C-GUARDIANS

III study is expected to begin enrollment of patients during the second quarter of 2026.

Growth

Strategy

Our

primary business objective is to utilize our proprietary MicroNet technology and products to become the industry standard for the treatment

of carotid disease and prevention of stroke and to provide a superior solution to the common acute problems caused by current stenting

procedures, such as restenosis, embolization and thrombosis. We are pursuing the following business strategies to achieve these objectives.

Competition

The

markets in which we compete are highly competitive, subject to change and impacted by new product introductions and other activities

of industry participants.

With

respect to competition for our carotid embolic prevention systems, CGuard EPS and CGuard Prime, the manufacturers of products used in

connection with carotid stenting procedures include a number of large companies, such as Abbott Laboratories, Boston Scientific Corporation,

Medtronic, Cordis Corporation and Terumo Medical Corporation.

Many

of these competitors are larger companies or divisions of publicly traded companies that have certain competitive advantages, including

greater capital resources, larger customer bases, broader product lines, larger sales forces, greater marketing and management resources,

larger research and development staffs and larger facilities than ours and have established reputations and relationships with our target

customers and worldwide distribution methods that are more extensive than ours.

We

believe the principal competitive factors in our market include the following:

● Strength of clinical evidence- patient outcomes and adverse event rates

● Scale and effectiveness of commercialization efforts/organizations

● Acceptance by treating physicians and referral sources

● Physician learning curve

● Ease-of-use and reliability

● Economic benefits and cost savings

● ● Availability of reimbursement Patient experience

Sales

and Marketing

Sales

and Marketing

In

October 2024, we established our global headquarters in Miami, Florida to support the anticipated U.S. launch and commercialization of

CGuard Prime. Since that time, we have continued building the infrastructure for commercial operations in the U.S. to support the commercialization

of CGuard Prime.

We

are designing our commercial strategy and expanding our direct sales force to drive adoption of CGuard Prime among U.S. interventionalists.

In parallel, we aim to support the transition from CEA to CAS and TCAR, leveraging CGuard Prime 80 cm for TCAR procedures and accessory

devices, including our SwitchGuard neuroprotection system. We plan to continue to focus our marketing efforts on key growth markets and

to evaluate opportunities in new territories as they become available. In addition, we are using international medical conferences to

gain market exposure and brand recognition. We continue to work with leading physicians to enhance our marketing efforts and are developing

relationships with new key opinion leaders to champion our technology and participate in clinical studies.

In

the United States, we market and sell CGuard Prime through a direct sales organization consisting of approximately 30 sales and clinical

support personnel, as of February 2, 2026. Our sales professionals have substantial experience launching and establishing new disruptive

therapies and converting open surgical procedures to minimally-invasive alternatives. We are continuing to expand our commercial and

distribution capabilities to support the commercialization of CGuard Prime.

Previously,

based on the positive CGuard EPS clinical data, we initiated the commercial launch of CGuard EPS in CE marked countries in early 2015.

In September 2015, we announced full market launch of CGuard EPS in Europe. Since 2017 we have focused on sales of our products through

local distribution partners and our own internal sales initiatives to gain greater reach into all the relevant clinical specialties and

to expand our geographic coverage.

Product

Positioning

We

believe that CGuard Prime has the potential to become the standard of care in treating carotid artery disease in the U.S. It is a second-generation

stent with positive patient outcomes demonstrating significant reduction in post-procedural neurological events.

We

continue to invest in new product generations and potential new clinical indications for the CGuard platform with a strategy of focusing

on advancing a “stent-first” approach to carotid revascularization. As part of this strategy, we are evaluating CGuard Prime

in TCAR-based clinical programs, including the CGUARDIANS II pivotal trial, which studies the use of the CGuard Prime 80 cm carotid

stent system in conjunction with an established neuroprotection device, and the CGUARDIANS III pivotal trial, which evaluates our proprietary

SwitchGuard NPS paired with CGuard Prime to enable flow-reversal neuroprotection during TCAR. In parallel, we are pursuing new clinical

applications outside TCAR, including the treatment of acute ischemic stroke with tandem lesions, which is currently being studied in

an early feasibility study conducted with the Jacobs Institute. In this acute-stroke setting, the flexible, low-metal-burden design and

MicroNet mesh of CGuard Prime may offer advantages where traditional embolic-protection devices cannot be used. We believe this strategy

may allow us to increase penetration in our existing geographies and better position us for entry into new markets.

Insurance

Reimbursement

While

most countries have established reimbursement codes for stenting procedures, certain countries may require additional clinical data before

recognizing coverage and/or to obtain a certain level of reimbursement for one or more of our products. In these situations, we intend

to complete the required clinical studies to obtain reimbursement approval in countries where it makes economic sense to do so.

In

October 2023, CMS issued its final National Coverage Determination (“NCD”), expanding coverage of both CAS and TCAR to include

both asymptomatic and standard risk patients, significantly expanding the U.S. addressable market.

Intellectual

Property

Patents

We

have 71 issued patents, including 20 patents issued in the U.S., and 27 pending patent applications, 6 of which are pending in the United

States. Many of these patents and applications cover aspects of our CGuard and MGuard (a predecessor product) technology. Patents outside

the U.S. have been filed in Canada, China, Europe, Israel, India, Japan, Australia, South Africa, and Hong Kong. The patents and applications

fall into a number of patent families, as listed below.

Devices for shunting blood USA China Europe India Japan

Intravascular sheath USA (UTI) PCT

The

patents and patent applications listed above cover various aspects of our products, specifically focusing on the mesh sleeve covering

our stents, as well as methods for production and delivery mechanisms of the stents. We believe that our patents, in particular those

covering the use of a knitted micron-level mesh sleeve over a stent for various indications, as well as our pending patent applications

(if issued as patents with claims substantially in their present form), create a significant barrier against other companies seeking

to use similar technology. We believe these patents and patent applications collectively cover all our existing products and may be useful

in protecting our future technological developments. We intend to aggressively continue patenting new technologies and to actively pursue

any infringement of our key patents.

Trade

Secrets

We

also rely on trade secret protection to protect our interests in proprietary know-how and/or for processes for which patents are difficult

to obtain or enforce. As part of our trade secret policy, we rely on non-disclosure and confidentiality agreements with employees, consultants

and other parties to protect trade secrets and other proprietary technology.

Trademarks

We

have registered or applied to register the following trademarks, which we use in connection with our products:

● InspireMD® (US, European Union, and UK)

● MGuard® (European Union, and UK)

● CGuard® (US, European Union, and UK)

● MGuard Prime® (European Union, and UK)

● NGuard® (European Union and UK)

● PVGuard® (European Union, and UK)

● Micronet® (US)

● (MNP Micronet Protection logo) (European Union and UK)

● Carenet®)European Union and UK)

● SmartFitTM (US, UK, EP and CN)

● SmartFit Logo (EP, UK, CN)

● CGuard Prime (EP, UK, US, CN, JP)

● SwitchGuard (EP, UK, US, JP)

● True North Medical (EP, UK)

● MicroMesh logo (EP, UK)

● Micronet logo (updated version) (US, EP, UK, JP)

The

trademarks are renewable indefinitely, so long as we continue using the marks and make the appropriate filings when required. We also

use and may have common-law rights to various trademarks, trade names, and service marks.

Government

Regulation