What changed in this filing

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Item 1. Business

2026-03-18 compared with 2025-03-12 · 749 added, 559 removed, 538 unchanged (71% of the section changed)

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

and other vascular disease, including our proprietary CGuard™ stent platform.

A stent is an expandable scaffold-like device, usually

constructed of a metallic material, that is inserted into the lumen of an artery to create patency and improved blood flow.

of MicroNet™ mesh is attached over a stent to provide embolic protection both during and after stenting procedures.

CGuard™ carotid embolic prevention system (“CGuard EPS”) combines MicroNet and a unique self-expandable nitinol stent

in a single device for use in carotid artery revascularization.

Our CGuard EPS originally received CE mark approval under Medical Device

Directive 93/42/EEC (“MDD”) in the European Union (“EU”) in March 2013 and was fully launched in Europe in September

Subsequently, we launched CGuard EPS in over 30 countries and on February 3, 2021, we executed a distribution agreement with Chinese

partners for the purpose of expanding our presence in the Asian markets.

In January 2024, we received CE mark recertification under the

EU’s Medical Device Regulation regulatory framework.

September 8, 2020, we received approval from the U.S.

Food and Drug Administration (“FDA”) of our Investigation Device Exemption

(“IDE”), thereby allowing us to proceed with a pivotal study of our CGuard™ Carotid Stent System, C-GUARDIANS, for

prevention of stroke in patients in the United States.

C-GUARDIANS is a prospective, 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 (“CAS”).

The study, which completed enrollment in June 2023, enrolled 316

patients across 24 trial sites in the U.S.

and Europe and from April 2023 included deployment of the CGuard stent using CGuard Prime,

our next generation CAS stent platform.

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 are 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.

November 2023, we announced positive 30-day follow up results from the C-GUARDIANS trial in which stenting with the CGuard Carotid Stent

System in patients with carotid artery stenosis and at high risk for carotid endarterectomy had a DSMI rate of 0.95%, measured from the

date of the procedure through 30 days follow-up post-procedure.

In May 2024, we announced positive one-year follow up results from the

C-GUARDIANS trial, with a rate of 30-day DSMI and ipsilateral stroke between 31 and 365 days of 1.95%.

data were used to support the premarket approval (“PMA”) submission in September 2024 with a view to potential FDA approval of the CGuard

Prime carotid stent system in the first half of 2025.

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

System during transcarotid revascularization (TCAR) procedures.

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

expanding coverage for both CAS and TCAR to include both asymptomatic and standard risk patients, significantly expanding and supporting

the future growth of the U.S.

CAS addressable market.

continue to invest in current and future potential new indications, products and manufacturing enhancements for CGuard that are expected

to reduce cost of goods and/or provide the best-in-class performing delivery systems, such as CGuard Prime.

In furtherance of our strategy

that focuses on establishing the CGuard Carotid Stent System as a viable alternative to vascular surgery, we are developing a new transcarotid

artery revascularization (TCAR) system, SwitchGuard™ neuroprotection system (“SwitchGuard NPS”), for transcarotid access

and neuro protection.

In addition, we intend to explore new indications for CGuard to leverage the advantages of stent design and mesh

protection, well suited in labels such as acute stroke with tandem lesions.

consider our current addressable market for our CGuard Carotid Stent System and SwitchGuard NPS to be both symptomatic and asymptomatic

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.

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.

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.

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.

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.

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.

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

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

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.

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.

includes not only carotid artery stenting patients but also individuals undergoing carotid endarterectomy, as the two approaches compete

for the same patient population.

Assuming full penetration of the intervention caseload by CGuard, we estimate that the addressable market

for CGuard Carotid Stent System 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 Carotid Stent System

and SwitchGuard NPS to be approximately $9.3 billion, which may grow over time if expanded treatment options such as CGuard Carotid Stent

System and SwitchGuard NPS lead to increased patient screening for carotid artery disease.

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.

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 anticipated U.S.

launch and commercialization of the CGuard Prime carotid stent system.

May 12, 2023, we entered into a securities purchase agreement (the “Purchase Agreement”) pursuant to which we agreed to sell

and issue in a private placement (the “Private Placement Offering”) an aggregate of 10,266,270 shares (the “Private

Placement Shares”) of our common stock, pre-funded warrants (the “Pre-Funded Warrants”) to purchase up to 15,561,894

shares of common stock and warrants to purchase up to an aggregate of 51,656,328 shares of common stock, consisting of Series H warrants

to purchase up to 12,914,086 shares of common stock (the “Series H Warrants”), Series I warrants to purchase up to 12,914,078

shares of common stock (the “Series I Warrants”), Series J warrants to purchase up to 12,914,086 shares of Common Stock (the

“Series J Warrants”) and Series K warrants to purchase up to 12,914,086 shares of common stock (the “Series K Warrants”

and together with the Series H Warrants, Series I Warrants and Series J Warrants, the “Warrants”), at an offering price of

$1.6327 per Private Placement Share and associated Warrants and an offering price of $1.6326 per Pre-Funded Warrant and associated Warrants.

Pre-Funded Warrants will be immediately exercisable at an exercise price of $0.0001 per share and will not expire until exercised in

The Warrants will be immediately exercisable upon issuance at an exercise price of $1.3827 per share, subject to adjustment as

set forth therein.

The Warrants have a term of the earlier of (i) five years from the date of issuance and (ii) (A) in the case of the

Series H Warrants, 20 trading days following the Company’s public release of primary and secondary end points related to one year

follow up study results from the Company’s C-GUARDIANS pivotal trial, (B) in the case of the Series I Warrants, 20 trading days

following the Company’s announcement of receipt of Premarket Approval from the Food and Drug Administration (“FDA”)

for the CGuard Prime Carotid Stent System (135 cm), (C) in the case of the Series J Warrants, 20 trading days following the Company’s

announcement of receipt of FDA approval for the SwitchGuard and CGuard Prime 80 and (D) in the case on the Series K Warrants, 20 trading

days following the end of the fourth fiscal quarter after the fiscal quarter in which the first commercial sales of the CGuard Carotid

Stent System in the United States begins.

Warrants may be exercised on a cashless basis if there is no effective registration statement registering the shares underlying the Warrants.

On May 23, 2023, we filed registration statement on Form S-3 (File No.

333-272149) registering the shares underlying the Warrants, which

was declared effective by the Securities and Exchange Commission on June 2, 2023.

Under the terms of the Pre-Funded Warrants and Warrants,

certain of the selling stockholders may not exercise the Pre-Funded Warrants or Warrants to the extent such exercise would cause such

selling stockholder, together with its affiliates and attribution parties, to beneficially own a number of shares of common stock which

would exceed 4.99% or 9.99% of our then outstanding common stock following such exercise, excluding for purposes of such determination

common stock issuable upon exercise of the Pre-Funded Warrants or Warrants which have not been exercised.

The Warrants may be exercised

into pre-funded warrants if the selling stockholder is unable to exercise the Warrant due to the foregoing beneficial ownership limitation

or at the selling shareholder’s election.

the announcement of the one year follow up study results from the Company’s C-GUARDIANS trial, Series H Warrants to purchase 12,914,086

shares of common stock were exercised in full into 292,996 of shares of common stock and pre-funded warrants to purchase 12,621,090 shares

of common stock.

The net proceeds to the Company from the exercise of the Series H Warrants were $16.9 million, after deducting placement

The Series H warrants, each exercisable at $1.3827 per common share and $1.3826 per pre-funded warrant, were issued as part

of the private placement financing that the Company consummated on May 15, 2023.

to support the U.S.

launch and commercialization of CGuard Prime.

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

strategy includes:

adoption of a stent-first approach :

We are strategically aligned with the ongoing

shift from CEA to CAS and TCAR (stenting).

Clinical data, including results from the C-GUARDIANS

pivotal trial and outcomes from CREST-2, support the safety and efficacy of carotid stents

and reinforce clinical evidence and outcomes of carotid stents for stroke prevention.

FDA PMA approval of CGuard Prime received in June 2025 and U.S.

commercial launch in July

2025, we are positioned to capitalize to lead this market shift with expanded reimbursement

coverage and growing procedural volumes.

clinical differentiation :

Our proprietary MicroNet mesh technology is designed to

reduce plaque prolapse and embolic events, delivering strong periprocedural and long-term

Across multiple clinical trials and real-world studies, CGuard has demonstrated

the lowest 30-day and one-year composite adverse event rates compared to historical carotid

We intend to continue generating and publishing clinical evidence to support

broader adoption, guideline inclusion, and physician confidence.

commercial infrastructure :

A core priority is building a high-performing U.S.

commercial organization to accelerate penetration of the approximately 155,000 annual carotid

procedures performed in the United States.

We are expanding our U.S.

direct sales force with

experienced CAS and neurovascular specialists, leveraging claims data to identify high-opportunity

accounts, and identifying centers with trained TCAR physicians for engagement following anticipated

label expansion of CGuard Prime to include TCAR.

Our objective is to drive consistent utilization

growth and increase market share of CGuard Prime in both CAS and TCAR procedures.

product portfolio :

We are advancing a broader carotid and neurovascular platform

strategy, including development of SwitchGuard neuroprotection technology and additional

indications for CGuard Prime, such as TCAR and acute stroke with tandem lesions.

a comprehensive procedural toolkit, we aim to deepen relationships with physicians and participate

more fully across the carotid intervention continuum.

international presence :

We currently commercialize CGuard in more than 30 countries

and maintain meaningful market share outside the United States.

Following U.S.

we are exploring further expansion into Asia, including potential opportunities in Taiwan,

Japan, and South Korea, while continuing to strengthen distribution partnerships and regulatory

registrations globally.

and extend intellectual property :

Our MicroNet platform is supported by a robust

and growing intellectual property portfolio.

We intend to continue strengthening our patent

position globally to protect our technology and enable future product pipeline expansion.

Operationally, we are scaling manufacturing, quality systems, and corporate infrastructure

to support sustained revenue growth and a path toward profitability.

arteries are located on each side of the neck and provide the primary blood supply to the brain.

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causes of stroke.

According to the World Health Organization (https://www.who.int/cardiovascular_diseases/resources/atlas/en/) 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.

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.

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 required intervention (according to the Health Research International Personal Medical Systems,

September 13, 2021 Results of Update Report on Global Carotid Stenting Procedures and Markets by Major Geography and Addressable

There are three current interventional treatments used for carotid artery disease.

The first is a carotid endarterectomy, where

a surgeon accesses the blocked carotid artery though an incision in the neck, and then surgically removes the plaque.

The second is transcarotid

artery revascularization (TCAR) where a surgeon accesses the blocked carotid artery though an incision in the neck, and then places a

stent to open the artery and prevent embolization while combining high-rate blood flow reversal to protect the brain.

The third is carotid

artery stenting (CAS), which is a minimally invasive endovascular treatment for using stents and carotid embolic protection systems to

protect against plaque and debris traveling downstream, blocking off the vessel and disrupting blood flow.

We believe that the availability

of less invasive treatment options like TCAR and CAS should increase the number of patients being treated since they avoid the need for

complex surgery.

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

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.

Mesh Platform Technology

is our proprietary knitted mesh which wraps around a stent to protect patients from plaque prolapse and embolization upon deployment.

MicroNet is made of a single fiber from a biocompatible polymer widely used in medical implants.

The size, or aperture, of the current

MicroNet ‘pore’ is only 150-180 microns, designed to maximize protection against the potentially dangerous plaque and thrombus.

The MicroNet mesh is the core technology around which we have developed products for specific applications.

– Carotid Artery Applications

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

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

EPS – Carotid Artery Applications

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.

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This danger is

one of the greatest limitations of carotid artery stenting with conventional carotid stents.

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

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

carotid stenting and surgical endarterectomy, given the superior embolic protection characteristics provided by the MicroNet.

the MicroNet will provide acute embolic protection at the time of the procedure, but more importantly, will provide post-procedure protection

against embolic dislodgement.

It is in this post-procedure time frame that embolization is the source of post-procedural strokes in the

Schofer, et al.

(“Late cerebral embolization after emboli-protected carotid artery stenting assessed by sequential diffusion-weighted

magnetic resonance imaging,” Journal of American College of Cardiology Cardiovascular Interventions , Volume 1, 2008) have

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.

1 unchanged sentence

Subsequently,

we launched CGuard EPS in 30 plus countries and on February 3, 2021, we executed a distribution agreement with Chinese partners for the

purpose of expanding our presence in China.

September 8, 2020, we received approval from the FDA of our IDE, thereby allowing us to proceed with a pivotal study of our CGuard™

Carotid Stent System, C-GUARDIANS, for prevention of stroke in patients in the United States.

C-GUARDIANS is a prospective, 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, which completed enrollment in June

2023, enrolled 316 patients across 24 trial sites in the U.S.

and Europe and from April 2023 included deployment of the CGuard stent

using CGuard Prime, our next generation CAS stent platform.

primary endpoint is 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 are

adjudicated by an independent clinical events committee.

The composite endpoint will be compared to a performance goal based on the observed

rate of the two components of the primary endpoint from previous pivotal stent trials which are considered industry standard.

The performance

goal will be 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.

November 2023, we announced positive 30-day follow up results from the C-GUARDIANS trial in which stenting with the CGuard Carotid Stent

System in patients with carotid artery stenosis and at high risk for carotid endarterectomy had a DSMI rate of 0.95%, measured from the

date of the procedure through 30 days follow-up post-procedure.

In May 2024, we announced positive one-year follow up results from the

C-GUARDIANS trial, with a rate of 30-day DSMI and Ipsilateral stroke between 31 and 365 days of 1.95%.

These data were used to support

the premarket approval, or PMA, submission in September 2024 with a view to potential FDA approval of the CGuard Prime carotid stent

system in the first half of 2025.

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.

Prime Stent System

CGuard Prime stent system is a mesh-covered self-expanding carotid stent that is loaded into a rapid exchange (Rx) delivery system that

is subject to regulatory approval.

CGuard Prime Carotid Stent is a self-expanding nitinol stent covered with a MicroNet bio-stable sleeve woven from a single strand of

23 μm Polyethylene Terephthalate (PET).

The MicroNet sleeve is designed to trap and seal thrombus and plaque against the vessel wall,

providing continuous embolic prevention.

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., we are currently seeking approval only for stent sizes in 8, 9 and 10 mm in diameter with

lengths of 30 and 40 mm.

Prime 135 cm 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 315 patients

in the CGuardians study, since April 2023.

In October 2024, the FDA approved the Company’s IDE to initiate the CGUARDIANS II study

of its CGuard Prime 80cm Carotid Stent System for use in the indication of transcarotid revascularization (TCAR) procedures.

CGuard Prime Technical Documentation is currently under Notified Body review for EU MDR certification.

NPS is a Class IIa 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.

is being developed to answer a need of flow reversal for cerebral protection in carotid interventions 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

submitted an IDE to the FDA for the C-GUARDIANS III clinical trial in December 2024, which, if approved, would allow us to initiate a

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

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

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.

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.

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.

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.”

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

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.

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.

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.

Stroke with Tandem Lesions

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

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.

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

historically developed and sold the MGuard Prime embolic protection system (“MGuard Prime EPS”) which was marketed for use

in patients with acute coronary syndromes, notably acute myocardial infarction (heart attack) and saphenous vein graft coronary interventions.

Over the past years there has been a shift in industry preferences towards drug eluting stents.

As a result of declining sales and utilization

of the MGuard Prime EPS, which was largely driven by the predominant industry preferences favoring drug-eluting stents, during the second

quarter of 2022 we ceased sales of MGuard Prime EPS following a phase out period.

Clinical Trials for CGuard EPS

1 unchanged sentence

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

for CASin a multi-operator, real-life setting.

for CAS in a multi-operator, real-life setting.

The acute, 30-day, magnetic resonance imaging (“MRI”), ultrasound and six-month

12 unchanged sentences

In addition, no stent restenosis

or external carotid artery occlusion occurred in CARENET by 5 years, indicating normal healing and uncompromised side-branch patency.

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

(myocardial infarction (“MI”), stroke or death) rate was 0.0% at 30 days.

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One of the measurements is called PSV (peak systolic

volume) 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.

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%).

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

(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 of PARADIGM-101 study, which was initiated in 2015.

( P rospective evaluation of A ll-comer pe R cutaneous c A roti D revascularization

I n symptomatic and increased-risk asymptomatic carotid artery stenosis, using C G uard M esh-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.

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

findings were:

death or stroke rate of 0.75%;

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12-month, the ISR rate (by Core Lab) is lower than those reported in the literature of first-generation stents (Naylor R, et al.

Society for Vascular Surgery (ESVS) 2023 Clinical Practice Guidelines on the Management of Atherosclerotic Carotid and Vertebral Artery

European Society for Vascular Surgery (ESVS) 2023 Clinical Practice Guidelines on the Management of Atherosclerotic Carotid and Vertebral

Artery Disease.

Eur J Vasc Endovasc Surg.

cases of stent thrombosis (0%) with CGuard EPS through 12 months of follow up

Paradigm-500 study confirms that carotid artery stenting (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 patient at standard and high risk for

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.

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

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in the Journal of Endovascular Therapy.

findings from the study are as follows:

findings from the study were as follows:

success in implanting CGuard EPS without residual stenosis;

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direction of tortuous vascular anatomies.

The MicroNet mesh of CGuard did not cause any changes to specific mechanical parameters of

the underlying stent.

The MicroNet mesh did not cause any changes to specific mechanical parameters of the underlying

and Efficacy of the New Micromesh-Covered Stent CGuard in Patients Undergoing Carotid Artery Stenting:

8 unchanged sentences

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.

findings from the study are as follows:

findings from the study were as follows:

success in implanting CGuard EPS;

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minor stroke was recorded within the peri-operative period following the acute stent thrombosis, mentioned above;

new adverse neurological events were recorded at the post-operative period.

new adverse neurological events were recorded at the post-operative period;and

was performed to assess the occurrence of new ischaemic brain lesions from the target vessel following placement of the CGuard stent

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

with the CGuard Embolic Prevention System.

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.

findings from the study are as follows:

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.

findings from the study were as follows:

procedural success in implanting CGuard EPS;

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10.1177/15266028211007466.

findings from the study are as follows:

findings from the study were as follows:

technical success was achieved in all patients:

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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)

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)

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 Acculink TM .

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 Acculink TM .

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

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14, November 21, 2021).

The conclusion of the study was that the CGuard™ Micronet™-covered

stent use 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.

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

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, Acculink TM , versus the MicroNet-Covered Stent, CGuard™.

findings from the study are as follows:

Procedure, the CGuard™ arm was observed to have a 57% reduction in new cerebral lesion average volume per patient (171 mm 3

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.

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,

Acculink TM , versus the MicroNet-Covered Stent, CGuard.

findings from the study were as follows:

Procedure, the CGuard arm was observed to have a 57% reduction in new cerebral lesion average volume per patient (171 mm 3 vs.

73 mm 3 ), a statistically significant improvement (p=0.017) and 222 mm 3 vs.

84 mm 3 (p=0.038);

Procedure (24-48 hours), the CGuard™ arm was observed to have a 78% reduction in the average volume of new cerebral lesions

(157 mm 3 vs.

Procedure (24-48 hours), the CGuard arm was observed to have a 78% reduction in the average volume of new cerebral lesions (157 mm 3

700 mm 3 ), a statistically significant improvement (p=0.007);

30 days, DW-MRI showed zero new cerebral lessons in the CGuard arm versus six in the Acculink arm (p=0.03);

30 days, there were zero strokes, myocardial infarctions or deaths in the CGuard arm and two events the Acculink™ arm (two

365 there were zero cases of restenosis and vessel occlusion in the CGuard™ arm versus 3 cases of restenosis and 1 case of

vessel occlusion in the Acculink™ arm;

365 days, there were one event in the CGuard arm (one death) and five events the Acculink™ arm (two strokes, two deaths and

one myocardial infarction).

and Planned Clinical Trials

is a prospective, 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.

30 days, there were zero strokes, myocardial infarctions or deaths in the CGuard arm and two events the Acculink arm (two strokes);

365 there were zero cases of restenosis and vessel occlusion in the CGuard arm versus 3 cases of restenosis and 1 case of vessel

occlusion in the Acculink arm;

365 days, there were one event in the CGuard arm (one death) and five events the Acculink arm (two strokes, two deaths and one myocardial

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.

study completed enrollment in June 2023.

The primary endpoint is a composite of:

The primary endpoint was a composite of:

(1) incidence of major adverse events including Death

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day 31 to day 365 post-procedure.

All events are adjudicated by an independent clinical events committee.

The composite index will be

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

which are considered industry standard.

The performance goal will be 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.

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.

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, our next generation CAS stent platform.

All CAS procedures were performed utilizing the CGuard

MicroNet TM 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.

May 28, 2024, we announced positive one-year follow up results from the C-GUARDIANS trial of the CGuard™ Carotid Stent Systemin

which stenting with the CGuard Carotid Stent System in patients with carotid artery stenosis and at high risk for carotid endarterectomy

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.

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.

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.

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

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

September 16, 2024, we submitted the clinical module of the PMA, which is currently under interactive review with the FDA.

June 23, 2025, the FDA granted PMA approval of CGuard Prime in the U.S.

with the following indication for use:

Prime, when used in conjunction with embolic protection devices specified in the labeling,

is indicated for improving carotid luminal diameter in patients at high risk for adverse

events from carotid endarterectomy who require carotid revascularization and meet both criteria

outlined below:

with neurological symptoms and ≥50% stenosis of the common or internal carotid artery

by angiogram, or

without neurological symptoms and ≥80% stenosis of the common or internal carotid artery

by angiogram;

having a vessel with reference diameters between 6.4 mm and 9.0 mm at the target lesion.

and Planned Clinical Trials

Post-Market Approval Study

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

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

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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 center, single-arm, open label, non-blinded study is expected to enroll 15 acute stroke patients across

sites to assess the safety and feasibility of using CGuard Carotid Stent System to treat acute ischemic stroke patients with

tandem lesions.

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.

We began enrollment in the first quarter of 2025.

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.

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.

II for TCAR procedures

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

of the CGuard Prime 80cm carotid stent system used in conjunction with the ENROUTE NPS during Transcarotid Artery Revascularization (TCAR)

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.

The study enrolled its first patient on December 16, 2024 and aims to enroll a minimum

of 50 evaluable patients.

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.

III for TCAR procedures using SwitchGuard NPS

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

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.

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.

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 Transcarotid Artery Revascularization (TCAR) approach.

The IDE submission is currently

under review at the FDA.

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.

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

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We are pursuing the following business strategies to achieve these objectives.

Grow our presence in existing and new markets for CGuard

We are focused on growing our presence in the U.S.

market through a direct sales organization, pending FDA approval of CGuard

Prime and to this end have been building the infrastructure for U.S.

commercial operations.

In addition, we have launched CGuard

EPS in most European and Latin American countries through a comprehensive distributor sales organizations network.

We are continuing

to focus on larger growing markets through this network by supporting our distributors with robust marketing and clinical education

We are pursuing additional product registrations and distribution contracts with local distributors in other countries

in Europe, Asia and Latin America.

In February 2021, we executed a distribution agreement with Chinese partners for the purpose of

expanding our presence in China.

Currently, we are seeking strategic partners for a potential launch of CGuard EPS in Asian countries.

the adoption of CGuard .

We are seeking to expand the population of CGuard patients in those countries in which CGuard is commercially

In particular, our focus is on establishing CGuard as a viable alternative (in appropriate cases) to carotid endarterectomy

and the use of conventional carotid stents within the applicable medical communities.

We intend to accomplish this goal by continuing

to publish and present our clinical data, supporting investigator-initiated clinical registries and exploring the addition of additional

devices to our portfolio, including the SwithchGuard NPS for use in TCAR cases.

We have partnered and will continue to seek out partnerships

with organizations focused on the treatment of stroke.

We will also continue to engage advisory boards and to develop a network of

key opinion leaders to assist us in our efforts to widen the adoption of CGuard.

expansion and pipeline development We plan to continue to invest in advancing our portfolio with new delivery system alternatives

to facilitate the use of CGuard and SwitchGuard by all physicians.

We believe our delivery systems, if approved, will enable all

endovascular access points including accessory devices for trans carotid artery revascularization .

approval of National Coverage Determination (NCD) – On October 11 2023, CMS issued an NCD covering the use of carotid stents

(both CAS and TCAR) for the treatment of both symptomatic and asymptomatic patients either at high- or standard-surgical risk.

decision significantly increases the available market to endovascular procedures.

Previously, only symptomatic patients at high-risk

to surgery were covered through the CMS coverage, NCA - Percutaneous Transluminal Angioplasty (PTA) of the Carotid Artery Concurrent

with Stenting (CAG-00085R8) - Tracking Sheet (cms.gov)

to leverage our MicroNet technology to develop additional applications for interventional cardiologists and vascular surgeons.

addition to the applications described above, we believe that we will eventually be able to utilize our proprietary MicroNet technology

to address imminent market needs for new product innovations to significantly improve patient care.

We continue to broadly develop

and protect intellectual property using our mesh technology.

Examples of some areas include peripheral vascular disease and neurovascular

penetration of CGuard EPS and CGuard Prime in existing markets, particularly the United States .

Our proprietary MicroNet mesh

technology is designed to reduce plaque prolapse and embolic events which we believe differentiates CGuard EPS and CGuard Prime to

deliver strong periprocedural and long-term outcomes.

Our CGuard carotid stent system has demonstrated the lowest 30-day and one-year

composite adverse event rates compared to historical carotid stent data for competing products.

We believe that these attributes

provide a significant opportunity for us to gain market share in existing markets where we compete.

In our most well-established

markets, we believe we have achieved market share of at least 25%, while in markets we have more recently entered, such as the U.S.,

our market share is much lower.

We believe that, through physician education about the superior attributes and safety outcomes of

our products, we can expand awareness and utilization of our products in all markets, particularly the U.S.

The potential for increased

market penetration will provide us significant opportunity for growth.

adoption of a stent-first approach .

Our long-term objective is to build a sustained clinical ecosystem by cultivating a global

network of scientific and clinical advisors, supporting multi-year registries and multi-national clinical collaborations and participating

in strategic alliances in stroke prevention and vascular innovation.

product portfolio.

We plan to expand the MicroNet platform with next-generation delivery system architectures designed

to enable additional access routes, improved ease of use across physician specialties and support for future accessory devices and

multi-procedural workflows.

and extend intellectual property and leverage clinical differentiation.

In addition to the applications described above, we believe

that we will eventually be able to utilize our proprietary MicroNet technology to address market needs for new product innovations

to significantly improve patient care.

We continue to broadly develop and protect intellectual property using our mesh technology.

Examples of some areas include peripheral vascular disease and neurovascular disease.

relationships with collaborative and development partners to fully develop and market our existing and future products.

seeking strategic partners for collaborative research, development, marketing, distribution, or other agreements, which could assist

with our development and commercialization efforts for CGuard and other potential products that are based on our MicroNet technology.

We plan to pursue long-term strategic collaborations focused on technology development and integration, clinical research expansion

and global market access enablement.

commercial infrastructure.

We are seeking to expand U.S.

direct sales force with experienced CAS and neurovascular specialists,

leveraging claims data to identify high-opportunity accounts, and identifying centers with trained TCAR physicians as we aim to drive

consistent utilization growth and increase market share of CGuard Prime in both CAS and TCAR procedures.

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

of industry participants.

respect to competition for our carotid embolic prevention system, CGuard EPS, the manufacturers of products used in connection with CAS

procedures include a number of large companies, such as Abbott Laboratories, Boston Scientific Corporation, Medtronic, Cordis Corporation

and Terumo Medical Corporation.

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.

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, relationships with our target

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

However, while there are currently many market participants

carotid stent market, we believe that the European market is somewhat more fragmented for CAS products, and, in our opinion,

smaller competitors may be able to gain market share with greater flexibility and more efficiency than in the United States.

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.

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

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launch and commercialization of

the CGuard Prime carotid stent system.

During 2024, we started the build-out of the infrastructure for commercial operations in the U.S.

designed to support the anticipated commercialization of the CGuard Prime carotid stent system.

are designing our commercial strategy and building our direct sales force to drive CGuard Prime penetration within the community of interventionalists.

In parallel, we aim at transitioning vascular surgeons from carotid endarterectomy procedures to CAS and TCAR with CGuard and accessory

devices, which we believe can greatly expand our customer base.

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.

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.

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 work with us in clinical studies.

the United States, we plan to market and sell the CGuard Prime carotid stent system through a direct sales organization consisting of

15 sales and clinical support personnel, as of March 12, 2025.

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

commercialization capabilities and to build our distribution capabilities to support the anticipated commercialization of the CGuard

Prime carotid stent system.

At this time, we do not have any commercially approved medical devices in the US, and we have not registered

as an establishment with the FDA.

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

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.

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

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to expand our geographic coverage.

believe that CGuard has the potential to become the standard of care in treating carotid artery disease.

It is a second-generation stent

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

Additionally,

we intend to continue to evaluate potential product and manufacturing enhancements for CGuard expected to reduce cost of goods or provide

the best-in-class performing delivery system and accessory solutions.

We believe these improvements may allow us to reduce cost of goods

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

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.

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.

Reimbursement

7 unchanged sentences

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

Many of these patents and applications cover aspects of our CGuard and MGuard technology.

Patents outside the U.S.

filed in Canada, China, Europe, Israel, India, Japan, Australia, and South Africa.

The patents and applications fall into a number of

patent families, as listed below:

Base Title of Patent Family

Pending patent

Issued patents

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

Patents outside

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.

Title of Patent Family

and Patent No.)

Bifurcated stent assemblies

stent assemblies

ZL 20078046676.2

Deformable tip for stent delivery and methods of use

Handle for Two-Stage Deployment of a Stent

Shunts with Blood-Flow Indicators

tip for stent delivery and methods of use

for Two-Stage Deployment of a Stent

with Blood-Flow Indicators

ZL 2022800089963

Device for Shunting Blood Between the Arterial and Venous Systems

for Shunting Blood Between the Arterial and Venous Systems

ZL 2022800098002

Devices for shunting blood

In Vivo Filter Assembly

Knitted Stent Jackets

EP4313255 HK40096715

for shunting blood

Vivo Filter Assembly

Stent Jackets

ZL200780046697.4

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of using a self-adjusting stent assembly and kits including same

202210380047X

Intravascular

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

manufacture and sale of our products are subject to regulation by numerous governmental authorities, principally the European Union CE

mark and other corresponding foreign agencies.

of medical devices outside the United States are subject to foreign regulatory requirements that vary widely from country to country.

These laws and regulations range from simple product registration requirements in some countries to complex approval process, clinical

trials and production controls in others.

As a result, the processes and time periods required to obtain foreign marketing approval may

be longer or shorter than those necessary to obtain FDA market authorization.

These differences may affect the timeliness of international

market introduction of our products.

For the European Union nations, medical devices must obtain a CE mark before they may be placed

on the market.

In order to obtain and maintain the CE mark, we must comply with EU law on medical devices, which, until May 26, 2021

was governed by the MDD, by presenting comprehensive technical files for our products demonstrating safety and efficacy of the product

to be placed on the market and passing initial and annual quality management system audit as per ISO 13485 standard by a European Notified

We have obtained ISO 13485 quality system certification and CGuard EPS that we currently distribute into the European Union, displays

the required CE mark.

In order to maintain certification, we are required to pass an annual surveillance audit conducted by Notified

Body auditors.

The European Union replaced the MDD with the new MDR regulation.

The MDR entered into force after a transitional period

of three years and a one year extension of that transition period due to the COVID-19 pandemic on May 26, 2021 and which changes several

aspects of the regulatory framework in the European Union.

Manufacturers had the duration of the transition period to update their technical

documentation and processes to meet the new requirements in order to obtain a CE Mark.

In January 2024, we received CE mark recertification

of CGuard EPS under the MDR.

have or had regulatory approval and made sales of CGuard EPS either through distributors pursuant to distribution agreements or directly,

in the countries listed in the table below.

While each of the European Union member countries accepts the CE mark as its sole requirement

for marketing approval, some of these countries still require us to take additional steps in order to gain reimbursement rights for our

Furthermore, while we believe that certain of the below-listed countries that are not members of the European Union and accept

the CE mark as a primary requirement for marketing approval, each such country requires additional regulatory requirements for final

marketing approval of our products.

Furthermore, we are currently targeting additional countries in Europe, Asia, and Latin America;

however, even if all governmental regulatory requirements are satisfied in each such country, we anticipate that obtaining marketing

approval in each country could take as few as three months or as many as twelve months or more, due to the nature of the approval process

in each individual country, including typical wait times for application processing and review, as discussed in greater detail below.

refer to the table below setting forth the approvals and sales made for CGuard EPS on a country-by-country basis

and Sales of CGuard EPS on a Country-by-Country Basis*

Czech Republic

Dominican Republic

Liechtenstein

United Kingdom

United States

to CGuard units used in our ongoing FDA trial.

products and operations are subject to extensive regulation in the United States, the European Union, and other international markets

in which we conduct business.

devices distributed in the United States are regulated by the FDA.

On June 24, 2025, the FDA granted Premarket Approval (PMA) for CGuard

Prime, authorizing commercial distribution in the United States.

We began initial U.S.

commercialization in July 2025, following receipt

of PMA approval and the establishment of our direct sales organization.

approval, our U.S.

operations remain subject to ongoing FDA regulatory requirements.

These include compliance with the Quality System

Regulation (21 CFR Part 820), labeling and promotional requirements, Medical Device Reporting obligations (21 CFR Part 803), reporting

of corrections and removals (21 CFR Part 806), and any post-market surveillance activities required by the FDA.

Our ability to expand

sales depends on continued compliance with these regulatory obligations.

Union and Other International Markets

the United States, the sale of medical devices is regulated by foreign authorities whose requirements vary by country.

order to sell our products in member countries of the European Economic Area, or EEA, our products must comply with the requirements

of Regulation (EU) 2017/745 on medical devices (Medical Device Regulation – MDR).

Compliance with these requirements is a prerequisite

to be able to affix the CE mark to our products, without which they cannot be sold or marketed in the EEA.

To demonstrate compliance,

we must undergo a conformity assessment procedure, which varies according to the type of medical device and its classification.

for low-risk medical devices (Class I), where the manufacturer can generally issue a EU Declaration of Conformity based on a self-assessment

of the conformity of its products with the requirements of the MDR, a conformity assessment procedure requires the involvement of an

organization designated by a member state of the EEA to carry out conformity assessments, called a Notified Body.

Depending on the relevant

conformity assessment procedure, the Notified Body would typically audit and examine the technical documentation and the quality management

system for the life cycle of our devices regarding their safety and performance.

The Notified Body may require the application to be

completed by having further tests carried out or requesting further evidence to be provided to allow assessment of conformity with the

relevant requirements of the MDR.

The Notified Body issues certificates of conformity following successful completion of a conformity

assessment procedure conducted in relation to the medical device and its manufacturer and their conformity with the requirements of the

These certificates entitle the manufacturer to affix the CE mark to its medical devices after having prepared and signed a related

EU Declaration of Conformity.

January 2024, we received CE Mark recertification for CGuard EPS under the MDR.

Our CGuard EPS previously held CE Mark approval under

the former Medical Device Directive (MDD), which was replaced by the MDR on May 26, 2021.

On June 12, 2025, we received CE Mark approval

under the EU’s MDR for the CGuard Prime Embolic Prevention System.

the EU, the General Data Protection Regulation (EU) 2016/679 (GDPR), effective since May 2018, imposes comprehensive data protection

requirements, including strict rules on international data transfers, enhanced individual rights, and significant penalties for non-compliance.

The GDPR is supplemented by national laws and guidance from the European Data Protection Board.

have obtained regulatory approvals for, and commercialized, CGuard EPS in multiple countries outside the United States, primarily through

distributors.

These international markets represented the majority of our revenues in 2025.

Although certain countries accept CE Mark

approval as the primary requirement for marketing authorization, others require additional regulatory steps, reimbursement approvals,

or local registrations before commercial sale.

Review timelines and reimbursement frameworks vary significantly by jurisdiction and may

affect the pace and extent of market access.

Government Regulation of Medical Devices for Human Subjects

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approval involves scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices for the purpose(s)

The FDA will either approve or deny a premarket approval application and we cannot market a device until the FDA approves a

premarket approval application.

The FDA approved the CGuard Prime PMA on June 23, 2025.

PMA must be supported by extensive data including, but not limited to, analytical, preclinical, clinical trials, manufacturing, statutory

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Clearance Pathway

do not currently market, distribute, or sell any products that have market clearance by the FDA under its 510(k) process that are generally

required as Class II devices.

If, in the future, we develop products where 510(k) clearance is required, we would be required to submit

a 510(k) demonstrating that such proposed devices are substantially equivalent to a respective previously cleared 510(k) device or a

device that was in commercial distribution before May 28, 1976, for which the FDA has not yet called for the submission of 510(k).

FDA’s 510(k) clearance pathway is established as 180 days for review, however, it usually takes from three to twelve months but

could take longer.

In some cases, the FDA may require additional information, including clinical data, to make a determination regarding

substantial equivalence.

do not currently market, distribute, or sell any products that have market clearance by the FDA under its 510(k) process.

future, we develop products where 510(k) clearance is required, we would be required to submit a premarket notification to the FDA demonstrating

that such proposed devices are substantially equivalent to a respective previously cleared 510(k) device or a device that was in commercial

distribution before May 28, 1976, for which the FDA has not yet called for the submission of 510(k).

The FDA’s 510(k) clearance

pathway is established as 180 days for review, however, it usually takes from three to twelve months but could take longer.

In some cases,

the FDA may require additional information, including clinical data, to make a determination regarding substantial equivalence.

a device receives 510(k) clearance, any modification that could significantly affect its safety or effectiveness, or that would constitute

32 unchanged sentences

of corrections or removals.

this time, we do not have any commercially approved medical devices in the US, and we have not filed for an Establishment Registration

with the FDA.

If we are approved or cleared to manufacture, prepare, or process a device in the United States, we and any third-party

manufacturers that we may use will be required to register our establishments with the FDA.

In addition, we and our manufacturing facilities

will be subject to FDA inspections for compliance with the FDA’s Quality System Regulation.

Additionally, some of our subcontractors

may also be subject to FDA announced and unannounced inspections for compliance with the FDA’s Quality System Regulation and assurances

that the Company is marketing appropriately the indications for use of the product.

These regulations will require that we manufacture

our products and maintain our documents in a prescribed manner with respect to design, manufacturing, testing and quality control activities

and ensure that marketing materials and promotion are in compliance.

As a medical device manufacturer, we will further be required to

comply with FDA requirements regarding the reporting of adverse events associated with the use of our medical devices, as well as product

malfunctions that would likely cause or contribute to death or serious injury if the malfunction were to recur.

FDA regulations also

govern product labeling and prohibit a manufacturer from marketing a medical device for unapproved applications.

and promotion of medical devices, in addition to being regulated by the FDA, are also regulated by the FTC and by state regulatory and

enforcement authorities.

Recently, promotional activities for FDA-regulated products have been the subject of enforcement action brought

under health care reimbursement laws and consumer protection statutes.

Competitors and others can also initiate litigation relating to

advertising claims under the federal Lanham Act and similar state laws.

In general, if the FDA determines that our promotional materials

or training constitutes promotion of an unapproved or uncleared use, then it could request that we modify our training or promotional

materials or subject us to regulatory or enforcement actions.

It is also possible that other federal, state, or foreign enforcement authorities

might take action if they consider our promotional or training materials to constitute promotion of an unapproved or uncleared use, which

could result in significant fines or penalties under other statutory authorities, such as laws prohibiting false claims for reimbursement.

this time, we have one commercially approved medical device in the U.S., and we have filed for an Establishment Registration with the

If we are approved or cleared to manufacture, prepare, or process a device in the United States, we and any third-party manufacturers

that we may use will be required to register our establishments with the FDA.

In addition, our manufacturing facilities are subject to

FDA inspections for compliance with the FDA’s Quality System Regulation.

Additionally, some of our subcontractors are also subject

to FDA announced and unannounced inspections for compliance with the FDA’s Quality System Regulation and assurances that the Company

is marketing appropriately the indications for use of the product.

These regulations require that we manufacture our products and maintain

our documents in a prescribed manner with respect to design, manufacturing, testing and quality control activities and ensure that marketing

materials and promotion are in compliance.

As a medical device manufacturer, we are required to comply with FDA requirements regarding

the reporting of adverse events associated with the use of our medical devices, as well as product malfunctions that would likely cause

or contribute to death or serious injury if the malfunction were to recur.

FDA regulations also govern product labeling and prohibit

a manufacturer from marketing a medical device for unapproved applications.

FDA has broad regulatory compliance and enforcement powers.

If the FDA determines that a manufacturer has failed to comply with applicable

regulatory requirements, it can take a variety of compliance or enforcement actions, which may result in any of the following sanctions:

warning letters, untitled letters, fines, injunctions, consent decrees and civil penalties;

recalls, withdrawals, or administrative detention or seizure of our products;

operating restrictions or partial suspension or total shutdown of production;

refusing or delaying requests for PMA approvals of new products or modified products;

withdrawing PMA approvals that have already been granted;

refusal to grant export approvals for our products;

criminal prosecution.

states require medical device manufacturers, distributors, and retailers to obtain a license, permit or certification to manufacture,

distribute, or sell a medical device.

Additionally, many states also require that medical device manufacturers, distributors, and retailers

comply with manufacturing, labeling, packaging, sterilizing, distributing, and retailing requirements that are greater than those of

Failure by us or our manufacturing partners to comply with these licensing and regulatory requirements could have an adverse

effect on our business.

and Reimbursement

are many reimbursement programs through private payors as well as government programs.

In some countries, government reimbursement is

the predominant program available to patients and hospitals.

Our commercial success depends in part on the extent to which governmental

authorities, private health insurers and other third-party payors provide coverage for and establish adequate reimbursement levels for

the procedures during which our products are used.

Failure by physicians, hospitals, ambulatory surgery centers and other users of our

products to obtain sufficient coverage and reimbursement from third-party payors for our products, or adverse changes in government and

private third-party payors’ coverage and reimbursement policies could materially adversely affect our business, financial condition,

results of operations and prospects.

payors are moving toward a managed care system and control their health care costs by limiting authorizations for surgical procedures,

including procedures using our devices.

Although no uniform policy of coverage and reimbursement among payors in the United States exists

and coverage and reimbursement for procedures can differ significantly from payor to payor, reimbursement decisions by particular third-party

payors may depend upon a number of factors, including the payor’s determination that use of a product is:

a covered benefit under its health plan;

appropriate and medically necessary for the specific indication;

cost effective;

neither experimental nor investigational.

payors are increasingly auditing and challenging the prices charged for medical products and services with concern for upcoding, miscoding,

using inappropriate modifiers, or billing for inappropriate care settings.

Some third-party payors must approve coverage for new or innovative

devices or procedures before they will reimburse health care providers who use the products or therapies.

Even though a new product may

have been cleared for commercial distribution by the FDA, we may find limited demand for the product unless and until reimbursement approval

has been obtained from governmental and private third-party payors.

key component in ensuring whether the appropriate payment amount is received for physician and other services, including those procedures

using our products, is the existence of a common procedural terminology code, or CPT code, to describe the procedure in which the product

To receive payment, health care practitioners must submit claims to insurers using these codes for payment for medical services.

CPT codes are assigned, maintained and annually updated by the American Medical Association and its CPT Editorial Board.

If the CPT codes

that apply to the procedures performed using our products are changed or deleted, reimbursement for performances of these procedures

may be adversely affected.

the United States, some insured individuals enroll in managed care programs, which monitor and often require pre-approval of the services

that a member will receive.

Some managed care programs pay their providers on a per capita (or per patient) basis, which puts the providers

at financial risk for the services provided to their patients by paying these providers a predetermined payment per member per month

and, consequently, may limit the willingness of these providers to use our products.

believe the overall escalating cost of medical products and services being paid for by the government and private health insurance has

led to, and will continue to lead to, increased pressures on the health care and medical device industry to reduce the costs of products

and services.

For example, HHS began implementation in 2025 of “Most Favored Nation” drug pricing by setting the Medicare

price of single-source brand drugs without generic or biosimilar competition to the lowest price available in wealthy countries with

a per capita GDP of at least 60% of that in the United States.

All third-party reimbursement programs are developing increasingly sophisticated

methods of controlling health care costs through prospective reimbursement and capitation programs, group purchasing, redesign of benefits,

requiring second opinions before major surgery, careful review of bills, encouragement of healthier lifestyles and other preventative

services and exploration of more cost-effective methods of delivering health care.

addition to uncertainties surrounding coverage policies, there are periodic changes to reimbursement levels.

Third-party payors regularly

update reimbursement amounts and also from time to time revise the methodologies used to determine reimbursement amounts.

This includes

routine updates to payments to physicians, hospitals and ambulatory surgery centers for procedures during which our products are used.

For example, CMS issued a national coverage determination on October 11, 2023, finding that Medicare coverage for percutaneous transluminal

angioplasty of the carotid artery concurrent with stenting with an FDA-approved or -cleared device to be reasonable and necessary for

Medicare reimbursement.

These and other updates could directly impact the demand for our products.

Healthcare Laws and Regulations

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in whole or in part under a Federal health care program;

federal Physician Self-Referral Law or “Stark” law prohibits a physician (defined to include a doctor of medicine or

osteopathy, a doctor of dental surgery or dental medicine, a doctor of podiatric medicine, a doctor of optometry, or a chiropractor)

from referring Medicare and Medicaid patients to certain types of entities with which the physician or any of the physician’s

immediate family members have a financial relationship, unless an exception to the law’s prohibition is met;

false claims laws and civil monetary penalty laws, including the False Claims Act, prohibit, among other things, individuals or entities

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any materially false statements in connection with the delivery of or payment for healthcare benefits, items or services;

as amended by the Health Information Technology for Economic and Clinical Health Act of 2009, and its implementing regulations, including

privacy protection that impose obligations and requirements on healthcare providers, health plans, and healthcare clearinghouses

as well as their respective business associates that perform certain services for them that involve the use or disclosure of individually

identifiable health information, with respect to safeguarding the privacy and security of certain individually identifiable health

federal transparency requirements under the Affordable Care Act, including the provision commonly referred to as the Open Payments

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are reimbursable under Medicare, Medicaid or Children’s Health Insurance Program to report annually to Centers for Medicare

and Medicaid Services (“CMS”) information related to payments and other transfers of value to physicians and teaching hospitals,

and ownership and investment interests held by physicians and their immediate family members;

state and foreign laws and regulations, such as state anti-kickback and false claims laws, which may be broader in scope and apply

to referrals and items or services reimbursed by both governmental and non-governmental third-party payors, including private insurers,

many of which differ from each other in significant ways and often are not preempted by federal law, thus complicating compliance

and Medicaid Services (“CMS”) information related to payments and other transfers of value to physicians and teaching

hospitals, and ownership and investment interests held by physicians and their immediate family members;

state and foreign laws and regulations, such as state anti-kickback and false claims laws, as well as state transparency laws, which

may be broader in scope and apply to referrals and items or services reimbursed by both governmental and non-governmental third-party

payors, including private insurers, many of which differ from each other in significant ways and often are not preempted by federal

law, thus complicating compliance efforts.

for violation of any of the health care laws described above or any other governmental regulations that apply to us include, without

limitation, civil, criminal and/or administrative penalties, damages, fines, disgorgement, imprisonment, exclusion from participation

in government programs, such as Medicare and Medicaid, injunctions, refusal to allow us to enter into government contracts, contractual

damages, reputational harm, administrative burdens, diminished profits and future earnings, and the curtailment or restructuring of an

entity’s operations.

of the breadth of these laws and the narrowness of the statutory exceptions and safe harbors available, it is possible that some of our

future business activities could be subject to challenge under one or more of such laws.

Efforts to ensure that our business arrangements

with third parties will comply with applicable laws and regulations will involve substantial costs.

It is possible that governmental

authorities will conclude that our business practices may not comply with current or future statutes, regulations or case law involving

applicable fraud and abuse or other health care laws and regulations.

If our operations are found to be in violation of any of these

laws or any other governmental regulations that may apply to us, we may be subject to significant civil, criminal and administrative

penalties, damages, fines, exclusion from government funded health care programs, such as Medicare and Medicaid, and the curtailment

or restructuring of our operations.

If any of the physicians or other providers or entities with whom we expect to do business are found

to be not in compliance with applicable laws, they may be subject to criminal, civil or administrative sanctions, including exclusions

from government funded health care programs.

and Security of Health Information

federal and state laws protect the privacy and security of health information.

For example, HIPAA protects the privacy and security of

individually identifiable health information by limiting its use and disclosure.

Many states have implemented similar laws to limit the

use and disclosure of patient specific health information.

HIPAA transaction regulations establish form, format and data content requirements for most electronic healthcare transactions, such

as healthcare claims that are submitted electronically.

The HIPAA privacy regulations establish comprehensive requirements relating to

the use and disclosure of protected health information or PHI.

The HIPAA security regulations establish minimum standards for the protection

of PHI that is stored or transmitted electronically.

The HIPAA breach notification regulations establish the applicable requirements

for notifying individuals, the HHS, and the media in the event of a data breach affecting protected health information.

Violations of

the privacy, security and breach notification regulations are punishable by civil and criminal penalties.

American Recovery and Economic Reinvestment Act of 2009, or ARRA, increased the amount of civil monetary penalties that can be imposed

for violations of HIPAA, and the amounts are updated annually for inflation.

For 2026, penalties for HIPAA violations can range from

$145 to $2,190,294 per violation with a maximum fine of $2,190,294 for identical violations during a calendar year.

ARRA also authorized

state attorneys general to bring civil enforcement actions under HIPAA, and attorney generals are actively engaged in enforcement.

penalties could be in addition to other penalties assessed by a state for a breach which would be considered reportable under the state’s

data breach notification laws.

was enacted in conjunction with ARRA.

Among other things, HITECH makes business associates of covered entities directly liable for compliance

with certain HIPAA requirements, strengthens the limitations on the use and disclosure of protected health information without individual

authorizations, and adopts the additional enhancements, including enforcement of noncompliance with HIPAA due to willful neglect.

changes to HIPAA enacted as part of ARRA reflect a Congressional intent that HIPAA’s privacy and security provisions be more strictly

These changes have stimulated increased enforcement activity and enhanced the potential that healthcare providers and their

business associates will be subject to financial penalties for violations of HIPAA.

In addition, the Secretary of HHS is required to

perform periodic audits to ensure covered entities (and their business associates, as that term is defined under HIPAA) comply with the

applicable HIPAA requirements, increasing the likelihood that a HIPAA violation will result in an enforcement action.

addition to the federal HIPAA regulations, the FTC and many states have laws that regulate the collection, storage, use, retention, security,

disclosure, transfer and other processing of health information and other confidential, sensitive and personal data.

Certain of these

laws grant individual rights with respect to their information, and we may be required to expend significant resources to comply with

For example, various states, such as California and Washington, have implemented privacy laws and regulations, such as the

California Confidentiality of Medical Information Act, that impose restrictive requirements regulating the use and disclosure of personally

identifiable information.

These laws in many cases are more restrictive than, and may not be preempted by, the HIPAA rules and may be

subject to varying interpretations by courts and government agencies.

to the rapidly changing nature of these data privacy laws, there is not always clear guidance from the respective governments and regulators

regarding the interpretation of the law, which may create the risk of an inadvertent violation.

Efforts to comply with these and other

data privacy and security restrictions that may be enacted could require us to modify our data processing practices and policies and

to incorporate privacy by design into our products and services, as well as significantly increase the cost of our operations.

to comply with such restrictions could subject us to criminal and civil sanctions and other penalties.

In part due to the uncertainty

of the legal climate, complying with regulations, and any applicable rules or guidance from self-regulatory organizations relating to

privacy, data protection, information security, and consumer protection, may result in substantial costs and may necessitate changes

to our business practices, which may compromise our growth strategy, adversely affect our ability to attract or retain customers, and

otherwise adversely affect our business, financial condition, and operating results.

the United States, there have been and continue to be a number of significant legislative initiatives to contain healthcare costs.

January 2013, the American Taxpayer Relief Act of 2012 was signed into law, which, among other things, reduced Medicare payments to several

providers, and increased the statute of limitations period for the government to recover overpayments to providers from three to five

These laws may result in additional reductions in Medicare and other healthcare funding, which could have a material adverse effect

on customers for our drugs, if approved, and, accordingly, our financial operations.

recently there has been heightened governmental scrutiny over the way manufacturers set prices for their commercial products.

been several recent U.S.

Congressional inquiries and proposed and enacted federal and state legislation designed to, among other things,

bring more transparency to health care pricing, review the relationship between pricing and manufacturer patient programs, reduce the

cost of health care products under Medicare, and reform government program reimbursement methodologies.

On August 16, 2022, Congress

enacted the Inflation Reduction Act allowing CMS to negotiate directly with drug manufacturers to lower the price of some of the costliest

drugs under the Medicare program, as well as requiring drug manufacturers to provide Medicare with a rebate if the price of drugs increases

faster than the rate of inflation.

In 2025, HHS began implementation of “Most Favored Nation” drug pricing by setting the

Medicare price of single-source brand drugs without generic or biosimilar competition to the lowest price available in wealthy countries

with a per capita GDP of at least 60% of that in the United States.

At the state level, legislatures have increasingly passed legislation

and implemented regulations designed to control pharmaceutical and biological product pricing, including price or patient reimbursement

constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures, and, in some

cases, designed to encourage importation from other countries and bulk purchasing.

Although a number of these, and other proposed measures

may require authorization through additional legislation to become effective, Congress has indicated that it will continue to seek new

legislative measures to control drug costs.

Additionally,

CMS issued a final rule, effective on July 9, 2019, that requires direct-to-consumer advertisements of pharmaceutical and biological

products, for which payment is available through or under Medicare or Medicaid, to include in the advertisement the Wholesale Acquisition

Cost, or list price, of that pharmaceutical or biological product if it is equal to or greater than $35 for a monthly supply or usual

course of treatment.

September 9, 2025, the FDA began requiring pharmaceutical advertisements to include full safety warnings during direct-to-consumer advertisements,

instead of footnoting such information.

Additionally, the FDA expanded its oversight on social medial promotional activities, including

influencer partnerships, algorithm-driven targeted advertising, and AI-generated health content, to ensure compliance with the FDA’s

advertisement requirements.

The FDA has indicated it will begin enforcement actions for any advertisement violations.

adopted health reform measure could reduce the ultimate demand for our products, if approved, or put pressure on our product pricing.

Individual states in the United States have also become increasingly active in passing legislation and implementing regulations designed

to control pharmaceutical product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product

access and marketing cost disclosure and transparency measures, and, in some cases, designed to encourage importation from other countries

and bulk purchasing.

In addition, regional healthcare authorities and individual hospitals are increasingly using bidding procedures

to determine what pharmaceutical products and which suppliers will be included in their prescription drug and other healthcare programs.

We expect that additional state and federal healthcare reform measures will be adopted in the future.

expect that additional state and federal healthcare reform measures, as well as legal changes by foreign governments, will be adopted

in the future, any of which could limit the amounts that governments will pay for healthcare products and services, which could result

in reduced demand for our product candidates or additional pricing pressures.

customer base is varied.

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with distributors are generally for a term of two to three years.

potential PMA approval in the U.S., our direct sales organization will support a varied customer base of multiple interventional and

PMA approval in the U.S., our direct sales organization has built and supported a varied customer base of multiple interventional and

surgical specialties, to include interventional cardiologists, neurologists, neuroradiologists and radiologists, as well as both vascular

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and Suppliers

polymer fiber for MicroNet is supplied by Biogeneral, Inc., a San Diego, California-based specialty polymer manufacturer for medical

and engineering applications.

catheter supplier for CGuard EPS supplies us with catheters that help create the base for our CGuard EPS stents.

Our agreement with the

supplier may be terminated by us upon eight months’ notice.

On September 17, 2019, we amended the agreement with the supplier so

that we are responsible for purchasing and handling inventory of components used in the manufacturing of CGuard EPS catheters, and they

are responsible for the manufacturing process.

catheter supplier for CGuard Prime supplies us with catheters that help create the base for our CGuard Prime stent system.

Our agreement

with the supplier which may be terminated by us upon 9 months’ notice, calls for non-binding minimum orders.

currently manufacture our CGuard EPS and our CGuard Prime at our own facility.

The self-expanding bare-metal stents for our CGuard EPS

and our CGuard Prime are being manufactured and supplied by a third-party.

Our agreement with the supplier for the production of electro

polished nitinol bare-metal stents for CGuard EPS and CGuard Prime is priced on a per-stent basis, subject to the quantity of stents

The complete assembly process for CGuard EPS and CGuard Prime, including knitting and securing the sleeve to the stent and the

crimping of the sleeved stent into a delivery catheter, is done at our manufacturing site in Israel.

Once CGuard EPS and CGuard Prime

have been assembled, they are sent for sterilization in a third-party facility in Israel, and then back to our facility for final packaging

and distribution.

support our anticipated production growth following the anticipated commercialization of the CGuard Prime carotid stent system, we

have engaged Aptyx Interventional Systems(“Aptyx”) a contract manufacturer that is a developer and manufacturer of

complex components and devices for the life sciences, to transfer the manufacturing of CGuard Prime finished goods to full-scale

production at their ISO Class 7 cleanroom facility in North Carolina.

We previously engaged Medical Murray, another contract

manufacturer that specializes in medical device development, prior to Aptyx’s acquisition of Medical Murray’s ISO Class

7 cleanroom facility in North Carolina.

Aptyx specializes in complex catheter and implant manufacturing and is FDA-registered and

ISO 13485-certified.

The transfer includes setting up a production line, conducting process validations, and implementing quality

control measures to meet our specifications.

Aptyx will also conduct operator training, execute qualification builds, and validate

the sterilization process for the CGuard Prime device.

We expect this transition to enable increased production capacity to meet

future demand, with volume forecasts growing from 20,000 units annually to an estimated 50,000 units by 2027.

EPS and CGuard Prime consist of a CGuard stent and the delivery system.

Each CGuard stent is manufactured from two main components, a

self-expanding nickel-titanium stent and the PET polymer mesh.

The mesh is made from polyethylene terephthalate (PET).

We have patent

rights that cover the proposed CGuard stent with mesh.

During 2022 our mesh supplier informed us that they will not be able to supply

the polymer fiber in the future due to supply issues with the current PET resin, therefore we purchased inventory which should be sufficient

to support our production needs until the end of 2027.

We are currently testing a different source of PET showing equivalent mechanical

properties and biocompatibility of the original raw material.

BioGeneral will produce the fiber from the new PET:

some samples were already

produced with different PET resins for preliminary R&D testing.

Once the new resin will be chosen, complete validation process will

take up to 18 months.

The delivery system of CGuard consists of several sub-assemblies procured from original equipment manufacturers

and assembled in-house.

In the event that one of our suppliers can no longer supply one of the components, we would need to qualify another

supplier, which could take up to a year depending on the component and its criticality.

In addition, in order to retain the approval

of the CE mark, we are required to perform periodic audits of the quality control systems of our key suppliers in order to ensure that

their products meet our predetermined specifications.

polymer fiber used to produce the MicroNet mesh for CGuard EPS and CGuard Prime is supplied by a specialty polymer manufacturer.

mesh is made from PET.

During 2022, our supplier notified us of supply constraints related to its existing PET resin source.

We subsequently

purchased sufficient inventory to support expected production through early 2028 and identified a new PET resin source with equivalent

mechanical and biocompatibility properties.

Our supplier has produced initial samples using the new PET, and we are initiating the full

validation process, which is expected to take up to 18 months.

supplier of the CGuard EPS delivery system provides the core components that form the base of the delivery system used to deliver and

deploy the CGuard EPS stent during carotid artery procedures.

Under a 2019 amendment to our agreement, we purchase

and maintain inventory of certain components, and the supplier performs the manufacturing process.

Our delivery-system supplier for CGuard

Prime provides the base delivery systems for the CGuard Prime stent system;

this agreement includes non-binding minimum order commitments

and may be terminated by us upon nine months’ notice.

currently perform the assembly of both CGuard EPS and CGuard Prime at our facility in Israel.

Assembly includes knitting and securing

the MicroNet mesh to a self-expanding nitinol stent and crimping the sleeved stent into the delivery system.

The bare-metal nitinol stents

used in both products are supplied by a third-party manufacturer under a per-unit pricing arrangement.

After assembly, the stent systems

are sterilized at a third-party facility in Israel and returned to our facility for final packaging and distribution.

support expected future demand for CGuard Prime in the United States, we have engaged Aptyx Interventional Systems (“Aptyx”),

an FDA-registered and ISO 13485-certified contract manufacturer, to transfer the production of finished CGuard Prime devices to their

ISO Class 7 cleanroom facility in North Carolina.

This transfer includes establishment of production lines, process and sterilization

validations, operator training, and qualification builds.

We expect this transition to significantly expand our annual production capacity

from approximately 20,000 units in 2025 to an estimated 50,000 units by 2027.

rely on key parts suppliers for major components of CGuard EPS and CGuard Prime, including the self-expanding nitinol stent, the MicroNet

mesh sleeve, and the subassemblies that make up the deployment systems for each product.

If a supplier becomes unable to provide a critical

component, qualifying an alternative supplier may take up to one year depending on component complexity.

To maintain CE Mark approval,

we conduct periodic audits of key suppliers to ensure compliance with applicable quality-system and performance requirements.

Capital Management

of December 31, 2024, we had 86 employees, 85 full-time and one part-time, consisting of six in executive management, six in research

and development, nine in quality assurance and compliance, seven in finance and accounting, 34 in operations/production, 14 in commercial

(including sales and marketing), three in clinical and seven in human resources, IT and administration.

Except for four of our employees

in Europe, our employees are not party to any collective bargaining agreements.

We do not expect the collective bargaining agreements

to which our employees are party to have a material effect on our business or results of operations.

We also employ 1 independent contractor

of December 31, 2025, we had 127 full-time employees.

Of our 127 total employees, 5 serve as executive management while also functioning

as heads of professional departments, and are therefore reflected within the following departmental breakdown:

8 employees in research

and development, 17 in quality assurance and compliance, 10 in finance and accounting, 36 in operations/production, 42 in commercial

(including sales and marketing), 2 in clinical and 12 in human resources, IT and administration.

for 4 of our employees in Europe, our employees are not party to any collective bargaining agreements.

We do not expect the collective

bargaining agreements to which our employees are party to have a material effect on our business or results of operations.

We also employ

3 independent contractors.

believe that our future success will depend, in part, on our continued ability to attract, hire, and retain qualified personnel.

10 unchanged sentences

consider our relations with our employees to be good.

maintain a corporate website at http://www.inspiremd.com.

The information contained on, or that can be accessed through, our website

is neither a part of nor incorporated into this Annual Report on Form 10-K.

of our reports on Forms 10-K, Forms 10-Q and Forms 8-K, may be obtained, free of charge, electronically through our corporate website

at http://www.inspiremd.com as soon as reasonably practicable after we file such material electronically with, or furnish to, the SEC.

Additionally, the SEC maintains an Internet site that contains reports, proxy and information statements, and other information regarding

issuers that file electronically with the SEC at www.sec.gov.

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1. Business