NASDAQ: NSPR

In
October 2023, the Centers for Medicare & Medicaid Services (“CMS”) issued its final National Coverage Determination (“NCD”),
expanding coverage for both carotid artery stenting (“CAS”) and TCAR procedures to include both asymptomatic and standard
risk patients, significantly expanding and supporting the future growth of the U.S. addressable market for CAS.

In
November 2025, the results of the CREST-2 study were released, which showed that CAS combined with medical therapy demonstrated a significantly
lower stroke risk as compared to intensive medical management alone in patients with severe asymptomatic carotid stenosis. CREST-2 was
an independent study sponsored by the National Institute of Health (NIH) with a set of two parallel, observer-blinded clinical trials
across 155 centers globally. CREST-2 showed that, among patients with high-grade carotid stenosis without recent neurological symptoms,
the addition of stenting led to significantly better outcomes than intensive medical management alone, as measured by a decreased risk
of the composite of perioperative stroke or death or ipsilateral stroke within four years. In a separate arm of the same trial, carotid
endarterectomy (“CEA”) did not achieve a significant benefit for these patients as compared to intensive medical management
alone.

We
continue to invest in new product generations and potential new clinical indications for the CGuard platform with a strategy of focusing
on advancing a “stent-first” approach to carotid revascularization. As part of this strategy, we are evaluating CGuard Prime
in TCAR-based clinical programs, including the CGUARDIANS II pivotal trial, which studies the use of the CGuard Prime 80 cm carotid
stent system in conjunction with an established neuroprotection device, and the CGUARDIANS III pivotal trial, which evaluates our proprietary
SwitchGuard neuroprotection system (“SwitchGuard NPS”) paired with CGuard Prime to enable flow-reversal neuroprotection during
TCAR. In parallel, we are pursuing new clinical applications outside TCAR, including the treatment of acute ischemic stroke with tandem
lesions, which is currently being studied in an early feasibility study conducted with the Jacobs Institute. In this acute-stroke setting,
the flexible, low-metal-burden design and MicroNet mesh of CGuard Prime may offer advantages where traditional embolic-protection devices
cannot be used.

5

We
consider our current addressable market for our CGuard EPS, CGuard Prime, and SwitchGuard NPS to be both symptomatic and asymptomatic
individuals with diagnosed high-grade carotid artery stenosis for whom intervention is preferable to medical (drug) therapy. This group
includes not only patients eligible for either CAS or TCAR procedures, but also individuals who are candidates for CEA, as all three
approaches can be options to treat these patients. Assuming full penetration of the intervention caseload, we estimate that the addressable
market for CGuard EPS, CGuard Prime, and SwitchGuard NPS is approximately $1.3 billion (source: Health Research International Personal
Medical Systems, Inc. September 13, 2021 Results of Update Report on Global Carotid Stenting Procedures and Markets by Major Geography
and Addressable Markets and internal estimates). According to this same report and internal estimates, assuming full penetration of treatment
for all individuals diagnosed with high-grade carotid artery stenosis, we estimate the total available market for CGuard EPS, CGuard
Prime, and SwitchGuard NPS to be approximately $9.3 billion, which may grow over time if expanded treatment options such as our products
lead to increased patient screening for carotid artery disease.

We
were organized in the State of Delaware on February 29, 2008. In October 2024, we established our global headquarters in Miami, Florida
to support the U.S. launch and commercialization of CGuard Prime.

Business
Strategy

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

●Drive
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. With
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.

●Leverage
clinical differentiation: Our proprietary MicroNet mesh technology is designed to
reduce plaque prolapse and embolic events, delivering strong periprocedural and long-term
outcomes. 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
stent data. We intend to continue generating and publishing clinical evidence to support
broader adoption, guideline inclusion, and physician confidence.

●Expand
U.S. 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.

●Broaden
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. By offering
a comprehensive procedural toolkit, we aim to deepen relationships with physicians and participate
more fully across the carotid intervention continuum.

●Grow
international presence: We currently commercialize CGuard in more than 30 countries
and maintain meaningful market share outside the United States. Following U.S. approval,
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.

●Protect
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.

6

Our
Industry

Carotid
Arteries

Carotid
arteries are located on each side of the neck and provide the primary blood supply to the brain. Carotid artery disease, also called
carotid artery stenosis, is a type of atherosclerosis (hardening of the arteries) that is one of the major risk factors for ischemic
stroke. In carotid artery disease, plaque accumulates in the artery walls, narrowing the artery and disrupting the blood supply to the
brain. This disruption in blood supply, together with plaque debris breaking off the artery walls and traveling to the brain, are significant
causes of stroke. According to the World Health Organization, every year, 15 million people worldwide suffer a stroke, and nearly six
million die and another five million are left permanently disabled. According to the same source, stroke is the second leading cause
of disability, after dementia.

In
2022, three million people between the age of 50 and 89 years old were estimated to be diagnosed with high grade carotid artery disease,
of which, approximately 394,000 of those received intervention, according to a September 2021 report from Health Research International
Personal Medical Systems, Inc. entitled Update Report on Global Carotid Stenting Procedures and Markets by Major Geography and Addressable
Markets.

There
are three current interventional treatments used to treat carotid artery disease. The first is CEA, in which a surgeon accesses the blocked
carotid artery though an incision in the neck and then surgically removes the plaque. The second treatment is TCAR, a minimally invasive
procedure in which a surgeon places a stent in the blocked carotid artery though a small incision in the neck while temporarily reversing
blood flow to protect the brain from stroke during the procedure. The third treatment is CAS, a minimally invasive procedure in which
a surgeon places a stent in the blocked carotid artery through access of the femoral, radial, or brachial arteries. We believe that the
availability of minimally invasive treatment options like TCAR and CAS should increase the number of patients being treated since they
avoid the need for complex surgery.

Our
Products

MicroNet
Mesh Platform Technology

MicroNet
is our proprietary biocompatible polymer mesh material woven from a single strand of 23 μm polyethylene terephthalate (“PET”),
a material widely used in medical implants. We apply the sleeve to our proprietary self-expanding stent to provide additional protection
to patients from plaque prolapse and embolization following deployment of the stent in the patient’s artery. The size, or aperture,
of the MicroNet “pore” is only 150-180 microns, designed to maximize protection against the release of potentially dangerous
plaque and thrombus by significantly limiting the size of any embolic debris that can dislodge from the diseased carotid artery and pass
through the MicroNet mesh. The MicroNet mesh is the core technology around which we have developed our proprietary CGuard carotid stent
technology.

CGuard
EPS – Carotid Artery Applications

Our
CGuard EPS combines our MicroNet mesh and a self- expanding nitinol stent (a stent that expands without balloon dilation pressure or
need of an inflation balloon) in a single device for use in carotid artery applications. MicroNet is placed over and attached to the
outside of an open cell nitinol stent, forming a highly flexible implant that conforms to the carotid anatomy designed to trap debris
and emboli that can dislodge from the diseased carotid artery and potentially travel to the brain and cause a stroke. This danger is
one of the greatest limitations of carotid artery stenting with conventional, non-mesh covered carotid stents.

We
believe that our CGuard EPS design provides advantages over existing therapies in treating carotid artery stenosis, such as conventional
carotid stenting and surgical CEA, given the superior embolic prevention characteristics provided by the MicroNet. We believe the MicroNet
provides acute embolic protection at the time of the procedure, but more importantly, provides post-procedure protection against embolic
dislodgement. According to an article published in the Journal of American College of Cardiology Cardiovascular Interventions entitled
Late cerebral embolization after emboli-protected carotid artery stenting assessed by sequential diffusion-weighted magnetic resonance
imaging, it is in this post-procedure time frame that embolization is the source of post-procedural strokes in the brain, which have
shown that the majority of the incidents of embolic showers associated with carotid stenting occur post-procedure.

7

Our
CGuard EPS originally received CE mark approval in the EU in March 2013 and was fully launched in Europe in September 2015. Subsequently,
we launched CGuard EPS in over 30 countries through a network of distributors. In January 2024, we received CE mark recertification under
the EU’s MDR regulatory framework.

CGuard
Prime Stent System

Our
CGuard Prime also combines our MicroNet mesh and a self-expanding nitinol stent, but with a differentiated deployment system as compared
to the CGuard EPS. The CGuard Prime Carotid Stent is available in diameters ranging from 6mm to 10mm and in lengths of 20, 30, 40 and
60mm. The CGuard Prime delivery system is a rapid exchange (Rx), delivery system with a 6Fr profile that can accommodate all stent sizes
from 6mm to 10mm. In the U.S., PMA approval was received for stent sizes in 8-, 9- and 10-mm diameters with lengths of 30 and 40 mm.

CGuard
Prime advances the first generation CGuard transfemoral delivery system with a new handle design for ease of deployment and a new catheter
design for more flexible navigation of tortuous anatomy. The CGuard Prime product was used in 32 patients out of 316 patients in the
C-GUARDIANS study, since April 2023. In October 2024, the FDA approved the Company’s IDE to initiate the CGUARDIANS II study of
its CGuard Prime 80 cm carotid stent system for use in TCAR procedures. In the first quarter of 2026, we completed enrollment in the CGUARDIANS II pivotal study.

On
June 23, 2025, the FDA approved our PMA for CGuard Prime. The approval was supported by data from our C-GUARDIANS pivotal trial, a prospective
multicenter study that enrolled 316 patients in the U.S. and Europe . The trial demonstrated low rates of death, stroke, and myocardial
infarction at 30 days (0.95%) and low rates of 30-day DSMI or ipsilateral stroke through one year (1.93%). For additional information,
see “Item 1 – Business – Completed Clinical Trials for CGuard EPS – C-GUARDIANS.”

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

SwitchGuard
NPS

SwitchGuard
NPS is a Class II neuroprotection system (“NPS”) that we have developed and that is subject to regulatory approval, composed
of medical grade tubing with male Luer lock connectors at each end and an in-line 200-micron blood filter. When connected to the included
arterial and venous sheaths, the system is intended as an external arterial-venous (A-V) shunt, allowing arterial blood to flow into
the venous system, while filtering particulate before returning blood to the patient on the venous side.

SwitchGuard
NPS is being developed to provide flow reversal for cerebral protection in carotid interventions utilizing the TCAR procedure since symptomatic
distal embolization, caused by the release of material (thrombotic, necrotic, or atherosclerotic) from the site of the lesion during
the intervention, is the most frequent and important complication of CAS. Reversing blood flow has been shown to reduce stroke risk during
carotid artery procedures.

We
submitted an IDE to the FDA for the C-GUARDIANS III clinical trial in December 2024, which was approved in June 2025. This approval allows
us to initiate a clinical trial to support the clearance of the SwitchGuard NPS coupled with CGuard Prime.

Acute
Stroke with Tandem Lesions

It
is estimated that 20-30% of acute ischemic strokes that are caused by large vessel occlusion involve tandem lesions- high grade stenosis/occlusion
of the internal carotid artery plus thrombotic occlusion of an intracranial vessel. Currently there is no indicated use of CAS for these
lesions during stroke treatment when the placement of an embolic protection device is not possible. We believe CGuard Prime is optimally
suited for intervention in this acute setting by its design (flexible / low metal structure) as well as MicroNet mesh offering embolic
protection both during and post procedure. Our goal is to develop CGuard Prime to mitigate strokes in this acute setting.

8

In
November 2023, we announced a strategic agreement with Jacobs Institute to execute an early feasibility study of CGuard Prime for the
treatment of acute stroke patients with tandem lesions. The study is expected to enroll 15 acute stroke patients across three U.S. sites
to explore the safety and feasibility of using CGuard Prime in this setting.

Completed
Clinical Trials for CGuard EPS

CARENET

The
CARENET trial was the first multi-center study of CGuard EPS following the receipt of CE mark of this device in March 2013. The CARENET
trial was designed to evaluate feasibility and safety of CGuard EPS in treatment of carotid lesions in consecutive patients suitable
for CAS in a multi-operator, real-life setting. The acute, 30-day, magnetic resonance imaging (“MRI”), ultrasound and six-month
clinical event results were presented at the LINC conference in Leipzig, Germany in February 2015. In the third quarter of 2015, the
results of the CGuard CARENET trial were published in the Journal of the American College of Cardiology. In November 2015, positive twelve-month
follow-up data from the CGuard CARENET trial was presented at the 42nd Annual Symposium on Vascular and Endovascular Issues, documenting
the benefits of the CGuard MicroNet technology as well as the patency benefits (maintaining the artery open) of the internal and external
carotid arteries at twelve months. In September 2022, the results of the CGuard CARENET trial five year follow up were published in the
Journal of the American College of Cardiology: Cardiovascular Interventions Vol. 15, No 18, 2022 September 26, 2022:1883-1891. There
was no ipsilateral stroke or ipsilateral stroke-related death which occurred throughout the five years. In addition, no stent restenosis
or external carotid artery occlusion occurred in CARENET within five years, indicating normal healing and uncompromised side-branch patency.

MACCE
(myocardial infarction (“MI”), stroke or death) rate was 0.0% at 30 days. At six months, there was one death, which was not
device or procedure-related but did result in a MACCE rate of 3.6% at six months. At twelve months there were two additional deaths,
which were not device or procedure-related resulting in a MACCE rate of 10.7% at one year.

30 days

(n=30)

6 months

(n=28)

12 months

(n=28)

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

MI
(0) 0.0%
(0) 0.0%
(0) 0.0%

stroke
(0) 0.0%
(0) 0.0%
(0) 0.0%

death
(0) 0.0%
(1) 3.6%
(3) 10.7%

CAS
carries the risk of cerebral embolization during and following the procedure, leading to life-threatening complications, mainly cerebral
ischemic events. Diffusion-weighted magnetic resonance imaging (DW-MRI) is a sensitive tool used to identify cerebral emboli during CAS
by measuring “lesions” within the brain which are areas that are ischemic and do not receive oxygenated blood due to cerebral
emboli. In the CARENET trial, 37.0% of patients treated with CGuard EPS had new ischemic lesions at 48 hours after the procedure, with
an average volume of 0.039 cm3. Of these lesions, there was only one that remained at 30 days following the procedure and all others
had resolved. Complete details appear in the following table. Where there is a second number shown below after a ± symbol, it
indicates the potential error in the measurement.

48 hours

n=27

30 days

n=26

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

Incidence of new lesions
37.0%
4.0%

Total number new AIL
83
1

Avg. number new AIL per patient
3.19 ± 10.33
0.04 ± 0.20

Average lesion volume (cm3)
0.039 ± 0.08
0.08 ± 0.00

Maximum lesion volume (cm3)
0.445
0.116

Permanent AIL at 30 days
—
1

9

The
healing process of the tissue and in-stent restenosis can be measured by a non-invasive form of ultrasound called duplex ultrasound.
This type of ultrasound measures the velocity of the blood that flows within the carotid arteries, which increases exponentially as the
lumen of the internal carotid artery narrows and the percent stenosis increases. One of the measurements is called PSV (peak systolic
velocity) and is known to be highly correlated to the degree of in-stent restenosis; PSV values higher than 300 cm/sec are indicative
of >70% stenosis, while PSV values lower than 104 cm/sec are indicative of <30% restenosis and healthy healing. In the CARENET
trial, duplex ultrasound measurements done at 30 days, 6 months and 12 months following the stenting procedure all attest to healthy
normal healing without restenosis concerns, as the PSV values were 60.96 cm/sec ± 22.31, 85.24 cm/sec ± 39.56, and 90.22
cm/sec ± 37.72 respectively. The internal carotid artery was patent in all patients (100%).

The
conclusions of the CARENET trial were:

●
The
CARENET trial demonstrated safety of the CGuard EPS stent, with a 30-day MACCE rate of 0%;

●
Incidence
of new ipsilateral lesions (percent of patients with new lesions on the ipsilateral side (same side where the stent was employed))
at 48 hours was reduced by almost half compared to published data, and volume was reduced almost tenfold;

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

●
Twelve-month
data showed no stroke or stroke-related deaths, and no cardiac adverse events;

●
Five-year
data showed no ipsilateral stroke or ipsilateral stroke-related deaths, and no stent restenosis or external carotid artery occlusion
occurred in CARENET by 5 years, indicating normal healing and uncompromised side-branch patency; and

●
CGuard
EPS offers enhanced benefits for patients undergoing CAS with unprecedented safety.

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

PARADIGM-101
(Prospective evaluation of All-comer peRcutaneous cArotiD revascularization
In symptomatic and increased-risk asymptomatic carotid artery stenosis, using CGuard Mesh-covered
embolic prevention stent system-101) was an investigator-led, single center study with the objective of evaluating feasibility and outcome
of routine use of CGuard EPS in 101 consecutive unselected all-comer patients referred for carotid revascularization, initiated in 2015.
In May 2016, the 30-day results were presented at the EuroPCR 2016 Late-Breaking Clinical Trial Session in Paris, and in the Journal
of EuroIntervention. In Dec 2020, the 12-month results were presented in the Official Journal of the EuroPCR and the European Association
of Percutaneous Coronary Interventions, EuroIntervention 2020;16:e950-e952. DOI: 10.4244/EIJ-D-19-01014) Key findings from the PARADIGM-101
study and the follow-up data are as follows:

●
CGuard
EPS delivery success was 99.1%. The clinical evaluation also found no device foreshortening or elongation;

●
Angiographic
diameter stenosis or vessel narrowing was reduced from 83±9% to only 6.7±5% (p<0.001);

●
Periprocedural
death/major stroke/ myocardial infarction (“MI”) rates were 0%; and

●
Between
30 days and 12 months, there were no strokes or stroke-related deaths. There were four non -device related deaths (heart failure
exacerbation, urosepsis, pulmonary embolism and microcellular pulmonary cancer).

The
results of the PARADIGM-101 study demonstrated that CGuard EPS can safely be used in a high risk, all-comer population of patients with
carotid artery stenosis and indicated that routine use of CGuard EPS may prevent cerebral events, such as strokes, by holding plaque
against the vessel wall, preventing emboli from being released into the blood stream. The PARADIGM-101 study found that CGuard EPS is
applicable in up to 90% of all-comer patients with carotid stenosis.

10

PARADIGM-500
(Prospective evaluation of All-comer peRcutaneous cArotiD revascularization
In symptomatic and increased-risk asymptomatic carotid artery stenosis, using CGuard Mesh-covered
embolic prevention stent system-500) is an investigator-initiated, single center study designed to evaluate the outcomes of routine CGuard
EPS in consecutive all-comer patients accepted by a multidisciplinary committee for carotid revascularisation. The PARADIGM-500 study
is an extension of the PARADIGM-101 study, which was initiated in 2015.

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

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

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

●
12-month
freedom from ipsilateral stroke, in stent restenosis (ISR) and target lesion revascularization (TLR) combined rate of 99.6%;

●
At
12-month, the ISR rate (by Core Lab) is lower than those reported in the literature of first-generation stents (Naylor R, et al.
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. 2023);and

●
No
cases of stent thrombosis (0%) with CGuard EPS through 12 months of follow up

The
Paradigm-500 study confirms that CAS with the CGuard EPS stent delivers reliable and low rates of 30-day composite DSMI, 12-month ipsilateral
stroke, ISR and no instances of stent thrombosis in a wide range of patients at standard and high risk for CEA.

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

“Clinical
Results and Mechanical Properties of the Carotid CGUARD Double-Layered Embolic Prevention Stent Study” was an investigator-led,
prospective single-center study which evaluated CGuard EPS in 30 consecutive patients with internal carotid artery stenosis disease with
the objective of reporting early clinical outcomes with a novel MicroNet covered stent for the internal carotid artery and the in vitro
investigation of the device’s mechanical properties. In October 2016, the 30-day positive results were published online-ahead-of-print
in the Journal of Endovascular Therapy.

Key
findings from the study were as follows:

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

●
No
peri- or post-procedural complications;

●
No
deaths, major adverse events, minor or major strokes, or new neurologic symptoms during the six months following the procedure;

●
Modified
Rankin Scale improved for the symptomatic patients from 1.56 prior to the procedure to 0 afterwards;

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

●
DW-MRI
performed in 19 of 30 patients found no new ipsilateral lesions after 30 days and after six months compared with the baseline DW-MRI
studies.

Additionally,
based on engineering evaluations, the study concluded that CGuard EPS provides a high radial force and strong support in stenotic lesions.
The stent is easy to use and safe to implant because it does not foreshorten and its structure adapts well to changes in diameter and
direction of tortuous vascular anatomies. The MicroNet mesh did not cause any changes to specific mechanical parameters of the underlying
stent.

11

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

“Safety
and Efficacy of the New Micromesh-Covered Stent CGuard in Patients Undergoing Carotid Artery Stenting: Early Experience From a Single
Center” was an investigator-led, single-center study which evaluated CGuard EPS in 82 consecutive patients. The aim of the study
was to evaluate the safety (technical success) and efficacy (clinical success) of the CGuard stent system – a new nitinol stent
covered by a closed-cell polyethylene and terephthalate mesh designed to prevent embolic events. In 2017, the 30-day positive results
were published online-ahead-of-print in the European Journal of Vascular and Endovascular Surgery (2017), https://doi.org/10.1016/j.ejvs.2017.09.015.

Key
findings from the study were as follows:

●
100%
success in implanting CGuard EPS;

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

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

●
No
new adverse neurological events were recorded at the post-operative period;and

●
DW-MRI
was performed to assess the occurrence of new ischaemic brain lesions from the target vessel following placement of the CGuard stent
peri- (48-72 hours) and post-operatively (30 days) in 21 and 11 patients, respectively. Five of 21 patients (23.8%) had new ischaemic
brain lesions peri-operatively (48-72 hours) on the ipsilateral side, for a total number of 30 lesions, with an average lesion volume
of 0.039 +/- 0.025 cm3. Four patients (19.1%) had new ischaemic brain lesions on the contralateral side, for a total number of nine
lesions, with an average lesion volume of 0.019 +/- 0.011 cm3 (range 0.016-0.034 cm3). At the postoperative period, spontaneous resolution
was noted in all the lesions recorded in the peri-operative period in the 11 patients participating. Only one symptomatic patient
had two new ischaemic brain lesions (1 ipsilateral and 1 contralateral).

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

“CGUARD
Mesh-Covered Stent in Real World: The IRON-Guard Registry using CGuard EPS” was a physician initiated prospective multi-center
registry that included 200 patients from 12 medical centers in Italy. The objective of the study was to report 30-day outcomes (including
MACCE) in a prospective series of patients who were treated with CGuard EPS between April 2015 and June 2016. In January 2017, 30-day
results were presented at the Leipzig Interventional Course (LINC) 2017 and published in the Journal of EuroIntervention in May 2017.
The 12-month follow-up was published in the Journal of EuroIntevention in October 2018.

Key
30-day results presented were:

●
100%
success in implanting CGuard EPS;

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

●
There
were two transient ischemic attacks and five periprocedural minor strokes, including one thrombosis solved by surgery;

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

●
DW-MRI
performed pre-procedure and between 24- and 72-hours post-procedure in 61 patients, indicated that 12 patients had new micro emboli
(19%);

12

●
At
12-month, there were no new major neurological adverse events, thrombosis or external carotid occlusion recorded; and

●
One
myocardial infarction occurred at 12 months.

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

“Initial
Clinical Study of the New CGuard EPS MicroNet Covered Carotid Stent: ‘One Size Fits All’” was an investigator-led,
single-center study, which evaluated CGuard EPS in 30 consecutive patients with symptomatic stenosis of the internal carotid artery with
the objective of evaluating the CGuard EPS MicroNet-covered stent for its ability to adjust to different vessel diameters. The results
of the study were published in the Journal of Endovascular Therapy in May 2019. The conclusion of the study as reported was that CGuard
EPS has high conformability combined with an almost equivalent outward radial force at expansion diameters ranging from 5.5 to 9.0 mm.
The first clinical results demonstrate the “One Size Fits All” stent can be implanted in internal carotid arteries with reference
diameters within this range.

Key
findings from the study were as follows:

●
100%
technical success in implanting CGuard EPS;

●
No
neurological events within 30 days;

●
The
chronic outward force normalized by stent length demonstrated a near-equivalent radial force outcome; and

●
The
stent displayed only a minor difference between the minimal radial force at 9.0 mm (0.195 N/mm) and the maximal radial force at 5.5
mm (0.330 N/mm).

Preliminary
Results from a Prospective Real-World Multicenter Clinical Practice of Carotid Artery Stenting Using the CGuard Embolic Prevention System:
The IRONGUARD 2 Study

“Preliminary
Results From a Prospective Real-World Multicenter Clinical Practice of Carotid Artery Stenting Using the CGuard Embolic Prevention System:
The IRONGUARD 2 Study” is a physician initiated prospective multi-center registry enrolling 733 patients from 20 medical centers
in Italy, from January 2017 to June 2019. The objective of the study is to evaluate periprocedural (24 hours), post-procedural (up to
30 days), and 12-month outcomes in a largest, prospective, multicenter series of patients submitted for protected carotid artery stenting
with the CGuard EPS. The 24-hour, 30-day and 12-month preliminary results (data available on 726 patients out of the 733 treated) were
presented at the Leipzig Interventional Course (LINC) in January 2021. The study’s preliminary results from the IRONGUAURD 2 study
suggested in a real-world evaluation of carotid artery stenting, CGuard EPS can be safely used for treatment of extracranial carotid
artery stenosis, allowing a low rate of post procedural adverse events by 12 months.

Key
findings from the study were as follows:

●
100%
procedural success in implanting CGuard EPS;

●
1
death from hemorrhagic stroke (patient was admitted for immediate treatment of CAS due to stroke), 2 minor strokes, 6 TIAs and one
nonfatal AMI at 24 hours;

●
1
minor stroke, 2 TIAs, three AMIs, no deaths and no stent thrombosis/occlusions between 24 hours and 30 days; and

●
1
minor stroke, 4 TIAs, 2 AMIs and 8 deaths (the 2 mentioned AMIs, 4 malignancies, 1 suicide and 1 undefined complication in Guillain-Barré
Syndrome) between 30 days and 1 year.

13

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

“Thirty-Day
Results of the Novel CGuard-Covered Stent in Patients Undergoing Carotid Artery Stenting” was an investigator-led, prospective
single-center study which evaluated CGuard EPS in 103 patients that underwent carotid artery stenting procedures. The aim of the study
was to provide early-term evaluation, safety, and efficacy of the novel CGuard micromesh self-expanding stent with embolic protection
system (EPS). In April 2021, the 30-day positive results were published in the Journal of Endovascular Therapy, DOI: 10.1177/15266028211007466.

Key
findings from the study were as follows:

●
100%
technical success was achieved in all patients:

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

The
SIBERIA Trial for Carotid Artery Stenosis: A Randomized Controlled Trial of Conventional Versus Micronet-Covered Stent Use in Percutaneous
Neuroprotected Carotid Artery Revascularization: Peri-procedural and 30-day Diffusion-Weighted Magnetic Resonance Imaging and Clinical
Outcomes (RCT trial)

“The
SIBERIA Trial for Carotid Artery Stenosis: A Randomized Controlled Trial of Conventional Versus Micronet-Covered Stent Use in Percutaneous
Neuroprotected Carotid Artery Revascularization: Peri-procedural and 30-day Diffusion-Weighted Magnetic Resonance Imaging and Clinical
Outcomes” was an investigator-initiated randomized clinical trial, single-center study, which evaluated one hundred patients who
qualified for carotid revascularization with high risk for surgery and were randomized 1:1 to either CGuard EPS or AcculinkTM.
The primary endpoints were incidence and volume of new cerebral embolic post-procedural lesions (24-48 hours) as determined by diffusion
weighted magnetic resonance imaging (DW-MRI). The principal secondary endpoints included incidence of periprocedural or postprocedural
stroke, myocardial infarction and death at 30 days. The 30-day results of the study were presented in a late-breaking session at the
EuroPCR in June 2020 and published (Randomized Controlled Trial of Conventional Versus MicroNet-Covered Stent in Carotid Artery Revascularization,
JACC Cardiovascular Interventions, Vol. 14, November 21, 2021). The conclusion of the study was that the use of CGuard EPS in consecutive
unselected patients subjected to neuroprotected carotid artery stenting was associated with a greater than three-fold reduction in the
procedure-generated mean cerebral lesion volume, and with zero post-procedural cerebral embolisms observed. The MicroNet covered stent
significantly reduced periprocedural and abolished post procedural cerebral embolism in relation to a conventional carotid stent. This
is consistent with the MicroNet covered stent’s sustained embolism prevention, translating into cerebral protection not only during
but after carotid artery stenting. The incidence of restenosis and vessel occlusion according to the ICA (internal carotid artery) ultrasound
and the incidence of strokes, myocardial infarctions or deaths between the study arms at 365 days were presented at the LINC conference
in Leipzig, Germany in June, 2022. The 12-month outcomes demonstrated a significantly higher prevalence of the combined endpoint of death,
stroke or myocardial infarctions and in-stent restenosis and vessel occlusion rate in the first generation (single layer) carotid stent,
AcculinkTM, versus the MicroNet-Covered Stent, CGuard.

Key
findings from the study were as follows:

●
Peri
Procedure, the CGuard arm was observed to have a 57% reduction in new cerebral lesion average volume per patient (171 mm3 vs.
73 mm3), a statistically significant improvement (p=0.017) and 222 mm3 vs. 84 mm3 (p=0.038);

●
Post
Procedure (24-48 hours), the CGuard arm was observed to have a 78% reduction in the average volume of new cerebral lesions (157 mm3
vs. 700 mm3), a statistically significant improvement (p=0.007);

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

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

14

●
At
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; and

●
At
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).

C-GUARDIANS

C-GUARDIANS
was a multicenter, single-arm, pivotal study to evaluate the safety and efficacy of the CGuard carotid stent system when used to treat
symptomatic and asymptomatic carotid artery stenosis in patients undergoing carotid artery stenting.

The
study completed enrollment in June 2023. The primary endpoint was a composite of: (1) incidence of major adverse events including Death
(all-cause mortality), any Stroke, and Myocardial Infarction (DSMI) through 30-days post index procedure, or (2) ipsilateral stroke from
day 31 to day 365 post-procedure. All events were adjudicated by an independent clinical events committee. The composite index was compared
to a performance goal based on the observed rate of the two components of the primary endpoint from previous pivotal stent trials which
were considered industry standard. The performance goal was considered met if the upper bound of the two-sided 95% confidence interval
calculated from the observed primary endpoint rate is < 11.6% and the p-value is less than 0.025.

From
July 2021 to June 2023, 316 patients were prospectively enrolled at 24 sites in the US and the EU and from April 2023 included deployment
of the CGuard stent using CGuard Prime. All CAS procedures were performed utilizing the CGuard MicroNet mesh covered stent and cleared
intra-procedural cerebral protection distal embolic filters or proximal embolic protection with flow cessation, or both. At 30 days,
the hierarchical DSMI rate was 0.95% in the intent to treat (ITT) analysis and 0.63% in the per- protocol (PP) analysis. Three patients
experienced major adverse cardiovascular events by 30-days: one patient who did not take dual antiplatelet therapy (protocol violation)
had a major stroke and died and two other patients had a stroke. There was no myocardial infarction (MI). These results support a potential
“neuroprotective” effect of the CGuard stent from the procedure to 30 days follow-up.

On
May 28, 2024, we announced positive one-year follow up results from the C-GUARDIANS trial of the CGuard carotid stent system in which
stenting with the CGuard carotid stent system in patients with carotid artery stenosis and at high risk for CEA had a 30-day DSMI and
Ipsilateral stroke between 31 and 365 days rate of 1.95%, measured from procedure to 1-year follow-up in the ITT analysis, using Kaplan-Meier
method. The primary endpoint rate was 1.71% in the per-protocol population.

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

●CGuard
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:

○Patients
with neurological symptoms and ≥50% stenosis of the common or internal carotid artery
by angiogram, or

○patients
without neurological symptoms and ≥80% stenosis of the common or internal carotid artery
by angiogram;

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

On-going
and Planned Clinical Trials

C-GUARDIANS
Post-Market Approval Study

The
C-GUARDIANS Post-Market Approval Study was a condition of PMA approval for CGuard Prime in the U.S. The C-GUARDIANS Post-Market Approval
Study is a prospective, multicenter follow-up of the C-GUARDIANS pivotal study. It will evaluate the long-term safety and effectiveness
of CGuard Prime. All 303 remaining subjects active at the end of the 12-month evaluation will continue to be followed annually through
36 months.

15

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

In
November 2023, we announced the entry into a strategic agreement with the Jacobs Institute at the State University of New York at Buffalo
to execute an early feasibility study of CGuard carotid stent system for the treatment of acute stroke patients with tandem lesions.
The study, a prospective, single-arm, open label, non-blinded study is expected to enroll 15 acute stroke patients across three U.S.
sites to assess the safety and feasibility of using CGuard carotid stent system to treat acute ischemic stroke patients with tandem lesions.
of Dr. Adnan Siddiqui, Vice-Chairman and Professor of Neurosurgery at the State University of New York at Buffalo, CEO of the Jacobs
Institute, is the Principal Investigator for the study. The trial began enrolling in the first quarter of 2025.

C-GUARDIANS
II for TCAR procedures

On
October 3, 2024, the FDA approved our IDE for CGUARDIANS II, a multicenter, single-arm, pivotal study to evaluate the safety and efficacy
of the CGuard Prime 80 cm carotid stent system used in conjunction with the ENROUTE NPS during TCAR procedures. Patrick Geraghty, M.D.,
professor of surgery and radiology, section of vascular surgery at Washington University School of Medicine in St. Louis, MO, and Patrick
Muck, M.D., program director and chief of vascular surgery at Good Samaritan Hospital in Cincinnati, OH, are lead principal investigators
for the trial. In the first quarter of 2026, we completed enrollment of 50 patients in our
CGUARDIANS II pivotal study.

C-GUARDIANS
III for TCAR procedures using SwitchGuard NPS

The
SwitchGuard NPS is designed to allow the treating physician to reverse cerebral blood flow during a TCAR procedure. SwitchGuard is intended
to prevent embolic debris generated during the procedure from traveling to the brain, passing the blood through the filter before returning
it to the patient to minimize blood loss.

On
December 30, 2024, we submitted an IDE to the FDA for CGUARDIANS III, a multicenter, single-arm, pivotal study to evaluate the safety
and efficacy of the SwitchGuard NPS used in conjunction with the CGuard Prime 80 cm carotid stent system for providing cerebral embolic
protection during carotid artery stenting via the TCAR procedure. The IDE submission was approved on June 6, 2025 by the FDA. The C-GUARDIANS
III study is expected to begin enrollment of patients during the second quarter of 2026.

Growth
Strategy

Our
primary business objective is to utilize our proprietary MicroNet technology and products to become the industry standard for the treatment
of carotid disease and prevention of stroke and to provide a superior solution to the common acute problems caused by current stenting
procedures, such as restenosis, embolization and thrombosis. We are pursuing the following business strategies to achieve these objectives.

●
Increase
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.

16

●
Drive
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.

●
Broaden
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.

●
Protect
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.

●
Establish
relationships with collaborative and development partners to fully develop and market our existing and future products.
We plan to pursue long-term strategic collaborations focused on technology development and integration, clinical research expansion
and global market access enablement.

●
Expand
U.S. 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.

Competition

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

With
respect to competition for our carotid embolic prevention systems, CGuard EPS and CGuard Prime, the manufacturers of products used in
connection with carotid stenting procedures include a number of large companies, such as Abbott Laboratories, Boston Scientific Corporation,
Medtronic, Cordis Corporation and Terumo Medical Corporation.

Many
of these competitors are larger companies or divisions of publicly traded companies that have certain competitive advantages, including
greater capital resources, larger customer bases, broader product lines, larger sales forces, greater marketing and management resources,
larger research and development staffs and larger facilities than ours and have established reputations and relationships with our target
customers and worldwide distribution methods that are more extensive than ours.

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

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

●
Scale
and effectiveness of commercialization efforts/organizations

●
Acceptance
by treating physicians and referral sources

●
Physician
learning curve

●
Ease-of-use
and reliability

●
Economic
benefits and cost savings

●

●

Availability
of reimbursement

Patient
experience

17

Sales
and Marketing

Sales
and Marketing

In
October 2024, we established our global headquarters in Miami, Florida to support the anticipated U.S. launch and commercialization of
CGuard Prime. Since that time, we have continued building the infrastructure for commercial operations in the U.S. to support the commercialization
of CGuard Prime.

We
are designing our commercial strategy and expanding our direct sales force to drive adoption of CGuard Prime among U.S. interventionalists.
In parallel, we aim to support the transition from CEA to CAS and TCAR, leveraging CGuard Prime 80 cm for TCAR procedures and accessory
devices, including our SwitchGuard neuroprotection system. We plan to continue to focus our marketing efforts on key growth markets and
to evaluate opportunities in new territories as they become available. In addition, we are using international medical conferences to
gain market exposure and brand recognition. We continue to work with leading physicians to enhance our marketing efforts and are developing
relationships with new key opinion leaders to champion our technology and participate in clinical studies.

In
the United States, we market and sell CGuard Prime through a direct sales organization consisting of approximately 30 sales and clinical
support personnel, as of February 2, 2026. Our sales professionals have substantial experience launching and establishing new disruptive
therapies and converting open surgical procedures to minimally-invasive alternatives. We are continuing to expand our commercial and
distribution capabilities to support the commercialization of CGuard Prime.

Previously,
based on the positive CGuard EPS clinical data, we initiated the commercial launch of CGuard EPS in CE marked countries in early 2015.
In September 2015, we announced full market launch of CGuard EPS in Europe. Since 2017 we have focused on sales of our products through
local distribution partners and our own internal sales initiatives to gain greater reach into all the relevant clinical specialties and
to expand our geographic coverage.

Product
Positioning

We
believe that CGuard Prime has the potential to become the standard of care in treating carotid artery disease in the U.S. It is a second-generation
stent with positive patient outcomes demonstrating significant reduction in post-procedural neurological events.

We
continue to invest in new product generations and potential new clinical indications for the CGuard platform with a strategy of focusing
on advancing a “stent-first” approach to carotid revascularization. As part of this strategy, we are evaluating CGuard Prime
in TCAR-based clinical programs, including the CGUARDIANS II pivotal trial, which studies the use of the CGuard Prime 80 cm carotid
stent system in conjunction with an established neuroprotection device, and the CGUARDIANS III pivotal trial, which evaluates our proprietary
SwitchGuard NPS paired with CGuard Prime to enable flow-reversal neuroprotection during TCAR. In parallel, we are pursuing new clinical
applications outside TCAR, including the treatment of acute ischemic stroke with tandem lesions, which is currently being studied in
an early feasibility study conducted with the Jacobs Institute. In this acute-stroke setting, the flexible, low-metal-burden design and
MicroNet mesh of CGuard Prime may offer advantages where traditional embolic-protection devices cannot be used. We believe this strategy
may allow us to increase penetration in our existing geographies and better position us for entry into new markets.

Insurance
Reimbursement

While
most countries have established reimbursement codes for stenting procedures, certain countries may require additional clinical data before
recognizing coverage and/or to obtain a certain level of reimbursement for one or more of our products. In these situations, we intend
to complete the required clinical studies to obtain reimbursement approval in countries where it makes economic sense to do so.

In
October 2023, CMS issued its final National Coverage Determination (“NCD”), expanding coverage of both CAS and TCAR to include
both asymptomatic and standard risk patients, significantly expanding the U.S. addressable market.

18

Intellectual
Property

Patents

We
have 71 issued patents, including 20 patents issued in the U.S., and 27 pending patent applications, 6 of which are pending in the United
States. Many of these patents and applications cover aspects of our CGuard and MGuard (a predecessor product) technology. Patents outside
the U.S. have been filed in Canada, China, Europe, Israel, India, Japan, Australia, South Africa, and Hong Kong. The patents and applications
fall into a number of patent families, as listed below.

Base
Title of Patent Family

Pending
patent

applications

(Countries)

Issued
patents

(Country
and Patent No.)

Issue
Date

Bifurcated
stent assemblies

USA

China

8,961,586

ZL 20078046676.2

24-Feb-2015

26-Sep-2012

Deformable
tip for stent delivery and methods of use

USA

Israel

10,258,491

260,945

16-Apr-2019

01-Jul-2020

Handle
for Two-Stage Deployment of a Stent

China

Japan

India

USA

USA

Europe

11,839,561

EP4032509

12-Dec-2023

18-Feb-2026

Shunts
with Blood-Flow Indicators

Europe

India

USA

China

USA

China

Japan

Hong
Kong

Japan
DIV

11,844,893

ZL 2022800089963

7449627

HK40100855

7794484

19-Dec-2023

26-Nov-2024

06-Mar-2024

14-Mar-2025

22-Dec-2025

Device
for Shunting Blood Between the Arterial and Venous Systems

India

USA (CON)

China (DIV)

Japan (DIV)

USA

China

Japan

Unitary
Patent

Ireland

UK

Spain

Switzerland

Hong
Kong

12,070,542

ZL 2022800098002

7576884

EP4313255

EP4313255

EP4313255

EP4313255
EP4313255 HK40096715

27-Aug-2024

10-Sep-2024

24-Oct-2024

13/Aug/2025

13/Aug/2025

13/Aug/2025

13/Aug/2025

13/Aug/2025

21/Feb/2025

Devices
for shunting blood

USA

China

Europe

India

Japan

In
Vivo Filter Assembly

USA

9,132,261

15-Sep-2015

Knitted
Stent Jackets

USA

China

India

Canada

China

Canada

Germany

France

UK

10,137,015

ZL200780046697.4

323792

2666728

ZL201210320950.3

2887189

EP2076212

EP2076212

EP2076212

27-Nov-2018

10-Oct-2012

28-Oct-2019

23-Jun-2015

02-Dec-2015

01-May-2018

29-Mar-2017

29-Mar-2017

29-Mar-2017

19

Optimized
stent jacket

USA

Canada

China

India

China

USA

USA

USA

USA

Israel

USA

USA

Canada

Belgium

Switzerland

Germany

France

UK

Italy

Ireland

Luxembourg

Netherlands

Europe

UK

Germany

France

Ireland

10,070,976

2670724

ZL20078043259.2

297257

ZL201210454357.8

9,132,003

9,782,281

9,526,644

10,406,006

230,922

10,406,008

11,051,959

3,013,758

EP2088962

EP2088962

EP2088962

EP2088962

EP2088962

EP2088962

EP2088962

EP2088962

EP2088962

EP3292837

EP3292837

EP3292837

EP3292837

EP3292837

11-Sep-2018

11-Dec-2018

02-Jan-2013

30-May-2018

09-Dec-2015

15-Sep-2015

10-Oct-2017

27-Dec-2016

10-Sep-2019

01-Oct-2020

10-Sep-2019

06-Jul-2021

14-Sep-2021

11-Oct-2017

11-Oct-2017

11-Oct-2017

11-Oct-2017

11-Oct-2017

11-Oct-2017

11-Oct-2017

11-Oct-2017

11-Oct-2017

09-Nov-2022

09-Nov-2022

09-Nov-2022

09-Nov-2022

09-Nov-2022

Stent
apparatus for treatment via body lumens and methods of use

Europe
(Div)

Europe

China

USA

Canada

South
Africa

USA

Canada

USA

USA

Germany

France

UK

Ireland

Italy

Switzerland

2609687

2007/10751

10,070,977

2843097

10,058,440

10,932,926

EP1885281

EP1885281

EP1885281

EP1885281

EP1885281

EP1885281

22-Apr-2014

27-Oct-2010

11-Sep-2018

27-Oct-2015

28-Aug-2018

02-Mar-2021

13-Feb-2019

13-Feb-2019

13-Feb-2019

13-Feb-2019

13-Feb-2019

13-Feb-2019

Stent
Thermoforming Apparatus and Methods

USA

USA

Japan

9,527,234

10,376,393

6553178

27-Dec-2016

13-Aug-2019

12-Jul-2019

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

USA

China

China
DIV

11,684,498

ZL
2019800679437

ZL
202210380047X

27-Jun-2023

03-May-2022

27-Feb
2026

Intravascular
sheath

USA
(UTI)

PCT

The
patents and patent applications listed above cover various aspects of our products, specifically focusing on the mesh sleeve covering
our stents, as well as methods for production and delivery mechanisms of the stents. We believe that our patents, in particular those
covering the use of a knitted micron-level mesh sleeve over a stent for various indications, as well as our pending patent applications
(if issued as patents with claims substantially in their present form), create a significant barrier against other companies seeking
to use similar technology. We believe these patents and patent applications collectively cover all our existing products and may be useful
in protecting our future technological developments. We intend to aggressively continue patenting new technologies and to actively pursue
any infringement of our key patents.

Trade
Secrets

We
also rely on trade secret protection to protect our interests in proprietary know-how and/or for processes for which patents are difficult
to obtain or enforce. As part of our trade secret policy, we rely on non-disclosure and confidentiality agreements with employees, consultants
and other parties to protect trade secrets and other proprietary technology.

20

Trademarks

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

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

●
MGuard®
(European Union, and UK)

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

●
MGuard
Prime® (European Union, and UK)

●
NGuard®
(European Union and UK)

●
PVGuard®
(European Union, and UK)

●
Micronet®
(US)

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

●
Carenet®)European
Union and UK)

●
SmartFit™
(US, UK, EP and CN)

●
SmartFit
Logo (EP, UK, CN)

●
CGuard
Prime (EP, UK, US, CN, JP)

●
SwitchGuard
(EP, UK, US, JP)

●
True
North Medical (EP, UK)

●
MicroMesh
logo (EP, UK)

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

The
trademarks are renewable indefinitely, so long as we continue using the marks and make the appropriate filings when required. We also
use and may have common-law rights to various trademarks, trade names, and service marks.

Government
Regulation

Our
products and operations are subject to extensive regulation in the United States, the European Union, and other international markets
in which we conduct business.

United
States

Medical
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.

Following
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
U.S. sales depends on continued compliance with these regulatory obligations.

European
Union and Other International Markets

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

21

In
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. Except
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
MDR. 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.

In
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.

In
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.

We
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.

FDA
Government Regulation of Medical Devices for Human Subjects

Many
of our activities are subject to regulatory requirements by the FDA under provisions of the Federal Food, Drug, and Cosmetic Act and
regulations and guidance thereunder, including requirements governing the development, marketing, labeling, promotional efforts, manufacturing,
and exporting of medical devices.

FDA
Approval/Clearance Requirements

In
the United States, most Class II or III medical devices must be cleared or approved by the FDA prior to commercialization. Unless an
exemption applies, each medical device that is marketed in the United States must receive either 510(k) clearance or PMA approval. Medical
devices that are class II devices generally receive 510(k) clearance are “cleared” by the FDA to market, distribute, and
sell in the United States. Medical devices that are class III devices obtain a premarket approval by the FDA are “approved”
to market, distribute, and sell in the United States.

Class
I devices are those for which safety and effectiveness can be assured by adherence to the FDA’s general regulatory controls
for medical devices, or the General Controls, which include compliance with the applicable portions of the FDA’s quality system
regulations, facility registration and product listing, reporting of adverse medical events, and appropriate, truthful and non-misleading
labeling, advertising, and promotional materials. Some Class I devices also require premarket clearance by the FDA through the 510(k)-process
described below.

Class
II devices are generally required to file a Premarket review, known as a 510(k) application, that may also require General Controls,
and any other special controls as deemed necessary by the FDA to ensure the safety and effectiveness of the device. Generally, the 510(k)
submission is generally considered “substantially equivalent to a previously marketed device. Pursuant to the Medical Device User
Fee and Modernization Act of 2002 (MDUFMA), as of October 2002, unless a specific exemption applies, 510(k) submissions are subject to
user fees. Certain Class II devices are exempt from this premarket review process.

22

Class
III devices generally are more complex devices or new devices where there is no substantially equivalent device on the market and
can have the greatest risk. Devices in this class must demonstrate safety and efficacy requirements and file a premarket filing reviewed
by the FDA. In addition, Class III devices cannot generally be marketed until they receive FDA approval. The safety and effectiveness
of Class III devices cannot be assured solely by the General Controls and the other requirements described above. These devices generally
require formal clinical studies to demonstrate safety and effectiveness. Under MDUFMA, PMAs (and supplemental PMAs) are subject to significantly
higher user fees than 510(k) applications, and they also require considerably more time and resources.

The
FDA establishes requirements whether a device must undergo either the 510(k) clearance or premarket approval based on statutory criteria
that utilize a risk-based classification system. Premarket approval (PMA) is the FDA process of scientific and regulatory review to evaluate
the safety and effectiveness of Class III medical devices and, such reviews may also be done for Class II medical devices. Class III
devices are those that support or sustain human life, are of substantial importance in preventing impairment of human health, or which
present a potential, unreasonable risk of illness or injury. The FDA uses these criteria to decide whether a premarket approval or a
510(k) is appropriate, including the level of risk that the agency perceives is associated with the device and a determination by the
agency of whether the product is a type of device that is similar to devices that are already legally marketed. Devices deemed to pose
relatively less risk are placed in either Class I or II. In many cases, the FDA requires the manufacturer to submit a 510(k) requesting
clearance (also referred to as a premarket notification), unless an exemption applies. The 510(k) must demonstrate that the manufacturer’s
proposed device is “substantially equivalent” in intended use and in safety and effectiveness to a legally marketed predicate
device. A “predicate device” is a pre-existing medical device to which equivalence can be drawn, generally by a Class II
device that was in commercial distribution before May 28, 1976, for which the FDA has not yet called for submission of a PMA. A product
that lacks a predicate device may default to a Class III device, although a company may seek to submit a De Novo classification request,
rather than a PMA. The De Novo request allows a regulatory pathway to classify novel medical devices for which no predicate device exists,
and FDA will determine which category is appropriate for that device and for which general controls alone, or general and special controls,
provide reasonable occurrence of safety and effectiveness for the intended use, but for which there is no legally marketed predicate
device.

Premarket
Approval Pathway

The
CGuard carotid stent system is classified as a Class III medical device (considered a PMA) by the FDA. Class III medical devices are
generally the highest risk devices and are subject to more rigorous regulatory requirements by the FDA, since the FDA process of premarket
approval involves scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices for the purpose(s)
intended. The FDA approved the CGuard Prime PMA on June 23, 2025.

A
PMA must be supported by extensive data including, but not limited to, analytical, preclinical, clinical trials, manufacturing, statutory
preapproval inspections, and labeling to demonstrate to the FDA’s satisfaction the safety and effectiveness of the device is safe
and effective for its intended use. Before a premarket approval application is submitted, a manufacturer must generally apply for an
Investigational Device Exemption (IDE) to conduct clinical trials. If the device presents a “significant risk,” as defined
by the FDA, to human health, the FDA requires the device sponsor to file an IDE application with the FDA and obtain IDE approval prior
to initiation of broader human clinical trials.

Part
of the PMA process is to ensure that the IDE is the first application that must be supported by appropriate data, such as analytical,
animal and laboratory testing results, manufacturing information, and an Investigational Review Board (IRB) approved protocol showing
that it is safe to test the device in humans and that the testing protocol is scientifically sound, as well as ensuring patient informed
consent is obtained.

A
clinical trial may be suspended by either the FDA or the IRB at any time for various reasons, including a belief that the risks to the
study participants outweigh the benefits of participation in the study. Even if a study is completed, clinical testing results may not
demonstrate the safety and efficacy of the device, or they may be equivocal or otherwise insufficient to obtain approval of the product
being tested. After the clinical trials have been completed, if at all, and the clinical trial data and results are collected and organized,
a manufacturer may complete a premarket approval application.

23

Following
the IDE, a PMA application must be prepared and after a PMA is sufficiently complete, then the FDA will accept the application and begin
an in-depth review of the submitted information. By statute, the FDA has 180 days to review the “accepted application,” although,
generally, FDA review of the application generally takes between one and three years, but it may take significantly longer. During this
review period, the FDA may request additional information or clarification of information already provided. Also, during the review period,
an advisory panel of experts from outside the FDA may be convened to review and evaluate the application and provide recommendations
to the FDA as to the approvability of the device. The preapproval inspections conducted by the FDA include an evaluation of the manufacturing
facility to ensure compliance with the Quality Systems Regulations, as well as inspections of the clinical trial sites by the Bioresearch
Monitoring group to evaluate compliance with good clinical practice and human subject protections. New premarket approval applications
or premarket approval supplements are required for modifications that affect the safety or effectiveness of the device, including, for
example, certain types of modifications to the device’s indication for use, manufacturing process, labeling and design. Significant
changes to an approved premarket approval require a 180-day supplement, whereas less substantive changes may utilize a 30-day notice,
or a 135-day supplement. Premarket approval supplements often require submission of the same type of information as a premarket approval
application, except that the supplement is limited to information needed to support any changes from the device covered by the original
premarket approval application, and it may not require as extensive clinical data or the convening of an advisory panel.

510(k)
Clearance Pathway

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

If
a device receives 510(k) clearance, any modification that could significantly affect its safety or effectiveness, or that would constitute
a new or major change in its intended use, will require a new 510(k) clearance or, depending on the modification, a premarket approval.
The FDA requires each device manufacturer to determine whether the proposed change requires submission of a new 510(k) or a premarket
approval, but the FDA can review any such decision and can disagree with a manufacturer’s determination. If the FDA disagrees with
a manufacturer’s determination, the FDA can require the manufacturer to cease marketing and/or recall the modified device until
510(k) clearance or premarket approval of the modified device is obtained.

Pervasive
and Continuing FDA Regulation

A
host of regulatory requirements apply to our devices, including the quality system regulation (which requires manufacturers to follow
elaborate design, testing, control, documentation and other quality assurance procedures), the Medical Device Reporting regulations (which
require that manufacturers report to the FDA specified types of adverse events involving their products), labeling regulations, and the
FDA’s general prohibition against promoting products for unapproved or “off-label” uses. Class II devices also can
have special controls such as performance standards, post-market surveillance, patient registries, and certain FDA guidelines may also
apply to Class I devices.

A
noncomprehensive list of the regulatory requirements that apply to our products classified as medical devices include:

●
product
listing and establishment registration, which helps facilitate FDA inspections and other regulatory action;

24

●
Quality
Systems Regulations, which requires manufacturers, including third-party manufacturers, to follow stringent design, testing, control,
documentation and other quality assurance procedures during all aspects of the development and manufacturing process;

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

●
clearance
of product modifications that could significantly affect safety or efficacy or that would constitute a major change in intended use
of one of our cleared devices (if obtained);

●
approval
of product modifications that affect the safety or effectiveness of one of our cleared devices (if obtained);

●
medical
device reporting regulations, which require that manufacturers comply with FDA requirements to report if their device may have caused
or contributed to a death or serious injury, or has malfunctioned in a way that would likely cause or contribute to a death or serious
injury if the malfunction of the device or a similar device were to recur;

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

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

●
the
FDA’s recall authority, whereby it can ask, or under certain conditions order, device manufacturers to recall from the market
a product that is in violation of governing laws and regulations;

●
regulations
pertaining to voluntary recalls; and,

●
notices
of corrections or removals.

Advertising
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.

At
this time, we have one commercially approved medical device in the U.S., and we have 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, 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.

25

The
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; or

●
criminal prosecution.

Many
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
the FDA. Failure by us or our manufacturing partners to comply with these licensing and regulatory requirements could have an adverse
effect on our business.

Coverage
and Reimbursement

There
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.

Some
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; and

●
neither experimental nor investigational.

Third-party
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.

26

A
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
is used. 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.

In
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.

We
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.

In
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.

U.S.
Healthcare Laws and Regulations

In
addition to the FDA regulations, there are a variety of other healthcare laws and regulations to which we may be subject if any of our
products are marketed, sold, distributed, and/or utilized in the United States. In the United States, we may be subject to the oversight
of FDA, Office of the Inspector General within the Department of Health and Human Services (OIG), the Center for Medicare and Medicaid
Services (CMS), the Department of Justice (DOJ), in addition to other governmental reviews. We supply products that may be reimbursed
by federally funded programs such as Medicare. As a result, our activities may be subject to regulation by CMS and potential enforcement
by CMS, OIG and DOJ. Of specific note are federal and state fraud and abuse laws, which prohibit the payment or receipt of kickbacks,
bribes or other remuneration, including the offer or solicitation of such payment, intended to induce or reward the purchase, recommendation
or generation of business involving healthcare products any item or service payable by a health-care program. Other provisions of federal
and state laws prohibit presenting, or causing to be presented, to third party payors (including, government programs, such as Medicare
and Medicaid) for reimbursement, claims that are false or fraudulent, or which are for items or services that were not provided as claimed.
In addition, other healthcare laws and regulations may apply, such as transparency and reporting requirements and privacy and security
requirements. Violations of these laws can lead to civil and criminal penalties, including exclusion from participation in federal and
state healthcare programs, any of which could have a material adverse effect on our business. These laws are potentially applicable to
manufacturers of products regulated by the FDA as medical devices, such as us, and hospitals, physicians and other institutional or individual
providers that may refer or purchase such products. The healthcare laws that may be applicable to our business or operations include,
but are not limited to:

●
The
federal Anti-Kickback Statute, which prohibits a person from knowingly and willfully offering, soliciting or receiving any remuneration,
directly or indirectly, overtly or covertly, in cash or in kind, in return for or to induce referring or recommending an individual
to another person to receive items or services or to purchase, lease, order, or arrange for any good, facility, item or service payable
in whole or in part under a Federal health care program;

27

●
The
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;

●
Federal
false claims laws and civil monetary penalty laws, including the False Claims Act, prohibit, among other things, individuals or entities
from knowingly presenting, or causing to be presented, claims for payment from Medicare, Medicaid or other government healthcare
programs that are false or fraudulent, or making a false statement to avoid, decrease or conceal an obligation to pay money to the
federal government. The False Claims Act imposes liability on any person or entity that, among other things, knowingly presents,
or causes to be presented, a false or fraudulent claim for payment by a federal health care program, knowingly makes, uses or causes
to be made or used, a false record or statement material to a false or fraudulent claim, or knowingly makes a false statement to
avoid, decrease or conceal an obligation to pay money to the U.S. federal government. The federal Civil Monetary Penalties Law prohibits,
among other things, the offering or transferring of remuneration to a Medicare or Medicaid beneficiary that the person knows or should
know is likely to influence the beneficiary’s selection of a particular supplier of Medicare or Medicaid payable items or services;

●
The
federal Health Insurance Portability and Accountability Act of 1996 (“HIPAA”), which includes provisions that prohibit
knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program or obtain, by means
of false or fraudulent pretenses, representations, or promises, any of the money or property owned by, or under the custody or control
of, any healthcare benefit program, and for knowingly and willfully falsifying, concealing or covering up a material fact or making
any materially false statements in connection with the delivery of or payment for healthcare benefits, items or services;

●
The
federal transparency requirements under the Affordable Care Act, including the provision commonly referred to as the Open Payments
Act or Physician Payments Sunshine Act, which requires certain manufacturers of drugs, devices, biologics and medical supplies that
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; and

●
Analogous
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.

Penalties
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.

Because
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.

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Privacy
and Security of Health Information

Various
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.

The
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.

The
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. These
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.

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

In
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
these laws. 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.

Due
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. Failure
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.

29

Health
Care Reform

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

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

On
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.

Any
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.

We
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.

30

Customers

Our
customer base is varied. We currently have distribution agreements for our CE mark-approved CGuard EPS with medical product distributors
based in Europe, the Middle East, Asia Pacific and Latin America, and are in discussions with additional potential partners.

Our
distribution agreements stipulate that, while we shall assist in training by providing training materials, marketing guidance, marketing
materials, and technical guidance, each distributor will be responsible for carrying out local registration, sales and marketing activities.
In addition, in most cases, all sales costs, including sales representatives, incentive programs, and other marketing activities, will
be borne by the distributor. Under current agreements, distributors purchase stents from us at a fixed price. Our current agreements
with distributors are generally for a term of two to three years.

Since
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
and neurosurgeons.

Manufacturing
and Suppliers

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

The
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.

We
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.

To
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.

We
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.

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Human
Capital Management

As
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.

Except
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.

We
believe that our future success will depend, in part, on our continued ability to attract, hire, and retain qualified personnel. In particular,
we depend on the skills, experience, and performance of our senior management and research personnel. We compete for qualified personnel
with other medical device, biotechnology, pharmaceutical and healthcare companies, as well as universities and non-profit research institutions.

We
provide competitive compensation and benefits programs to help meet the needs of our employees. In addition to salaries, these programs
(which vary by country/region and employment classification) include incentive compensation plan, pension, healthcare and insurance benefits,
paid time off, family leave, and on-site services, among others. We also use targeted equity-based grants with vesting conditions to
facilitate retention of personnel, particularly for our key employees.

We
consider our relations with our employees to be good.

Available
Information

We
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.

Copies
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.

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