What changed in this filing

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Item 1. Business

2025-03-12 compared with 2024-03-05 · 497 added, 473 removed, 600 unchanged (62% of the section changed)

are a medical device company focusing on the development and commercialization of our proprietary MicroNet™ stent platform for

the treatment of carotid artery disease and other vascular disease.

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

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

A stent is an expandable scaffold-like device, usually

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

MicroNet, a micron mesh sleeve, is attached over a stent to provide embolic protection both during and after stenting procedures.

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

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

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

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EU’s Medical Device Regulation regulatory framework.

Currently, we are seeking strategic partners for a potential launch of CGuard

EPS in Japan and other Asian countries.

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

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our next generation CAS stent platform.

primary endpoint is a composite of:

(1) incidence of major adverse events including Death (all-cause mortality), any Stroke, and

Myocardial Infarction (DSMI) through 30-days post index procedure, or (2) ipsilateral stroke from day 31 to day 365 post-procedure.

All events are adjudicated by an independent clinical events committee.

The composite index will be compared to a performance goal

based on the observed rate of the two components of the primary endpoint from previous pivotal stent trials which are considered

industry standard.

The performance goal will be considered met if the upper bound of the two-sided 95% confidence interval

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

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

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

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

We anticipate reporting primary endpoint results from the

C-GUARDIANS trial mid 2024 that may support the submission of a premarket approval, or PMA, application in the third quarter of 2024

with a view to potential FDA approval of the CGuard Prime stent system in the first half of 2025.

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

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

In furtherance

of our strategy that focuses on establishing the CGuard Carotid Stent System as a viable alternative to vascular surgery, we are

developing a new transcarotid artery revascularization (TCAR) system, SwitchGuard™ neuroprotection system (“SwitchGuard

NPS”), for transcarotid access and neuro protection.

In addition, we intend to explore new indications for CGuard to

leverage the advantages of stent design and mesh protection, well suited in labels such as acute stroke with tandem

primary endpoint was a composite of:

(1) incidence of major adverse events including Death (all-cause mortality), any Stroke, and Myocardial

Infarction (DSMI) through 30-days post index procedure, or (2) ipsilateral stroke from day 31 to day 365 post-procedure.

All events were

adjudicated by an independent clinical events committee.

The composite index was compared to a performance goal based on the observed

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

The performance

goal was considered met if the upper bound of the two-sided 95% confidence interval calculated from the observed primary endpoint rate

is < 11.6% and the p-value is less than 0.025.

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

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

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

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

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

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

Prime carotid stent system in the first half of 2025.

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

System during transcarotid revascularization (TCAR) procedures.

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

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

the future growth of the U.S.

CAS addressable market.

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

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

In furtherance of our strategy

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

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

and neuro protection.

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

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

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

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for CGuard Carotid Stent System and SwitchGuard NPS is approximately $1.3 billion (source:

Health Research International Personal

Medical Systems, Inc.

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

and Addressable Markets and internal estimates).

According to this same report and internal estimates, assuming full penetration of treatment

for all individuals diagnosed with high-grade carotid artery stenosis, we estimate the total available market for CGuard Carotid Stent System and SwitchGuard

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

to increased patient screening for carotid artery disease.

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

expanding coverage of CAS to include both asymptomatic and standard risk patients, significantly expanding the U.S.

CAS addressable market.

mission is to offer a comprehensive set of delivery solutions (TCAR and Transfemoral) in order to deliver best in class results through

patient outcomes by way of stent performance with CGuard Carotid Stent System and SwitchGuard NPS.

Health Research International Personal Medical

Systems, Inc.

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

Markets and internal estimates).

According to this same report and internal estimates, assuming full penetration of treatment for all

individuals diagnosed with high-grade carotid artery stenosis, we estimate the total available market for CGuard Carotid Stent System

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

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

were organized in the State of Delaware on February 29, 2008.

In October 2024, we established our global headquarters in Miami, Florida

to support the anticipated U.S.

launch and commercialization of the CGuard Prime carotid stent system.

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

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

Under the terms of the Pre-Funded Warrants and Warrants, certain of the selling stockholders may not exercise the Pre-Funded Warrants

or Warrants to the extent such exercise would cause such selling stockholder, together with its affiliates and attribution parties, to

beneficially own a number of shares of common stock which would exceed 4.99% or 9.99% of our then outstanding common stock following

such exercise, excluding for purposes of such determination common stock issuable upon exercise of the Pre-Funded Warrants or Warrants

which have not been exercised.

The Warrants may be exercised into pre-funded warrants if the selling stockholder is unable to exercise

the Warrant due to the foregoing beneficial ownership limitation or at the selling shareholder’s election.

connection with the Purchase Agreement, we entered into a registration rights agreement (the “Registration Rights Agreement”).

Pursuant to the Registration Rights Agreement, we were required to file a resale registration statement (the “Registration Statement”)

with the SEC to register for resale the Private Placement Shares and the shares of common stock issuable upon exercise of the Pre-Funded

Warrants and Warrants, within 20 days of the signing date of the Purchase Agreement (the “Signing Date”), and to have such

Registration Statement declared effective within 45 days after the Signing Date in the event the Registration Statement is not reviewed

by the SEC, or 90 days of the Signing Date in the event the Registration Statement is reviewed by the SEC.

We were obligated to pay certain

liquidated damages if we fail to file the Registration Statement when required, fails to cause the Registration Statement to be declared

effective by the SEC when required, of if we fail to maintain the effectiveness of the Registration Statement.

The Registration Statement

was subsequently filed on May 23, 2023 and declared effective on June 1, 2023.

We paid LifeSci Capital LLC, a placement fee equal to

5.6% of the aggregate gross proceeds from the closing of the Private Placement Offering, or approximately $2.4 million, and legal expenses

In addition, we paid Piper Sandler & Co.

a financial advisory fee of $1.5 million, AGP/Alliance Global Partners a financial

advisory fee of $250,000 and lead investor counsel expenses of $125,000.

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

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

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

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

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

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

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

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

The Warrants may be exercised

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

or at the selling shareholder’s election.

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

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

of common stock.

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

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

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

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

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

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

primary causes of stroke.

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

every year, 15 million people worldwide suffer a stroke, and nearly six million die and another five million are left permanently disabled.

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 (https://www.who.int/cardiovascular_diseases/resources/atlas/en/) every

year, 15 million people worldwide suffer a stroke, and nearly six million die and another five million are left permanently disabled.

According to the same source, stroke is the second leading cause of disability, after dementia.

2022, 3.0 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 diagnosed required intervention for carotid artery disease (according to the 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).

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

is a carotid endarterectomy where a surgeon accesses the blocked carotid artery though an incision in the neck, and then surgically removes

The second is transcarotid artery revascularization where a surgeon accesses the blocked carotid artery though an incision

in the neck, and then places a stent to open the artery and prevent embolization while combining high-rate blood flow reversal to protect

The third is carotid artery stenting, which is a minimally invasive endovascular treatment for carotid artery disease and

an alternative to carotid endarterectomy.

Endovascular techniques using stents and carotid embolic prevention system protect against

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

We believe that the use of a stent with an

embolic protection system should increase the number of patients being treated since it would avoid the need for complex surgery.

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

of which, approximately 394,000 of those required intervention (according to the Health Research International Personal Medical Systems,

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

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

The first is a carotid endarterectomy, where

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

The second is transcarotid

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

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

The third is carotid

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

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

We believe that the availability

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

complex surgery.

Mesh Platform Technology

is our proprietary circular knitted mesh which wraps around a stent to protect patients from plaque debris flowing downstream upon deployment.

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

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

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

The size, or aperture, of the current

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

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

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

CGuard – Carotid Artery Applications

– Carotid Artery Applications

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

need of an inflation balloon) in a single device for use in carotid artery applications.

MicroNet is placed over and attached to an open

cell nitinol metal stent platform which is 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

carotid stents and stenting methods.

The CGuard EPS technology is a highly flexible stent system that conforms to the carotid anatomy.

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 carotid stents.

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

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

the MicroNet will provide acute embolic protection at the time of the procedure, but more importantly, we believe that CGuard EPS will

provide post-procedure protection against embolic dislodgement, which can occur up to 48 hours post-procedure.

It is in this post-procedure

time frame that embolization is the source of post-procedural strokes in the brain.

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

against embolic dislodgement.

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

Schofer, et al.

(“Late cerebral embolization

after emboli-protected carotid artery stenting assessed by sequential diffusion-weighted magnetic resonance imaging,” Journal

of American College of Cardiology Cardiovascular Interventions , Volume 1, 2008) have shown that the majority of the incidents of

embolic showers associated with carotid stenting occur post-procedure.

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

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

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

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

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

and Europe and from April 2023 included deployment of the CGuard stent using CGuard Prime, our next generation CAS stent platform.

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

using CGuard Prime, our next generation CAS stent platform.

primary endpoint is a composite of:

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All events are

adjudicated by an independent clinical events committee.The composite index will be compared to a performance goal based on the observed

adjudicated by an independent clinical events committee.

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

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

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rate is < 11.6% and the p-value is less than 0.025.

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

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

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

We anticipate reporting primary endpoint results from the

C-GUARDIANS trial in mid 2024 that may support the submission of a PMA application in the third quarter of 2024 with a view to

potential FDA approval of the CGuard Prime stent system in the first half of 2025.

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

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

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

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

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

These data were used to support

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

system in the first half of 2025.

Prime Stent System

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

delivery system that we are developing and that is subject to regulatory approval.

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

is subject to regulatory approval.

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

23 μm Polyethylene Terephthalate (PET).

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

wall, providing continuous embolic prevention.

The CGuard Prime Carotid Stent is available in diameters ranging from 6.0mm 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.

The CGuard Prime is available in two lengths:

Prime advances the first generation CGuard transfemoral delivery system with new handle design for deployment accuracy, new catheter

design for more flexible navigation of tortuous anatomy especially in acute revascularize settings as well as two lengths, 135cm and

80cm for booth transfemoral and transcarotid access.

From April 2023, the C-GUARDIANS trial included deployment of the CGuard

stent using CGuard Prime.

NPS is a Class IIa, non-invasive transcarotid artery revascularization (TCAR) device that we are developing and that is subject to regulatory

approval that is composed of medical grade tubing with male Luer lock connectors at each end and an in-line 200-micron blood filter.

The device 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 arterio-venous extension line with filter is intended for flow circuit and particle removal when connecting arterial and/or

venous introducers during interventional procedures.

is being developed to answer a need of flow reversal for cerebral protection in coronary artery stenting (“CAS”) 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.

frequently use extension lines constructed from blood filter transfusion sets during interventional procedures for the purpose of A-V

expect to submit an IDE to the FDA for the C-GUARDIANS II clinical trial during the second half of 2024, which, if approved, would

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

In February 2024,

we appointed the principal investigators for the C-GUARDIANS II clinical trial of SwitchGuard NPS.

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

providing continuous embolic prevention.

The CGuard Prime Carotid Stent is available in diameters ranging from 6mm to 10mm and in lengths

of 20, 30, 40 and 60mm.

The CGuard Prime delivery system is a rapid exchange (Rx), delivery system with a 6Fr profile that can accommodate

all stent sizes from 6mm to 10mm.

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

lengths of 30 and 40 mm.

Prime 135 cm advances the first generation CGuard transfemoral delivery system with a new handle design for ease of deployment and a

new catheter design for more flexible navigation of tortuous anatomy.

The CGuard Prime product was used in 32 patients out of 315 patients

in the CGuardians study, since April 2023.

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

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

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

NPS is a Class IIa neuroprotection system (NPS) that we have developed and that is subject to regulatory approval, composed of medical

grade tubing with male Luer lock connectors at each end and an in-line 200-micron blood filter.

When connected to the included arterial

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

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

is being developed to answer a need of flow reversal for cerebral protection in carotid interventions since symptomatic distal embolization,

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

the most frequent and important complication of CAS.

Reversing blood flow has been shown to reduce stroke risk during carotid artery

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

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

Stroke with Tandem Lesions

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

stenosis/occlusion 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 way for design (flexible / low metal

structure) as well as MicroNet mesh offering embolic protection both during and post procedural implantation.

Our goal is to develop

CGuard Prime to mitigate strokes in this acute setting.

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

sites to explore the safety and feasibility.

of using CGuard Prime to treat acute ischemic stroke patients with tandem

is estimated that 20-30% of acute ischemic strokes 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.

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.

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

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

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indicates the potential error in the measurement.

Subjects with new Acute Ischemic

Lesions (“AIL”)

Subjects with new Acute Ischemic Lesions (“AIL”)

Incidence of new lesions

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

was subsequently increased to include 500 consecutive patients with symptomatic or increased stroke risk asymptomatic atherosclerotic

carotid stenosis patients.

The new study is known as PARADIGM -500.

In June 2022, the 1-year results were presented at the EuroPCR in

Leipzig, Germany.

findings from the PARADIGM-500 study are as follows.

Day Death/Stroke rate of 0.75%;

30-day death/stroke/myocardial infarction rate of 0.94%;

freedom from ipsilateral stroke, in stent restenosis and target lesion revascularization rate of 99.6%.

(prospective evaluation of all-comer percutaneous carotid revascularization in symptomatic and increased-risk asymptomatic carotid artery

stenosis, using CGuard™ mesh-covered embolic prevention stent system-500) is an investigator-initiated, single center study designed

to evaluate the outcomes of routine CGuard EPS in consecutive all-comer patients accepted by a multidisciplinary committee for carotid

revascularisation.

The PARADIGM-500 study is an extension of the of PARADIGM-101 study, which was initiated in 2015.

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

findings were:

death or stroke rate of 0.75%

death, stroke and myocardial infarction (DSMI) rate of 0.94%

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

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

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

Eur J Vasc Endovasc Surg.

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

Paradigm-500 study confirms that carotid artery stenting (CAS) with the CGuard EPS stent delivers reliable and low rates of 30-day composite

DSMI, 12-month ipsilateral stroke, ISR and no instances of stent thrombosis in a wide range of patient at standard and high risk for

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

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

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

Prime, our next generation CAS stent platform.

All CAS procedures were

performed utilizing the CGuard MicroNet TM mesh covered stent and cleared intra-procedural cerebral protection distal

embolic filters or proximal embolic protection with flow cessation, or both.

At 30 days, the hierarchical DSMI rate was 0.95% in the

intent to treat (ITT) analysis and 0.63% in the per- protocol (PP) analysis.

Three patients experienced major adverse cardiovascular

events by 30-days:

one patient who did not take dual antiplatelet therapy (protocol violation) had a major stroke and died and two

other patients had a stroke.

There was no myocardial infarction (MI).

These results support a potential

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

expect the primary endpoint at 1-year will be analyzed during the third quarter of 2024 when the last patient enrolled reaches

1-year of follow-up.

We anticipate reporting primary endpoint results from the C-GUARDIANS trial in mid 2024 that may support the

submission of a PMA application in the third quarter of 2024 with a view to potential FDA approval of

the CGuard Prime stent system in the first half of 2025.

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

of the CGuard stent using CGuard Prime, our next generation CAS stent platform.

All CAS procedures were performed utilizing the CGuard

MicroNet TM mesh covered stent and cleared intra-procedural cerebral protection distal embolic filters or proximal embolic

protection with flow cessation, or both.

At 30 days, the hierarchical DSMI rate was 0.95% in the intent to treat (ITT) analysis and 0.63%

in the per- protocol (PP) analysis.

Three patients experienced major adverse cardiovascular events by 30-days:

one patient who did not

take dual antiplatelet therapy (protocol violation) had a major stroke and died and two other patients had a stroke.

There was no myocardial

infarction (MI).

These results support a potential “neuroprotective” effect of the CGuard stent from the procedure to 30

days follow-up.

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

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

had a 30-day DSMI and Ipsilateral stroke between 31 and 365 days rate of 1.95%, measured from procedure to 1-year follow-up in the ITT

analysis, using Kaplan-Meier method.

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

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

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

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 EPS for the treatment of acute stroke patients with tandem lesions.

The study, a prospective,

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

sites to assess

the safety and feasibility .of using CGuard EPS to treat acute ischemic stroke patients with tandem lesions.

Adnan Siddiqui, Vice-Chairman

and Professor of Neurosurgery at the State University of New York at Buffalo, CEO of the Jacobs Institute, is the Principal Investigator

for the study.

First patient enrollment is expected in the second quarter of 2024.

II for SwitchGuard NPS

to execute an early feasibility study of CGuard Carotid Stent System for the treatment of acute stroke patients with tandem lesions.

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

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

tandem lesions.

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

of the Jacobs Institute, is the Principal Investigator for the study.

We began enrollment in the first quarter of 2025.

II for TCAR procedures

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

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

Patrick Geraghty, M.D., professor of surgery and radiology, section of vascular surgery at Washington University School of

Medicine in St.

Louis, MO, and Patrick Muck, M.D., program director and chief of vascular surgery at Good Samaritan Hospital in Cincinnati,

OH, are lead principal investigators for the trial.

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

of 50 evaluable patients.

III for TCAR procedures using SwitchGuard NPS

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

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

housed within the SwitchGuard™ before returning it to the patient to minimize blood loss.

plan to submit an IDE to the FDA in the second half of 2024 for C-GUARDIANS II, a multicenter, single-arm, pivotal study to evaluate

the safety and efficacy of the SwitchGuard NPS for providing cerebral embolic protection during carotid artery stenting via the Transcarotid

Artery Revascularization (TCAR) approach.

We appointed 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, to act as lead principal investigators for the trial.

Additionally,

William Gray, M.D., system chief of the cardiovascular division at Main Line Health in Wynnewood, PA and professor of medicine at Thomas

Jefferson University in Philadelphia, PA, will act as a strategic advisor to the Company.

Clinical Trials

and post-marketing clinical trials (outside the United States) could be conducted to further evaluate the safety and efficacy of CGuard

EPS in specific indications.

before returning it to the patient to minimize blood loss.

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

and efficacy of the SwitchGuard NPS used in conjunction with the CGuard Prime 80cm Carotid Stent System for providing cerebral embolic

protection during carotid artery stenting via the Transcarotid Artery Revascularization (TCAR) approach.

The IDE submission is currently

under review at the FDA.

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, embolic showers and late thrombosis.

We are pursuing the following business strategies to achieve this

procedures, such as restenosis, embolization and thrombosis.

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

Grow our presence in existing and new markets for CGuard

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

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

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

commercial operations.

In addition, we have launched CGuard

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

We are continuing

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

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

in Europe, Asia and Latin America.

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

expanding our presence in China.

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

the adoption of CGuard .

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

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

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

We intend to accomplish

this goal by continuing to publish and present our clinical data, supporting investigator-initiated clinical registries and exploring

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

We have partnered and

will continue to seek out partnerships with organizations focused on the treatment of stroke.

We will also continue to engage advisory

boards and to develop a network of key opinion leaders to assist us in our efforts to widen the adoption of CGuard.

be the only company focusing on both the surgeons and interventionalists who perform both CAS and TCAR procedures.

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

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

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

We intend to accomplish this goal by continuing

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

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

We have partnered and will continue to seek out partnerships

with organizations focused on the treatment of stroke.

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

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

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

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

our presence in existing and new markets for CGuard EPS.

We have launched CGuard EPS in most European and Latin American countries

through a comprehensive distributor sales organizations network.

We are continuing to focus on larger growing markets through this

network by supporting our distributors with robust marketing and clinical education programs.

We plan to continue to evaluate the

transition to a direct selling model in certain currently served distributor markets, increasing our control on the market and gross

profit margins.

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

in Europe, Asia and Latin America.

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

expanding our presence in China.

Currently, we are seeking strategic partners for a potential launch of CGuard EPS in Japan and other

Asian countries.

In addition, we plan to commercialize in the United States through a direct sales organization upon potential PMA

approval of CGuard Prime.

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

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of industry participants.

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

with CAS procedures in the United States, including a number of large companies, including Abbott Laboratories, Boston Scientific Corporation,

Medtronic and Cordis Corporation.

In Europe, in addition to the above-mentioned manufacturers, Terumo Medical Corporation also participates

in the market for products used in connection with CAS procedures.

As we develop and seek regulatory approval in the United States and

Europe for our new TCAR neuroprotection system SwitchGuard, and continue to seek greater market share for CGuard, we

expect to compete with Silk Road Medical in the total carotid artery revascularization market that comprises CAS, TCAR and carotid endarterectomy

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

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

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

and Terumo Medical Corporation.

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,

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

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

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

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

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and Marketing

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

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

Our current strategy seeks to broaden our sales efforts to increase CGuard EPS penetration within the community of interventionalists.

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

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

We have focused and we plan to continue to focus our marketing

efforts primarily on key growth markets and to evaluate opportunities in new territories as they become available.

In addition, we are

using international trade shows and industry conferences to gain market exposure and brand recognition.

We continue to work with leading

physicians to enhance our marketing efforts and are developing relationships with new key opinion leaders to champion our technology

and work with us in clinical studies.

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

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

launch and commercialization of

the CGuard Prime carotid stent system.

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

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

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

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

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

We plan to continue to focus our marketing efforts on key growth markets

and to evaluate opportunities in new territories as they become available.

In addition, we are using international medical conferences

to gain market exposure and brand recognition.

We continue to work with leading physicians to enhance our marketing efforts and are developing

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

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

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

Our sales professionals have substantial experience launching and establishing

new disruptive therapies and converting open surgical procedures to minimally-invasive alternatives.

We are continuing to expand our

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

Prime carotid stent system.

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

as an establishment with the FDA.

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.

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

It is a second-generation stent

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Additionally,

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

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

We believe these improvements may allow us to reduce cost

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

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

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

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

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

Reimbursement

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

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

and standard risk patients, significantly expanding the U.S.

CAS addressable market.

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.

have 66 issued patents, including 20 patents issued in the U.S., and 27 pending patent applications, 6 of which are pending in the United

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patent families, as listed below:

Title of Patent Family

Base Title of Patent Family

Pending patent

Issued patents

and Patent No.)

Stent Assemblies

Bifurcated stent assemblies

ZL 20078046676.2

Tip for Stent Delivery and Methods of Use

for Two-Stage Deployment of a Stent

with Blood-Flow Indicators

for Shunting Blood Between the Arterial and Venous Systems

for shunting blood

Vivo Filter Assembly

Stent Jackets

Deformable tip for stent delivery and methods of use

Handle for Two-Stage Deployment of a Stent

Shunts with Blood-Flow Indicators

ZL 2022800089963

Device for Shunting Blood Between the Arterial and Venous Systems

ZL 2022800098002

Devices for shunting blood

In Vivo Filter Assembly

Knitted Stent Jackets

ZL200780046697.4

ZL201210320950.3

CH, DE, FR, UK, IT, IE, LX, NL)

Apparatuses for Treatment Via Body Lumens and Methods of Use

Africa 2007/10751

DE, FR, GB, IE, IT)

Thermoforming Apparatus and Methods

or using a self-adjusting stent assembly and kits including the same

ZL20078043259.2

ZL201210454357.8

apparatus for treatment via body lumens and methods of use

Thermoforming Apparatus and Methods

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

Intravascular

(provisional)

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

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Liechtenstein

United Kingdom

United States

to CGuard units used in our ongoing FDA trial.

Government Regulation of Medical Devices for Human Subjects

of our activities are subject to regulatory oversight by the FDA under provisions of the Federal Food, Drug, and Cosmetic Act and regulations

thereunder, including regulations governing the development, marketing, labeling, promotion, manufacturing, and export of medical devices.

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.

Approval/Clearance Requirements

the United States, most Class II or III medical devices must be cleared or approved by the FDA prior to commercialization.

exemption applies, each medical device that is marketed in the United States must receive either 510(k) clearance or PMA.

Medical devices

that are class II devices receive 510(k) clearance are “cleared” by the FDA to market, distribute, and sell in the United

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, after FDA performs an on-site audit at the company premises.

exemption applies, each medical device that is marketed in the United States must receive either 510(k) clearance or PMA approval.

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.

I devices are those for which safety and effectiveness can be assured by adherence to the FDA’s general regulatory controls

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labeling, advertising, and promotional materials.

Some Class I devices also require premarket clearance by the FDA through the 510(k)

process described below.

II devices are required to file a Premarket review of 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

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.

Some Class I devices also require premarket clearance by the FDA through the 510(k)-process

described below.

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

Certain Class II devices are exempt from this premarket review process.

III includes devices with the greatest risk.

Devices in this class must demonstrate safety and efficacy requirements.

In addition, Class III devices cannot generally be marketed until they receive a premarket

The safety and effectiveness of Class III devices cannot be assured solely by the General Controls and the other

requirements described above.

These devices 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.

FDA decides whether a device line must undergo either the 510(k) clearance or premarket approval based on statutory criteria that

utilize a risk-based classification system.

Premarket approval is the FDA process of scientific and regulatory review to evaluate

the safety and effectiveness of Class III medical devices and, in many cases, 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.

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

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.

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.

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 will 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 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.

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

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.

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

Approval Pathway

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 therefore 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 will either approve or deny a premarket approval application and we cannot market a device

until the FDA approves a premarket approval application.

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.

IDE application 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.

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)

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

premarket approval application.

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.

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.

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

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a manufacturer may complete a premarket approval application.

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, review of the application can take 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

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.

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.

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.

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.

Clearance Pathway

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

future, we develop products where 510(k) clearance is required, we would be required to submit a 510(k) demonstrating that such proposed

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

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

The FDA’s 510(k) clearance pathway usually

takes from three to twelve months but could take longer.

In some cases, the FDA may require additional information, including clinical

data, to make a determination regarding substantial equivalence.

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

required as Class II devices.

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

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

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

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

could take longer.

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

substantial equivalence.

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

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and Continuing FDA Regulation

host of regulatory requirements apply to our approved 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 do

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.

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

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

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

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of corrections or removals.

this time, we have not registered as an establishment with the FDA.

If we are approved or cleared to manufacture, prepare, or

process a device in the United States, we and any third-party manufacturers that we may use will be required to register our

establishments with the FDA.

In addition, we and our manufacturing facilities will be subject to FDA inspections for compliance with

the FDA’s Quality System Regulation.

Additionally, some of our subcontractors may also be subject to FDA announced and

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

appropriately the indications for use of the product.

These regulations will require that we manufacture our products and maintain

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

device manufacturer, we will further be required to comply with FDA requirements regarding the reporting of adverse events

associated with the use of our medical devices, as well as product malfunctions that would likely cause or contribute to death or

serious injury if the malfunction were to recur.

FDA regulations also govern product labeling and prohibit a manufacturer from

marketing a medical device for unapproved applications.

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

with the FDA.

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

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

In addition, we and our manufacturing facilities

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

Additionally, some of our subcontractors

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

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

These regulations will require that we manufacture

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

and ensure that marketing materials and promotion are in compliance.

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

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

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

FDA regulations also

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

Healthcare Laws and Regulations

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 others.

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

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:

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:

federal Anti-Kickback Statute, which prohibits a person from knowingly and willfully offering, soliciting or receiving any remuneration,

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

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

impose obligations and requirements on healthcare providers, health plans, and healthcare clearinghouses as well as their respective

business associates that perform certain services for them that involve the use or disclosure of individually identifiable health

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

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

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

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

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

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

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

and Medicaid Services, or CMS, information related to payments and other transfers of value to physicians and teaching hospitals,

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;

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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.

We are currently in discussions with additional distribution companies

in Europe, Asia, and Latin America.

based in Europe, the Middle East, Asia Pacific and Latin America, and are in discussions with additional potential partners.

distribution agreements stipulate that, while we shall assist in training by providing training materials, marketing guidance, marketing

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

February 3, 2021, we entered into a Distribution Agreement with three China-based partners, pursuant to which the Chinese partners will

be responsible for conducting the necessary registration trials for commercial approval of our products in China, followed by an exclusive

distribution right to sell our products in China.

Under the Distribution Agreement, the China-based partners will be subject to minimum

purchase obligations.

potential PMA approval in the U.S., our direct sales organization will support 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

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

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

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

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

Our agreement with the supplier for the production of electro polished

L605 bare-metal stents for CGuard EPS and CGuard Prime is priced on a per-stent basis, subject to the quantity of stents ordered.

complete assembly process for CGuard EPS and CGuard Prime, including knitting and securing the sleeved to the stent and the crimping

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

Once CGuard EPS and CGuard Prime have been

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

distribution.

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

Each CGuard stent is manufactured from two main components,

a self-expending nickel-titanium stent and the mesh polymer.

This material is readily available and we acquire it in the open market.

The mesh is made from polyethylene terephthalate (polyester).

We have patent rights that cover the proposed CGuard stent with mesh.

2022 our mesh supplier informed us that it will not be able to supply the polymer fiber in the future due to issues with raw materials,

therefore we purchased inventory which should be sufficient to support our production needs until the end of 2026.

We are currently testing

a different source of PET showing equivalent mechanical properties of the original raw material.

BioGeneral will produce the fiber from

samples were already produced for preliminary R&D testing.

Complete validation process will take up to 18 months.

delivery system for CGuard is made out of polymer tubes we acquire from an original equipment manufacturer.

In the event that our supplier

can no longer supply this material, we would need to qualify another supplier, which could take up to a year.

In addition, in order to

retain the approval of the CE mark, we are required to perform periodic audits of the quality control systems of our key suppliers in

order to ensure that their products meet our predetermined specifications.

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

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

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

Our agreement with the supplier for the production of electro

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

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

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

Once CGuard EPS and CGuard Prime

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

and distribution.

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

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

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

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

We previously engaged Medical Murray, another contract

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

7 cleanroom facility in North Carolina.

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

ISO 13485-certified.

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

control measures to meet our specifications.

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

the sterilization process for the CGuard Prime device.

We expect this transition to enable increased production capacity to meet

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

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

Each CGuard stent is manufactured from two main components, a

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

The mesh is made from polyethylene terephthalate (PET).

We have patent

rights that cover the proposed CGuard stent with mesh.

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

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

to support our production needs until the end of 2027.

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

properties and biocompatibility of the original raw material.

BioGeneral will produce the fiber from the new PET:

some samples were already

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

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

take up to 18 months.

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

and assembled in-house.

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

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

In addition, in order to retain the approval

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

their products meet our predetermined specifications.

Capital Management

of December 31, 2023, we had 66 employees, 65 full-time and 1 part-time, consisting of 5 in executive management, 6 in research and development,

10 in quality assurance and compliance, 5 in finance and accounting, 26 in operations/production, 11 in sales, marketing and clinical,

and 3 in all other miscellaneous roles, Human resources, and administration.

Except for 5 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 2 independent contractors in Poland and 1 in Brazil.

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

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

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

Except for four of our employees

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

We do not expect the collective bargaining agreements

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

We also employ 1 independent contractor

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

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

What changed 10-K

Item 1. Business