What changed in this filing

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Item 1. Business

2024-03-05 compared with 2023-03-30 · 520 added, 492 removed, 553 unchanged (65% of the section changed)

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

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

stent in a single device for use in carotid artery revascularization.

Our CGuard EPS originally received CE mark approval under Medical

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

in September 2015.

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

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

Currently, we are seeking strategic partners for

a potential launch of CGuard EPS in Japan and other Asian countries.

CE mark for CGuard EPS under the MDD expired on November 12, 2022 and we are in the final stages of technical documentation review

by the Notified Body auditor to meet the Medical Device Regulation (“MDR”) (MDR 2017/745) requirements (which replaced

the MDD) for recertification.

In the meantime, on February 14, 2023, we received a derogation per Article 97 paragraph 1 of

Regulation 2017/745 from the Agency for Medicines and Health Products (FAMHP) allowing us to continue marketing CGuard EPS in the EU

until August 15, 2023 subject to certain procedural requirements.

Subsequently, on March 20, 2023, Regulation (EU) 2023/607 was

published allowing us to continue marketing CGuard EPS in EU countries under the MDD directive until December 31, 2027.

of the foregoing, we may market and sell CGuard EPS in the EU and certain other jurisdictions subject to certain procedural

requirements while our MDR CE recertification is pending.

We continue to expedite the review process for recertification under the

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

in a single device for use in carotid artery revascularization.

Our CGuard EPS originally received CE mark approval under Medical Device

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

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

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

In January 2024, we received CE mark recertification under the

EU’s Medical Device Regulation regulatory framework.

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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C-GUARDIANS is a prospective, multicenter, single-arm, pivotal study to evaluate

the safety and efficacy of the CGuard™ Carotid Sten System when used to treat symptomatic and asymptomatic carotid artery stenosis

in patients undergoing carotid artery stenting.

The trial was designed to enroll approximately 315 subjects in a maximum of 40 study

sites located in the United States and Europe.

Study sites in Europe may contribute a maximum of approximately 50% of the total enrollees.

The primary endpoint of the study will be the composite of incidence of death (all-cause mortality), all stroke, and myocardial infarction

(DSMI) through 30-days post-index procedure, based on the clinical events committee (CEC) adjudication and ipsilateral stroke from 31-365

day follow-up, based on Clinical Events Committee (CEC) adjudication.

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.

July 23, 2021, we announced the initiation of enrollment and successful completion of the first cases of our C-Guardian trial of CGuard

These are 315 patients who are expected to be enrolled in the trial and receive CGuard EPS in the treatment of carotid artery stenosis

in symptomatic and asymptomatic patients undergoing carotid artery stenting.

We are currently continuing with the enrolment phase at

approximately 20 trial sites and expect it to be completed approximately at the end of the second quarter of 2023.

Additionally,

we intend to continue to invest in current and future potential new indications, products and manufacturing enhancements for CGuard EPS

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

transfemoral access.

In furtherance of our strategy that focuses on establishing CGuard EPS as a viable alternative to vascular surgery,

we are developing a new transcarotid artery revascularization (TCAR) delivery system, SwitchGuard™, for transcarotid access and

neuro protection.

In addition, we intend to explore new indications for CGuard EPS 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 EPS to be individuals with diagnosed, symptomatic high-grade carotid artery stenosis

(HGCS, ≥70% occlusion) for whom intervention is preferable to medical (drug) therapy.

This group includes not only carotid artery

stenting patients but also individuals undergoing carotid endarterectomy, as the two approaches compete for the same patient population.

Assuming full penetration of the intervention caseload by CGuard EPS, we estimate that the addressable market for CGuard EPS will be

approximately $1.3 billion in 2023 (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).

to this same report, and internal estimates, assuming full penetration of the caseload for all individuals diagnosed with high-grade

carotid artery stenosis, we estimate that the total available market for CGuard EPS in 2022 will be approximately $9.3 billion.

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 EPS.

the safety and efficacy of the CGuard™ Carotid Stent System when used to treat symptomatic and asymptomatic carotid artery stenosis

in patients undergoing carotid artery stenting (“CAS”).

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

patients across 24 trial sites in the U.S.

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

our next generation CAS stent platform.

primary endpoint 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

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

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

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

for the same patient population.

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

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

Health Research International Personal

Medical Systems, Inc.

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

and Addressable Markets and internal estimates).

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

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

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

to increased patient screening for carotid artery disease.

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.

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

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

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

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

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

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

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

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

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

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

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

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

set forth therein.

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

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

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

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

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

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

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

Stent System in the United States begins.

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

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.

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

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

in the neck, and then surgically removes the plaque while combining high-rate blood flow reversal to protect the brain.

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.

Products and Product Candidates

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.

Mesh Platform Technology

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

EPS – Carotid Artery Applications

CGuard – Carotid Artery Applications

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

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embolic showers associated with carotid stenting occur post-procedure.

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

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

Subsequently,

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purpose of expanding our presence in China.

On October 13, 2021, we announced that our CGuard EPS stent system received a positive opinion

regarding reimbursement in France.

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

Asian countries.

CE mark for CGuard EPS under the MDD expired on November 12, 2022 and we are in the final stages of technical documentation review by

the Notified Body auditor to meet the MDR requirements for recertification.

In the meantime, on February 14, 2023, we received a derogation

per Article 97 paragraph 1 of Regulation 2017/745 from the Agency for Medicines and Health Products (FAMHP) allowing us to continue marketing

CGuard EPS in the EU until August 15, 2023, subject to certain procedural requirements.

Subsequently, on March 20, 2023, Regulation (EU) 2023/607 was published allowing us to continue

marketing CGuard EPS in EU countries under the MDD directive until December 31, 2027.

As a result of the foregoing, we may market and sell CGuard EPS in

the EU and certain other jurisdictions subject to certain procedural requirements while our MDR CE recertification is pending.

We continue to expedite the

review process for recertification under the MDR.

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

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

The trial was designed to enroll approximately

315 subjects in a maximum of 40 study sites located in the United States and Europe.

Study sites in Europe may contribute a maximum of

approximately 50% of the total enrollees.

The primary endpoint of the study will be the composite of incidence of death (all-cause mortality),

all stroke, and myocardial infarction (DSMI) through 30-days post-index procedure, based on the clinical events committee (CEC) adjudication

and ipsilateral stroke from 31-365 day follow-up, based on Clinical Events Committee (CEC) adjudication.

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.

July 23, 2021, we announced the initiation of enrollment and successful completion of the first cases of our C-Guardian trial of

Since then we have continue to enroll subjects in the trial at approximately 20 trial sites and expect to complete

enrollment approximately at the end the second quarter of 2023.

Prime Delivery System

CGuard Prime™ 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.

The study, which completed enrollment in June

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

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

primary endpoint is a composite of:

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

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

All events are

adjudicated by an independent clinical events committee.The composite 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 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.

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 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 Rx Delivery Systems are available in two lengths:

80 cm and 135 cm.

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 trans ,carotid access.

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

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.

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venous introducers during interventional procedures.

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

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

EPS – Acute Stroke with Tandem Lesions

approximately 20% of acute strokes, the carotid artery is included in the cerebral occlusion pathway.

Currently there is no indicated

use of CAS for these lesions during stroke treatment.

We believe CGuard EPS 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 EPS to mitigate strokes in this acute setting.

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

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

or bypass surgery.

Over the past years there has been a shift in industry preferences away from bare-metal stents, such as MGuard Prime

and as a result of declining sales and practical market utilization of the MGuard Prime EPS, which we believe was largely driven by the

predominant industry preferences favoring drug-eluting or drug-coated, stents, during the second quarter of 2022 we ceased sales of our

MGuard Prime EPS following a phase out period.

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.

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

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

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

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

As a result of declining sales and utilization

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

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

Clinical Trials for CGuard EPS

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

for coronary artery stenting (“CAS”) in a multi-operator, real-life setting.

The acute, 30 day, magnetic resonance imaging

(“MRI”), ultrasound and six month clinical event results were presented at the LINC conference in Leipzig, Germany in February,

In the third quarter of 2015, the results of the CGuard CARENET trial were published in the Journal of the American College of

In November 2015, positive twelve month follow-up data from the CGuard CARENET trial was presented at the 42nd Annual Symposium

on Vascular and Endovascular Issues, documenting the benefits of the CGuard MicroNet technology as well as the patency benefits (maintaining

the artery open) of the internal and external carotid arteries at twelve months.

In September 2022, the results of the CGuard CARENET

trial five year follow up were published in the Journal of the American College of Cardiology:

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

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

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

In the third quarter of 2015, the

results of the CGuard CARENET trial were published in the Journal of the American College of Cardiology.

In November 2015, positive twelve-month

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

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

carotid arteries at twelve months.

In September 2022, the results of the CGuard CARENET trial five year follow up were published in the

Journal of the American College of Cardiology:

Cardiovascular Interventions Vol.

15, No 18, 2022 September 26, 2022:1883-1891.

There was no ipsilateral stroke or ipsilateral stroke-related death which occurred throughout

the five years.

In addition, no stent restenosis or external carotid artery occlusion occurred in CARENET by 5 years, indicating normal

healing and uncompromised side-branch patency.

was no ipsilateral stroke or ipsilateral stroke-related death which occurred throughout the five years.

In addition, no stent restenosis

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

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

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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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but one lesion had resolved completely by 30 days.

month data showed no stroke or stroke-related deaths, and no cardiac adverse events.

year data showed no ipsilateral stroke or ipsilateral stroke-related deaths, and no stent restenosis or external carotid artery occlusion

data showed no stroke or stroke-related deaths, and no cardiac adverse events.

data showed no ipsilateral stroke or ipsilateral stroke-related deaths, and no stent restenosis or external carotid artery occlusion

occurred in CARENET by 5 years, indicating normal healing and uncompromised side-branch patency.

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30 days and 12 months, there were no strokes or stroke-related deaths.

There were four non

-device related deaths (heart failure exacerbation, urosepsis, pulmonary embolism and microcellular

pulmonary cancer).

There were four non -device related deaths (heart failure

exacerbation, urosepsis, pulmonary embolism and microcellular pulmonary cancer).

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

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

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

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

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

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the underlying stent.

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

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

Early Experience From a Single

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of 0.039 +/- 0.025 cm3.

Four patients (19.1%) had new ischaemic brain lesions on the contralateral side, for a total number

of nine lesions, with an average lesion volume of 0.019 +/- 0.011 cm3 (range 0.016-0.034 cm3).

At the postoperative period,

spontaneous resolution was noted in all the lesions recorded in the peri-operative period in the 11 patients participating.

one symptomatic patient had two new ischaemic brain lesions (1 ipsilateral and 1 contralateral).

Four patients (19.1%) had new ischaemic brain lesions on the contralateral side, for a total number of nine

lesions, with an average lesion volume of 0.019 +/- 0.011 cm3 (range 0.016-0.034 cm3).

At the postoperative period, spontaneous resolution

was noted in all the lesions recorded in the peri-operative period in the 11 patients participating.

Only one symptomatic patient

had two new ischaemic brain lesions (1 ipsilateral and 1 contralateral).

Mesh-Covered Stent in Real World:

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performed pre-procedure and between 24- and 72-hours post-procedure in 61 patients, indicated that 12 patients had new micro emboli

12 months, there were no new major neurological adverse events, thrombosis or external carotid occlusion recorded;

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

myocardial infarction occurred at 12 months.

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vessel occlusion in the Acculink™ arm;

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

myocardial infarction).

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

one myocardial infarction).

and Planned Clinical Trials

is a prospective, multicenter, single-arm, pivotal study to evaluate the safety and efficacy of the CGuard Carotid Stent System when

used to treat symptomatic and asymptomatic carotid artery stenosis in patients undergoing carotid artery stenting.

study completed enrollment in June 2023.

The 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.

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.

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

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 and new products, such as SwitchGuard.

These trials would be designed to facilitate market acceptance and

expand the use of the product.

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

of stroke and complex vascular disease 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 objective.

the adoption of CGuard EPS .

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

EPS is commercially available.

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

to conventional carotid stents and vascular surgery within the applicable medical communities.

We intend to accomplish this goal

by continuing to publish and present our clinical data, support investigator-initiated clinical registries and exploring addition

of a procedural protection device to our portfolio incorporating the principal of reverse flow of the carotid artery as an adjunctive

alternative to femoral access.

We have partnered and will continue to seek out partnerships with organizations focused on the treatment

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 EPS.

We aim to be the only company focusing on the broadest category of sub specialists

treating Carotid Artery Disease, both surgeons and interventional sub specialists and the only company offering both a TCAR and TFEM

delivery option.

EPS in specific indications.

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

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.

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

to facilitate the use of CGuard by all physicians.

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

points including accessory devices for trans carotid artery revascularization .

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

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

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

our presence in existing and new markets for CGuard EPS.

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We are continuing to focus on larger growing markets through this

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

In additional we have begun

to sell direct to hospitals in certain markets and continue to evaluate the transition to a direct selling to hospitals 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.

February 2021, we executed a distribution agreement with Chinese partners for the purpose of expanding our presence in China.

we are seeking strategic partners for a potential launch of CGuard EPS in Japan and other Asian countries.

In addition, we are conducting

a pivotal study of our CGuard™ Carotid Stent System, C-Guardians, for prevention of stroke in patients in the United States.

approval of National Coverage Determination – During January 2023, CMS approved the first step of reimbursement of a national

Coverage Decision for standard risk stent intervention of carotid disease.

This decision has the potential to profoundly increase

the available market to endovascular procedures as payment is pending for approval for a much boarder definition of surgical risk.

Currently, only high-risk patients to surgery are paid through the CMS coverage, NCA - Percutaneous Transluminal Angioplasty (PTA)

of the Carotid Artery Concurrent with Stenting (CAG-00085R8) - Tracking Sheet (cms.gov)

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

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

decision significantly increases the available market to endovascular procedures.

Previously, only symptomatic patients at high-risk

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

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

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

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

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

We continue to broadly

develop and protect intellectual property using our mesh technology.

Examples of some areas include peripheral vascular disease and

neurovascular disease.

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

We continue to broadly develop

and protect intellectual property using our mesh technology.

Examples of some areas include peripheral vascular disease and neurovascular

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

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

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

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

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

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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, is comprised of a number of large companies, including Abbott Laboratories, Boston Scientific

Corporation, Covidien Ltd.

(currently part of Medtronic, Inc.) and Cordis Corporation.

In Europe, in addition to the above mentioned

manufacturers, Terumo Medical Corporation is also a market participant that has a share of 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 delivery system, SwitchGuard™,

and continue to seek greater market share for CGuard EPS™, we expect to compete with Silk Road Medical in the total carotid artery

revascularization market that comprises both CAS and carotid endarterectomy (“CEA”).

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

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However, while there are currently many market participants

carotid stent market, we believe that the European market is somewhat more fragmented for CEA and 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.

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.

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

outcomes and adverse event rates;

of clinical evidence- patient outcomes and adverse event rates;

and effectiveness of commercialization efforts/organizations

by treating physicians and referral sources;

learning curve;

● Ease-of-use

and reliability;

recovery time and level of discomfort;

benefits and cost savings;

● Availability

of reimbursement;

of clinical evidence.

and Marketing

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2015, we announced full market launch of CGuard EPS in Europe.

Since 2017 we are focusing on sales of our products through local distribution

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 EPS and

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 if and when they become available.

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 effort and are developing relationships with new key opinion leaders to champion our technology

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.

In additional we have begun to sell direct to hospitals in certain markets, such as France and

the United Kingdom, in order to increase our growth in the market and gross profit margins.

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

It is a second-generation stent with positive patient outcomes demonstrating significant reduction in post-procedural neurological events.

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

It is a second-generation stent

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

Additionally,

we intend to continue to evaluate potential product enhancements and manufacturing enhancements for CGuard EPS 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 do not expect that it would be crucial to use a drug-eluting stent platform to compete in certain new markets such as the neurovascular

market, and hence, we plan to continue to explore this area of opportunity.

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

most countries, a significant portion of a patient’s medical expenses is covered by third-party payors.

Third-party payors can

include both government-funded insurance programs and private insurance programs.

While each payor develops and maintains its own coverage

and reimbursement policies, payors, in many instances, have similarly established policies, and in the U.S., for example, coverage policies

and reimbursement rates of private payors are often influenced by those established by the U.S.

Department of Health and Human Services

Centers for Medicare and Medicaid Services (CMS).

The CGuard product sold to-date in applicable foreign countries have been designed

and labeled to facilitate the utilization of existing reimbursement codes for such countries, and we intend to continue to design and

label our present and future products in a manner consistent with this goal.

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

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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.

have 59 issued patents, including 19 patents issued in the U.S., and 26 pending patent applications, 7 of which are pending in the United

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Stent Assemblies

China ZL200780046676.2

ZL200780046676.2

Tip for Stent Delivery and Methods of Use

Israel 260,945

for Two-Stage Deployment of a Stent

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Stent Jackets

Canada 2,887,189

China ZL200780046697.4

China ZL201210320950.3

Germany, France, & UK

Canada 3,013,758

China ZL201210454357.8

China ZL200780043259.2

India 297,257

Israel 230,922

US 10,070,976

US 10,406,006

US 10,406,008

US 11,051,959

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

ZL200780046697.4

ZL201210320950.3

ZL201210454357.8

ZL200780043259.2

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

Apparatuses for Treatment Via Body Lumens and Methods of Use

Africa 2007/10751

Canada 2,609,687

Canada 2,843,097

(CH, DE, FR, GB, IE, IT)

US 10,932,926

US 10,058,440

US 10,070,977

DE, FR, GB, IE, IT)

Thermoforming Apparatus and Methods

US 10,376,393

Australia 2015326517

Canada 2962713

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

ZL 2019800679437

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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Union and UK)

(US, UK and CN)

(US, UK, EP and CN)

Logo (EP, UK, CN)

1 unchanged sentence

(EP, UK, US, JP)

North Medical (US, EP, UK)

logo (US, EP, UK CN, JP)

logo (updated version) (US, EP, UK, CN, JP)

North Medical (EP, UK)

logo (EP, UK)

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

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

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

our specific case, our CE mark for CGuard EPS under the MDD expired on November 12, 2022, and we are in the final stages of technical

documentation review by the Notified Body auditor to meet the MDR requirements for recertification.

In the meantime, on February 14,

2023, we received a derogation per Article 97 paragraph 1 of Regulation 2017/745 from the Agency for Medicines and Health Products (FAMHP)

allowing us to continue marketing CGuard EPS in the EU until August 15, 2023, subject to certain procedural requirements.

Subsequently, on March 20, 2023, Regulation (EU) 2023/607

was published allowing us to continue marketing CGuard EPS in EU countries under the MDD directive until December 31, 2027.

As a result of the foregoing, we may market and sell CGuard EPS in the EU and certain other jurisdictions subject to certain procedural requirements while our MDR CE recertification is

We continue to expedite the review process for recertification under the MDR.

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

directly, in the countries listed in the table below.

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

sole requirement for marketing approval, some of these countries still require us to take additional steps in order to gain

reimbursement rights for our products.

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

of the European Union and accept the CE mark as a primary requirement for marketing approval, each such country requires additional

regulatory requirements for final marketing approval of our products.

Furthermore, we are currently targeting additional countries

in Europe, Asia, and Latin America;

however, even if all governmental regulatory requirements are satisfied in each such country, we

anticipate that obtaining marketing approval in each country could take as few as three months or as many as twelve months or more,

due to the nature of the approval process in each individual country, including typical wait times for application processing and

review, as discussed in greater detail below.

In January 2024, we received CE mark recertification

of CGuard EPS under the MDR.

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

in the countries listed in the table below.

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

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

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

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

marketing approval of our products.

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

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

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

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

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

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

Czech Republic

Dominican Republic

Liechtenstein

* As discussed elsewhere, our CE mark for the marketing and sale of CGuard EPS in the EU under the MDD expired

on November 12, 2022 and was reinstated during March 2023.

to units used in our ongoing FDA trial.

EPS approval to sell expired during prior twelve months.

FAMHP derogation does not apply.

to CGuard units used in our ongoing FDA trial.

Government Regulation of Medical Devices for Human Subjects

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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 we market or wish to market in the United States must receive 510(k) clearance or

premarket approval.

Medical devices that are class II devices 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.

We anticipate filing a premarket approval

application, or PMA, in the future for our product and do not anticipate filing a 510(k) premarket notification, provided that the

FDA will not instruct us otherwise.

We cannot guarantee that we will obtain premarket approval, which will likely include clinical

Descriptions of the premarket approval and 510(k) clearance processes are provided below.

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.

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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process described below.

II devices are subject to the FDA’s General Controls, and any other special controls as deemed necessary by the FDA to ensure

the safety and effectiveness of the device.

Premarket review and clearance by the FDA for Class II devices is accomplished through the

510(k) process.

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.

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.

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

The FDA has recently indicated that it intends to modernize the 510(k) process and has issued new guidance documents that may change

the way that devices are cleared by the FDA.

III includes devices with the greatest risk.

Devices in this class must meet all of the requirements in Classes I and II.

Class III devices cannot generally be marketed until they receive a premarket 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 require formal clinical studies

to demonstrate safety and effectiveness.

Under MDFUMA, 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.

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, that is either in Class I, Class II, or is a Class III 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

The De Novo request allows a regulatory pathway to classify novel medical devices 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.

expect that unless an exemption applies, each medical device that we market or wish to market in the United States must receive 510(k)

clearance or premarket approval.

Medical devices that receive 510(k) clearance are “cleared” by the FDA to market, distribute,

and sell in the United States.

Medical devices that obtain a premarket approval by the FDA are “approved” to market, distribute,

and sell in the United States.

We anticipate that each device that we wish to commercialize will be considered a Class III device by

the FDA and therefore we anticipate filing a PMA in the future and do not anticipate filing a 510(k) premarket notification, provided

that the FDA will not instruct us otherwise.

We cannot guaranty that we will obtain a premarket approval.

Descriptions of the premarket

approval and 510(k) clearance processes are provided below.

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.

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.

Approval Pathway

expect that current and future applications of our technology will result in medical devices that are considered Class III devices subject

to premarket approval.

A PMA must be submitted if a device cannot be cleared through the 510(k) process, unless FDA permits a De Novo

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

statutory preapproval inspections, and labeling to demonstrate to the FDA’s satisfaction the safety and effectiveness of the device

for its intended use.

Before a premarket approval application is submitted, a manufacturer must 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 enrollment of

human subjects for clinical trials.

The IDE provides the manufacturer with a legal pathway to perform clinical trials on human subjects

where without the IDE, only approved medical devices may be used on human subjects.

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,

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protocol is scientifically sound, as well as ensuring patient informed consent is obtained.

If the clinical trial design is deemed to

have “non-significant risk,” the clinical trial may be eligible for “abbreviated” IDE requirements.

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.

a PMA is sufficiently complete, the FDA will accept the application and begin an in-depth review of the submitted information.

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 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.

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.

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.

Clearance Pathway

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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”

Class II devices also can have special controls such as performance standards, post-market surveillance, patient registries,

and certain FDA guidelines do apply to Class I devices.

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

apply to Class I devices.

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

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of corrections or removals.

do not currently have a registered 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.

As such, 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.

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.

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.

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

CGuard EPS is classified as a Class III medical device by the FDA.

Class III medical devices are generally the highest risk devices and

are therefore subject to the highest level of regulatory control 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.

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

expect the approval process in the U.S.

to take a significant amount of time, require the expenditure of significant resources, involve

rigorous clinical investigations and testing, and potentially require changes to products.

The approval process may result in limitations

on the indicated uses of the medical devices for which we are able to obtain approval (since the FDA can take action against a company

that promotes off-label uses) and will also require increased post-market surveillance.

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.

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/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 enforcement by 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

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:

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, also

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

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

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in Europe, Asia, and Latin America.

of our current agreements with our distributors stipulate that, and we expect our future agreements with our distributors to stipulate

that, while we shall assist in training by providing training materials, marketing guidance, marketing materials, and technical guidance,

each distributor will be responsible for carrying out local registration, sales and marketing activities.

In addition, in most cases,

all sales costs, including sales representatives, incentive programs, and marketing trials, will be borne by the distributor.

Under current

agreements, distributors purchase stents from us at a fixed price.

Our current agreements with distributors are generally for a term

of two to three years.

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

materials, and technical guidance, each distributor will be responsible for carrying out local registration, sales and marketing activities.

In addition, in most cases, all sales costs, including sales representatives, incentive programs, and other marketing activities, will

be borne by the distributor.

Under current agreements, distributors purchase stents from us at a fixed price.

Our current agreements

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

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

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purchase obligations.

have also engaged in direct sales in certain geographic markets such as United Kingdom and France.

Manufacturing

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

Our agreement with with

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

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

so that we are responsible for purchasing and handling inventory of CGuard EPS delivery system, and they are responsible for the manufacturing

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

Our agreement with the

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

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

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

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

are responsible for the manufacturing process.

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

Our agreement

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

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 supplier.

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 sleeve to the stent and the crimping of

the sleeve stent on 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.

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.

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

the last year 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 in the next 2.5 years.

currently in the process of finding and qualifying another supplier or other material source which could take up to a year.

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.

headquarters are located in Tel Aviv, Israel, where we lease a 1,250 square meter office and manufacturing facility that has the capacity

to manufacture and assemble 1,750 stents per month, based upon the production schedule of one shift per day.

We believe that our current

facility is sufficient to meet anticipated future demand by adding additional shifts to our current production schedule.

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.

Capital Management

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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