What changed in this filing

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Item 1. Business

2023-03-30 compared with 2022-03-07 · 385 added, 536 removed, 660 unchanged (58% of the section changed)

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

for the treatment of complex vascular and coronary disease.

A stent is an expandable “scaffold-like” device, usually constructed

of a metallic material, that is inserted into an artery to expand the inside passage and improve blood flow.

MicroNet, a micron mesh

sleeve, is wrapped over a stent to provide embolic protection in stenting procedures.

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

single device for use in carotid artery applications.

Our CGuard EPS received CE mark approval in the European Union in March 2013 and

was fully launched in Europe in September 2015.

Subsequently, we launched CGuard EPS in Russia and certain countries in Latin America

and Asia, including India.

In September 2020, we launched CGuard EPS in Brazil after receiving regulatory approval in July 2020 and as

discussed below, on February 3, 2021, we executed a distribution agreement with Chinese partners for the purpose of expanding our presence

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

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

the treatment of carotid artery disease and other vascular disease.

A stent is an expandable “scaffold-like” device, usually

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

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

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

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 Stent System when used to treat symptomatic and asymptomatic carotid artery stenosis

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.

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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

The first patients, who were under the care of principal investigator, Chris Metzger, M.D., system chair of clinical research at

Ballard Health System in Eastern Tennessee, were successfully implanted with the CGuard EPS stent device.

These are the first of 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 enrollment phase.

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 product and manufacturing enhancements for CGuard EPS that are expected

to reduce cost of goods and/or provide the best-in-class performing delivery system.

In furtherance of our strategy that focuses on establishing

CGuard EPS as a viable alternative to vascular surgery, we are exploring adding new delivery systems and accessory solutions for procedural

protection to our portfolio.

consider the current addressable market for our CGuard EPS to be individuals with diagnosed, symptomatic high-grade carotid artery stenosis

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.

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

approximately $666 million in 2022 (source:

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).

According to this same report,

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 $5 billion.

MGuard™ Prime™ embolic protection system (“MGuard Prime EPS”) is marketed for use in patients with acute coronary

syndromes, notably acute myocardial infarction (heart attack) and saphenous vein graft coronary interventions, or bypass surgery.

Prime EPS combines MicroNet with a bare-metal cobalt-chromium based stent.

MGuard Prime EPS received CE mark approval in the European

Union in October 2010 for improving luminal diameter and providing embolic protection.

Over the past years there has been a shift in

industry preferences away from bare-metal stents, such as MGuard Prime EPS in ST-Elevation Myocardial Infarction (“STEMI”)

As a result of declining sales of the MGuard Prime EPS, which we believe this is largely driven by the predominant industry

preferences favoring drug-eluting, or drug-coated, stents, we intend to phase out future sales of our MGuard Prime EPS in 2022.

also intend to develop a pipeline of other products and indications by leveraging our MicroNet technology to improve peripheral procedures

such as the treatment of the superficial femoral artery disease and vascular disease below the knee as well as neurovascular procedures,

such as the treatment of acute stroke.

none of our products may be sold or marketed in the United States, but we do derive revenues from the use of our products in the currently

ongoing trials.

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.

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

February 8, 2021, we closed an underwritten public offering of 1,935,484 units, with each such unit being comprised of one share of our

common stock, par value $0.0001 per share, and one Series G Warrant to purchase one-half of one share of common stock (the “February

2021 Offering”).

The offering price to the public was $9.30 per unit.

The Series G Warrants were immediately exercisable at a price

of $10.23 per share, subject to adjustment in certain circumstances, and expire five years from the date of issuance.

We also granted

the underwriter of the offering an option to purchase an additional 290,322 shares of common stock and Series G Warrants to purchase

145,161 shares of common stock, which the underwriter exercised in full.

In connection with the offering we granted to the underwriter

a compensation warrant to purchase up to 111,290 shares of common stock with an exercise price of $10.23 per share and which are exercisable

for five years from February 3, 2021.

Our net proceeds from the offering, after giving effect to the exercise of the underwriter’s

over-allotment option, were approximately $18.9 million, after deducting underwriting discounts and commissions and payment of other

expenses associated with the offering, but excluding the proceeds, if any, from the exercise of Series G Warrants sold in the offering.

and Purchase Agreement with Chinese Partners

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

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

exclusive distribution right to sell our products in China with the term of the agreement continuing on a year-to-year basis unless terminated.

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

The Distribution Agreement

may be terminated for cause upon failure to meet minimum purchase obligations, failure to obtain regulatory approvals or for other material

addition, and on the same day, we entered into an investment transaction with QIDI, which included (i) an SPA, pursuant to which QIDI

agreed to invest $900,000 in exchange for shares of our common stock at a purchase price of $10.062 per share, and (ii) an IRA, whereby

QIDI was provided certain customary registration rights, including a commitment by us to file a registration statement with the SEC on

Form S-1 or Form S-3 and have such registration statement become effective not later than 150 days following the closing of the transactions

under the SPA.

transactions closed on February 5, 2021.

Equity Incentive Plan

September 30, 2021, at our 2021 annual meeting of stockholders, our stockholders approved our 2021

Equity Incentive Plan.

July 28, 2020, we entered into a Sales Agreement with Alliance Global Partners (“A.G.P.”) pursuant to which we may offer

and sell, from time to time, at our option, through or to A.G.P., up to an aggregate of approximately $9,300,000 of shares of common

stock (the “ATM Facility”).

Any shares to be offered and sold under the Sales Agreement will be issued and sold pursuant

to the Company’s Registration Statement on Form S-3 (File No.

333-223130), filed with the SEC on February 21, 2018 and the prospectus

supplement thereto filed with the SEC on July 28, 2020, by methods deemed to be an “at the market offering” as defined in

Rule 415(a)(4) promulgated under the Securities Act of 1933, as amended, or if specified by us, by any other method permitted by law.

On January 11, 2021, we increased the aggregate amount of our shares of common stock that may be sold under the Sales Agreement from

$9,300,000 to $10,382,954, and, as a result, utilized and sold the maximum amount allowable under the ATM Facility, which resulted in

an aggregate amount of $10,381,958.

April 14, 2021, our stockholders approved a reverse stock split of our common stock, following which, and on the same date, our board

of directors approved a ratio of 1-for-15 for the reverse stock split, or the Reverse Stock Split.

On April 14, 2021, the Delaware Secretary

of State approved our Certificate of Amendment to our Amended and Restated Certificate of Incorporation, which set an effective date

of April 26, 2021, for the Reverse Stock Split.

The post-Reverse Stock Split CUSIP number for our common stock is 45779A 846.

the April 26, 2021, the total number of shares of our common stock held by each stockholder was converted automatically into the number

of whole shares of common stock equal to (i) the number of issued and outstanding shares of common stock held by such stockholder immediately

prior to the Reverse Stock Split, divided by (ii) 15.

fractional shares were issued in connection with the Reverse Stock Split, and no cash or other consideration was be paid.

issued one whole share of the post-Reverse Stock Split common stock to any shareholder who otherwise would have received a fractional

share as a result of the Reverse Stock Split.

of Kathryn Arnold to our Board of Directors

May 10, 2021, the board of directors appointed Ms.

Kathryn Arnold as a Class III member of the Board, effective as of that date, with

a term expiring at the Company’s 2023 annual meeting of stockholders.

In connection with her appointment, on May 10, 2021, Ms.

Arnold was granted (a) options to purchase 3,512 shares of Common Stock (the “Options”), and (b) 10,536 shares of restricted

stock (the “Restricted Stock”, together with the Options the “Arnold Grant”).

The Options have an exercise price

equal to the closing fair market value of the Common Stock on the date of grant, subject to the terms and conditions of the Company’s

2013 Long-Term Incentive Plan (the “Plan”).

The Options and the Restricted Stock will vest and become exercisable in three

equal annual installments beginning on the one-year anniversary of the date of the Arnold Grant, provided that in the event that Ms.

Arnold is either (i) not reelected as a director at the Company’s 2023 annual meeting of stockholders, or (ii) not nominated for

reelection as a director at the Company’s 2023 annual meeting of stockholders, any unvested Options or Restricted Stock will vest

in full and become exercisable on the date of the decision not to reelect or nominate her (as applicable).

The Options have a term of

10 years from the date of grant.

May 10, 2021, we announced that our shares that previously traded on the NYSE American were approved for listing on the Nasdaq Capital

Market (“Nasdaq”) and such shares began trading on Nasdaq on May 21, 2021 under the symbol, “NSPR.” On May 27,

2021, we announced that our warrants that previously traded on the NYSE American were approved for listing on Nasdaq, and such warrants

began trading on June 8, 2021.

On July 7, 2021, our Series A warrants that previously traded under symbol “NSPRW” expired.

Commission for the Evaluation of Medical Devices and Health Technologies

October 13, 2021, we announced that our CGuard EPS stent system received a positive opinion from the National Commission for the Evaluation

of Medical Devices and Health Technologies (CNEDIMTS) of the French National Authority for Health (HAS) regarding reimbursement in France,

and the CGuard EPS was being added to the list of reimbursed medical products (LPPR) effective October 25, 2021.

This was the final step

to full commercial launch of CGuard EPS following CNEDIMTS’ positive opinion for reimbursement received by the Company on May 11,

2021 for the treatment of symptomatic and non-symptomatic lesions when surgery is not indicated.

COVID-19 global pandemic has led governments and authorities around the globe to take various precautionary measures in order to limit

the spread of COVID-19, including government-imposed quarantines, lockdowns, and other public health safety measures.

We experienced

a significant COVID-19 related impact on our financial condition and results of operations, primarily during the year ended December

31, 2020, which we primarily attribute to the postponement of CGuard EPS procedures (non-emergency procedures), as hospitals have shifted

resources to patients affected by COVID-19.

To the best of our knowledge, there are European countries in which we operate reinstated

non-emergency procedures.

However, new COVID-19 variants, and potentially increasing infection rates make the current COVID-related environment

highly volatile and uncertain and we anticipate that the continuation of the pandemic and related restrictions and safety measures will

likely result in continued fluctuations in sales of our products, potentially enrollments in our studies as well as potential disruptions

to our supply chain for the upcoming periods.

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

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by Major Geography and Addressable Markets).

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

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

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

The second is 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.

vascular diseases (“PVD”) are caused by the formation of atherosclerotic plaques in arteries, which carry blood to organs,

limbs and head.

It is also known as peripheral artery occlusive disease or peripheral artery disease.

It comprises diseases pertaining

to both peripheral veins and peripheral arteries, affecting the peripheral and cardiac circulation in the body.

PVD includes diseases

outside of the heart and brain, but most times refers to the leg and foot.

stents are more often used in combination with balloon angioplasty to open the veins, so that blood can flow through the blocked veins

growing prevalence of PVD is expected to cause increased demand for treatment options.

PVD is age related and its prevalence increases

markedly with advancing age.

In addition, PVD is more prevalent in lower and medium income countries than in higher income countries

(https://www.thelancet.com/journals/langlo/article/PIIS2214-109X(19)30255-4)

is a summary of our current products and products under development, and their intended applications.

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

Mesh Platform Technology

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

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

– Carotid Applications

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

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

single device for use in carotid artery applications.

Our CGuard EPS received CE mark approval in the European Union in March 2013 and

was fully launched in Europe in September 2015.

Subsequently, we launched CGuard EPS in Russia and certain countries in Latin America

and Asia, including India.

In September 2020, we launched CGuard EPS in Brazil after receiving regulatory approval in July 2020 and on

February 3, 2021, we executed a distribution agreement with Chinese partners for the purpose of expanding our presence in China.

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.

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

Subsequently,

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

purpose of expanding our presence in China.

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

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

The first patients, who were under the care of principal investigator, Chris Metzger, M.D., system chair of clinical research at

Ballard Health System in Eastern Tennessee, were successfully implanted with the CGuard EPS stent device.

These are the first of 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 enrollment phase.

Additionally, we

intend to continue to invest in current and future potential product and manufacturing enhancements for CGuard EPS that are expected

to reduce cost of goods and/or provide the best-in-class performing delivery system.

In furtherance of our strategy that focuses on establishing

CGuard EPS as a viable alternative to vascular surgery, we are exploring adding new delivery systems and accessory solutions for procedural

protection to our portfolio.

Products– Coronary Applications

Stent MGuard Product.

Our MGuard Prime EPS coronary product is comprised of MicroNet wrapped around a cobalt-chromium based

bare-metal stent.

In comparison to a conventional bare-metal stent, we believe our MGuard Prime EPS coronary product with MicroNet mesh

provides protection from dangerous embolic showers in patients experiencing ST-segment elevation myocardial infarction, the most severe

form of a heart attack, referred to as STEMI.

Standard stents were not engineered for heart attack patients.

Rather, they were designed

for treating stable angina patients whose occlusion is different from that of an occlusion in a heart attack patient.

In acute heart

attack patients, the plaque or thrombus is unstable and often breaks up as the stent is implanted causing downstream blockages in a significant

portion of heart attack patients.

Our MGuard Prime EPS is integrated with a precisely engineered micro net mesh that is designed to prevent

the unstable arterial plaque and thrombus that caused the heart attack blockage from breaking off.

Over the past years there has been

a shift in industry preferences away from bare-metal stents, such as MGuard Prime EPS in ST-Elevation Myocardial Infarction STEMI patients.

As a result of declining sales of the MGuard Prime EPS, which we believe this is largely driven by the predominant industry preferences

favoring drug-eluting, or drug-coated, stents, we intend to phase out future sales of our MGuard Prime EPS in 2022.

— Peripheral Vascular Applications

intend to develop our MicroNet mesh sleeve and a self-expandable stent for use in peripheral vascular applications, to which we refer

to as PVGuard.

PVDs are usually characterized by the accumulation of plaque in arteries in the legs.

This accumulation can lead to the

need for amputation or even death, when untreated.

PVD is treated either by trying to clear the artery of the blockage, or by implanting

a stent in the affected area to push the blockage out of the way of normal blood flow.

in carotid procedures, peripheral procedures are characterized by the necessity of controlling embolic showers both during and post-procedure.

Controlling embolic showers is so important in these indications that physicians often use fully covered stents, at the risk of blocking

branching vessels, to ensure that emboli do not fall into the bloodstream and move to the brain.

We believe that our MicroNet design

will provide substantial advantages over existing therapies in treating peripheral artery stenosis.

as we plan to focus our resources on the further expansion of our sales and marketing activities for CGuard EPS and potential product

enhancements and manufacturing enhancements for CGuard EPS expected to reduce cost of goods and/or provide the best-in-class performing

delivery system and its submission for CE mark approval, we do not intend to pursue the development of PVGuard in the near future.

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.

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.

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

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

The device is intended as an external arterial-venous (A-V) shunt, allowing arterial blood to flow into the venous system, while filtering

particulate before returning blood to the patient on the venous side.

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

venous introducers during interventional procedures.

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

Clinical Trials for CGuard EPS

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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.

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.

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

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

(MI, stroke, death)

MACCE (MI, stroke, death)

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

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indicates the potential error in the measurement.

with new Acute Ischemic Lesions (“AIL”)

of new lesions

number new AIL

Subjects with new Acute Ischemic Lesions (“AIL”)

Incidence of new lesions

Total number new AIL

number new AIL per patient

lesion volume (cm 3 )

AIL at 30 days

Average lesion volume (cm 3 )

Maximum lesion volume (cm 3 )

Permanent AIL at 30 days

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

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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

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

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

Physician-Sponsored

Clinical Trials for CGuard—PARADIGM-101 Study

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

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

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of EuroIntervention.

findings from the PARADIGM-101 study and the follow-up data are as follows:

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

of Percutaneous Coronary Interventions, EuroIntervention 2020;16:e950-e952.

10.4244/EIJ-D-19-01014) Key findings from the PARADIGM-101

study and the follow-up data are as follows.

EPS delivery success was 99.1%.

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

event was adjudicated by the Clinical Events Committee as a minor stroke (0.9%), with no change in NIH Stroke Scale or modified Ranking

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).

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

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

carotid stenosis patients.

The new study is known as PARADIGM -500.

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

Leipzig, Germany.

findings from the PARADIGM-500 study are as follows.

Day Death/Stroke rate of 0.75%;

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

month 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:

Early Experience From a Single

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

Early Experience From a Single

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

The aim of the study

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

covered by a closed-cell polyethylene and terephthalate mesh designed to prevent embolic events.

In 2017, the 30-day positive results

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

findings from the study are as follows:

success in implanting CGuard EPS;

case of acute stent thrombosis occurred within 4 hours of the procedure:

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

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

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

peri- (48-72 hours) and post-operatively (30 days) in 21 and 11 patients, respectively.

Five of 21 patients (23.8%) had new ischaemic

brain lesions peri-operatively (48-72 hours) on the ipsilateral side, for a total number of 30 lesions, with an average lesion volume

of 0.039 +/- 0.025 cm3.

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

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

At the postoperative period,

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

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

Mesh-Covered Stent in Real World:

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myocardial infarction occurred at 12 months.

Peri-procedural

brain lesions prevention in CAS (3PCAS):

Randomized trial comparing CGuard stent vs.

WallStent™ Study

study was an independent investigator-led single center randomized clinical trial, comparing CGuard EPS vs.

WallStent™, intended

to evaluate the incidence of peri-procedural diffusion-weighted-magnetic-resonance-imaging (DW-MRI) new brain lesions after carotid artery

Sixty-one consecutive patients referred for carotid revascularization (between January 2015 and October 2016) were eligible

for the study.

The results of the 3PCAS study was published in the International Journal of Cardiology in September 2018.

The discussion

distinguished between peri-procedural (from procedure to 48h -72h) and post-procedural periods (72h to 30 days) where the CGuard EPS

demonstrated a reduction in the post-procedural embolic effect during the carotid plaque healing period.

In contrast, there was no difference

between the two stent groups during the peri-procedural stage because of, according to the published article, the presence of bilateral/contralateral

lesions (lesions resulting from the contralateral artery from the non-treated carotid) which suggest that the peri-procedural neurological

damage may have originated from extra-carotid sources (outside of the artery which was treated and outside the stent itself).

Clinical Study of the New CGuard EPS MicroNet Covered Carotid Stent:

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Syndrome) between 30 days and 1 year.

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

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

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

The aim of the study

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

system (EPS).

In April 2021, the 30-day positive results were published in the Journal of Endovascular Therapy, DOI:

10.1177/15266028211007466.

findings from the study are as follows:

technical success was achieved in all patients:

major adverse events (death, stroke, or myocardial infarction) at 30 days.

SIBERIA Trial for Carotid Artery Stenosis:

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Peri-procedural and 30-day Diffusion-Weighted Magnetic Resonance Imaging

and Clinical Outcomes

and Clinical Outcomes (RCT trial)

SIBERIA Trial for Carotid Artery Stenosis:

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stroke, myocardial infarction and death at 30 days.

The results of the study were presented in a late-breaking session at the EuroPCR

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

The 30 day results of the study were presented in a late-breaking session at the

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

JACC Cardiovascular Interventions, Vol.

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not only during but after carotid artery stenting.

The incidence of restenosis and vessel occlusion according to the ICA (internal carotid

artery) ultrasound and the incidence of strokes, myocardial infarctions or deaths between the study arms at 365 days were presented at

the LINC conference in Leipzig, Germany in June , 2022.

The 12 month outcomes demonstrated a significantly higher prevalence of the combined

endpoint of death, stroke or myocardial infarctions and in-stent restenosis and vessel occlusion rate in the first generation (single

layer) carotid stent, Acculink TM , versus the MicroNet-Covered Stent, CGuard™.

findings from the study are as follows:

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

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

strokes and one myocardial infarction).

Clinical Trials for MGuard Bare-Metal Coronary Products

have completed eight clinical trials with respect to our first generation stainless steel-based MGuard coronary device and our cobalt-chromium

based MGuard Prime EPS stent.

Our first generation MGuard stent combining the MicroNet with a stainless steel stent received CE mark

approval for the treatment of coronary artery disease in the European Union in October 2007.

We subsequently replaced the stainless steel

stent with a more advanced cobalt-chromium based stent for MGuard Prime EPS.

First in Men (FIM) study conducted in Germany from the fourth quarter of 2006 through the second quarter of 2008 focused on patients

with occlusion in their stent graft.

This group is considered to be in “high risk” for complications during and shortly after

the procedure due to the substantial risk of occurrence of a thromboembolic event.

The study demonstrated MGuard’s safety in this

high risk group.

This study was followed by the GUARD study in Brazil in 2007 with a similar patient population which reinforced the

safety profile of MGuard in patients prone to procedural complications.

The MAGICAL study was a pilot study in STEMI patients conducted

in Poland from 2008 through 2012 which demonstrated safety, measured by MACE rates at 30 days following the procedure, as well as efficacy

results, measured by the ability of MGuard to reestablish blood flow into the infarcted area of the muscle.

Furthermore, we conducted

three registries (iMOS, IMR and iMOS Prime) that confirmed the feasibility of MGuard and MGuard Prime EPS for the treatment of STEMI

patients and the safety of MGuard and MGuard Prime EPS in the STEMI patient group.

Safety was repeatedly demonstrated in these trials

and registries by the low mortality rate in the first month after the procedure.

the second calendar quarter of 2011, we began the MGuard for Acute ST Elevation Reperfusion Trial (which we refer to as our “MASTER

I trial”), a prospective, randomized study, which demonstrated that among patients with acute STEMI undergoing emergency PCI, patients

treated with MGuard had superior rates of epicardial coronary flow (blood flow within the vessels that run along the outer surface of

the heart) and complete ST-segment resolution, or restoration of blood flow to the heart muscle after a heart attack, compared to those

treated with commercially-approved bare metal or drug-eluting stents.

The results of this trial are summarized in greater detail below.

the MASTER II trial, which we initially initiated as part of our efforts to seek approval of our MGuard Prime EPS by the FDA, was discontinued

at our election in its current form in light of market conditions moving toward the use of drug-eluting stents over bare-metal stents.

Analysis of the patients already enrolled in the MASTER II trial prior to its suspension, however, reconfirmed the MASTER I safety results

due to a continued low mortality rate.

the second calendar quarter of 2011, we began the MASTER I trial, a prospective, randomized study in Europe, South America and Israel

to compare the MGuard with commercially-approved bare metal and drug-eluting stents in achieving superior myocardial reperfusion (the

restoration of blood flow) in primary angioplasty for the treatment of acute STEMI, the most severe form of heart attack.

I trial enrolled 433 subjects, 50% of whom were treated with MGuard and 50% of whom were treated with a commercially-approved bare metal

or drug-eluting stents.

The detailed acute and 30 days results from the trial were presented at the TCT conference on October 24, 2012

and published (Prospective, Randomized, Multicenter Evaluation of a Polyethylene Terephthalate Micronet Mesh–Covered Stent (MGuard)

in ST-Segment Elevation Myocardial Infarction, Stone et.

al, JACC , 60;

The results were as follows:

primary endpoint of post-procedure complete ST-segment resolution (restoration of blood flow to the heart muscle after a heart attack)

was statistically significantly improved in patients randomized to the MGuard compared to patients receiving a commercially-approved

bare metal or drug-eluting stent (57.8% vs.

receiving MGuard exhibited superior rates of thrombolysis in myocardial infarction (TIMI) 3 flow, which evidences normal coronary

blood flow that fills the distal coronary bed completely, as compared to patients receiving a commercially-approved bare metal or

drug-eluting stent (91.7% vs.

82.9%), with comparable rates of myocardial blush grade 2 or 3 (83.9% vs.

84.7%) and corrected TIMI

frame count (cTFC) (17.0 vs.

success rates (attainment of <50% final residual stenosis of the target lesion and final TIMI 3 flow) were higher in the MGuard

group compared to commercially-approved bare metal or drug-eluting stents (91.7% vs 82.4%).

1.9%) and major adverse cardiac events (1.8% vs.

2.3%) at 30 days post procedure were not statistically significantly different

between patients randomized to MGuard as opposed to patients randomized to commercially-approved bare metal or drug-eluting stents.

All other major adverse cardiac event components, as well as stent thrombosis, were comparable between the MGuard and commercially-approved

bare metal or drug-eluting stents.

six month results from the MASTER I trial were presented at the 2013 EuroPCR Meeting, the official annual meeting of the European Association

for Percutaneous Cardiovascular Interventions, on May 23, 2013 in Paris, France.

The results were as follows:

2.8%) and major adverse cardiac events (5.2% vs.

3.4%) at 6 months post procedure were not statistically significantly

different between patients randomized to the MGuard as compared to patients randomized to commercially-approved bare metal or drug-eluting

All other major adverse cardiac event components, as well as stent thrombosis, were comparable between patients treated with

MGuard and those treated with commercially-approved bare metal or drug-eluting stents.

twelve month results from the MASTER I trial were presented at the TCT conference on October 29, 2013 and published (Mesh-Covered Embolic

Protection Stent Implantation in ST-Segment–Elevation Myocardial Infarction Final 1-Year Clinical and Angiographic Results From

the MGUARD for Acute ST Elevation Reperfusion Trial, Dudek et.

al, Coronary Interventions , 2014).

The results were as follows:

3.3%) and major adverse cardiac events (9.1% vs.

3.3%) at 12 months post procedure were not statistically significantly

different between patients randomized to the MGuard as opposed to those randomized to commercially-approved bare metal or drug-eluting

All other major adverse cardiac events, as well as stent thrombosis, were comparable between the MGuard and commercially-approved

bare metal or drug-eluting stents.

summary, the MASTER I trial demonstrated that among patients with acute STEMI undergoing emergency PCI patients treated with MGuard had

superior rates of epicardial coronary flow (blood flow within the vessels that run along the outer surface of the heart) and complete

ST-segment resolution compared to those treated with commercially-approved bare metal or drug-eluting stents.

In addition, patients treated

with MGuard showed a slightly lower mortality rate and a slightly higher major adverse cardiac event rate as compared to patients treated

with commercially-approved bare metal or drug-eluting stents six and twelve months post procedure.

detailed table with the results from the MASTER I trial is set forth below.

The “p-Value” refers to the probability of obtaining

a given test result.

Any p value less than 0.05 is considered statistically significant.

Metal Stents/Drug

blush grade 0-1

blush grade 3

segment resolution >70

day major adverse cardiac event

month major adverse cardiac event

Clinical Trials for CGuard EPS and MGuard Prime EPS

Post-marketing

clinical trials (outside the United States) could be conducted to further evaluate the safety and efficacy of CGuard EPS in specific

These trials would be designed to facilitate market acceptance and expand the use of the product.

We expect to be able to

rely upon CE mark approval of the product and other supporting clinical data to obtain local approvals.

do not anticipate conducting additional post-marketing clinical trials for our bare-metal MGuard coronary products.

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

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

vessel occlusion in the Acculink™ arm;

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

myocardial infarction).

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, complex vascular and coronary 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

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 .

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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 adjuctive

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.

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to widen the adoption of CGuard EPS.

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

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.

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.

Our delivery systems will enable all endovascular access points including accessory

devices for Arterial Venous (AV) shunting .

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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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.

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.

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)

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

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of industry participants.

carotid stent markets in the United States and Europe are dominated by Abbott Laboratories, Boston Scientific Corporation, Covidien Ltd.

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

Gore Medical and Terumo Medical

Corporation produce a polytetrafluoroethylene mesh-covered stent and a double layer metal stent, respectively.

All of these larger companies

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

management resources, larger research and development staffs and larger facilities than ours and have established reputations and relationships

with our target customers, as well as worldwide distribution methods that are more effective than ours.

However, we believe that the

European market is somewhat fragmented, and, in our opinion, smaller competitors may be able to gain market share with greater flexibility.

Neurovascular

industry players in the global neurovascular devices market include Medtronic, Stryker, Terumo and Johnson & Johnson.

and mergers are increasingly used as a strategy for product portfolio expansion and to grow footprint.

(Global Market Insights, Inc.

- Devices Market Share 2018-2024 Industry Size Report.

https://www.gminsights.com/industry-analysis/neurovascular-devices-market)

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”).

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

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

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

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

However, while there are currently many market participants

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

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

outcomes and adverse event rates;

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

a result of declining sales of the MGuard Prime EPS, which we believe is largely driven by the predominant industry preferences favoring

drug-eluting stents rather than bare metal stents such as MGuard Prime EPS in STEMI patients, we intend to phase out future sales of

our MGuard Prime EPS in 2022.

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

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Centers for Medicare and Medicaid Services (CMS).

The CGuard products and MGuard coronary products 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.

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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for Two-Stage Deployment of a Stent

Visualization

of blood flow in a venous/arterial shunting system

(Provisional)

for shunting blood between the arterial and venous systems of a patient

(provisional)

air from fluid in vascular and/or arterial delivery lines or blood circuits

(provisional)

with Blood-Flow Indicators

for Shunting Blood Between the Arterial and Venous Systems

for shunting blood

Vivo Filter Assembly

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Canada 2,887,189

China ZL200780046697.4

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Germany, France, & UK

)US 10,137,015

Canada 3,013,758

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US 11,051,959

(validated in 9 countries:

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

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US 10,058,440

US 10,070,977

Thermoforming Apparatus and Methods

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

ZL 2019800679437

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

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(US, European Union, and UK)

Prime ® (US, European Union, and UK)

(US, European Union)

(US, European Union, and UK)

Prime ® (European Union, and UK)

(European Union and UK)

(European Union, and UK)

Micronet Protection logo) (European Union and UK)

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Union and UK)

Logo (EP, UK, US);

CN & JP in preparation

Prime (EP, UK, US)

(US, UK and CN)

Logo (EP, UK, CN)

Prime (EP, UK, US, CN, JP)

(EP, UK, US, JP)

North Medical (US, EP, UK)

logo (US, EP, UK CN, JP)

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

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

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on the market.

In order to obtain and maintain the CE mark, we must comply with the Medical Device Directive 93/42/EEC (“MDD”)

by presenting comprehensive technical files for our products demonstrating safety and efficacy of the product to be placed on the market

and passing initial and annual quality management system audit as per ISO 13485 standard by a European Notified Body.

We have obtained

ISO 13485 quality system certification and the products we currently distribute into the European Union display the required CE mark.

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

Union replaced the MDD with the new European Medical Devices Regulation, or MDR (MDR 2017/745, Council Directive 93/42/EEC).

will apply after a transitional period of three years ending on May 26, 2021, which is expected to change several aspects of the existing

regulatory framework in Europe.

Manufacturers have the duration of the transition period to update their technical documentation and

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

After May 26, 2021, medical devices can still be placed on the market

under the provision of the MDD until May 26, 2024;

provided the CE Mark was issued prior to this date and the manufacturer continues

to comply with this directive.

By May 26, 2024, all medical devices entering the EU will need to have a CE Mark under the MDR, even if

they have been on the market previously under the MDD.

In our case, CGuard and MGuard Prime can continue to be marketed under the MDD

until November 12, 2022.

Specifically, the EU MDR will require changes in the clinical evidence required for medical devices, post-market

clinical follow-up evidence, annual reporting of safety information for Class III products, Unique Device Identification (“UDI”)

for all products, submission of core data elements to a European UDI database prior to placement of a device on the market, and multiple

other labeling changes.

Approvals for certain of our currently-marketed products could be curtailed or withdrawn as a result of the implementation

and recertification process of the EU MDR and acquiring approvals for new products could be more challenging, time consuming and costly.

noted below, we have or had regulatory approval and made sales of CGuard EPS, MGuard Prime EPS or both products either through distributors

pursuant to distribution agreements or directly, in the following countries:

Argentina, Australia, Austria, Belarus, Belgium, Brazil,

Bulgaria, Chile, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Estonia, Finland, France, Germany, Hong Kong, Hungary,

India Ireland, Israel, Italy, Latvia, Lithuania, Luxembourg, Malaysia, Malta, Mexico, Netherlands, New Zealand, Norway, Peru, Poland,

Portugal, Romania, Russia, Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Turkey, Vietnam, Taiwan

and the United Kingdom.

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.

while we believe that certain of the above-listed countries that are not members of the European Union accept the CE mark as a primary

requirement for marketing approval, each such country requires additional regulatory requirements for final marketing approval of our

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.

October 2007, our first generation MGuard stent combining the MicroNet with a stainless-steel stent received CE mark approval for the

treatment of coronary artery disease in the European Union.

We subsequently replaced the first generation MGuard product with MGuard

Prime EPS, which uses a more advanced cobalt-chromium based stent.

Our MGuard Prime EPS received CE mark approval in the European Union

in October 2010 and marketing approval in those countries listed in the table below.

CGuard EPS received CE mark approval in the European Union on March 14, 2013 and marketing approval in the countries listed in the table

We are currently seeking marketing approval for CGuard EPS in, South Korea.

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

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

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

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

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

the required CE mark.

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

Body auditors.

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

The MDR entered into force after a transitional period

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

aspects of the regulatory framework in the European Union.

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

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

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.

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*

Liechtenstein

to temporary approval to import limited amount of units (400) to Kazakhstan.

Refers to units used in our ongoing FDA trial.

* 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.

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

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

Medical devices that 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 testing.

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

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.

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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host of regulatory requirements apply to our approved devices, including the quality system regulation (which requires manufacturers

to follow elaborate design, testing, control, documentation and other quality assurance procedures), the Medical Device Reporting regulations

(which require that manufacturers report to the FDA specified types of adverse events involving their products), labeling regulations,

and the FDA’s general prohibition against promoting products for unapproved or “off-label” uses.

Class II devices also

can have special controls such as performance standards, post-market surveillance, patient registries, and FDA guidelines that do not

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”

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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customer base is varied.

We began shipping our MGuard product to customers in Europe in January 2008 and CGuard product to customers

in Europe in 2014 and have since expanded our global distribution network to Southeast Asia, India, Latin America and Israel.

have distribution agreements for our CE mark-approved CGuard EPS with medical product distributors based in Europe, the Middle East,

Asia Pacific and Latin America.

We are currently in discussions with additional distribution companies in Europe, Asia, and Latin America.

We currently have distribution agreements for our CE mark-approved CGuard EPS with medical product distributors

based in Europe, the Middle East, Asia Pacific and Latin America.

We are currently in discussions with additional distribution companies

in Europe, Asia, and Latin America.

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

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purchase obligations.

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

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

Manufacturing

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and engineering applications.

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

Our agreement with Natec Medical Ltd., as

amended, may be terminated by us upon eight months’ notice.

On August 1, 2017, we amended the agreement with Natec Medical Ltd.,

so that we are responsible for purchasing and handling inventory of CGuard EPS delivery system, and Natec Medical Ltd.is responsible

for the manufacturing process.

supplies us with catheters that help create the base for our MGuard Prime EPS.

Our agreement with Natec Medical Ltd., which

may be terminated by either party upon six months’ notice, calls for non-binding minimum orders.

cobalt-chromium stent for our MGuard Prime EPS was designed by Svelte Medical Systems Inc.

We have an agreement with Svelte Medical Systems

Inc., as amended, that grants us a non-exclusive, worldwide license for production and use of the MGuard Prime cobalt-chromium stent

for the life of the stent’s patent, subject to the earlier termination of the agreement upon the bankruptcy of either party or

the uncured default by either party under any material provision of the agreement.

Our royalty payments to Svelte Medical Systems Inc.

are determined by the sales volume of MGuard Prime EPS.

Currently, the royalty rate is 2.9% of all net sales.

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

The bare-metal cobalt-chromium stents for our MGuard Prime EPS and

the self-expanding bare-metal stents for our CGuard EPS are being manufactured and supplied by MeKo Laserstrahl-Materialbearbeitung.

Our agreement with MeKo Laserstrahl-Materialbearbeitung for the production of electro polished L605 bare-metal stents for MGuard Prime

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

The complete assembly process for MGuard

Prime EPS and CGuard EPS, 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 MGuard Prime EPS and CGuard EPS 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.

MGuard stent is manufactured from two main components, the stent and the mesh polymer.

The stent is made out of cobalt chromium.

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

The mesh is made from polyethylene terephthalate (polyester).

material is readily available in the market as well, because it is used for many medical applications.

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

Each CGuard stent is manufactured from two main components, a self-expending

nickel-titanium stent and the mesh polymer.

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.

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.

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.

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

Each CGuard stent is manufactured from two main components,

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

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

The mesh is made

from polyethylene terephthalate (polyester).

The mesh is made from polyethylene terephthalate (polyester).

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

This material is readily

available in the market as well, because it is used for many medical applications.

In the event that our supplier can no longer supply

this material in fiber form, we would need to qualify another supplier, which could take several months.

The 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 several months.

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.

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

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8 in quality assurance and compliance, 5 in finance and accounting, 21 in operations/production, 12 in sales, marketing and clinical,

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

Except for 5 of our employees

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

We do not expect the collective bargaining agreements

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

We also employ 3 independent contractors

in Poland and 1 in Brazil.

and 2 in all other miscellaneous roles, Human resources, and administration.

Except for 5 of our employees in Europe, our employees are

not party to any collective bargaining agreements.

We do not expect the collective bargaining agreements to which our employees are party

to have a material effect on our business or results of operations.

We also employ 3 independent contractors in Poland and 1 in Brazil.

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

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facilitate retention of personnel, particularly for our key employees.

success of our business is fundamentally connected to the well-being of our people.

Accordingly, we are committed to the health and safety

of our employees.

In response to the COVID-19 pandemic, we follow government regulations which may include at certain periods having

employees work from home, while implementing additional safety measures for employees continuing critical on-site work.

consider our relations with our employees to be good.

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