What changed in this filing

/stocks — the workspaceLOADING

Item 2. Management’s Discussion and Analysis

2024-05-13 compared with 2023-11-06 · 163 added, 279 removed, 112 unchanged (80% of the section changed)

20 unchanged sentences

to obtain and could dilute out stockholders’ ownership interests;

acceptance of our products;

inability to secure and maintain regulatory approvals for the sale of our products;

clinical trial results or lengthy product delays in key markets;

ability to maintain compliance with the Nasdaq Capital Market listing standards;

ability to maintain compliance with the Nasdaq listing standards;

ability to generate revenues from our products and obtain and maintain regulatory approvals for our products;

ability to adequately protect our intellectual property rights;

dependence on a single manufacturing facility and our ability to comply with stringent manufacturing quality standards;

ability to adequately protect our intellectual property;

dependence on a single manufacturing facility and our ability to comply with stringent manufacturing quality standards and to increase

production as necessary;

risk that the data collected from our current and planned clinical trials may not be sufficient to demonstrate that our technology

is an attractive alternative to other procedures and products;

competition in our industry, with competitors having greater financial, technological, research and development, regulatory and clinical,

manufacturing, marketing and sales, distribution and personnel resources than we do;

competition in our industry, with competitors having substantially greater financial, technological, research and development, regulatory

and clinical, manufacturing, marketing and sales, distribution and personnel resources than we do;

of new competitors and products and potential technological obsolescence of our products;

4 unchanged sentences

increases for supplies and components;

economic conditions;

or inadequate reimbursement by governmental and other third-party payers for our products;

federal, state and local government regulation in the United States, Europe, Israel and other foreign jurisdictions;

efforts to successfully obtain and maintain intellectual property protection covering our products, which may not be successful;

federal, state and local government regulation, in the United States, Europe or Israel and other foreign jurisdictions;

fact that we conduct business in multiple foreign jurisdictions, exposing us to foreign currency exchange rate fluctuations, logistical

and communications challenges, burdens and costs of compliance with foreign laws and political and economic volatility in certain

jurisdictions;

and communications challenges, burdens and costs of compliance with foreign laws and political and economic instability in each jurisdiction;

political and economic instability in the Middle East that could harm our business, including due to the current war between Israel

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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.

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

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

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.

4 unchanged sentences

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

in patients undergoing carotid artery stenting.

The 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.

In June 2023, we completed enrollment of 316 patients across

24 trial sites in the U.S.

and Europe in our IDE clinical trial.

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

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 at the end of May 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 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.

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 are 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 will be 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 of $41,600.

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.

Results from the U.S.

Investigational Device Exemption (IDE) clinical trial

November 1, 2023, the Company released 30-day results from the C-GUARDIANS U.S.

Investigational Device Exemption (IDE) clinical trial.

From July 2021 to June 2023, 316 patients were prospectively enrolled in a single-arm carotid artery stenting study performed at 24 sites

in the United States and the European Union.

The primary endpoint in the clinical trial was a composite of:

(1) incidence of major adverse

events including death (all-cause mortality), any stroke, or myocardial infarction (“DSMI”) through 30-days post index procedure,

or (2) ipsilateral stroke from day 31 to day 365 post-procedure.

Stenting with the C-Guard 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.

Developments Potentially Affecting Our Business.

October 2023, Hamas terrorists infiltrated Israel’s southern border from the Gaza Strip and conducted a series of attacks on civilian

and military targets.

Hamas also launched extensive rocket attacks on the Israeli population and industrial centers located along Israel’s

Hamas also launched extensive rocket attacks on Israeli population and industrial centers located along Israel’s

border with the Gaza Strip and in other areas within the State of Israel.

These attacks resulted in thousands of deaths and injuries,

and Hamas additionally kidnapped many Israeli civilians and soldiers.

Following the attack, Israel’s security cabinet declared

war against Hamas and commenced a military campaign against Hamas and other terrorist organizations in parallel to their continued rocket

and terror attacks.

These attacks resulted in extensive deaths, injuries and kidnapping

of civilians and soldiers.

Following the attack, Israel’s security cabinet declared war against Hamas and a military campaign against

these terrorist organizations commenced in parallel to their continued rocket and terror attacks.

In addition, since the commencement

of these events, there have been continued hostilities along Israel’s northern border with Lebanon (with the Hezbollah terror organization)

and southern border (with the Houthi movement in Yemen).

It is possible that hostilities with Hezbollah in Lebanon will escalate, and

that other terrorist organizations, including Palestinian military organizations in the West Bank as well as other hostile countries

will join the hostilities.

In addition, Iran recently launched a direct attack on Israel involving

hundreds of drones and missiles and has threatened to continue to attack Israel and is widely believed to be developing nuclear weapons.

Iran is also believed to have a strong influence among extremist groups in the region, such as Hamas in Gaza, Hezbollah in Lebanon, the

Houthi movement in Yemen and various rebel militia groups in Syria and Iraq.

Such clashes may escalate in the future into a greater

regional conflict.

We cannot currently predict the intensity or duration of Israel’s war against Hamas, nor can we predict how

7 unchanged sentences

Statements included in the Annual Report on Form 10-K for the year ended December 31, 2023.

Other than the following new accounting policies,

there have not been any material changes to such critical accounting policies since December 31, 2022.

and Cash Equivalents

consider all highly liquid investments purchased with original maturities of three months or less from the purchase date to be cash equivalents.

As of September 30, 2023, cash and cash equivalents consisted of cash, short-term deposits (up to three months from the date of deposit)

and money market funds.

As of December 31, 2022, this balance consisted solely of cash.

securities consist of debt securities.

we elected the fair value option to measure and recognize its investments in debt securities in

accordance with ASC 825, Financial Instruments as we manage our portfolio and evaluates the performance on a fair value basis.

in fair value, realized gains and losses on sales of marketable securities, are reflected in the statements of operation as finance expense

(income), net.

There have not been any material changes

to such critical accounting policies since December 31, 2023.

currency of the primary economic environment in which our operations are conducted is the U.S.

dollar (“$” or “dollar”).

Contingencies

and our subsidiaries are involved in legal proceedings that arise from time to time in the ordinary course of business.

We record accruals

for these types of contingencies to the extent that we conclude the occurrence of such contingencies is probable and that the related

liabilities are estimable.

When accruing these costs, we recognize an accrual in the amount within a range of loss that is the best estimate

within the range.

When no amount within the range is a better estimate than any other amount, we accrue for the minimum amount within

Legal costs are expensed as incurred.

of Operations

months ended September 30, 2023, compared to the three months ended September 30, 2022

For the three months ended September 30, 2023, revenue increased by $125,000, or 8.7%, to $1,556,000, from $1,431,000 during the three

months ended September 30, 2022.

months ended March 31, 2024, compared to the three months ended March 31, 2023

For the three months ended March 31, 2024, revenue increased by $272,000, or 22.0%, to $1,511,000, from $1,239,000 during the three months

ended March 31, 2023.

This increase was predominantly driven by growth in existing markets.

respect to geographical regions, the increase in revenue was primarily attributable to a $169,000 increase in Europe, a $115,000 increase

in Asia and a $30,000 increase in other geographies, for reasons mentioned in the paragraph above.

This increase was offset by a $41,000

decrease in the United States as we completed in June 2023 the enrollment of all patients in our C-Guardians IDE clinical trial and accordingly

there were no further enrollments in the three months ended September 30, 2023.

For the three months ended September 30, 2023, gross profit (revenue less cost of revenues) increased by $72,000, or 19.7%,

to $438,000, from $366,000 during the three months ended September 30, 2022.

This increase in gross profit resulted from a $85,000 increase

in revenues less the associated related material and labor offset by $13,000 in miscellaneous expenses.

Gross margin (gross profits as

a percentage of revenue) increased to 28.1% during the three months ended September 30, 2023, from 25.6% during the three months ended

September 30, 2022, driven by the factors mentioned above.

in Latin America, $50,000 increase in Asia and a $10,000 increase in other geographies, for reasons mentioned in the paragraph above.

This increase was offset by a $59,000 decrease in the United States as we completed in June 2023 the enrollment of all patients in our

C-Guardians IDE clinical trial and accordingly there were no further enrollments in the three months ended March 31, 2024 and a $13,000

decrease in other territories.

For the three months ended March 31, 2024, gross profit (revenue less cost of revenues) decreased by $81,000, or 21.6%, to

$292,000, from $373,000 during the three months ended March 31, 2023.

This decrease in gross profit resulted from a $85,000 increase

in training costs for new hires to build capacity for anticipated increased volume requirements, offset by $4,000 in miscellaneous expenses.

Gross margin (gross profits as a percentage of revenue) decreased to 19.4% during the three months ended March 31, 2024, from 30.1% during

the three months ended March 31, 2023, driven by the factors mentioned above.

and Development Expenses .

For the three months ended September 30, 2023, research and development expenses increased by $49,000,

or 2.4%, to $2,110,000, from $2,061,000 during the three months ended September 30, 2022.

For the three months ended March 31, 2024, research and development expenses increased by $782,000, or

42.4%, to $2,625,000, from $1,843,000 during the three months ended March 31, 2023.

This increase resulted primarily from an increase

of $178,000 in expenses related to the SwitchGuard regulatory and approval process, an increase in compensation expenses of $145,000,

mainly due to an increase of share-based compensation-related expenses due to the expense recognition of grants made during the second

quarter of 2023 and an increase of $107,000 in miscellaneous expenses.

These increases were partially offset by a $381,000 decrease in

expenses related to the C-Guardians FDA study.

The enrollment of all patients in our IDE clinical trial was completed in June 2023, resulting

in no enrollment expenses for the three months ended September 30, 2023.

in compensation expenses of $567,000, mainly due to an increase of share-based compensation-related expenses due to the expense recognition

of grants made during the second quarter of 2023 and the first quarter of 2024 and due to the hiring of the Executive Vice President

and General Manager of North America in connection with our expansion plans in the United States, an increase of $159,000 related to

an early feasibility study of CGuard Prime for the treatment of acute stroke patients with tandem lesions and an increase of $56,000

in miscellaneous expenses.

and Marketing Expenses .

For the three months ended September 30, 2023, selling and marketing expenses increased by $31,000, or 3.7%,

to $876,000, from $845,000 during the three months ended September 30, 2022.

This increase resulted from an increase of $31,000 in miscellaneous

For the three months ended March 31, 2024, selling and marketing expenses increased by $449,000, or 57.0%,

to $1,237,000, from $788,000 during the three months ended March 31, 2023.

This increase resulted primarily from an increase in compensation

expenses of $381,000, mainly due to an increase of share-based compensation-related expenses due to the expense recognition of grants

made during the second quarter of 2023 and the first quarter of 2024 and an increase of $68,000 in miscellaneous expenses.

and Administrative Expenses .

For the three months ended September 30, 2023, general and administrative expenses increased by $1,021,000,

or 49.3%, to $3,091,000, from $2,070,000 during the three months ended September 30, 2022.

For the three months ended March 31, 2024, general and administrative expenses increased by $1,721,000,

or 81.1%, to $3,844,000, from $2,123,000 during the three months ended March 31, 2023.

This increase resulted primarily from an increase

in compensation expenses of $941,000, mainly due to an increase of approximately $755,000 of share-based compensation-related expenses

due to the expense recognition of grants made during the second quarter of 2023 and an increase in salary expenses and related accruals

of $186,000 mainly due to hiring of a General Manager of North America and VP of Global Marketing (who was subsequently promoted to the

Company’s Chief Commercial Officer in the third quarter of 2023) and an increase of $80,000 in miscellaneous expenses.

For the three months ended September 30, 2023, financial income increased by $380,000, to $461,000, from $81,000 during the

three months ended September 30, 2022.

in compensation expenses of $1,682,000, mainly due to an increase of share-based compensation-related expenses due to the expense recognition

of grants made during the second quarter of 2023 and the first quarter of 2024, and an increase of $39,000 in miscellaneous expenses.

For the three months ended March 31, 2024, financial income increased by $257,000 or 205.6%, to $382,000, from $125,000 during

the three months ended March 31, 2023.

The increase in financial income primarily resulted from a $264,000 increase in interest income

from investment in marketable securities, money market funds and short-term bank deposits.

For the three months ended September 30, 2023, there was no change in our tax expenses as compared to the three months

ended September 30, 2022.

Our net loss increased by $649,000, or 14.3%, to $5,178,000, for the three months ended September 30, 2023, from $4,529,000

during the three months ended September 30, 2022.

The increase in net loss resulted primarily from an increase of $1,101,000 in operating

expenses partially offset by an increase of $380,000 in financial income and an increase of $72,000 in gross profit.

months ended September 30, 2023, compared to the Nine months ended September 30, 2022

For the nine months ended September 30, 2023, revenue increased by $299,000, or 7.2%, to $4,444,000, from $4,145,000 during the Nine

months ended September 30, 2022.

This increase was predominantly driven by a 8.5% increase in sales volume of CGuard EPS from $4,097,000

during the nine months ended September 30, 2022, to $4,444,000 during the nine months ended September 30, 2023.

This sales increase was

mainly due to growth in existing markets.

respect to geographical regions, the increase in revenue was primarily attributable to a $251,000 increase in Europe, a $90,000 increase

and a $4,000 increase in the Middle East.

This increase in sales of was partially offset by a $46,000 decrease in other geographies

mainly driven by 41,000 decrease in the United States as we completed in June 2023 the enrollment of all patients in our C-Guardians

IDE clinical trial and accordingly there were no further enrollments in the three months ended September 30, 2023.

For the nine months ended September 30, 2023, gross profit (revenue less cost of revenues) increased by 41.7%, or $383,000,

to $1,302,000, compared to a $919,000 for the same period in 2022.

This increase in gross profit resulted from a $246,000 increase in

revenues less the associated related material and labor costs and a decrease in write-offs of $199,000.

This increase was partially offset

by an increase of $62,000 in miscellaneous expenses.

Gross margin (gross profits as a percentage of revenue) increased to 29.3% during

the nine months ended September 30, 2023, from 22.2% during the Nine months ended September 30, 2022, driven by the reasons mentioned

and Development Expenses .

Research and Development Expenses .

For the nine months ended September 30, 2023, research and development

expenses increased by 2.6%, or $149,000, to $5,946,000, from $5,797,000 during the nine months ended September 30, 2022.

This increase

resulted primarily from an increase of compensation expenses of $314,000, an increase of $187,000 in expenses related to the SwitchGuard

regulatory and approval process, an increase of $130,000 in expenses related to the CGuard Prime regulatory and approval process and

an increase of $261,000 in miscellaneous expenses offset, in part, by a decrease of $743,000 in expenses related to the C-Guardians FDA

and Marketing Expenses .

For the nine months ended September 30, 2023, selling and marketing expenses decreased by 0.8%, or $21,000,

to $2,556,000, from $2,577,000 during the nine months ended September 30, 2022.

This decrease resulted from a decrease of $21,000 in

miscellaneous expenses.

and Administrative Expenses .

For the nine months ended September 30, 2023, general and administrative expenses increased by 28.7%,

or $1,813,000, to $8,135,000, from $6,322,000 during the nine months ended September 30, 2022.

This increase resulted primarily from

an increase in compensation expenses of $1,148,000, mainly due to an increase of approximately $702,000 of share-based compensation-related

expenses due to the expense recognition of grants made during the second quarter of 2023 and an increase in salary expenses and related

accruals of $446,000 mainly due to hiring of a General Manager of North America and VP of Global Marketing (who was subsequently promoted

to the Company’s Chief Commercial Officer in the third quarter of 2023), an increase in legal expenses of $254,000, an increase

in regulatory expenses of $215,000 related to MDR registration process and an increase of $196,000 in miscellaneous expenses.

For the nine months ended September 30, 2023, financial income increased by $693,000, to $824,000 of financial income, from

$131,000 of financial income during the nine months ended September 30, 2022.

The increase in financial income primarily resulted from

a $689,000 increase in interest income from investment in marketable securities, money market funds and short-term bank deposits.

For the nine months ended September 30, 2023, there was no change in our tax expenses as compared to the nine months ended

September 30, 2022.

Our net loss increased by $865,000, or 6.3%, to $14,511,000, for the nine months ended September 30, 2023, from $13,646,000

during the nine months ended September 30, 2022.

The increase in net loss resulted primarily from an increase of $1,941,000 in operating

expenses, offset by an increase of $693,000 in financial income and increase of $383,000 in gross profit.

For the three months ended March 31, 2024, there was no change in our tax expenses as compared to the three months ended

March 31, 2023.

Our net loss increased by $2,776,000, or 65.2%, to $7,032,000, for the three months ended March 31, 2024, from $4,256,000 during

the three months ended March 31, 2023.

The increase in net loss resulted primarily from an increase of $2,952,000 in operating expenses

and a decrease of $81,000 in gross profit, partially offset by an increase of $257,000 in financial income.

and Capital Resources

of September 30, 2023, we have the ability to fund our planned operations for at least the next 12 months from issuance date of the financial

of March 31, 2024, we have the ability to fund our planned operations for at least the next 12 months from issuance date of the financial

However, we expect to continue incurring losses and negative cash flows from operations until our products (primarily CGuard™

8 unchanged sentences

curtail or cease operations.

May 2023, we closed a Private Placement Offering that resulted in aggregate gross proceeds of approximately $42.2 million, before deducting

fees payable to the placement agent and other offering expenses payable by the Company.

If the Warrants from the Private Placement Offering

are exercised in cash in full this would result in an additional $71.4 million of gross proceeds.

months ended September 30, 2023 compared to the Nine months ended September 30, 2022

At September 30, 2023, we had cash and cash equivalents of $13,839,000 and marketable securities of $29,159,000 as compared to cash and

cash equivalents of $4,632,000 and short-term bank deposits of $13,171,000 as of December 31, 2022.

We have historically met our cash

needs through a combination of issuing new shares, borrowing activities and product sales.

May 2023, we closed a private placement offering 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

that resulted in aggregate gross proceeds of approximately $42.2 million, before deducting fees payable to the placement agent and other

offering expenses payable by us.

If the Warrants issued in the private placement offering are exercised in cash in full this would result

in an additional $71.4 million of gross proceeds.

months ended March 31, 2024 compared to the Three months ended March 31, 2023

At March 31, 2024, we had cash and cash equivalents of $9,389,000 and marketable securities of $24,561,000 as compared to cash and cash

equivalents of $9,640,000 and short-term bank deposits of $29,383,000 as of December 31, 2023.

We have historically met our cash needs

through a combination of issuing new shares, borrowing activities and product sales.

Our cash requirements are generally for research

and development, marketing and sales activities, finance and administrative costs, capital expenditures and general working capital.

the nine months ended September 30, 2023, net cash used in our operating activities decreased by $148,000, or 1.2%, to $12,199,000,

from $12,347,000 during the same period in 2022.

The primary reason for the decrease in cash used in our operating activities was an

increase of $613,000 in interest income received from money market funds and short-term bank deposits, an increase of $298,000 in

payments received from customers, to $4,433,000 during the nine months ended September 30, 2023 from $4,135,000 during the same

period in 2022, offset in part by an increase of $637,000 in compensation costs paid during the nine months ended September 30, 2023

from $6,695,000 in the nine months ended June 30, 2022 to $7,332,000 during the same period in 2023 and an increase of $127,000 in

payments for third party related expenses and for professional services.

used in our investing activities was $16,056,000 during the nine months ended September 30, 2023, compared to cash provided of $4,555,000

during the nine months ended September 30, 2022.

The primary reason for the increase in cash used by our investing activities is an investment

in marketable securities of $28,838,000, offset by an increase in withdrawal from short-term bank deposits, net of investment in short-term

deposits, of $8,000,000, and a decrease of $212,000 in payments made for purchase of property, plant and equipment during the nine months

ended September 30, 2023.

provided by financing activities for the nine months September 30, 2023, was $37,534,000.

The principal source of the cash provided by

financing activities during the nine months ended September 30, 2023 were the proceeds from the Private Placement Offering in May 2023

that resulted in approximately $37,534,000 of aggregate net proceeds.

Cash used by financing activities for the nine months ended September

30, 2022 was $140,000, the cash used by financing activities during the nine months ended September 30, 2022 were due to issuance costs

associated with a shelf registration statement on Form S-3 filed with the SEC on June 3, 2022.

of September 30, 2023, our current assets exceeded our current liabilities by a multiple of 10.0.

Current assets increased by $25,402,000

during the period and current liabilities decreased by $380,000 during the period.

As a result, our working capital increased by $25,782,000

to $42,038,000 as of September 30, 2023.

the three months ended March 31, 2024, net cash used in our operating activities increased by $233,000, or 4.8%, to $5,064,000, from

$4,831,000 during the same period in 2023.

The primary reason for the increase in cash used in our operating activities was an increase

of $917,000 in payments for third party related expenses and for professional services, an increase of $547,000 in compensation costs

paid during the three months ended March 31, 2023, from $3,128,000 in the three months ended March 31, 2023 to $3,675,000 during the

same period in 2024, offset in part by an increase of $1,185,000 in payments received from customers, and an increase of $46,000 in interest

income received from money market funds and marketable securities.

provided in our investing activities was $4,817,000 during the three months ended March 31, 2024, compared to cash provided of $4,449,000

during the three months ended March 31, 2023.

The primary reason for the increase in cash provided by our investing activities is a withdrawal

of marketable securities of $5,040,000, net of investment in marketable securities in the three months ended March 31, 2024, compared

to a withdrawal of short-term bank deposits of $4,500,000, net of investment in short-term bank deposits in the three months ended March

31, 2023, offset by an increase of $170,000 in payments made for purchase of property, plant and equipment during the three months ended

March 31, 2024.

was no cash provided by financing activities for the three months ended March 31, 2024 and for the three months ended March 31, 2023.

of March 31, 2024, our current assets exceeded our current liabilities by a multiple of 7.9.

Current assets decreased by $5,648,000 during

the period and current liabilities decreased by $1,143,000 during the period.

As a result, our working capital decreased by $4,505,000

to $33,634,000 as of March 31, 2024.

Balance Sheet Arrangements

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Obligations and Commitments

the three months ended September 30, 2023, there were no material changes to our contractual obligations and commitments.

the three months ended March 31, 2024, there were no material changes to our contractual obligations and commitments since the year ended

December 31, 2023.

Adopted and Issued Accounting Pronouncements

2 unchanged sentences

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-Q

Item 2. Management’s Discussion and Analysis