What changed in this filing

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Item 7. Management’s Discussion and Analysis

2026-03-18 compared with 2025-03-12 · 196 added, 203 removed, 67 unchanged (86% of the section changed)

2 unchanged sentences

consolidated financial statements and related notes included elsewhere in this Annual Report on Form 10-K.

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

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

A stent is an expandable scaffold-like device, usually

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

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

CGuard 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 the MDD in the 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 FDA of our IDE, thereby allowing us to proceed with a pivotal study of our CGuard™

Carotid Stent System, C-GUARDIANS, for prevention of stroke in patients in the United States.

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 in patients undergoing 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 was a composite of:

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

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

All events were

adjudicated by an independent clinical events committee.

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

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

The performance

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

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

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

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

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

data were used tothat may support the PMA submission in September 2024 with a view to potential FDA approval of the CGuard Prime carotid

stent system in the first half of 2025.

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

System during transcarotid revascularization (TCAR) procedures.

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) delivery system, SwitchGuard NPS, for transcarotid access and neuro protection.

In addition, we intend

to explore new indications for CGuard to leverage the advantages of stent design and mesh protection, well suited in labels such as acute

stroke with tandem lesions.

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

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 Carotid Stent System, 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.

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 12,914,078 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.

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

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

of common stock.

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

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

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

In connection with the exercise of the Series H Warrants,

we also paid LifeSci Capital LLC, a placement fee equal to 5.6% of the aggregate gross proceeds from such exercise, or approximately

$1.0 million.

The discussion that follows includes a comparison of our results of operations and liquidity and capital resources

for fiscal years 2025 and 2024.

For a comparison of our results of operations and financial condition for fiscal years 2024 and 2023,

see “Item 7—Management’s Discussion and Analysis of Financial Condition and Results of Operations” of our 2024

Annual Report on Form 10-K, filed with the SEC on March 12, 2025.

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

and other vascular conditions.

Our portfolio includes two commercial products based on our proprietary CGuard carotid stent technology,

designed to provide market-leading embolic protection during and after stenting procedures.

A stent is an expandable scaffold-like metallic

device placed in an artery to widen the lumen and restore blood flow.

first product, the CGuard Carotid Embolic Prevention System (“CGuard EPS”), integrates a self-expanding nitinol stent with

a MicroNet mesh sleeve as a single device for carotid artery revascularization.

In January 2024, we received CE Mark recertification

for CGuard EPS under the EU Medical Device Regulation (“MDR”).

Our CGuard EPS previously held CE Mark approval under the

former Medical Device Directive (“MDD”).

CGuard EPS is marketed in over 30 countries outside the United States through a

network of distributors.

second product, the CGuard Prime Carotid Stent System (“CGuard Prime”), uses the same stent and MicroNet mesh with a differentiated

deployment mechanism.

CGuard Prime received premarket approval (“PMA”) by the U.S.

Food and Drug Administration (“FDA”)

on June 23, 2025, and is marketed exclusively in the United States through our direct salesforce.

It also received MDR CE Mark approval

on June 12, 2025.

more information regarding our business and operations, see “Item 1 – Business” above.

2023 Private Placement Offering

May 12, 2023, we entered into a securities purchase agreement pursuant to which we issued and sold in a private placement (the “May

2023 Private Placement Offering”) (i) an aggregate of 10,266,270 shares of common stock (the “May 2023 Shares”), (ii)

pre-funded warrants to purchase up to 15,561,894 shares of common stock (the “May 2023 Pre-Funded Warrants”), and (iii) warrants

to purchase up to an aggregate of 51,656,328 shares of common stock (the “May 2023 Warrants”), consisting of Series H warrants,

Series I warrants, Series J warrants and Series K warrants.

May 2023 Shares and associated warrants were sold at an offering price of $1.6327 per share and associated warrants, and the May 2023

Pre-Funded Warrants were sold at an offering price of $1.6326 per May Pre-Funded Warrant and associated warrants.

Aggregate gross proceeds

totaled approximately $42.2 million, and after deducting placement agent fees and other issuance costs of approximately $4.6 million,

net proceeds to the Company were approximately $37.6 million.

of the May 2023 Pre-Funded Warrants

May 2023 Pre-Funded Warrants were immediately exercisable at an exercise price of $0.0001 per share and did not expire until exercised

As of the date of this Annual Report on Form 10-K, the May 2023 Pre-Funded Warrants have been exercised in full.

terms, holders were not able to exercise a Pre- May 2023 Funded Warrant if the exercise would result in the holder beneficially owning

more than 4.99% or 9.99% of our outstanding shares of common stock (as elected by the holder), subject to customary permitted increases

with advance notice.

of the May 2023 Warrants (Series H, I, J and K)

May 2023 Warrants were immediately exercisable at an exercise price of $1.3827 per share and are exercisable until the earlier of (i)

five years after issuance and (ii) the applicable milestone-triggered expiration date, as follows:

expire 20 trading days following our public release of one-year primary and secondary

endpoint results from the C-GUARDIANS pivotal trial.

expire 20 trading days following the announcement of PMA by the FDA for CGuard

Prime 135 cm carotid stent system.

expire 20 trading days following our announcement of FDA approval for the SwitchGuard

system and CGuard Prime 80 cm carotid stent system.

expire 20 trading days following the end of the fourth fiscal quarter after the

fiscal quarter in which the first U.S.

commercial sale of the CGuard carotid stent system

May 2023 Warrants may be exercised on a cashless basis if there is no effective registration statement for the underlying shares of common

stock issuable upon the exercise thereof.

A registration statement on Form S-3 (File No.

333-272149) registering the shares underlying

the May 2023 Warrants was declared effective on June 2, 2023.

Milestone-Based

Exercises Under the May 2023 Warrants

the achievement of the applicable milestones during 2024 and 2025, the May 2023 Warrants were exercised as follows:

H Warrant Exercise

we announced positive one-year results from the C-GUARDIANS pivotal trial, all Series H Warrants were exercised in full into 292,996

shares of common stock and 12,621,090 pre-funded warrants.

Gross proceeds totaled approximately $17.9 million, and after deducting placement

agent fees and issuance costs of approximately $1.0 million, net proceeds were approximately $16.9 million.

I Warrant Exercise

our June 24, 2025 announcement that the FDA granted PMA approval for CGuard Prime in the United States, all Series I Warrants were exercised

in full into 2,352,393 shares of common stock and 10,561,685 pre-funded warrants.

Gross proceeds totaled approximately $17.9 million,

and net proceeds were approximately $16.9 million after issuance costs of approximately $1.0 million.

2025 Private Placement Offering

July 30, 2025, we entered into a securities purchase agreement with investors pursuant to which we issued and sold in a private placement

(the “August 2025 Private Placement Offering”) an aggregate of 6,791,380 shares (the “August 2025 Shares”) of

common stock and pre-funded warrants (the “August 2025 Pre-Funded Warrants”) to purchase up to 9,764,804 shares of common

stock, at an offering price of $2.42 per August 2025 Share and $2.4199 per August 2025 Pre-Funded Warrant.

The August 2025 Pre-Funded

Warrants are immediately exercisable at an exercise price of $0.0001 per share and will not expire until exercised in full.

gross proceeds totaled approximately $40.1 million, after deducting placement agent fees and other issuance costs of approximately $3.1

million, net proceeds to the Company were approximately $37 million.

approval of the CGuard Prime Carotid Stent System and Commercial Launch in the United States

June 23, 2025, the FDA granted PMA approval of CGuard Prime in the United States.

such approval, in July 2025, we announced the official commercial launch of CGuard Prime in the United States.

In October 2024, we established

our global headquarters in Miami, Florida to support the U.S.

launch and commercialization of CGuard Prime.

Mark Approval for CGuard Prime Under European MDR

June 12, 2025, we received CE Mark approval under the EU’s MDR for CGuard Prime.

Accounting Policies

27 unchanged sentences

of Operations

months ended December 31, 2024 compared to the twelve months ended December 31, 2023

For the twelve months ended December 31, 2024, revenue increased by $804,000, or 13.0%, to $7,009,000, from $6,205,000 during the twelve

months ended December 31, 2023.

This increase was predominantly driven by growth in existing and new markets.

respect to regions, the increase in revenue was primarily attributable to a $772,000 increase in Europe, a $141,000 increase in Asia

and a $14,000 increase in the Middle East.

This growth was mainly due to growth in existing and new markets.

This increase was offset

by a $103,000 decline in clinical revenue in the U.S .

mainly driven by the completion in June 2023 of the enrollment of patients in

our CGuardians IDE clinical trial as well as a $20,000 decline in other markets.

For the twelve months ended December 31, 2024, gross profit (revenue less cost of revenues) decreased by 16.7%, or $301,000,

to $1,506,000, compared to a gross profit of $1,807,000 for the same period in 2023.

This decrease in gross profit resulted from an increase

in cost of goods sold of $1,105,000.

This increase was primarily due to an $891,000 increase in material and labor costs, driven mainly

from higher sales volume, and increased compensation expense for new and current employees.

In addition, there were an additional $214,000

other cost of goods sold related expenses.

The increase of cost of goods sold was offset by the increase in revenues of $804,000 as described

Gross margin (gross profits as a percentage of revenue) decreased to 21.5% during the year ended December 31, 2024, from 29.1%

during the year ended December 31, 2023, driven by the factors mentioned above.

ended December 31, 2025 compared to the year ended December 31, 2024

For the year ended December 31, 2025, revenue was $8,979,000, an increase of $1,970,000, or 28.1%, compared to $7,009,000 during the

year ended December 31, 2024.

The increase was driven by the commercial launch of the CGuard Prime product through direct sales in the

following FDA approval in June 2025, and continued growth in sales of the CGuard EPS product through distributors in international

respect to regions, the increase in revenue was primarily attributable to $1,385,000 increase in North America due to the commercial

launch of CGuard Prime in the U.S.

in the second half of 2025, and a $585,000 increase in international markets from continued penetration

of our CGuard EPS product.

For the year ended December 31, 2025, gross profit (revenue less cost of revenues) was $2,649,000 compared to gross profit

of $1,506,000 for 2024.

The increase resulted mainly from the increase in revenue year-on-year.

margin represents our gross profit as a percentage of our revenue.

Gross margin was 29.5% for the year ended December 31, 2025, an increase

of 8.0 percentage points compared to 21.5% for the year ended December 31, 2024.

This increase in gross margin resulted primarily from

a more favorable revenue mix driven by direct U.S.

sales, which carry higher margins due to a higher average selling price per unit compared

with international distributor sales.

and Development Expenses .

For the twelve months ended December 31, 2024, research and development expenses increased by 70.8%, or

$5,653,000, to $13,634,000, from $7,981,000 during the twelve months ended December 31, 2023.

This increase resulted primarily from an

increase in compensation expenses of $2,705,000, mainly due to an increase of share-based compensation-related expenses and due to hiring

personnel in connection with our expansion plans in the United States, an increase of $1,379,000 of SwitchGuard NPS development and regulatory

cost, $961,000 related to clinical trials for CGuardians II and CGuardians III, an increase of $914,000 related to CGuard Prime product

preparation expenses for the anticipated U.S.

commercial launch of CGuard Prime, an increase of $448,000 related to an early feasibility

study of CGuard Prime for the treatment of acute stroke patients with tandem lesions, an increase of $239,000 related to the establishment

of operations in the United States and an increase of $71,000 in miscellaneous expenses.

These increases were offset by a decrease of

$1,064,000 in expenses associated with the C-Guardians FDA Study as the one-year follow-up finalized in the second quarter of 2024 and

the submission this quarter of the PMA application to the U.S.

For the year ended December 31, 2025, research and development expenses were $15,003,000, an increase of

$1,369,000, or 10.0%, compared to $13,634,000 during the year ended December 31, 2024.

This increase resulted primarily due to higher

staff levels in connection with our expansion in the U.S., and higher development and clinical expenses for the SwitchGuard NPS and CGuard

Prime 80 cm carotid stent system, respectively.

These increases were partially offset by a decrease in expenses for the C-GUARDIANS clinical

study and related product preparation activity prior to the FDA approval of CGuard Prime in June 2025.

and Marketing Expenses .

For the twelve months ended December 31, 2024, selling and marketing expenses increased by 57.0%, or $2,204,000

to $6,069,000, from $3,865,000 during the twelve months ended December 31, 2023.

This increase resulted primarily from an increase in

compensation expenses of $1,870,000 as we build our commercial sales force in the United States in anticipation for FDA approval, an

increase of $254,000 of promotional activities and an increase of $80,000 in miscellaneous expenses.

For the year ended December 31, 2025, selling and marketing expenses were $16,553,000, an increase of $10,484,000,

or 172.7%, compared to $6,069,000 during the year ended December 31, 2024.

This increase resulted primarily from higher commercial staffing

levels in connection with the commercial launch of CGuard Prime in the U.S.

and Administrative Expenses .

For the twelve months ended December 31, 2024, general and administrative expenses increased by

37.8%, or $4,202,000, to $15,306,000, from $11,104,000 during the twelve months ended December 31, 2023.

The increase was primarily

driven by a $3,113,000 increase in share-based compensation expenses, a $877,000 increase in salary expenses and related accruals

(mainly due to expected severance payments accrued for following the CFO’s announced retirement, new hires for our Miami

headquarters, and salary increases), and a $284,000 increase in employee headhunting fees.

These increases were offset by a $72,000

decrease in miscellaneous expenses.

For the year ended December 31, 2025, general and administrative expenses were $20,707,000, an increase

of $5,401,000, or 35.3%, compared to $15,306,000 during the year ended December 31, 2024.

The increase was primarily driven by new hires,

professional services expenses, and occupancy-related costs related to the Company’s expansion of U.S.

operations to support the

commercial launch of CGuard Prime.

Income, net .

For the twelve months ended December 31, 2024, financial income increased by $265,000, to $1,557,000 from $1,292,000

during the twelve months ended December 31, 2023.

The increase in financial income primarily resulted from a $293,000 increase in interest

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

For the twelve months ended December 31, 2024, tax decreased by $6,000 compared to the twelve months ended December 31,

Our expenses for income taxes reflect primarily the tax liability due to potential tax exposure.

Our net loss increased by $12,089,000, or 60.7%, to $32,005,000 for the twelve months ended December 31, 2023, from $19,916,000

during the twelve months ended December 31, 2023.

The increase in net loss resulted primarily from an increase of $12,059,000 in operating

For the year ended December 31, 2025, financial income was $891,000, a decrease of $666,000, compared to $1,557,000

during the year ended December 31, 2024.

The decrease in financial income primarily resulted from a $403,000 increase in financial expenses

related to changes in exchange rates and a $264,000 decrease in income from investment in marketable securities and money market funds

due to lower interest rates.

For the year ended December 31, 2025, tax expenses increased by $4,000 compared to the year ended December 31, 2024.

expenses for income taxes reflect primarily the tax liability due to potential tax exposure.

Our net loss for the year ended December 31, 2025 was $48,786,000, an increase of $16,781,000, or 52.4%, compared to $32,005,000

during the year ended December 31, 2024.

The increase in net loss resulted primarily from an increase of $17,254,000 in operating expenses.

and Capital Resources

had an accumulated deficit as of December 31, 2024, of $254 million, as well as a net loss of $32.0 million and negative operating cash

We expect to continue incurring losses and negative cash flows from operations until our product, CGuard EPS, reaches commercial

profitability.

As a result of these expected losses and negative cash flows from operations, along with our current cash position, we

believe we do not have sufficient resources to fund operations for at least the next 12 months.

Therefore, there is substantial doubt

about our ability to continue as a going concern.

had an accumulated deficit as of December 31, 2025, of $302.3 million, as well as a net loss of $48.8 million and negative operating

cash flows for fiscal year 2025.

We expect to continue incurring losses and negative cash flows from operations until we expand our commercial

revenue to a scale that funds our commercial resources, development activities and support functions.

As a result of these expected losses

and negative cash flows from operations, along with our current cash position, we believe we do not have sufficient resources to fund

operations for at least the next 12 months.

Therefore, there is substantial doubt about our ability to continue as a going concern.

plans include continued commercialization of our products and raising capital through sale of additional equity securities, debt or capital

4 unchanged sentences

to reduce activities, 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.

There can be no assurance that we will

achieve any of the milestones set forth in the Warrants or that the Warrants will be exercised in cash in full.

May 2023, we closed the May 2023 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 us.

If the May 2023 Warrants are exercised

in cash in full this would result in an additional $71.4 million of gross proceeds (of which approximately $33.8 million has been received

as of the date of this Annual Report on Form 10-K).

There can be no assurance that we will achieve any of the remaining milestones set

forth in the May 2023 Warrants or that the outstanding May 2023 Warrants will be exercised in cash in full.

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

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

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

of common stock.

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

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

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

The net proceeds from the exercise of the Series H Warrants were $16.9 million after deducting placement agent fees.

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

2023 Private Placement Offering.

the announcement of the PMA approval of the CGuard Prime carotid stent system in the United States, Series I warrants to purchase 12,914,078

shares of common stock were exercised in full into 2,352,393 shares of common stock and pre-funded warrants to purchase 10,561,685 shares

of common stock during June and July 2025.

The net proceeds from the exercise of the Series I Warrants were $16.9 million after deducting

placement agent fees.

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

as part of the May 2023 Private Placement Offering.

May 2024, we entered into an Equity Distribution Agreement (the “Distribution Agreement”) with Piper Sandler & Co., as

sales agent (“Piper Sandler”), pursuant to which we may offer and sell from time to time, at our option, through or to Piper

Sandler shares of our common stock having an aggregate offering price of up to $17 million (the “ATM Facility”).

pay Piper Sandler a commission at a fixed rate of 3.0% of the aggregate gross proceeds from each sale of the shares under the Distribution

As of the date hereof, we sold 845,399 shares pursuant to the Distribution Agreement for aggregate gross proceeds of

approximately $2,199,395.

months ended December 31, 2024 compared to the twelve months ended December 31, 2023

At December 31, 2024, we had cash and cash equivalents of $18,916,000 and marketable securities of $15,721,000 as compared to $9,640,000

sales agent (“Piper Sandler”).

Pursuant to the Distribution Agreement, we may offer and sell from time to time, at our option,

through or to Piper Sandler shares of our common stock having an aggregate offering price of up to $75 million (the “ATM Facility”).

We will pay Piper Sandler a commission at a fixed rate of 3.0% of the aggregate gross proceeds

from each sale of the shares under the Distribution Agreement.

As of the date hereof, we sold 1,366,190 shares pursuant to the

Distribution Agreement for aggregate gross proceeds of approximately $3,473,314.

July 2025, we closed August 2025 that resulted in aggregate gross proceeds of approximately $40.1 million, before deducting fees payable

to the placement agent and other offering expenses payable by us.

ended December 31, 2025 compared to the year ended December 31, 2024

As of December 31, 2025, we had cash and cash equivalents of $8,939,000 and marketable securities of $45,272,000, as compared to $18,916,000

of cash and cash equivalents and $15,721,000 marketable securities as of December 31, 2024.

1 unchanged sentence

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 cost, capital expenditures and general working capital.

the twelve months ended December 31, 2024, net cash used in our operating activities increased by $5,492,000 to $21,868,000, from $16,376,000

Our cash requirements are generally for manufacturing costs,

research and development activities, sales and marketing efforts, finance and administrative expenses, capital expenditures and general

working capital.

the year ended December 31, 2025, net cash used in our operating activities increased by $13,235,000 to $35,103,000, from $21,868,000

during the same period in 2024.

The primary reason for the increase in cash used in our operating activities was an increase of $13,163,000

in payments for third party related expenses and for professional services, an increase of $2,518,000 in salary and bonus payments from

$9,495,000 in the twelve months ended December 31, 2023 to $12,013,000 during the same period in 2024, offset, in part, by an increase

of $1,746,000 in payments received from customers to $7,216,000 during the twelve months ended December 31, 2024, from $5,470,000 during

the same period in 2023 and an decrease of $311,000 in interest income received from marketable securities and money market funds.

provided by our investing activities was $12,641,000 during the twelve months ended December 31, 2024, compared to cash used by our investing

activities of $16,092,000 during the twelve months ended December 31, 2023.

The primary reason for the increase in cash provided by our

investing activities is proceeds from matured marketable securities, net of withdrawal of $43,200,000, offset by a decrease in withdrawal

from short-term bank deposits, net of investment in short-term deposits, of $13,000,000, an increase in an investment in long- term lease

deposits of $426,000 and an increase of $1,021,000 in payments made for purchase of property, plant and equipment during the twelve months

ended December 31, 2024.

provided by financing activities for the twelve months December 31, 2024, was $18,452,000.

The principal source of the cash provided

by financing activities during the twelve months ended December 31, 2024 were the proceeds from exercise of warrants of $16,854,000 net

of issuance costs and funds received from our ATM Facility that resulted in approximately $1,598,000 of aggregate net proceeds.

provided by financing activities for the twelve months ended December 31, 2023, was $37,534,000.

The principal source of the cash provided

by financing activities during the twelve months ended December 31, 2023, were the proceeds from the Private Placement Offering in May

in compensation costs paid during the year ended December 31, 2025 (from $12,013,000 in the year ended December 31, 2024 to $25,176,000

in the year ended December 31, 2025) and an increase of $1,509,000 in payments for third party related expenses and for professional

services, offset, in part, by an increase of $1,374,000 in payments received from customers to $8,590,000 during the year ended December

31, 2025, from $7,216,000 during the same period in 2024.

used in our investing activities was $30,560,000 during the year ended December 31, 2025, compared to cash provided by our investing

activities of $12,641,000 during the year ended December 31, 2024.

The primary reason for the increase in cash used in our investing

activities is investments of $43,748,000, net of withdrawal in marketable securities.

provided by financing activities for the year ended December 31, 2025, was $55,569,000.

The source of the cash provided by financing

activities during the year ended December 31, 2025, were the proceeds from the August 2025 Private Placement Offering as well as proceeds

from issuance of shares received from our ATM Facility that resulted in approximately of $38,714,000 aggregate net proceeds and proceeds

from the exercise of Series I Warrants of $16,855,000.

Cash provided by financing activities for the year December 31, 2024, was $18,452,000.

The principal source of the cash provided by financing activities during the year ended December 31, 2024, was the proceeds from exercise

of warrants of $16,854,000 net of issuance costs and funds received from our ATM Facility that resulted in approximately $1,598,000 of

aggregate net proceeds.

lease payments represent our commitment for future rent made under non-cancelable lease for our offices in the U.S.

future payments for our operating lease obligation at December 31, 2024 were approximately $2,939,000.

future payments for our operating lease obligation on December 31, 2025, were approximately $3,966,000.

For additional details regarding

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What changed 10-K

Item 7. Management’s Discussion and Analysis