What changed in this filing

/stocks — the workspaceLOADING

Item 2. Management’s Discussion and Analysis

2026-05-07 compared with 2025-11-10 · 208 added, 262 removed, 101 unchanged (82% of the section changed)

20 unchanged sentences

need to raise additional capital to meet our business requirements in the future and such capital raising may be costly or difficult

to obtain and could dilute out stockholders’ ownership interests;

to obtain and could dilute our stockholders’ ownership interests;

clinical development, commercialization and market acceptance of our products;

1 unchanged sentence

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

impact of a product recall, including the current recall in the U.S.

regarding the CGuard Prime 135cm Carotid Stent System, on our

business, results of operations and financial conditions;

clinical trial results or lengthy product delays in key markets;

35 unchanged sentences

statement to reflect events or circumstances after the date on which any such statement is made or to reflect the occurrence of unanticipated

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.

On June 23, 2025, CGuard Prime, our next generation

carotid artery stenting (“CAS”) stent platform, was granted premarket application (“PMA”) approval the U.S.

and Drug Administration (“FDA”).

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.

A sleeve of MicroNet™ mesh is attached

over a stent to provide embolic protection both during and after stenting procedures.

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

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 (“MDR”) regulatory framework.

September 8, 2020, we received approval from the FDA of our Investigation Device Exemption (“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

C-GUARDIANS was 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 CGuard Carotid Stent

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

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

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

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

data were used to support the PMA submission in September 2024, which was approved by the FDA on June 23, 2025.

On June 12, 2025, we

received CE Mark approval under the EU’s MDR for the CGuard Prime Embolic Prevention System.

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

System during transcarotid revascularization (TCAR) procedures.

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

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

the future growth of the U.S.

CAS addressable market.

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

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

In furtherance of our strategy

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

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

and neuro protection.

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

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

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

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.

In the first quarter of 2026, we submitted a premarket approval for the CGuard EPS with a view to potential

FDA approval in the in the third quarter of 2026.

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

EPS 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.

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

stent system during transcarotid revascularization (“TCAR”) procedures.

In the first quarter of 2026, we completed enrollment

in the CGUARDIANS II pivotal study.

In May 2026, the FDA approved the Company’s IDE to initiate the CGUARDIANS III pivotal

study of its CGuard Prime 80 cm carotid stent system during TCAR procedures.

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

expanding coverage for both carotid artery stenting (“CAS”) and TCAR procedures to include both asymptomatic and standard

risk patients, significantly expanding and supporting the future growth of the U.S.

addressable market for CAS.

November 2025, the results of the CREST-2 study were released, which showed that CAS combined with medical therapy demonstrated a significantly

lower stroke risk as compared to intensive medical management alone in patients with severe asymptomatic carotid stenosis.

an independent study sponsored by the National Institute of Health (NIH) with a set of two parallel, observer-blinded clinical trials

across 155 centers globally.

CREST-2 showed that, among patients with high-grade carotid stenosis without recent neurological symptoms,

the addition of stenting led to significantly better outcomes than intensive medical management alone, as measured by a decreased risk

of the composite of perioperative stroke or death or ipsilateral stroke within four years.

In a separate arm of the same trial, carotid

endarterectomy (“CEA”) did not achieve a significant benefit for these patients as compared to intensive medical management

continue to invest in new product generations and potential new clinical indications for the CGuard platform with a strategy of focusing

on advancing a “stent-first” approach to carotid revascularization.

As part of this strategy, we are evaluating CGuard Prime

in TCAR-based clinical programs, including the CGUARDIANS II pivotal trial, which studies the use of the CGuard Prime 80 cm carotid

stent system in conjunction with an established neuroprotection device, and the CGUARDIANS III pivotal trial, which evaluates our proprietary

SwitchGuard neuroprotection system (“SwitchGuard NPS”) paired with CGuard Prime to enable flow-reversal neuroprotection during

In parallel, we are pursuing new clinical applications outside TCAR, including the treatment of acute ischemic stroke with tandem

lesions, which is currently being studied in an early feasibility study conducted with the Jacobs Institute.

In this acute-stroke setting,

the flexible, low-metal-burden design and MicroNet mesh of CGuard Prime may offer advantages where traditional embolic-protection devices

cannot be used.

consider our current addressable market for our CGuard EPS, CGuard Prime, 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.

includes not only patients eligible for either CAS or TCAR procedures, but also individuals who are candidates for CEA, as all three

approaches can be options to treat these patients.

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

market for CGuard EPS, CGuard Prime, 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 EPS, CGuard

Prime, and SwitchGuard NPS to be approximately $9.3 billion, which may grow over time if expanded treatment options such as our products

lead to increased patient screening for carotid artery disease.

May 2026, we announced a voluntary recall in the U.S.

of CGuard Prime, initiated in consultation with the FDA.

The Company acted

after determining during a controlled launch that the technical success of the delivery system during CAS procedures had not met

performance expectations.

The voluntary action pertained specifically to the CGuard Prime delivery system and did not include the CGuard

stent implant.

The action was voluntary with no implications for the safety of patients who had previously received the

CGuard stent.

The Company expects to establish a reserve for customer returns of approximately

$700,000 and a reserve for inventory impairment and remediation costs of approximately $650,000.

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

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

to support the anticipated U.S.

launch and commercialization of the CGuard Prime carotid stent system.

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

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

such approval, in July 2025, we announced the official commercial launch of the CGuard Prime Carotid Stent System 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 Carotid Stent System.

Mark Approval for CGuard Prime EPS Under European MDR

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

of Series I Warrants

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

July 30, 2025, the Company entered into a securities purchase agreement with investors pursuant to which the Company issued and sold

in a private placement (the “Private Placement Offering”) an aggregate of 6,791,380 shares (the “Private Placement

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

common stock, at an offering price of $2.42 per Private Placement Share and $2.4199 per Pre-Funded Warrant.

The Pre-Funded Warrants are

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

Certain of the Company’s

directors participated in the Private Placement Offering.

The Private Placement Offering closed on August 1, 2025.

gross proceeds to the Company in respect of the Private Placement Offering were approximately $40.1 million, before deducting fees payable

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

In addition, the Company paid the placement agent for the

offering a placement fee equal to 6.0% of the aggregate gross proceeds from the closing of the Private Placement Offering, or approximately

$2.4 million, and expense reimbursement of $75,000.

to support the U.S.

launch and commercialization of CGuard Prime.

Accounting Policies

10 unchanged sentences

of Operations

months ended September 30, 2025, compared to the three months ended September 30, 2024

For the three months ended September 30, 2025, revenue increased by $713,000, or 39.4%, to $2,523,000, from $1,810,000 during the three

months ended September 30, 2024.

Growth in the quarter was driven mainly by the commercial launch of direct sales of the CGuard Prime

product in the U.S.

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

international markets.

respect to geographical regions, the increase in revenue was primarily attributable to a $490,000 increase in North America due to the

official commercial launch of CGuard Prime in the U.S.

following FDA approval in June 2025, and a $223,000 increase in international

markets outside North America due to continued adoption of our CGuard technology.

For the three months ended September 30, 2025, gross profit (revenue less cost of revenues) increased by $450,000, or 108.7%,

to $864,000 from $414,000 during the three months ended September 30, 2024.

This increase in gross profit resulted from a $529,000 increase

in revenues, less the associated material and labor costs and was augmented by the contribution of revenue from direct sales in the U.S.,

which carry higher unit profit due to higher average selling price per unit, as compared to international sales through distributors.

The increase in gross profit was partially offset by an increase in manufacturing and miscellaneous expenses of $79,000.

(gross profit as a percentage of revenue) increased to 34.2% during the three months ended September 30, 2025, from 22.9% during the

three months ended September 30, 2024, driven by the factors mentioned above.

and Development Expenses .

For the three months ended September 30, 2025, research and development expenses decreased by $280,000,

or 7.2%, to $3,635,000, from $3,915,000 during the three months ended September 30, 2024.

This decrease resulted primarily due to the

completion of the C-GUARDIANS clinical study and related product preparation expense prior to the FDA approval of the CGuard Prime product

in June 2025, partially offset by an increase in compensation expenses due to hiring of new employees in connection with our expansion

and Marketing Expenses .

For the three months ended September 30, 2025, selling and marketing expenses increased by $2,920,000, or

198.4%, to $4,392,000 from $1,472,000 during the three months ended September 30, 2024.

This increase resulted primarily from an increase

in compensation and headcount related expenses from higher commercial staffing levels in connection with the commercial launch of CGuard

Prime in the U.S.

and Administrative Expenses .

For the three months ended September 30, 2025, general and administrative expenses increased by $2,399,000,

or 68.8%, to $5,888,000, from $3,489,000 during the three months ended September 30, 2024.

The increase was primarily driven by higher

compensation and headcount related expenses from new hires to support the Company’s expansion of U.S.

General and administrative

expenses were also higher due to an increase in professional services and miscellaneous expenses to support the expansion of U.S.

following the commercial launch of CGuard Prime.

For the three months ended September 30, 2025, financial income decreased by $229,000 or 40.0% to $343,000, from $572,000

during the three months ended September 30, 2024.

The decrease in financial income primarily resulted from a $118,000 decrease in financial

income from investment in marketable securities and money market funds due to lower interest rates and a $104,000 increase in financial

expenses related to changes in exchange rates.

For the three months ended September 30, 2025, there was no material change in our tax expenses as compared to the three

months ended September 30, 2024.

Our net loss increased by $4,818,000, or 61.1%, to $12,708,000, for the three months ended September 30, 2025, from $7,890,000

during the three months ended September 30, 2024.

The increase in net loss resulted primarily from an increase of $5,039,000 in operating

months ended September 30, 2025, compared to the nine months ended September 30, 2024

For the nine months ended September 30, 2025, revenue increased by $770,000, or 15.2%, to $5,830,000, from $5,060,000 during the nine

months ended September 30, 2024.

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

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

respect to geographical regions, the increase in revenue was primarily attributable to a $522,000 increase in North America due to the

official commercial launch of CGuard Prime in the U.S.

following FDA approval in June 2025, and a $248,000 increase in international

markets outside North America due to continued adoption of our CGuard technology.

For the nine months ended September 30, 2025, gross profit (revenue less cost of revenues) increased by $432,000, or 41.7%,

to $1,469,000, compared to $1,037,000 for the same period in 2024.

This increase in gross profit resulted from a $589,000 increase in

revenues, less the associated material and labor costs and was augmented by the contribution of revenue from direct sales in the U.S.,

which carry higher unit profit due to higher average selling price per unit, as compared to international sales through distributors.

The increase in gross profit was partially offset by an increase in manufacturing and miscellaneous expenses of $157,000.

(gross profit as a percentage of revenue) increased to 25.2% for the nine months ended September 30, 2025, from 20.5% for the nine months

ended September 30, 2024, driven by the factors mentioned above.

months ended March 31, 2026, compared to the three months ended March 31, 2025

For the three months ended March 31, 2026, revenue was $3,398,000, an increase of $1,869,000, or 122 %, compared to $1,529,000 during

the three months ended March 31, 2025.

Growth in the quarter was driven mainly by the commercial launch of direct sales of the CGuard

Prime product in the U.S.

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

in international markets.

respect to geographical regions, the increase in revenue was primarily attributable to a $1,151,000 increase in North America due to

the commercial launch of CGuard Prime in the U.S.

following FDA approval in June 2025, and a $718,000 increase in international markets

outside North America due to continued adoption of our CGuard technology.

For the three months ended March 31, 2026, gross profit (revenue less cost of revenues) was $687,000 compared to gross profit

of $292,000 for the three months ended March 31, 2025.

The increase resulted mainly from the increase in revenue year-on-year, partially

offset by higher cost of revenues resulting from an impairment charge of $473,000 for inventory obsolescence related to our CGuard Prime

delivery system

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

Gross margin was 20.2% for the three months ended March 31, 2026,

an increase of 1.1 percentage points compared to 19.1% for the three months ended March 31, 2025.

This increase in gross margin resulted

primarily from a more favorable revenue mix driven by direct sales in the U.S., which carry higher margins due to a higher average selling

price per unit compared with sales to international distributors.

The impact from the favorable sales mix was primarily offset by the

impact of the impairment charge for excess and obsolete inventory referenced above.

and Development Expenses .

For the nine months ended September 30, 2025, research and development expenses increased by 16.0%, or

$1,587,000 to $11,528,000, from $9,941,000 during the nine months ended September 30, 2024.

This increase resulted primarily due to an

increase in compensation and headcount related expenses due to higher staff levels in connection with our expansion in the United States,

and higher development and regulatory expenses for of the SwitchGuard NPS and CGuard Prime 80cm Carotid Stent System, respectively.

increases were partially offset by a decrease of expenses for the C-GUARDIANS clinical study, which was completed prior to the approval

by the FDA in June 2025.

For the three months ended March 31, 2026, research and development expenses were $4,763,000, an increase

of $704,000, or 17.4%, compared to $4,059,000 during the three months ended March 31, 2025.

This increase resulted primarily due to higher

staff levels in connection with our expansion in the U.S., an increase in regulatory activities expenses, 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 nine months ended September 30, 2025, selling and marketing expenses increased by $7,160,000, or

172.4%, to $11,314,000, from $4,154,000 during the nine months ended September 30, 2024.

This increase resulted primarily from an increase

in compensation and headcount related expenses from higher commercial staffing levels in connection with the commercial launch of CGuard

Prime in the U.S.

For the three months ended March 31, 2026, selling and marketing expenses were $5,180,000, an increase of

$2,430,000, or 88.4%, compared to $2,750,000 during the three months ended March 31, 2025.

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 nine months ended September 30, 2025, general and administrative expenses increased by 45.8%,

or $5,079,000, to $16,157,000, from $11,078,000 during the nine months ended September 30, 2024.

The increase was primarily driven higher

compensation and headcount related expenses from new hires to support the Company’s expansion of U.S.

General and administrative

expenses were also higher due to an increase in professional services and occupancy expenses related to the expansion of U.S.

following the commercial launch of CGuard Prime.

For the nine months ended September 30, 2025, financial income decreased by $800,000, to $505,000 of financial income, from

$1,305,000 of financial income during the nine months ended September 30, 2024.

The decrease in financial income primarily resulted from

a $398,000 decrease in income from investment in marketable securities and money market funds due to lower interest rates and a $393,000

increase in financial expenses related to changes in exchange rates.

For the nine months ended September 30, 2025, there was no material change in our tax expenses as compared to the nine

months ended September 30, 2024.

Our net loss increased by $14,194,000, or 62.2%, to $37,025,000, for the nine months ended September 30, 2025, from $22,831,000

during the nine months ended September 30, 2024.

For the three months ended March 31, 2026, general and administrative expenses were $4,722,000, a decrease

of $221,000, or 4.5%, compared to $4,943,000 during the three months ended March 31, 2025.

The decrease was primarily driven by a reduction

in share-based compensation expense resulting from forfeitures associated with executive employees who departed during the period.

For the three months ended March 31, 2026, financial income was $289,000, a decrease of $5,000 or 1.7% compared to $2 94 ,000

during the three months ended March 31, 2025.

We did not incur any tax expenses during the three months ended March 31, 2026 and March 31, 2025.

For the three months ended March 31, 2026, our net loss was $13,689,000, an increase of $2,523,000, or 22.6%, compared to $11,166,000

during the three months ended March 31, 2025.

The increase in net loss resulted primarily from an increase of $2,913,000 in operating

and Capital Resources

had an accumulated deficit as of September 30, 2025, of $291 million, as well as a net loss of $37.0 million for the nine months

ended September 30, 2025 and negative operating cash flows.

We expect to continue incurring losses and negative cash flows from

operations until our product, CGuard Prime, 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.

had an accumulated deficit as of March 31, 2026, of $316 million, as well as a net loss of $13.7 million for the three months ended March

31, 2026 and negative operating cash flows.

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

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.

5 unchanged sentences

to reduce activities, curtail or cease operations.

May 2023, we closed a private placement offering of 10,266,270 shares of our common stock, 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, of which $35.7 million have been received as of the date of this Quarterly Report on

May 2024, we entered into an Equity 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 up to $75,000,000 of our common stock (the

“ATM Program”).

As of the issuance date of this report, we have sold 920,898 shares of our common stock for total gross proceeds

of approximately $2.4 million under the ATM Program.

June 2024, Series H warrants to purchase 12,914,086 shares of common stock that were issued in the May 2023 private placement 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 agent fees.

June and July 2025, Series I warrants to purchase 12,914,078 shares of common stock that were issued in the May 2023 private placement

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.

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

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 us, pursuant to which we issued and sold 10,266,270 shares

of our common stock, 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 “May 2023 Warrants”), at an offering price of $1.6327 per Private Placement Share and associated

May 2023 Warrants and an offering price of $1.6326 per pre-funded warrant and associated May 2023 Warrants.

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 Quarterly Report on Form 10-Q).

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, the Series H Warrants 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 from

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

the announcement of the PMA approval of the CGuard Prime carotid stent system in the United States, the Series I warrants 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

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

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

as sales agent (“Piper Sandler”).

Pursuant to the 2024 Distribution Agreement, we were able 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.

Piper Sandler a commission at a fixed rate of 3.0% of the aggregate gross proceeds from each sale of the shares under the 2024

Distribution Agreement.

On April 3, 2026, we terminated the 2024 Distribution Agreement

in connection with our entry into the 2026 Distribution Agreement (as defined below) with BTIG (as defined below).

During the first quarter

of 2026, we did not sell any shares pursuant to the 2024 Distribution Agreement.

August 2025, we closed the private placement offering 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 the Company.

months ended September 30, 2025, compared to the Nine months ended September 30, 2024

At September 30, 2025, we had cash and cash equivalents of $63,403,000, as compared to cash and cash equivalents of $18,916,000 and marketable

securities of $15,721,000 as of December 31, 2024.

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, 2025, net cash used in our operating activities increased by $10,640,000, or 70.4%, to $25,758,000,

from $15,118,000 during the same period in 2024.

The primary reasons for the increase in cash used in our operating activities were an

increase of $9,005,000 in compensation costs paid during the nine months ended September 30, 2025 (from $8,838,000 in the nine months

ended September 30, 2024 to $17,843,000 in the nine months ended September 30, 2025) and an increase of $1,709,000 in payments for third

party related expenses and for professional services.

provided by our investing activities was $14,575,000 during the nine months ended September 30, 2025, compared to $4,399,000 during the

nine months ended September 30, 2024.

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

of $10,343,000, net of investment in marketable securities.

provided by financing activities for the nine months ended September 30, 2025, was $55,569,000.

The source of the cash provided by financing

activities during the nine months ended September 30, 2025, were the proceeds from the Private Placement Offering in July 2025 as well

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

and proceeds from exercise of Series I warrants of $16,855,000.

Cash provided by financing activities for the nine months September 30,

2024, was $16,889,000.

The source of the cash provided by financing activities during the nine months ended September 30, 2024, were

the proceeds from exercise of Series H warrants.

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

April 2026, we entered into an Equity Distribution Agreement (the “2026 Distribution Agreement”) with BTIG, LLC, as sales

agent (“BTIG”).

Pursuant to the 2026 Distribution Agreement, we may offer and sell from time to time, at our option, through

or to BTIG shares of our common stock having an aggregate offering price of up to $75 million.

pay BTIG a commission at a fixed rate of up to 3.0% of the aggregate gross proceeds from each sale of the shares under the 2026

Distribution Agreement.

As of the date hereof, we have not sold any shares pursuant to the

2026 Distribution Agreement.

months ended March 31, 2026, compared to the Three months ended March 31, 2025

As of March 31, 2026, we had cash and cash equivalents of $11,362,000 and marketable securities of $30,208,000, as compared to cash and

cash equivalents of $8,939,000 and marketable securities of $45,272,000 as of December 31, 2025.

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 three months ended March 31, 2026, net cash used in our operating activities increased by $3,545,000, or 40.3%, to $12,337,000, from

$8,792,000 during the same period in 2025.

The primary reasons for the increase in cash used in our operating activities were an increase

of $5,038,000 in compensation costs paid during the three months ended March 31, 2026 (from $6,132,000 in the three months ended March

31, 2025 to $11,170,000 in the three months ended March 31, 2026) offset by an increase of $1,561,000 in payments received from customers

during the three months ended March 31, 2026 (from $1,555,000 in the three months ended March 31, 2025 to $3,116,000 during the three

months ended March 31, 2026).

provided by our investing activities was $14,779,000 during the three months ended March 31, 2026, compared to $1,702,000 during the

three months ended March 31, 2025.

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

$15,000,000 from our investment in marketable securities.

was no cash provided by financing activities for the three months ended March 31, 2026.

Cash provided by financing activities for the

three months ended March 31, 2025, was $506,000.

The source of the cash provided by financing activities during the three months ended

March 31, 2025, were the proceeds from issuance of shares of $506,000, net of issuance costs, received from the 2024 Distribution Agreement.

Balance Sheet Arrangements

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commercial launch, cyclical nature of the ordering patterns of our distributors, timing of regulatory

approvals, the implementation of various phases of our clinical trials and manufacturing efficiencies due to the learning curve of utilizing

new materials and equipment.

Our operating results could also be impacted by a weakening of the Euro and strengthening of the NIS, both

against the U.S.

Lastly, other economic conditions we cannot foresee may affect customer demand, such as individual country reimbursement

policies pertaining to our products.

approvals, the implementation of various phases of our clinical trials, manufacturing efficiencies due to the learning curve of utilizing

new materials and equipment and the costs or other consequences associated with any current or future product recall that may occur.

Product recalls in particular may adversely affect our operating results through the direct costs of executing a recall, lost revenues

resulting from the removal of affected products from the market and the interruption of sales during any remediation period, costs associated

with redesigning and remanufacturing affected products, potential regulatory, litigation and other legal costs, and longer-term reputational

harm that may reduce market acceptance of our current and future products.

Our operating results could also be impacted by a weakening

of the Euro and strengthening of the NIS, both against the U.S.

Lastly, other economic conditions we cannot foresee may affect

customer demand, such as individual country reimbursement policies pertaining to our products.

Obligations and Commitments

the nine months ended September 30, 2025, there were no material changes to our contractual obligations and commitments since the year

ended December 31, 2024.

the three months ended March 31, 2026, there were no material changes to our contractual obligations and commitments since the year ended

December 31, 2025.

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