What changed in this filing

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Item 2. Management’s Discussion and Analysis

2026-08-14 compared with 2026-05-07 · 228 added, 110 removed, 199 unchanged (63% of the section changed)

79 unchanged sentences

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.

FDA approval in the second half of 2026.

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

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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.

Administration (“FDA”) on June 23, 2025.

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

of CGuard Prime, undertaken

in consultation with the FDA after a controlled launch demonstrated that the technical success of its delivery system during CAS procedures

did not meet performance expectations, with the voluntary action pertaining specifically to the delivery system and not to the CGuard

stent implant.

For additional information, see “ FDA Matters ” below.

CGuard Prime 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

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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.

in the CGUARDIANS II pivotal study, and in June 2026, we announced summary 30-day outcome data from the study, which showed

acute device success of 100% with no major adverse events.

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, and in June 2026, we announced enrollment

of the first patient.

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

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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

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

met performance expectations.

The voluntary action was limited to the CGuard Prime delivery system and did not involve 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 U.S.

launch and commercialization of CGuard Prime.

The Company’s assessment did not identify new safety concerns for patients who had previously received a CGuard

We believe we have identified the root cause of the deployment resistance and are implementing design modifications

intended to address the issue.

We are currently performing verification and validation testing of these modifications in support of

a PMA supplement to the FDA which we expect to submit in the fourth quarter of 2026.

We cannot provide any assurance that the FDA

will be satisfied with the corrective actions we are implementing in connection with the voluntary recall, or as to the timing of

the resolution of such issues.

Until these issues are resolved to the FDA’s satisfaction, we may be unable to resume

commercialization of CGuard Prime in the United States.

If the FDA determines that our corrective actions are inadequate or requires additional remediation, testing, validation

or regulatory submissions, such requirements could increase costs, delay or prevent FDA acceptance or approval of our proposed PMA supplement, extend

the duration of the voluntary recall, delay our ability to reintroduce CGuard Prime to the U.S.

market or otherwise adversely affect our

future commercialization plans, which could have a material

adverse effect on our business, financial condition and results of operations.

During the six months ended June 30, 2026,

substantially all affected products were returned, and credits were issued to customers.

We recorded approximately $734,000 as a

reduction of revenue related to these returns and approximately $612,000 of inventory impairment associated with the

Workforce Reduction Initiative

Subsequent to June 30, 2026, we

commenced implementation of a workforce reduction as part of a broader initiative to reduce our operating expenses, improve operational

efficiency and better align our resources with our strategic priorities.

The workforce reduction is expected to reduce the number of positions in the organization by almost 20%.

We expect the initiative to result in annualized operating expense savings of approximately $9.0 million, primarily

through reduced personnel-related expenses resulting from both the elimination of certain employee positions and the decision not to fill

certain currently vacant positions.

These estimates are based on management’s current expectations regarding personnel reductions and

hiring plans, and actual cost savings may differ from those currently anticipated.

We expect to incur aggregate restructuring

charges of approximately $0.9 million to $1.2 million, consisting primarily of employee severance and related employee termination costs.

Because the workforce reduction was initiated after June 30, 2026, no liability associated with these actions was recorded in the accompanying

consolidated financial statements as of June 30, 2026.

We expect the workforce reduction

to be substantially completed by the end of the third quarter of 2026.

Actual costs incurred may differ from current estimates.

these actions to better align our resources with key product development, regulatory, clinical and commercialization priorities while

reducing our overall operating expense base.

Accounting Policies

critical accounting policy is one that is both important to the portrayal of our financial condition and results of operation and requires

critical accounting policy is one that is both important to the portrayal of our financial condition and results of operations and requires

management’s most difficult, subjective or complex judgments, often as a result of the need to make estimates about the effect

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of Operations

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.

months ended June 30, 2026, compared to the three months ended June 30, 2025

For the three months ended June 30, 2026, revenue was $1,771,000, a decrease of $7,000, or 0.4 %, compared to $1,778,000 during the three

months ended June 30, 2025.

The decrease was primarily attributable to the net impact of $734,000 of credits issued in connection with

the voluntary recall of CGuard Prime products in the U.S.

in May 2026, which offset revenues generated from direct sales of the CGuard

Prime product in the U.S., and continued growth in sales of the CGuard product through distributors in international markets.

respect to geographical regions, U.S.

revenue was $(351,000) for the three months ended June 30, 2026, compared to $27,000 for the

three months ended June 30, 2025.

The decrease of $378,000 in the U.S., was primarily due to the aforementioned credits issued in

connection with the voluntary recall of CGuard Prime products.

This decrease was partially offset by 21% growth in international

markets, with international revenue increasing to $2,122,000 for the three months ended June 30, 2026, compared to $1,751,000 for

the three months ended June 30, 2025, including increases of $128,000 in Europe, $176,000 in Latin America and $67,000 in all other

regions, reflecting continued growth in demand in these markets.

Profit (Loss) .

For the three months ended June 30, 2026, gross loss (revenue less cost of revenues) was $774,000 compared to gross

profit of $313,000 for the three months ended June 30, 2025.

The decrease in gross profit was primarily attributable to the voluntary

recall of CGuard Prime products in the U.S., including the net credits of $734,000 issued to customers, which reduced revenues, and approximately

$612,000 of inventory impairment associated with CGuard Prime inventory, which increased cost of revenues.

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

Gross margin was negative 43.7% for the three months ended June

30, 2026, a decrease of 61.3 percentage points compared to gross margins of 17.6% for the three months ended June 30, 2025, primarily

due to the factors discussed above.

and Development Expenses .

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.

For the three months ended June 30, 2026, research and development expenses were $4,295,000, an increase

of $461,000, or 12%, compared to $3,834,000 during the three months ended June 30, 2025.

This increase resulted primarily from higher

development and clinical expenses for the SwitchGuard NPS and CGuard Prime 80 cm carotid stent system, regulatory activity related to

the PMA for CGuard NPS, and redesign work for the CGuard Prime 135 cm.

and Marketing Expenses .

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.

For the three months ended June 30, 2026, selling and marketing expenses were $5,221,000, an increase of

$1,049,000, or 25.1%, compared to $4,172,000 during the three months ended June 30, 2025.

This increase resulted primarily from higher

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

commercial staffing levels following the commercial launch of CGuard Prime in the U.S.

in July 2025.

and Administrative Expenses .

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

For the three months ended June 30, 2026, general and administrative expenses were $4,155,000, a decrease

of $1,171,000, or 22%, compared to $5,326,000 during the three months ended June 30, 2025.

The decrease was primarily driven by lower

compensation expenses, mainly due to severance costs related to our former chief financial officer’s retirement that were recognized

in the three months ended June 30, 2025, and lower share-based compensation expense.

For the three months ended June 30, 2026, financial income was $121,000 compared to financial expense of $132,000 during

the three months ended June 30, 2025, representing a decline in the financial expense of $253,000, or 191.7%.

The increase in financial income primarily resulted from higher income from investment in marketable securities and

money market funds and lower financial expenses related to changes in exchange rates.

We did not incur any tax expenses during the three months ended June 30, 2026 and June 30, 2025.

For the three months ended June 30, 2026, our net loss was $14,324,000, an increase of $1,173,000, or 8.9%, compared to $13,151,000

during the three months ended June 30, 2025.

The increase in net loss resulted primarily from a decrease in gross profit of $1,087,000

and an increase in total operating expenses of $339,000, partially offset by an increase in financial income of $253,000 compared to

the prior-year period.

months ended June 30, 2026, compared to the six months ended June 30, 2025

For the six months ended June 30, 2026, revenue was $5,169,000, an increase of $1,862,000, or 56.3%, compared to $3,307,000 during

the six months ended June 30, 2025.

The increase was driven mainly by direct sales of the CGuard Prime product in the U.S.

continued growth in sales of the CGuard product through distributors in international markets.

The increase was partially offset by

$734,000 of credits issued in connection with the voluntary recall of CGuard Prime products in the U.S.

during the six months ended

June 30, 2026.

respect to geographical regions, U.S.

revenue was $827,000 for the six months ended June 30, 2026, compared to $54,000 for the six

months ended June 30, 2025.

The increase of approximately $772,000 was driven by commercial sales of CGuard Prime, partially offset by

credits issued in connection with the voluntary recall of CGuard Prime in May 2026.

International revenue was $4,342,000 for the six months ended June 30,

2026, compared to $3,253,000 for the six months ended June 30, 2025.

Revenue from international markets grew

by $1,089,000, or 33%, including $557,000 in Europe, $348,000 in Latin America and $184,000 in all other regions.

The international

sales performance reflects continued growth in demand in these markets.

For the six months ended June 30, 2026, gross loss (revenue less cost of revenues) was $87,000 compared to gross profit of

$605,000 for the six months ended June 30, 2025.

The decrease in gross profit was primarily attributable to the voluntary recall of CGuard

Prime products in the U.S., including $734,000 in net credits issued to customers, which reduced revenues, as well as inventory impairment

and inventory obsolescence charges of a combined $1,085,000 related to our CGuard Prime delivery system, which increased cost of revenues.

These impacts were partially offset by the increase in revenue year-over-year.

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

Gross margin was negative 1.7% for the six months ended June 30,

2026, a decrease of 20.0 percentage points compared to gross margin of 18.3% for the six months ended June 30, 2025, primarily due to

the factors discussed above.

and Development Expenses .

For the six months ended June 30, 2026, research and development expenses were $9,058,000, an increase

of $1,165,000, or 14.8%, compared to $7,893,000 during the six months ended June 30, 2025.

The increase was primarily driven by higher

clinical trial expenses related to the initiation of the CGUARDIANS III pivotal trial and higher compensation expenses due to the hiring

of new employees in connection with our expansion in the United States.

These increases were partially offset by lower clinical trial

expenses due to the completion of the CGUARDIANS I and CGUARDIANS II pivotal trials.

and Marketing Expenses .

For the six months ended June 30, 2026, selling and marketing expenses were $10,401,000, an increase of $3,479,000,

or 50.3%, compared to $6,922,000 during the six months ended June 30, 2025.

This increase resulted primarily from higher commercial staffing

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

in July 2025.

and Administrative Expenses .

For the six months ended June 30, 2026, general and administrative expenses were $8,877,000, a decrease

of $1,392,000, or 13.6%, compared to $10,269,000 during the six months ended June 30, 2025.

The decrease was primarily driven by lower

compensation expenses, mainly due to severance costs related to our former chief financial officer’s retirement that were recognized

in the six months ended June 30, 2025, and lower share-based compensation expense.

For the six months ended June 30, 2026, financial income was $410,000, an increase of $248,000, or 153.1%, compared

to $162,000 during the six months ended June 30, 2025.

The increase in financial income primarily resulted from higher income from investment

in marketable securities and money market funds and lower financial expenses related to changes in exchange rates.

For the six months ended June 30, 2026, there was no material change in our tax expenses as compared to the six months

ended June 30, 2025.

For the six months ended June 30, 2026, our net loss was $28,013,000, an increase of $3,696,000, or 15.2%, compared to $24,317,000

during the six months ended June 30, 2025.

The increase in net loss resulted primarily from a decrease in gross profit and an increase

in total operating expenses, partially offset by an increase in financial income compared to the prior-year period.

and Capital Resources

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

had an accumulated deficit as of June 30, 2026, of $330 million, as well as a net loss of $28 million for the six months ended June 30,

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.

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.

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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.

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 outstanding May 2023 Warrants or that the outstanding May 2023 Warrants will be exercised

in cash in full.

The exercise price of the outstanding May 2023 Warrants is $1.3827 per share.

The Series J Warrants expire 20 trading

days after FDA approval of SwitchGuard and CGuard Prime 80 cm, while the Series K Warrants expire on October 28, 2026, which is 20 trading

days after the end of the fourth fiscal quarter following the commencement of first U.S.

commercial sales of CGuard Prime in July 2025.

The last reported sale price of our shares of common stock on August 13, 2026 was $0.8401 per share.

We believe that the likelihood that

warrant holders will exercise their outstanding May 2023 Warrants, and therefore the amount of cash proceeds we would receive, is dependent

upon the trading price of our shares of common stock.

If the trading price of our shares of common stock is less than $1.3827 per share,

we believe that warrant holders will be unlikely to exercise their outstanding May 2023 Warrants.

the announcement of the one year follow up study results from the Company’s C-GUARDIANS trial, the Series H Warrants were exercised

7 unchanged sentences

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

Pursuant to the 2024 Distribution Agreement, we were able to 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.

We paid 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.

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 half 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

4 unchanged sentences

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

We will 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 June 30, 2026, compared to the Six months ended June 30, 2025

As of June 30, 2026, we had cash and cash equivalents of $15,149,000 and marketable securities of $15,272,000 as compared to cash and

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

3 unchanged sentences

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

the six months ended June 30, 2026, net cash used in our operating activities increased by $6,107,000, or 35.7%, to $23,232,000, from

$17,125,000 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.

of $6,741,000 in compensation costs paid during the six months ended June 30, 2026 (from $11,474,000 in the six months ended June 30,

2025 to $18,215,000 in the six months ended June 30, 2026), an increase of $1,937,000 in payments to vendors, clinical service providers

and other professional service providers, offset by an increase of $2,617,000 in payments received from customers during the six months

ended June 30, 2026 (from $3,380,000 in the six months ended June 30, 2025 to $5,997,000 during the six months ended June 30, 2026).

provided by our investing activities was $29,432,000 during the six months ended June 30, 2026, compared to $7,024,000 during the six

months ended June 30, 2025.

The primary reason for the increase in cash provided by our investing activities is withdrawal of $30,000,000

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.

was no cash provided by financing activities for the six months ended June 30, 2026.

Cash provided by financing activities for the six

months ended June 30, 2025, was $2,643,000.

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

30, 2025, were the proceeds from exercise of Series I warrants of $1,947,000, and proceeds from issuance of shares of $696,000, net of

issuance costs, received from our ATM Program.

Balance Sheet Arrangements

8 unchanged sentences

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.

Product recalls in particular have adversely affected and may continue to 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 three months ended March 31, 2026, there were no material changes to our contractual obligations and commitments since the year ended

the six months ended June 30, 2026, there were no material changes to our contractual obligations and commitments since the year ended

December 31, 2025.

3 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