Form 8-K

8-K — InspireMD, Inc.

Accession: 0001493152-26-021105

Filed: 2026-05-04

Period: 2026-05-04

CIK: 0001433607

SIC: 3841 (SURGICAL & MEDICAL INSTRUMENTS & APPARATUS)

Item: Results of Operations and Financial Condition

Item: Financial Statements and Exhibits

Documents

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UNITED

STATES

SECURITIES

AND EXCHANGE COMMISSION

Washington,

D.C. 20549

FORM

8-K

CURRENT

REPORT

Pursuant

to Section 13 OR 15(d) of The Securities Exchange Act of 1934

Date

of Report (Date of earliest event reported): May 4, 2026

InspireMD,

Inc.

(Exact

name of registrant as specified in its charter)

Delaware

001-35731

26-2123838

(State

or other jurisdiction

of incorporation)

(Commission

File

Number)

(IRS

Employer

Identification No.)

6303

Waterford District Drive, Suite 215

Miami,

Florida 33126

6744832

(Address

of principal executive offices)

(Zip

Code)

Registrant’s

telephone number, including area code: (888) 776-6804

(Former

name or former address, if changed since last report.)

Check

the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under

any of the following provisions:

☐

Written

communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐

Soliciting

material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐

Pre-commencement

communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐

Pre-commencement

communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities

registered pursuant to Section 12(b) of the Act:

Title of each class

Trading

Symbol(s)

Name of each exchange on which registered

Common

Stock, $0.0001 par value per share

NSPR

The

Nasdaq Capital Market

Indicate

by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405

of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging

growth company ☐

an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying

with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Item

2.02 Results of Operations and Financial Condition

May 4, 2026, InspireMD, Inc. issued a press release announcing its financial and operating results and recent highlights for the first

quarter ended March 31, 2026. A copy of this press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.

accordance with General Instruction B.2 of Form 8-K, the information in this Current Report on Form 8-K that is furnished pursuant to

this Item 2.02 shall not be deemed to be “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as

amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, and shall not be incorporated by reference

into any registration statement or other document filed under the Securities Act of 1933, as amended, or the Exchange Act, except as

shall be expressly set forth by specific reference in such filing.

Item

9.01 Financial Statements and Exhibits.

(d)

Exhibits

Exhibit

Number

Description

99.1

Press release, dated May 4, 2026 (furnished herewith pursuant to Item 2.02)

104

Cover

Page Interactive Data File (embedded within the Inline XBRL document)

SIGNATURES

Pursuant

to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by

the undersigned hereunto duly authorized.

INSPIREMD,

INC.

Date:

May 4, 2026

By:

/s/

Marvin Slosman

Name:

Marvin

Slosman

Title:

Chief

Executive Officer

EX-99.1

Filename: ex99-1.htm · Sequence: 2

Exhibit

99.1

InspireMD

Reports First Quarter 2026 Financial Results

Reports total Q1 2026 revenue of $3.4 million, representing year-over-year growth of 122% -

Received IDE approval from FDA to initiate the CGUARDIANS III clinical trial of its SwitchGuard neuro protection system for use in TCAR

procedures -

FDA approval of the original CGuard delivery system anticipated in Q3 2026 -

On track for expected FDA approval of the CGuard Prime 80 cm for TCAR procedures in H2 2026, potentially doubling the Company’s

addressable market -

Miami,

FL — May 4, 2026 – InspireMD, Inc. (Nasdaq: NSPR) (“InspireMD” or the “Company”), developer of

the CGuard® Prime carotid stent system for the prevention of stroke, today announced financial and operating results for the first

quarter ended March 31, 2026.

Recent

Business Highlights:

● Generated

revenue of $3.4 million in the first quarter of 2026, up 122% year-over-year, with significant

growth in demand for CGuard Prime in the U.S. and original CGuard in international markets.

● Supported

over 625 cumulative carotid procedures utilizing CGuard Prime across over 100 leading U.S.

hospitals and integrated delivery networks since launch.

● Filed

for and anticipate FDA approval of the original, clinically proven CGuard stent delivery

system in Q3 2026.

● Received

Investigational Device Exemption (“IDE”) approval from the FDA to initiate the

CGUARDIANS III clinical trial that will evaluate the Company’s next-generation SwitchGuard

neuro protection system (“NPS”) with CGuard Prime 80 cm for use in transcarotid

artery revascularization (“TCAR”) procedures.

● Initiated

a voluntary recall of CGuard Prime 135 cm carotid stent delivery system to address the need

for technical enhancements to improve user experience and delivery system performance.

“Our

first quarter results reflect strong underlying demand and consistent clinical outcomes for our CGuard carotid stent implant both in

the U.S. and internationally,” stated Marvin Slosman, Chief Executive Officer of InspireMD. “While our decision to voluntarily

pause commercialization of CGuard Prime 135 cm in the U.S. will impact its availability in the short term, we are in the process of implementing

several enhancements to the delivery system that we are confident will elevate technical performance and accelerate rapid adoption. Importantly,

our TCAR program is unaffected by this voluntary action, and we were also pleased to have recently received FDA approval to initiate

the CGUARDIANS III clinical trial with our SwitchGuard NPS, which, if successful, would enable us to offer a full TCAR tool kit leveraging

our best-in-class implant.”

“In

parallel, we are pursuing FDA approval of our commercially-proven CGuard stent delivery system which we anticipate in the third quarter

of 2026. This delivery system was successfully used in over 70,000 implants globally. Having this additional delivery system available

in the U.S. will enable us to offer physicians multiple options to deliver the best implant to their patients,” Mr. Slosman concluded.

Financial

Results for the First Quarter Ended March 31, 2026

For

the first quarter of 2026, total revenue was $3.4 million, representing an increase of 122%, as compared to $1.5 million during the same

period of 2025.

U.S.

revenue for the first quarter of 2026 was $1.2 million, representing a quarter-over-quarter increase of 36% as compared to $0.9 million

for the fourth quarter of 2025. International revenue was $2.2 million, representing a year-over-year increase of 48%, as compared to

$1.5 million for the first quarter of 2025.

Gross

profit for the first quarter of 2026 was $0.7 million, or 20.2% of revenue, compared to $0.3 million, or 19.1% of revenue, for the same

period of 2025. The increase in gross margin (gross profit as a percentage of revenue) was driven by a favorable shift in sales mix towards

significantly higher margin revenue from sales in the U.S., offset by an inventory impairment charge of $0.5 million. On a non-GAAP basis,

which excludes the impact of the impairment charge as calculated in the attached non-GAAP reconciliation table, adjusted gross profit

was $1.2 million, or 34.1% of revenue.

Total

operating expenses for the first quarter of 2026 were $14.7 million, an increase of $2.9 million, compared to $11.8 million for the first

quarter of 2025. This increase was primarily due to greater headcount-related expenses for the U.S. commercial team, as well as additional

investment in resources and infrastructure to support U.S. commercialization.

Financial

income, net, for the first quarter of 2026 was $0.3 million, roughly flat with the first quarter of 2025.

Net

loss for the first quarter of 2026 was $13.7 million, or $0.16 per basic and diluted share, compared to a net loss of $11.2 million,

or $0.22 per basic and diluted share, for the same period in 2025.

The

Company currently expects the financial impact of the U.S. recall of CGuard Prime to include a reserve

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

Conference

Call and Webcast Details

Management

will host a conference call at 4:30 pm ET today, May 4th, to review financial results and provide an update on corporate developments.

Following management’s formal remarks, there will be a question-and-answer session. A live audio webcast and an archive of the

recording will be available here and through the Investors page of InspireMD’s corporate website at https://investors.inspiremd.com.

About

InspireMD, Inc.

InspireMD

seeks to utilize its proprietary MicroNet™ mesh technology to make its products the industry standard for carotid stenting by

providing outstanding acute results and durable, stroke-free long-term outcomes. InspireMD’s common stock is quoted on Nasdaq under

the ticker symbol NSPR. We routinely post information that may be important to investors on the Company’s website. For more information,

please visit www.inspiremd.com.

Forward-looking

Statements

This

press release contains “forward-looking statements.” Forward-looking statements include, but are not limited to, statements

regarding InspireMD or its management team’s expectations, hopes, beliefs, intentions or strategies regarding future events, future

financial performance, strategies, expectations, competitive environment and regulation. Such statements may be preceded by the words

“intends,” “may,” “will,” “plans,” “expects,” “anticipates,”

“projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,”

“potential”, “scheduled” or similar words. In particular, forward-looking statements in this press release include

the Company’s expectations regarding potential FDA approvals for original CGuard and the CGuard Prime 80 cm stent for TCAR procedures,

the Company’s expectations regarding enhancements to the CGuard Prime 135 cm delivery system, the Company’s beliefs regarding

the potential adoption of its products, statements relating to the Company’s addressable markets and the Company’s expectations

regarding reserves for customer returns and inventory impairment and remediation as result of the U.S. recall of CGuard Prime. Forward-looking

statements are not guarantees of future performance, are based on certain assumptions and are subject to various known and unknown risks

and uncertainties, many of which are beyond the Company’s control, and cannot be predicted or quantified and consequently, actual

results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include,

without limitation, risks and uncertainties associated with the voluntary U.S. recall of the CGuard Prime 135 cm delivery system, including

current and future costs associated with the recall, including refunds or inventory write-off costs and other remediation costs, loss

of sales and customers due to the recall or otherwise, our ability to effectively implement enhancements to CGuard Prime 135 cm delivery

system, potential actions by regulators or other governmental entities associated with the recall, potential claims and lawsuits by customers

and patients, including class action product liability lawsuits, other operational impacts and consequences of the recall, such as business

disruption and distraction of management and other key employees; the Company’s history of recurring losses and negative cash flows

from operating activities, significant future commitments and the uncertainty regarding the adequacy of its liquidity to pursue its complete

business objectives, and substantial doubt regarding its ability to continue as a going concern; the Company’s need to raise additional

capital to meet its business requirements in the future and such capital raising may be costly or difficult to obtain and could dilute

out stockholders’ ownership interests; the clinical development, commercialization and market acceptance of the Company’s

products; whether the clinical trial results for the Company’s products will be predictive of real-world results; an inability

to secure and maintain regulatory approvals for the sale of the Company’s products; negative clinical trial results or lengthy

product delays in key markets; the Company’s ability to maintain compliance with the Nasdaq listing standards; the Company’s

ability to generate significant revenues from its products; estimates of the Company’s expenses, future revenues, capital requirements

and its needs for and ability to access sufficient additional financing, including any unexpected costs or delays in the ongoing commercial

launch of its products; the Company’s dependence on a single manufacturing facility and its ability to comply with stringent manufacturing

quality standards and to increase production as necessary; the risk that the data collected from the Company’s current and planned

clinical trials may not be sufficient to demonstrate that its technology is an attractive alternative to other procedures and products;

intense competition in the Company’s industry, with competitors having substantially greater financial, technological, research

and development, regulatory and clinical, manufacturing, marketing and sales, distribution and personnel resources than it does; entry

of new competitors and products and potential technological obsolescence of the Company’s products; inability to carry out research,

development and commercialization plans; loss of a key customer or supplier; technical problems with the Company’s research and

products and potential product liability claims; product malfunctions; price increases for supplies and components; whether access to

the Company’s products is achieved in a commercially viable manner and whether its products receive adequate reimbursement by governmental

and other third-party payers; the Company’s efforts to successfully obtain and maintain intellectual property protection covering

its products, which may not be successful; adverse federal, state and local government regulation, in the United States, Europe or Israel

and other foreign jurisdictions; the fact that the Company conducts business in multiple foreign jurisdictions, exposing it to foreign

currency exchange rate fluctuations, logistical and communications challenges, burdens and costs of compliance with foreign laws and

political and economic instability in each jurisdiction; security, political and economic instability in the Middle East that could harm

the Company’s business, including due to the current security situation in Israel; current or future unfavorable economic and market

conditions and adverse developments with respect to financial institutions and associated liquidity risk; and changes in tariffs, trade

barriers, price and exchange controls and other regulatory requirements and the impact of such policies on the Company, its customers

and suppliers, and the global economic environment. More detailed information about the Company and the risk factors that may affect

the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission

(SEC), including the Company’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Investors and security holders

are urged to read these documents free of charge on the SEC’s web site at http://www.sec.gov. The Company assumes no obligation

to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise.

Non-GAAP

Financial Measures

supplement its consolidated financial statements, which are prepared and presented in accordance with U.S. Generally Accepted Accounting

Principles (“GAAP”), this press release and the accompanying tables include supplemental financial information, referred

to as non-GAAP financial measure, that have not been prepared in accordance GAAP, including adjusted gross profit. The Company believes

that the use of non-GAAP accounting measures is useful to its investors as an additional tool to enhance the overall understanding of

past financial performance and future prospects, and allow for greater transparency with respect to key measures used by management in

its financial and operational decision making. The Company defines adjusted gross profit as gross profit excluding the impact of the

reserve for inventory impairment recognized during the period.

The

non-GAAP financial data are not measures of the Company’s financial performance under GAAP and should not be considered as alternatives

to gross margin or any other performance measures derived in accordance with GAAP. Non-GAAP financial measures may not provide information

that is directly comparable to that provided by other companies in other industries or within InspireMD’s industry, as other companies

may calculate non-GAAP financial results differently, particularly related to non-recurring, unusual items. In addition, there are limitations

in using non-GAAP financial measures because the non-GAAP financial measures are not prepared in accordance with GAAP, may be different

from non-GAAP financial measures used by other companies and exclude expenses that may have a material impact on the Company’s

reported financial results. Further, the reserve for inventory impairment recognized during the period is a significant item that affects

gross profit and may obscure the Company’s underlying operating performance and comparability between periods.

The

presentation of non-GAAP financial information is not meant to be considered in isolation, as a substitute for, or superior to the directly

comparable financial measures prepared in accordance with GAAP. In addition, non-GAAP measures should not be construed as an inference

that the Company’s future results will be unaffected by unusual or non-recurring items. InspireMD urges investors to review the

financial results calculated in accordance with GAAP and the reconciliation of the Company’s non-GAAP financial measures to the

comparable GAAP financial measures included below, and not to rely on any single financial measure to evaluate the Company’s business.

Investor

Contacts:

Jeff

Warren

LifeSci

Advisors

jwarren@lifesciadvisors.com

investor-relations@inspiremd.com

CONDENSED

CONSOLIDATED STATEMENTS OF OPERATIONS(1)

(Unaudited)

(U.S.

dollars in thousands, except share and per share data)

Three months ended

March 31,

2026

2025

Revenues

$ 3,398

$ 1,529

Cost of revenues

2,711

1,237

Gross Profit

687

292

Operating Expenses:

Research and development

4,763

4,059

Selling and marketing

5,180

2,750

General and administrative

4,722

4,943

Total operating expenses

14,665

11,752

Loss from operations

(13,978 )

(11,460 )

Financial Income, net

289

294

Net Loss

$ (13,689 )

$ (11,166 )

Net loss per share – basic and diluted

$ (0.16 )

$ (0.22 )

Weighted average number of common stock used in computing net loss per share – basic and diluted

83,801,839

49,993,509

CONDENSED CONSOLIDATED BALANCE SHEETS (2)

(Unaudited)

(U.S. dollars in thousands other than share and per share data)

March 31,

December 31,

2026

2025

ASSETS

Current Assets:

Cash and cash equivalents

$ 11,362

$ 8,939

Marketable securities

30,208

45,272

Accounts receivable:

Trade, net

2,381

2,168

Other

407

400

Prepaid expenses

1,200

1,296

Inventory

3,036

3,396

Total current assets

48,594

61,471

Non-current assets:

Long term deposit

446

442

Property, plant and equipment, net

3,651

3,584

Operating lease right of use assets

2,595

2,758

Funds in respect of employee rights upon retirement

1,185

1,149

Total non-current assets

7,877

7,933

Total assets

$ 56,471

$ 69,404

March 31,

2026

December 31,

2025

LIABILITIES AND EQUITY

Current liabilities:

Accounts payable and accruals:

Trade

$ 1,954

$ 1,255

Other

7,489

9,457

Total current liabilities

9,443

10,712

Long-term liabilities:

Operating lease liabilities net of current maturities

2,042

2,224

Liability for employee rights upon retirement and others

1,369

1,267

Total long-term liabilities

3,411

3,491

Total liabilities

$ 12,854

$ 14,203

COMMITMENTS AND CONTINGENT LIABILITIES

Equity:

Common stock, par value $0.0001 per share; 150,000,000 shares authorized at March 31, 2026 and December 31, 2025; 46,838, 963 and 43,532,281 shares issued and outstanding at March 31, 2026 and December 31, 2025, respectively

Preferred C shares, par value $0.0001 per share;

1,172,000 shares authorized at March 31, 2026 and December 31, 2025; 1,718 shares issued and outstanding at March 31, 2026 and December 31, 2025

Additional paid-in capital

359,594

357,489

Accumulated deficit

(315,981 )

(302,292 )

Total equity

43,617

55,201

Total liabilities and equity

$ 56,471

$ 69,404

(1)

All 2026 financial information is derived from the Company’s 2026 unaudited financial statements, as disclosed in the Company’s

Quarterly Report on Form 10-Q, filed with the Securities and Exchange Commission; all 2025 financial information is derived from the

Company’s 2025 unaudited financial statements, as disclosed in the Company’s Quarterly Report on Form 10-Q, filed with the

Securities and Exchange Commission.

(2)

All March 31, 2026 financial information is derived from the Company’s 2026 unaudited financial statements, as disclosed in the

Company’s Quarterly Report on Form 10-Q, filed with the Securities and Exchange Commission. All December 31, 2025 financial information

is derived from the Company’s 2025 audited financial statements as disclosed in the Company’s Annual Report on Form 10-K,

for the twelve months ended December 31, 2025 filed with the Securities and Exchange Commission.

Adjusted

Gross Profit

The

following table reconciles Adjusted Gross Profit to Gross Profit, which we consider to be the most directly comparable GAAP financial

measure

Three Months Ended

March 31, 2026

March 31, 2025

Dollars in thousands

% of revenues

Gross profit

$ 687

20.2 %

$ 292

19.1 %

Adjustments:

Inventory impairment charge

$ 473

Adjusted gross profit

$ 1,160

34.1 %

$ 292

19.1 %

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Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 13e

-Subsection 4c

+ Details

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Balance Type:

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- Definition

Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 14d

-Subsection 2b

+ Details

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Namespace Prefix:

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- Definition

Title of a 12(b) registered security.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 12

-Subsection b

+ Details

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Data Type:

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- Definition

Name of the Exchange on which a security is registered.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 12

-Subsection d1-1

+ Details

Name:

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Namespace Prefix:

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Data Type:

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Balance Type:

Period Type:

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- Definition

Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as soliciting material pursuant to Rule 14a-12 under the Exchange Act.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 14a

-Subsection 12

+ Details

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Namespace Prefix:

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- Definition

Trading symbol of an instrument as listed on an exchange.

+ References

No definition available.

+ Details

Name:

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Namespace Prefix:

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Data Type:

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Balance Type:

Period Type:

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- Definition

Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as written communications pursuant to Rule 425 under the Securities Act.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Securities Act

-Number 230

-Section 425

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