Form 8-K

8-K — InspireMD, Inc.

Accession: 0001493152-26-020891

Filed: 2026-05-01

Period: 2026-05-01

CIK: 0001433607

SIC: 3841 (SURGICAL & MEDICAL INSTRUMENTS & APPARATUS)

Item: Regulation FD Disclosure

Item: Other Events

Item: Financial Statements and Exhibits

Documents

8-K — form8-k.htm (Primary)

EX-99.1 (ex99-1.htm)

EX-99.2 (ex99-2.htm)

GRAPHIC (ex99-1_001.jpg)

GRAPHIC (ex99-2_001.jpg)

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8-K

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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 1, 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

7.01. Regulation FD Disclosure.

May 1, 2026, InspireMD, Inc. (the “Company”) issued press releases announcing the events described in Item 8.01 of

this Current Report on Form 8-K (“Form 8-K”). A copy of each of the press releases is furnished herewith as

Exhibit 99.1 and Exhibit 99.2, respectively, to this Form 8-K and is incorporated by reference in this Item 7.01.

accordance with General Instruction B.2 of Form 8-K, the information in this Form 8-K that is furnished pursuant to this Item 7.01, including

Exhibit 99.1 and Exhibit 99.2, 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

8.01. Other Events.

May 1, 2026, the Company announced that it initiated a voluntary recall in the United States of its CGuard® Prime 135 cm carotid

stent delivery system after determining during a controlled launch that the technical success of the delivery system during carotid artery

stenting (“CAS”) procedures has not met performance expectations. The voluntary recall pertains specifically to the CGuard

Prime 135 cm delivery system and does not include the CGuard stent implant.

May 1, 2026, the Company announced that the U.S. Food and Drug Administration (FDA) has approved the company’s Investigational

Device Exemption (“IDE”) Application to initiate the CGUARDIANS III pivotal study of its SwitchGuard neuro protection

system (“NPS”), including next generation enhancements from the prior IDE approval, for use with its CGuard Prime 80 cm

stent platform, in transcarotid artery revascularization (“TCAR”) procedures.

Item

9.01 Financial Statements and Exhibits.

(d)

Exhibits.

Exhibit Number

Description

99.1

Press Release, dated May 1, 2026

99.2

Press Release, dated May 1, 2026

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 1, 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

Initiates Voluntary U.S. Recall of CGuard® Prime 135 cm

Carotid

Stent Delivery System

Strong clinical demand continues in Q1 2026 with global year-over-year unit sales growth of 53% and quarter-over-quarter U.S. unit sales

growth of 34% -

FDA approval anticipated with U.S. market availability of original CGuard delivery system in the third quarter of 2026 -

Continuing to anticipate FDA approval of CGuard Prime 80 cm for TCAR procedures during 2H 2026 -

Miami,

FL, May 1, 2026 — InspireMD, Inc. (Nasdaq: NSPR) (“InspireMD,” or the “Company”), developer of the

CGuard® Prime carotid stent system for the prevention of stroke, today

announced that, in consultation with the U.S. Food and Drug Administration (“FDA”), the Company has initiated a voluntary

recall in the U.S. for its CGuard® Prime 135 cm carotid stent delivery system.

The

Company acted after determining during a controlled launch that the technical success of the delivery system during carotid artery stenting

(“CAS”) procedures has not met performance expectations. This action is voluntary with no implications for the safety of

patients who have previously received the CGuard stent.

This

voluntary action pertains specifically to the CGuard Prime 135 delivery system, and does not include the CGuard stent implant, which

continues to generate unmatched clinical outcomes, including the lowest major adverse event rates and most durable stroke prevention

among CAS carotid interventions.

InspireMD

anticipates FDA approval for its original CGuard stent delivery system for CAS procedures in the U.S. in the third quarter of 2026. The

delivery system has been successfully used in over 70,000 cases worldwide, including the majority of clinical study cases in the CGUARDIANS

clinical trial.

The

Company is also implementing design improvements to the CGuard Prime stent delivery system and anticipates FDA approval in the first

half of 2027.

“Our

continued strong unit sales growth worldwide in the first quarter 2026 reflects significant demand for this novel stent technology with

our best-in-class CGuard implant,” stated Marvin Slosman, Chief Executive Officer.

“However,

the controlled launch of CGuard Prime in the U.S. has revealed opportunities to improve the technical performance of the delivery system,”

continued Mr. Slosman. “As a result, we have taken the proactive step to pause commercialization of the CGuard Prime delivery system

to implement the necessary enhancements. This voluntary action reflects our unwavering commitment to providing our customers with the

highest quality carotid stent platform on the market, while minimizing market disruptions and achieving the optimal physician satisfaction

and patient safety for which we are known.”

TCAR

Initiatives On-Track

InspireMD

anticipates FDA approval later this year for its CGuard Prime 80 cm carotid stent delivery system for transcarotid artery revascularization

(“TCAR”) procedures, designed to be compatible with neuroprotection systems that are already in use. With approximately 35,000

TCAR procedures annually in the United States, an approved TCAR indication could potentially double the size of the addressable market

for the CGuard stent implant. The technical performance of the CGuard Prime 80 cm version meets all technical expectations. Additionally,

the Company anticipates potential FDA clearance of its SwitchGuard neuroprotection system for TCAR procedures in the second half of 2027.

2026

Financial Guidance

Concurrent

with today’s announcement, the Company is withdrawing its prior full year 2026 revenue guidance. Management believes this is the

most prudent step given the impact of the temporary discontinuation of commercial activity in the U.S. pending the anticipated FDA approval

of its original CGuard stent delivery system in the third quarter of 2026.

Management

intends to provide a full company update on this and other recent developments during its conference call for the results of the first

quarter of 2026 on May 4th.

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.

routinely post information that may be important to investors on our 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 the Company 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

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

regarding enhancements to the CGuard Prime 135 cm delivery system and recommencement of sales. 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.

Investor

Contacts:

Jeff

Warren

LifeSci

Advisors

jwarren@lifesciadvisors.com

investor-relations@inspiremd.com

EX-99.2

Filename: ex99-2.htm · Sequence: 3

Exhibit 99.2

InspireMD Announces FDA Approval

of Investigational Device Exemption for CGUARDIANS III Pivotal Study of the SwitchGuard Neuro Protection System

Miami, FL —

May 1, 2026 – InspireMD, Inc. (Nasdaq: NSPR) (“InspireMD” or the “Company”), developer of the

CGuard® Prime carotid stent system for the prevention of stroke, today announced that the U.S. Food and Drug Administration (“FDA”)

has approved the company’s Investigational Device Exemption (“IDE”) Application to initiate the CGUARDIANS III pivotal

study of its SwitchGuard neuro protection system (“NPS”), including next generation enhancements from our prior IDE approval,

for use with its CGuard Prime 80 cm stent platform, in transcarotid artery revascularization (“TCAR”) procedures.

Patrick Geraghty, M.D., professor of surgery

and radiology, section of vascular surgery at Washington University School of Medicine in St. Louis, MO, and Patrick Muck, M.D., program

director and chief of vascular surgery at Good Samaritan Hospital in Cincinnati, OH, who previously led the CGUARDIANS II trial as co-lead

investigators, will continue in the roles for the CGUARDIANS III trial.

“The approval of our CGUARDIANS III IDE

represents a meaningful advancement in our quest to offer the full TCAR tool kit leveraging our best-in-class CGuard Prime 80 cm stent

platform for unmatched stroke prevention and carotid disease management,” said Marvin Slosman, CEO of InspireMD. “We look

forward to the efficient execution of this important study as we target U.S. commercial launch of the SwitchGuard NPS in 2027, if approved.”

For additional information: https://clinicaltrials.gov/study/NCT07277296

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. 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 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