AI Earnings Predictions for InspireMD Inc. (NSPR)

EX-99.1

2 ex99-1.htm

EX-99.1

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

EX-99.1

2 ex99-1.htm

EX-99.1

Exhibit 99.1

InspireMD Reports Fourth Quarter and Full Year 2025 Financial Results

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Miami, FL — March 18, 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 fourth quarter and year ended December 31, 2025.

Recent Business Highlights:

●Generated revenue of $3.1 million in the fourth quarter of 2025, up 62% year-over-year.

●Sustained strong commercial traction in the U.S. with the launch of CGuard Prime and continued growth in international demand for CGuard.

●Supported over 500 cumulative carotid procedures utilizing CGuard Prime across leading hospitals and integrated delivery networks since launch.

●Completed enrollment in CGUARDIANS II pivotal trial evaluating the safety and performance of CGuard Prime designed for use in transcarotid artery revascularization (“TCAR”) procedures.

●Submitted a PMA-S to the U.S. Food and Drug Administration (“FDA”) seeking an approval for indications of use of CGuard Prime in TCAR procedures.

●Published C-GUARDIANS manuscript of pivotal trial results in the Journal of the American College of Cardiology.

“We continue to see robust early momentum in our U.S. business with CGuard Prime and growing demand internationally for CGuard as we build a platform designed to position us to be a global leader in the treatment of carotid artery disease and the prevention of stroke,” said Marvin Slosman, CEO of InspireMD. “In addition, we are committed to advancing CGuard Prime for use in TCAR procedures. Once approved, this will potentially double our addressable U.S. market opportunity. We expect more catalysts in 2026 that may accelerate the adoption of our next-generation stent platform and the growth of our business.”

Financial Results for the Fourth Quarter Ended December 31, 2025

For the fourth quarter of 2025, total revenue was $3.1 million, representing an increase of 62%, as compared to $1.9 million during the same period of 2024 and a sequential increase of 25% over the third quarter of 2025.

U.S.

revenue for the fourth quarter of 2025 was $0.9 million, representing sequential growth of 74% during the Company’s second quarter of launch of CGuard Prime. International revenue was $2.3 million, a 17% increase over the fourth quarter of 2024, reflecting increased penetration of international markets with CGuard.

Gross profit for the fourth quarter of 2025 was $1.2 million, or 37.5% of revenue, compared to $0.5 million, or 24.1% of revenue, for the same period of 2024. 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.

Total operating expenses for the fourth quarter of 2025 were $13.3 million, an increase of $3.5 million, compared to $9.8 for the fourth quarter of 2024. 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 the U.S. commercial launch of CGuard Prime.

Financial income, net for the fourth quarter of 2025 was $0.4 million, an increase of $0.1 million, compared to financial income of $0.3 million for the fourth quarter of 2024. This increase was primarily due to an increase in financial income from investments in marketable securities and money market funds, partially offset by an increase in financial expenses related to changes in exchange rates.

Net loss for the fourth quarter of 2025 was $11.8 million or $0.14 per basic and diluted share, compared to a net loss of $9.2 million or $0.19 per basic and diluted share, for the same period in 2024.

Financial Results for the Year Ended December 31, 2025

For the full year 2025, total revenue was $9.0 million, representing an increase of 28%, as compared to $7.0 million during the full year 2024.

U.S.

revenue for the full year 2025 was $1.4 million, representing the first two quarters of launch of CGuard Prime in the U.S. International revenue was $7.6 million, an 8% increase over the full year 2024 driven by increasing sales of CGuard through distributors in key international markets.

Gross profit for the full year 2025 was $2.7 million, or 29.5% of revenue, compared to $1.5 million, or 21.5% of revenue, for the full year 2024. Gross margin was driven by a favorable shift in sales mix towards significantly higher margin revenue from sales in the U.S.

Total operating expenses for the full year 2025 were $52.3 million, an increase of $17.3 million, compared to $35.0 million for the full year 2024. This increase was primarily due to greater headcount-related expenses for the U.S. commercial team, as well as additional resources and infrastructure to support the U.S. commercial launch of CGuard Prime.

Financial income, net for the full year 2025 was $0.9 million, a decreas

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UNITED STATES

SECURITIES AND EXCHANGE

COMMISSION

WASHINGTON, DC 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): November 4, 2025

InspireMD, Inc.

(Exact Name of Registrant as Specified in Its Charter)

Delaware

(State or Other Jurisdiction of Incorporation)

001-35731

26-2123838

(Commission

File Number)

(IRS Employer

Identification No.)

6303 Waterford District Drive, Suite 215

Miami, Florida

33126

(Address of Principal Executive Offices)

(Zip Code)

(888) 776-6804

(Registrant’s Telephone Number, Including Area Code)

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, par value $0.0001 per share

NSPR

The Nasdaq Capital Market LLC

Indicate by check mark whether the registrant is an emerging growth company as defined in 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 ☐

If 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

On November 4, 2025, InspireMD, Inc. (the “Company”) issued a press release announcing its financial and operating results and recent highlights for the three and nine months ended September 30, 2025. A copy of this press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.

In 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 7.01 Regulation FD Disclosure.

On November 4, 2025, the Company made available an updated investor presentation. A copy of the presentation is attached hereto as Exhibit 99.2 and incorporated by reference in this Item 7.01. A copy of the presentation is also available on the Company’s website https://www.inspiremd.com/en/investors/.

In 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 7.01 shall not be deemed to be “filed” for the purposes of Section 18 of 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 November 4, 2025 (furnished herewith pursuant to Item 2.02)

99.2

Investor Presentation November 2025 (furnished herewith pursuant to Item 7.01)

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: November 4, 2025 By: /s/ Michael Lawless

Name: Michael Lawless

Title: Chief Financial Officer