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InspireMD resets warrants, eyes up to $11M proceeds

Amended NSPR warrants could raise up to $11 million if exercised, helping fund the planned CGuard Prime 80 cm U.S. launch tied to anticipated FDA approval.

(Very High)
(Neutral)
Form Type
8-K

Rhea-AI Filing Summary

InspireMD, Inc. (NSPR) amended certain existing Series J and Series K common stock warrants to better align their potential exercise with an anticipated FDA approval milestone. The amendments apply to approximately 4.8 million shares underlying Series J warrants and 9.5 million shares underlying Series K warrants held by participating holders. For 50% of the amended Series J warrants and all of the amended Series K warrants, the exercise price was reset to $0.7674 per share, equal to the Nasdaq Official Closing Price on September 18, 2026, and the termination date now falls at 5:00 p.m. Eastern time on the earlier of May 15, 2028 or 20 trading days after the company announces FDA approval of CGuard Prime 80 cm. The remaining 50% of Series J warrants retain the original $1.3827 exercise price and prior FDA-related triggers, and no additional warrants or shares were issued. InspireMD states that, if the amended warrants are fully exercised, they could generate up to $11 million in gross proceeds, which, together with existing cash, are expected to support the planned U.S. launch of CGuard Prime 80 cm for transcarotid artery revascularization following anticipated FDA approval in the fourth quarter of 2026.

The company highlights CGuard Prime 80 cm clinical data, including 100% acute device success and zero major adverse events at 30 days in the first 36 patients in the CGUARDIANS II pivotal study, and estimates more than 35,000 TCAR procedures occur annually in the United States, potentially doubling the addressable market. At the same time, InspireMD notes significant risks, including costs and business impacts from a voluntary U.S. recall of the CGuard Prime 135 cm delivery system, recurring losses and negative operating cash flows, substantial doubt about its ability to continue as a going concern, and dependence on raising additional capital and maintaining Nasdaq listing compliance.

Positive

  • Up to $11 million potential gross proceeds if amended Series J and K warrants are fully exercised, which the company expects, with existing cash, to help fund the CGuard Prime 80 cm launch after FDA approval.
  • CGuard Prime 80 cm targets an estimated 35,000 TCAR procedures annually in the U.S., which the company states would roughly double its domestic addressable market.
  • In the CGUARDIANS II pivotal study, CGuard Prime 80 cm showed 100% acute device success and zero major adverse events at 30 days in the first 36 patients, supporting the product’s clinical profile.
  • The company emphasizes that the warrant amendments do not issue any additional warrants or shares, limiting incremental warrant overhang from this transaction.

Negative

  • The company discloses a voluntary U.S. recall of the CGuard Prime 135 cm delivery system, with potential refunds, inventory write-offs, remediation costs, loss of sales, regulatory actions and litigation risk.
  • InspireMD cites a history of recurring losses and negative cash flows, significant future commitments and substantial doubt about its ability to continue as a going concern without additional capital.
  • The company states it needs to raise additional capital to meet future business requirements, which may be costly or difficult and could dilute existing stockholders’ interests.
  • There is risk around maintaining compliance with Nasdaq listing standards, which could affect trading liquidity and market perception if not maintained.

Filing Explained

The amendments add no new shares or warrants; existing liquidity equaled 254.1 days of the latest quarterly operating cash use.

Certain participating holders are members of InspireMD’s board, and the company reports the amended securities under Item 3.02 as unregistered equity securities; any sale remains subject to registration or qualification where required.

A holder electing a pre-funded warrant pays slightly below the amended warrant price; the pre-funded warrant converts into shares when exercised.

At June 30, 2026, the company reported $15,149,000 of cash and equivalents plus $15,272,000 of short-term investments. At the latest reported operating cash-use rate, those balances equal 254.1 days of historical operating cash use.

Sources and calculations
  • Available liquidity against the last reported quarterly operating outflow, in days at that rate ($15,149,000 + $15,272,000) / ($10,895,000 / 91) = 254.1 days
Item 1.01 Entry into a Material Definitive Agreement Business
The company signed a significant contract such as a merger agreement, credit facility, or major partnership.
Item 3.02 Unregistered Sales of Equity Securities Securities
The company sold equity securities in a private placement or other unregistered transaction.
Item 7.01 Regulation FD Disclosure Disclosure
Material non-public information disclosed under Regulation Fair Disclosure, often investor presentations or guidance.
Item 9.01 Financial Statements and Exhibits Exhibits
Financial statements, pro forma financial information, or exhibit attachments filed with this report.
Series J warrants outstanding 9,543,952 shares Maximum shares underlying Series J warrants referenced in the amendments
Series K warrants outstanding 9,543,947 shares Maximum shares underlying Series K warrants referenced in the amendments
Shares covered by amended Series J warrants Approximately 4,800,000 shares Approximate number of Series J underlying shares subject to the amendments
Shares covered by amended Series K warrants Approximately 9,500,000 shares Approximate number of Series K underlying shares subject to the amendments
New exercise price (amended warrants) $0.7674 per share Equal to the Nasdaq Official Closing Price on September 18, 2026
Original exercise price (unaltered portion of Series J) $1.3827 per share Exercise price for the remaining 50% of Series J warrants not amended
Potential gross proceeds $11 million Estimated proceeds if amended Series J and K warrants are exercised in full
Estimated annual TCAR procedures in U.S. Over 35,000 procedures Company estimate of the TCAR market that CGuard Prime 80 cm targets
warrants financial
"amendments with certain of the holders of the Company’s existing warrants to purchase common stock"
Warrants are special documents that give you the right to buy a company's stock at a set price before a certain date. They are often used as a way for companies to attract investors or raise money, and their value can increase if the company's stock price goes up.
transcarotid artery revascularization medical
"for transcarotid artery revascularization (“TCAR”) procedures"
A minimally invasive procedure that opens a narrowed carotid artery by accessing it directly through a small incision in the neck and placing a stent while temporarily controlling blood flow to reduce the chance of stroke. Think of it as clearing and propping open a critical pipeline from a nearby service hatch to prevent a dangerous backup. Investors care because its use affects demand for medical devices, hospital procedure volumes, treatment costs, reimbursement rules and regulatory approvals.
Nasdaq Official Closing Price financial
"exercise price to $0.7674 per share, representing the Nasdaq Official Closing Price"
going concern financial
"substantial doubt regarding its ability to continue as a going concern"
Going concern is the accounting assumption that a company will keep operating and meeting its obligations for the foreseeable future. The phrase matters most when a company or its auditors disclose substantial doubt about it, a formal warning that the business may not have enough resources to continue without raising money, restructuring, or selling assets. That language in a filing or press release signals elevated financial risk.
MicroNet mesh technology technical
"utilize its proprietary MicroNet ™ mesh technology to make its products"
Phase III clinical study medical
"FDA approval of the SwitchGuard transcarotid system, which is currently in a Phase III clinical study"
A phase III clinical study is a large, late-stage trial that tests whether a drug or medical treatment works and is safe in a broad group of patients, often by comparing it to standard care or a placebo. Think of it as the final dress rehearsal before regulators decide on approval; successful results can unlock commercial sales, while failures can stop a product from reaching the market, affecting a company’s revenue prospects and valuation.

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What warrant changes did InspireMD (NSPR) announce on September 21, 2026?

InspireMD amended certain outstanding Series J and Series K warrants, covering about 4.8 million Series J and 9.5 million Series K underlying shares, to adjust the exercise price and termination date for a portion of these warrants tied to an anticipated FDA approval milestone.

What is the new exercise price for the amended NSPR warrants?

For 50% of the participating holders’ Series J warrants and all of their Series K warrants, InspireMD set a new exercise price of $0.7674 per share, equal to the Nasdaq Official Closing Price of its common stock on September 18, 2026.

How much capital could InspireMD (NSPR) raise from the amended warrants?

If the amended Series J and Series K warrants are exercised in full, InspireMD estimates they could generate up to $11 million in gross proceeds, which, along with existing cash, are expected to support the launch of CGuard Prime 80 cm after FDA approval.

When do the amended InspireMD warrants expire?

The amended portion of the warrants now expires at 5:00 p.m. Eastern on the earlier of May 15, 2028 or 20 trading days after InspireMD announces receipt of FDA approval for CGuard Prime 80 cm.

Will the NSPR warrant amendment create new dilution for shareholders?

InspireMD states that the amendments do not include issuance of any additional warrants or additional shares underlying the existing warrants. The changes apply only to terms of certain already outstanding Series J and Series K warrants.

What market opportunity does CGuard Prime 80 cm represent for InspireMD (NSPR)?

InspireMD estimates that over 35,000 TCAR procedures are performed annually in the U.S., which it says would double the addressable U.S. market for CGuard Prime when combined with carotid artery stenting.

What major risks does InspireMD highlight alongside this warrant amendment?

InspireMD notes risks from a voluntary U.S. recall of the CGuard Prime 135 cm delivery system, a history of recurring losses, going concern uncertainty, reliance on raising additional capital, and the need to maintain Nasdaq listing compliance.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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false 0001433607 0001433607 2026-09-21 2026-09-21 iso4217:USD xbrli:shares iso4217:USD xbrli:shares

 

 

 

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): September 21, 2026

 

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 1.01 Entry into a Material Definitive Agreement.

 

On September 21, 2026, InspireMD, Inc. (the “Company”) entered into amendments (the “Warrant Amendments”) with certain of the holders of the Company’s existing warrants to purchase common stock, par value $0.0001 per share (the “Common Stock”), consisting of (i) Series J warrants to purchase up to 9,543,952 shares of Common Stock (the “Series J Warrants”) and (ii) Series K warrants to purchase up to 9,543,947 shares of Common Stock (the “Series K Warrants” and, collectively with the Series J Warrants, the “Existing Warrants”). Certain holders of the Existing Warrants that entered into Warrant Amendments are also members of the Company’s board of directors.

 

Pursuant to the Warrant Amendments, the Company agreed to amend the Series J Warrants with respect to 50% of the shares underlying such amending holders’ Series J Warrants and all of the shares underlying such amending holders’ Series K Warrants to modify (i) the exercise price to $0.7674 (less $0.0001 for holders of Existing Warrants that elect to receive pre-funded warrants upon the exercise of such Existing Warrants) and (ii) the termination date to 5:00 p.m. Eastern time on the earlier of (a) May 15, 2028 and (b) 20 trading days following the Company’s announcement of receipt of FDA approval for the CGuard Prime 80 cm. The exercise price and termination date with respect to the other 50% of the shares underlying such amending holders’ Series J Warrants remained unchanged.

 

All other terms and conditions of the Existing Warrants remain unchanged and in full force and effect. All terms and conditions of the Series J Warrants and Series K Warrants held by existing holders that elected not to enter into the Warrant Amendments remain unchanged and in full force and effect.

 

This Current Report on Form 8-K shall not constitute an offer to sell or the solicitation to buy nor shall there be any sale of the shares or warrants in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

 

The foregoing descriptions of the Warrant Amendments are not complete, and are qualified in their entireties by reference to the full text of such documents, copies of which are filed as exhibits to this Current Report on Form 8-K and are incorporated by reference herein.

 

Item 3.02 Unregistered Sales of Equity Securities.

 

The information under Item 1.01 of this Current Report on Form 8-K regarding the unregistered securities described herein is incorporated herein by reference.

 

Item 7.01 Regulation FD Disclosure.

 

On September 21, 2026, the Company also issued a press release announcing entry into the Warrant Amendments. A copy of this press release is attached hereto as Exhibit 99.1.

 

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, including Exhibit 99.1, 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.

 

Warning Concerning Forward Looking Statements

 

This Current Report on Form 8-K contains statements which constitute forward looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other securities laws. These forward-looking statements are based upon the Company’s present intent, beliefs or expectations, but forward-looking statements are not guaranteed to occur and may not occur for various reasons, including some reasons which are beyond the Company’s control. For this reason, among others, you should not place undue reliance upon the Company’s forward-looking statements. Except as required by law, the Company undertakes no obligation to revise or update any forward-looking statements in order to reflect any event or circumstance that may arise after the date of this Current Report.

 

Item 9.01 Financial Statements and Exhibits.

 

(d) Exhibits

 

Exhibit Number   Description
4.1   Form of Series J Common Stock Purchase Warrant Amendment.
4.2   Form of Series K Common Stock Purchase Warrant Amendment.
99.1   Press Release, dated September 21, 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: September 21, 2026 By: /s/ Michael Lawless
  Name: Michael Lawless
  Title: Chief Financial Officer

 

 

 

 

Exhibit 99.1

 

 

InspireMD Announces Amendments to Certain Series J and Series K Warrants, Providing Potential Gross Proceeds of Up to $11 Million

 

- Amendments align trigger event of existing warrants with anticipated FDA approval of CGuard Prime 80 cm, which the Company continues to anticipate in Q4 2026 -

 

- The amended warrants, if exercised in full, together with existing cash balances, expected to provide additional resources to fund launch of CGuard Prime 80 cm following FDA approval -

 

- No additional warrants issued in connection with the amendments -

 

Miami, FL — September 21, 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 it has entered into amendments with certain of the existing holders of its outstanding Series J and Series K warrants originally issued as part of the Company’s May 2023 private placement financing. The amendments are intended to align the potential exercise of these warrants with the anticipated FDA approval of CGuard Prime 80 cm for transcarotid artery revascularization (“TCAR”) procedures, which the Company continues to anticipate to take place during the fourth quarter of 2026, potentially providing additional capital to support the Company’s commercial plans and ongoing pipeline initiatives.

 

The amendments apply to approximately 4.8 million shares underlying the Series J warrants and 9.5 million shares underlying the Series K warrants held by participating holders. Pursuant to the amendments, the Company agreed to amend the Series J Warrants with respect to 50% of the shares underlying the participating holders’ Series J Warrants and all of the shares underlying the participating holders’ Series K Warrants to modify (i) the exercise price to $0.7674 per share, representing the Nasdaq Official Closing Price of the Company’s common stock on September 18, 2026, and (ii) the termination date to 5:00 p.m. Eastern time on the earlier of (a) May 15, 2028 and (b) 20 trading days following the Company’s announcement of receipt of FDA approval for the CGuard Prime 80 cm.

 

The exercise price and termination date with respect to the other 50% of the shares underlying the participating holders’ Series J Warrants remained unchanged, including the original exercise price of $1.3827 per share and the termination trigger events which include the Company’s announcement of FDA approval of the SwitchGuard transcarotid system, which is currently in a Phase III clinical study. All terms and conditions of the Series J Warrants and Series K Warrants held by existing holders that did not elect to enter into the amendments remain unchanged. The amendments do not include the issuance of any additional warrants or any additional shares underlying the existing warrants.

 

“These amendments align a meaningful portion of our outstanding warrants with a significant near-term regulatory milestone with important commercial implications: the anticipated FDA approval of CGuard Prime 80 cm for TCAR expected later this year,” said Marvin Slosman, Chief Executive Officer of InspireMD. “The expected proceeds, combined with our existing cash resources, will enable us to launch the CGuard Prime 80 into the TCAR market and support other strategic priorities. We appreciate the continued confidence and financial support of many of our major equity holders, as we work to expand the CGuard Prime platform across both the carotid artery stenting (“CAS”) and TCAR markets.”

 

CGuard Prime 80 cm is designed for use in TCAR procedures, expanding the CGuard Prime platform beyond CAS to both major carotid stenting techniques. The Company estimates that over 35,000 TCAR procedures are performed annually in the United States, representing a doubling of the U.S. addressable market for CGuard Prime. In the CGUARDIANS II pivotal study, CGuard Prime 80 cm demonstrated 100% acute device success and zero major adverse events at 30 days in the first 36 patients evaluated.

 

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any sale of any securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such jurisdiction.

 

Additional information regarding the warrant amendments will be included in a Current Report on Form 8-K to be filed by the Company with the Securities and Exchange Commission (“SEC”).

 

 
 

 

 

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 approval for CGuard Prime 80 cm; ; anticipated gross proceeds from the potential exercise of the Series J Warrants and Series K Warrants and expectations regarding the cash runway of the Company; the Company’s ability to compete effectively in the carotid stenting market and increase adoption of its products; expectations regarding market penetration, commercialization, revenue growth and future operating performance; the anticipated benefits of recent organizational and cost-saving initiatives, including expected annualized savings and improved operational efficiency; and the Company’s strategic priorities, growth plans and future business prospects. 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

 

 

 

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