InspireMD (NSPR) reports 100% device success in TCAR trial
Rhea-AI Filing Summary
InspireMD, Inc. reported 30-day results from its CGUARDIANS II clinical trial evaluating the CGuard Prime 80 cm implant for use in TCAR procedures. In 50 patients, acute device success was achieved in 100% of cases, with no deaths, strokes, myocardial infarctions, or stent thrombosis within 30 days and complete stent patency in evaluable subjects.
The CGuard Prime 80 cm carotid stent system is currently an investigational device in the United States, and a Premarket Approval supplement is under FDA review. InspireMD anticipates potential approval in the second half of 2026, which could expand its addressable market to include TCAR in addition to carotid artery stenting.
Positive
- Exceptionally strong 30-day safety and performance data from CGUARDIANS II, including 100% acute device success in 50 TCAR patients with no deaths, strokes, myocardial infarctions, or stent thrombosis and complete stent patency in evaluable subjects, support the ongoing FDA PMA supplement review.
Negative
- None.
Insights
Strong 30-day TCAR trial data support InspireMD’s FDA PMA review.
InspireMD reported CGUARDIANS II 30-day outcomes for the CGuard Prime 80 cm stent in TCAR procedures. All 50 treated patients achieved acute device success, with no deaths, strokes, myocardial infarctions, or stent thrombosis, and complete stent patency in evaluable subjects.
The device is investigational in the U.S., and a Premarket Approval supplement is under FDA review. The company anticipates potential approval in the second half of 2026, which, if granted, could extend use beyond carotid artery stenting into TCAR, a setting with more than 35,000 procedures annually in the U.S.
Actual impact will depend on the FDA’s decision, future real-world performance versus trial results, and how quickly physicians adopt CGuard Prime and related systems such as the CGUARDIANS III SwitchGuard neuro-protection platform once regulatory reviews are complete.
8-K Event Classification
Key Figures
Key Terms
transcarotid artery revascularization (TCAR) medical
Premarket Approval (PMA) Supplement regulatory
investigational device regulatory
carotid endarterectomy medical
neuro-protection system medical
MicroNet mesh technology technical
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Item 7.01. Regulation FD Disclosure.
On June 11, 2026, InspireMD, Inc. (the “Company”) issued a press release titled “InspireMD Announces 30-Day Results from the CGUARDIANS II Clinical Trial of the CGuard Prime 80 cm Implant for Use in TCAR Procedures.” A copy of the press release is furnished herewith as Exhibit 99.1 to this Form 8-K and is incorporated by reference in this Item 7.01.
In 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, 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 June 11, 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: | June 11, 2026 | By: | /s/ Marvin Slosman |
| Name: | Marvin Slosman | ||
| Title: | Chief Executive Officer | ||
Exhibit 99.1
InspireMD Announces 30-Day Results from the CGUARDIANS II Clinical Trial of the CGuard Prime 80 cm Implant for Use in TCAR Procedures
PMA supplement under FDA review with potential approval in H2 2026, potentially expanding the Company’s addressable market to include TCAR in addition to CAS carotid stenting procedures
Miami, FL — June 11, 2026 – InspireMD, Inc. (Nasdaq: NSPR) (“InspireMD” or the “Company”), developer of the CGuard® Prime carotid stent system for the prevention of stroke, today announced 30-day outcomes from the CGUARDIANS II clinical trial of the CGuard Prime 80cm implant for use in transcarotid artery revascularization (TCAR) procedures. InspireMD anticipates potential approval of the CGuard Prime 80 cm stent implant in the second half of this year.
Key 30-day outcomes observed in the CGUARDIANS II trial include:
| ● | Acute device success was achieved in 100% (50/50) of patients; | |
| ● | No deaths, strokes, or myocardial infarctions were reported within 30 days; | |
| ● | No stent thrombosis was observed within 30 days; | |
| ● | Complete stent patency observed at 30 days in evaluable subjects. |
Dr. Patrick J. Geraghty, professor of surgery and radiology at Washington University School of Medicine in St. Louis and co-lead investigator of the CGUARDIANS II study, commented, “The 30-day results observed in the CGUARDIANS II trial suggest that the CGuard Prime 80 cm stent may deliver exceptional safety and efficacy when used with a TCAR approach. Notably, the 100% acute device success rate with zero major adverse events has the potential to make CGuard Prime the gold standard implant for high-risk patients undergoing TCAR procedures. I look forward to incorporating it into my own practice, if approved.”
“We believe the 30-day CGUARDIANS II results represent a significant achievement in our quest to tap into the large and growing TCAR market,” said Marvin Slosman, CEO of InspireMD. “Together with our recently initiated CGUARDIANS III clinical trial of our proprietary SwitchGuard neuroprotection system, we potentially have line-of-sight to offering the full TCAR toolkit, subject to regulatory review and approval, leveraging our best-in-class CGuard Prime Carotid Stent System with its unmatched clinical outcomes, for the more than 35,000 TCAR procedures that are performed in the U.S. every year.”
CGUARDIANS II is a prospective, multi-center, single-arm pivotal study that enrolled 50 patients across 11 trial sites. The objective of the study is to evaluate acute device success and technical success of the CGuard Prime 80 cm when used in conjunction with the FDA-cleared ENROUTE TCAR neuro-protection system in patients considered at high risk for adverse events from carotid endarterectomy.
Regulatory Disclaimer: The CGuard Prime Carotid Stent System 80 cm is an investigational device in the United States and is limited by federal law to investigational use. InspireMD submitted a Premarket Approval (PMA) Supplement to the U.S. Food and Drug Administration (FDA) which is currently under review.
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 expectations regarding potential FDA approvals for CGuard Prime Carotid Stent System 80 cm implant for use in TCAR procedures. 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 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
FAQ
What did InspireMD (NSPR) report from the CGUARDIANS II TCAR clinical trial?
InspireMD reported 30-day outcomes from its CGUARDIANS II trial of the CGuard Prime 80 cm implant for TCAR. All 50 patients achieved acute device success, with no deaths, strokes, myocardial infarctions, or stent thrombosis, and complete stent patency in evaluable subjects.
How many patients and sites were included in InspireMD’s CGUARDIANS II study for TCAR?
The CGUARDIANS II study enrolled 50 patients across 11 trial sites. It is a prospective, multi-center, single-arm pivotal trial evaluating acute device and technical success of the CGuard Prime 80 cm implant when used with the FDA-cleared ENROUTE TCAR neuro-protection system.
Is InspireMD’s CGuard Prime 80 cm stent approved for TCAR procedures in the United States?
The CGuard Prime 80 cm carotid stent system is an investigational device in the United States and limited to investigational use. InspireMD has submitted a Premarket Approval supplement to the FDA, which is under review, with anticipated potential approval in the second half of 2026.
How could CGUARDIANS II trial results affect InspireMD’s (NSPR) addressable market?
InspireMD states that, if approved, the CGuard Prime 80 cm implant for TCAR could expand its addressable market beyond carotid artery stenting. The company references more than 35,000 TCAR procedures performed annually in the U.S. as a potential opportunity.
What are the key 30-day safety outcomes reported for InspireMD’s CGUARD Prime 80 cm TCAR device?
Key 30-day outcomes include 100% acute device success in 50 patients, no deaths, strokes, or myocardial infarctions, no stent thrombosis, and complete stent patency in evaluable subjects. These findings suggest favorable short-term safety and performance in high-risk TCAR patients.