InspireMD · Nasdaq: NSPR · Miami, Florida
InspireMD describes itself as “a medical device company specializing in the development and commercialization of products for the treatment of carotid artery disease and other vascular conditions.” Its two commercial products, CGuard EPS and CGuard Prime, each combine a self-expanding nitinol stent with a MicroNet mesh sleeve. 10-K, Item 1
The scaffold
A stent is “an expandable scaffold-like metallic device placed in an artery to widen the lumen and restore blood flow.” This one expands without balloon dilation pressure or an inflation balloon. 10-K, Item 1
The sleeve
Woven from a single strand of 23 µm polyethylene terephthalate, with pores of 150 to 180 microns, applied to the stent “to provide additional protection” from plaque prolapse and embolization after deployment. 10-K, Item 1
Read first
Each is in the company’s own filings and is linked to the one it comes from. Figures for the six months ended Jun 30, 2026 and balances at Jun 30, 2026 are unaudited.
CGuard Prime received premarket approval from the FDA, supported by the C-GUARDIANS pivotal trial. U.S. commercial launch followed in July 2025. 10-K, Item 1
The company submitted a premarket approval application to the FDA for CGuard EPS, the product it sells outside the United States. 10-Q, Item 2
The company entered an equity distribution agreement with BTIG for up to $75 million of common stock. As of the 10-Q date it had sold no shares under it. 8-K, Apr 3, 2026 10-Q, Liquidity
The company announced a voluntary U.S. recall of the CGuard Prime 135 cm delivery system after a controlled launch showed its technical success in carotid artery stenting did not meet performance expectations. The recall does not include the stent implant. The same release said the company was pausing commercialization of the CGuard Prime delivery system and withdrawing its full-year 2026 revenue guidance. 8-K, May 1, 2026
Nasdaq notified the company that its closing bid price had been below $1.00 for 30 consecutive business days. The company has until Jan 13, 2027 to regain compliance. 8-K, Jul 23, 2026
The 10-Q says the company does not have sufficient resources to fund operations for at least the next 12 months, and that there is substantial doubt about its ability to continue as a going concern. The 10-K filed Mar 18, 2026 reached the same conclusion, and the auditor’s report on the 2025 financial statements includes an explanatory paragraph on going concern. 10-Q, Liquidity 10-K, Item 1A
For certain holders, including directors, the company amended 50% of their Series J warrants and all of their Series K warrants to an exercise price of $0.7674 and an end date of the earlier of May 15, 2028 and 20 trading days after it announces FDA approval of CGuard Prime 80 cm. Series K warrants that were not amended are scheduled to expire Oct 28, 2026. 8-K, Sep 21, 2026 10-Q, Liquidity
The tags mark the kind of item, not a judgment: filled green is an approval, an outline is a filing or a financing, solid blue is a change to terms, and a ringed dark tag is a matter covered in full under Disclosures.
The product
The company says its products treat carotid artery disease, in which plaque builds up in the artery wall and narrows the artery. Plaque debris breaking off and travelling to the brain is, in the 10-K’s words, one of the “significant causes of stroke.” 10-K, Item 1
The CGuard Carotid Embolic Prevention System joins a self-expanding nitinol stent and a MicroNet mesh sleeve in a single device. It is marketed in over 30 countries outside the United States through a network of distributors.
The same stent and MicroNet mesh with a differentiated deployment mechanism, sold in the United States through the company’s direct salesforce. The 135 cm delivery system has been under a voluntary U.S. recall since May 2026 (see Disclosures).
A Class II neuroprotection system the company has developed, which the 10-K says is “subject to regulatory approval.” It is paired with CGuard Prime in the CGUARDIANS III pivotal trial to enable flow-reversal neuroprotection during TCAR.
The mesh, drawn to the stated size
Market and evidence
The market numbers are the company’s estimates and rest on a 2021 third-party report plus internal estimates. This page adds none of its own.
Assuming full penetration of the intervention caseload. The same sources give $9.3 billion for everyone diagnosed with high-grade carotid artery stenosis. The 10-K cites a Health Research International report dated Sep 13, 2021 and internal estimates. 10-K, Item 1
Of about 3 million people aged 50 to 89 estimated to have been diagnosed with high-grade carotid artery disease, per the same report as cited in the 10-K. 10-K, Item 1
The figure the 10-K uses for the U.S. opportunity behind its plan to expand its direct salesforce. 10-K, Item 1
The trials
| Study | Device and setting | Status as filed | What the filing reports |
|---|---|---|---|
| C-GUARDIANS pivotal |
CGuard stent in carotid artery stenting; supported the CGuard Prime PMA. CGuard Prime was used in 32 of the 316 patients, from April 2023 | Completed | 316 patients in the U.S. and Europe. Death, stroke or myocardial infarction at 30 days (hierarchical DSMI): 0.95% intent-to-treat and 0.63% per protocol. At one year, announced in May 2024, DSMI at 30 days plus ipsilateral stroke from day 31 to day 365 was 1.95% in the intent-to-treat analysis (Kaplan-Meier method); the 10-K gives 1.71% as the primary endpoint rate per protocol, and its CGuard Prime overview gives 1.93% for DSMI or ipsilateral stroke through one year. Three patients had major adverse events by 30 days: one who did not take dual antiplatelet therapy (a protocol violation) had a major stroke and died, and two had strokes. There was no myocardial infarction. 10-K, Item 1 |
| CGUARDIANS II pivotal |
CGuard Prime 80 cm in TCAR, with an established neuroprotection device | Enrollment completed in Q1 2026 | Summary 30-day outcomes announced in June 2026: acute device success of 100% with no major adverse events. Longer follow-up is not yet reported. 10-Q, Item 2 8-K, Jun 11, 2026 |
| CGUARDIANS III pivotal |
CGuard Prime 80 cm with SwitchGuard NPS, for flow-reversal neuroprotection during TCAR | FDA IDE approved Jun 6, 2025; an IDE with next generation enhancements approved in May 2026; enrollment of the first patient announced in June 2026 | No results reported. 10-K, Item 1 10-Q, Item 2 8-K, May 1, 2026 |
| Early feasibility with the Jacobs Institute |
CGuard Prime in acute ischemic stroke with tandem lesions | Under way | No results reported in the filings reviewed. 10-Q, Item 2 |
DSMI is death, stroke or myocardial infarction. The study results are the company’s description of its trials in its filings; this page does not interpret them. Each row links the filings it comes from.
Financials
In the six months ended Jun 30, 2026 (unaudited), revenue was $5.17M and the net loss was $28.0M. Amounts are US dollars as filed; the filings state thousands. 10-K, Item 8 10-Q, financial statements
Years ended December 31. The 2024 and 2025 bars are in the 10-K for 2025; the 2021 to 2023 bars come from the SEC’s XBRL data for the company’s earlier annual reports, which are not among the filings linked on this page. Only 2021 to 2025 are drawn: those years use one XBRL revenue tag, and earlier years cross three, so they are not like-for-like. EDGAR’s company record shows the name Saguaro Resources, Inc. until April 2011; no history before then is implied. 10-K, Item 8 EDGAR
Unaudited; by the location of the customer. United States: $0.83M against $0.05M. International: $4.34M against $3.25M, up 33%. In the three months to Jun 30, 2026 total revenue was $1.77M, down 0.4% from $1.78M; U.S. revenue was −$0.35M after $0.73M of recall credits, and international revenue was $2.12M, up 21%. 10-Q, MD&A
Jun 30, 2026 is unaudited. Net cash used in operating activities was $23.2M in the six months (2025: $17.1M) and $35.1M in the year ended Dec 31, 2025. The accumulated deficit was $330.3M. This page makes no estimate of how long the cash lasts; the company’s own conclusion is under Disclosures. 10-Q, financial statements 10-K, Item 8
Revenue for the year ended Dec 31, 2025 rose 28.1% (derived), while operating expenses rose to $52.3M from $35.0M. Selling and marketing was $16.6M against $6.1M. 10-K, Item 8
In the six months ended Jun 30, 2026 (unaudited) the gross result was a loss of $0.09M. It includes $0.73M of recall credits and $1.1M of inventory impairment and obsolescence charges on the CGuard Prime delivery system; for the second quarter alone the 10-Q gives about $0.61M of inventory impairment. Share-based compensation was $4.3M (2025: $5.9M). 10-Q, MD&A
Statements of operations
| Year ended Dec 31, 2025 | Year ended Dec 31, 2024 | Six months ended Jun 30, 2026, unaudited | Six months ended Jun 30, 2025, unaudited | |
|---|---|---|---|---|
| Revenues | 8.979 | 7.009 | 5.169 | 3.307 |
| Cost of revenues | 6.330 | 5.503 | 5.256 | 2.702 |
| Gross profit (loss) | 2.649 | 1.506 | -0.087 | 0.605 |
| Gross margin, % (derived) | 29.5 | 21.5 | -1.7 | 18.3 |
| Research and development | 15.003 | 13.634 | 9.058 | 7.893 |
| Selling and marketing | 16.553 | 6.069 | 10.401 | 6.922 |
| General and administrative | 20.707 | 15.306 | 8.877 | 10.269 |
| Loss from operations | -49.614 | -33.503 | -28.423 | -24.479 |
| Financial income, net | 0.891 | 1.557 | 0.410 | 0.162 |
| Tax expenses | 0.063 | 0.059 | – | – |
| Net loss | -48.786 | -32.005 | -28.013 | -24.317 |
| Net loss per share, basic and diluted, USD | -0.76 | -0.76 | -0.33 | -0.48 |
| Weighted shares used, millions (include pre-funded warrants) | 64.3 | 41.9 | 84.2 | 50.5 |
Sources: 10-K for the years; 10-Q for the six months, which are unaudited. Negative figures are losses; a dash means the statement shows no such line. 10-K, Item 8 10-Q, financial statements
Balance sheet
| Jun 30, 2026, unaudited | Dec 31, 2025 | |
|---|---|---|
| Cash and cash equivalents | 15.149 | 8.939 |
| Marketable securities | 15.272 | 45.272 |
| Total current assets | 36.628 | 61.471 |
| Total assets | 44.641 | 69.404 |
| Total current liabilities | 9.646 | 10.712 |
| Total liabilities | 13.130 | 14.203 |
| Total equity | 31.511 | 55.201 |
| Accumulated deficit | -330.305 | -302.292 |
Disclosures
Eight matters a reader should have in front of them. Each is in the company’s own filings and carries its source. Figures for the six months ended Jun 30, 2026 and balances at Jun 30, 2026 are unaudited.
01 · Going concern: the company’s conclusion
“we believe we do not have sufficient resources to fund operations for at least the next 12 months. Therefore, there is substantial doubt about our ability to continue as a going concern.”
That is from the Liquidity discussion in the 10-Q for the quarter ended Jun 30, 2026. The same filing reports an accumulated deficit of $330.3M, a net loss of $28.0M and net cash used in operating activities of $23.2M for the six months, against cash and marketable securities of $30.4M. The stated plans are “continued commercialization of our products and raising capital through sale of additional equity securities, debt or capital inflows from strategic partnerships and exercise of warrants.” The company adds that “there are no assurances” it will obtain the financing it needs, and that if it does not it “may need to reduce activities, curtail or cease operations.” The 10-K for 2025, filed Mar 18, 2026, reached the same conclusion, and the report of its auditor, Kesselman & Kesselman, on the 2025 financial statements includes an explanatory paragraph on the company’s ability to continue as a going concern. 10-Q, Liquidity 10-K, Item 1A
On May 1, 2026 the company announced a voluntary U.S. recall of the CGuard Prime 135 cm delivery system after a controlled launch showed that its technical success in carotid artery stenting “has not met performance expectations.” The recall covers the delivery system, not the stent implant. The company’s assessment “did not identify new safety concerns for patients who had previously received a CGuard implant,” and by Jun 30, 2026 substantially all affected products had been returned and credits issued. The same release said the company was pausing commercialization of the CGuard Prime delivery system and withdrawing its full-year 2026 revenue guidance. 8-K, May 1, 2026 10-Q, Note 1
In the quarter ended Jun 30, 2026 the recall reduced revenue by $0.73M, U.S. revenue was −$0.35M, and about $0.61M of inventory was impaired; the gross margin was negative 43.7%. The 10-Q says the company cannot assure that the FDA will be satisfied with its corrective actions, that until the issues are resolved to the FDA’s satisfaction it “may be unable to resume commercialization of CGuard Prime in the United States,” and that such requirements could “delay or prevent FDA acceptance or approval” of the proposed PMA supplement, which it expects to submit in the fourth quarter of 2026. 10-Q, Item 2
On Jul 17, 2026 Nasdaq notified the company that it no longer meets the $1.00 minimum bid price in Listing Rule 5550(a)(2), based on the 30 consecutive business days from Jun 3 to Jul 16, 2026. The notice has no immediate effect on trading under the symbol NSPR. The company has 180 calendar days, until Jan 13, 2027, and must close at or above $1.00 for at least ten consecutive business days to regain compliance. The company says it will monitor the bid price and evaluate options to regain compliance, including, if necessary, effecting a reverse stock split. It may be eligible for a second 180-day period if it meets the continued-listing requirement for the market value of publicly held shares and all other initial-listing standards except the bid price, and gives Nasdaq written notice of its intention to cure. 8-K, Jul 23, 2026
The last sale price the 10-Q reports is $0.8401 on Aug 13, 2026. The 10-K lists failure to keep the Nasdaq minimum listing requirements, and the delisting that would follow, among its risks. 10-Q, Liquidity 10-K, Item 1A
At-the-market sales. On Apr 3, 2026 the company replaced its 2024 agreement with Piper Sandler with one with BTIG for up to $75 million of common stock at a commission of up to 3.0%. The 10-Q says no shares had been sold under it. 8-K, Apr 3, 2026 10-Q, Liquidity
Warrants. The May 2023 Series J and Series K warrants have an exercise price of $1.3827. By the 10-Q date $33.8M of the $71.4M of gross proceeds possible from all four series had been received, and the company believes holders are unlikely to exercise while the share price is below $1.3827. The Series J warrants run to the earlier of May 15, 2028 and 20 trading days after the company announces FDA approval of SwitchGuard and CGuard Prime 80 cm; the Series K warrants are scheduled to expire Oct 28, 2026. 10-Q, Liquidity
Amendments on Sep 21, 2026. The amendments were made with certain holders of Series J warrants for up to 9,543,952 shares and Series K warrants for up to 9,543,947 shares. For those holders, who include directors, the exercise price became $0.7674 on 50% of their Series J shares and all of their Series K shares, with an end date of the earlier of May 15, 2028 and 20 trading days after the company announces FDA approval of CGuard Prime 80 cm. The company’s headline gave potential gross proceeds of up to $11 million. 8-K, Sep 21, 2026 press release, investor site
Share counts and their bases. 46,921,061 common shares at Jun 30, 2026 and 46,489,118 at Aug 14, 2026, both excluding pre-funded warrants. Authorized common shares are 250,000,000. At Jun 30, 2026 there were also 43,092,107 pre-funded warrants and 25,828,164 Series J and Series K warrants outstanding, and the 46,921,061 shares include 6,734,737 unvested restricted shares. The company closed a private placement of about $40.1M gross in August 2025 and one of $42.2M gross in May 2023. 10-Q, balance sheet 10-Q, cover 10-Q, notes 10-Q, Liquidity
CGuard EPS has CE Mark approval; its PMA was submitted to the FDA in Q1 2026 and is not approved. CGuard Prime is FDA approved, but the company says it may be unable to resume U.S. commercialization until the recall issues are resolved. The 80 cm version for TCAR and SwitchGuard NPS are in pivotal trials and are not approved. 10-Q, Item 2 The company’s Jun 11, 2026 release, in its note on the 80 cm device, says it submitted a PMA supplement to the FDA that is currently under review; the release does not say which approval the supplement seeks. 8-K, Jun 11, 2026
Among the risks the 10-K lists are that the results of the company’s trials “may be insufficient to obtain regulatory approval,” that the trials needed for a premarket approval “will be lengthy and expensive,” and that its products may be subject to recalls. It also lists that it will need to raise additional capital, and that such capital raising may dilute stockholders. 10-K, Item 1A
The company makes CGuard EPS and CGuard Prime at one leased facility of 1,830 square meters in Tel Aviv, Israel, with capacity of about 5,500 products a quarter on a single shift; the lease runs through Dec 31, 2028. The 10-K says that if the facility, its raw materials or its shipping were disrupted it “would have no other means of manufacturing and distributing” the two products until it restored capacity or developed alternatives. 10-K, Item 1A 10-K, Item 2
The 10-K also lists conditions in Israel and its neighbors as a risk, and says a substantial part of revenue is expected in euros and U.S. dollars while a significant part of expenses is in new Israeli shekels. 10-K, Item 1A
On Feb 27, 2026 the company gave notice of dismissal to its Chief Operating Officer. On Jul 23, 2026 it told its Chief Commercial Officer that the position had been eliminated, effective Jul 31. On May 20, 2026 the Chair of the Board gave notice of a decision not to seek reelection and to retire at the 2027 annual meeting. Directors resigned effective Dec 31, 2025 and Jul 1, 2026; neither resignation was due to a disagreement with the company. The 10-Q also refers to severance for the former chief financial officer’s retirement, recognized in the quarter ended Jun 30, 2025. After Jun 30, 2026 the company began a workforce reduction expected to cut the number of positions by almost 20%, with annualized operating expense savings of about $9.0 million and aggregate restructuring charges of about $0.9 million to $1.2 million, mostly severance. 8-K, Mar 4, 2026 8-K, Jul 29, 2026 8-K, May 22, 2026 8-K, Dec 19, 2025 8-K, Jul 2, 2026 10-Q, MD&A
Two principal customers were 14% and 12% of revenue in 2025 (2024: 13%, 10% and 10%). By customer location the United States was $1.42M of the $8.98M, Germany $1.23M, Italy $1.23M, Poland $1.04M and other countries $4.06M. Russia was $0.71M in 2024 and is shown as a dash in 2025. 10-K, Item 8
In the six months ended Jun 30, 2026 (unaudited) U.S. revenue was $0.83M, about 16% of revenue (derived), after the recall credits; international revenue was $4.34M. 10-Q, MD&A
The record
The left column is the company’s own news and events list as shown on its investor site. The right column lists its 10-K, 10-Q and 8-K filings and its definitive proxy statement from Mar 4 to Sep 21, 2026; EDGAR has every filing.
Headlines only, as listed on the investor site on Oct 11, 2026. This page does not summarize releases it has not read.
Contact IR
This concept page is not InspireMD’s. For the company’s official news, presentations, stock information, email alerts and FAQs, use its investor site.
