InspireMD filings document regulatory disclosures for a Nasdaq-listed medical device company focused on CGuard carotid stent systems and related neuro protection technology. Recent Form 8-K reports cover operating and financial results, Regulation FD materials, FDA IDE and product-recall disclosures, capital-raising arrangements under an at-the-market equity distribution agreement, and executive employment matters.
Proxy materials describe annual meeting voting items, board and compensation governance, and stockholder procedures. Registration-statement references and capital-structure disclosures identify common stock, shelf registration mechanics, offering terms, and Nasdaq Capital Market listing information.
InspireMD, Inc. director Michael Berman reported indirect transactions dated September 18, 2026, involving Series J and Series K warrants tied to common stock. The Series J entries list a disposition and an acquisition of 30,625 warrants each, with exercise prices of $1.3827 and $0.7674, respectively. The Series K entries list a disposition and an acquisition of 61,248 warrants each, with the same respective exercise prices. No Rule 10b5-1 plan is reported.
InspireMD, Inc. (NSPR) director Gary S. Roubin reported four direct warrant acquisitions and dispositions on September 18, 2026. For Series J, he reported dispositions and acquisitions involving warrants covering 15,313 common shares; for Series K, each side covered 30,624 common shares. The exercise price was $1.3827 per share for the dispositions and $0.7674 per share for the acquisitions.
InspireMD, Inc. director Stuka Paul reported four indirect warrant transactions dated September 18, 2026: an acquisition and a disposition each involving Series J and Series K warrants. Each Series J transaction covered 43,750 underlying common shares, and each Series K transaction covered 87,500. The records list exercise prices of $1.3827 per share for the dispositions and $0.7674 per share for the acquisitions. No Rule 10b5-1 plan is reported.
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.
InspireMD, Inc. reported second quarter 2026 results marked by U.S. recall impacts but strong international growth. For the quarter ended June 30, 2026, revenue was $1.77 million, down slightly from $1.78 million a year earlier, as a voluntary recall of the CGuard Prime 135 cm delivery system led to $(351,000) U.S. revenue due to $734,000 of customer credits. International revenue rose to $2.12 million, a 21% increase year over year.
Quarterly gross loss was $774,000 versus gross profit of $313,000, including a $612,000 inventory impairment and the recall-related credits; non-GAAP adjusted gross profit was $572,000. Operating expenses were $13.67 million, up 2.5%. Net loss was $14.32 million, or $0.17 per share.
For the first six months of 2026, revenue increased 56.3% to $5.17 million, with international sales up 33%. However, inventory-related charges and recall credits produced a $87,000 gross loss and a $28.01 million net loss. Cash, cash equivalents and marketable securities totaled $30.42 million at June 30, 2026, down from $54.21 million at year-end 2025. The company highlighted ongoing FDA interactions on its CGuard platforms and continued redesign work on the recalled 135 cm system.
InspireMD, Inc. reported higher sales but significantly larger losses for the quarter and six months ended June 30, 2026. Revenue was $1.77 million for the quarter (flat year over year) and $5.17 million for the six months, up 56.3%, driven mainly by U.S. commercialization of CGuard Prime and growth in international distributor sales.
A voluntary U.S. recall of the CGuard Prime delivery system weighed heavily on results, including $734,000 of revenue credits and $612,000 of inventory impairment in the quarter, pushing gross margin to −43.7%. Operating expenses remained high, with six‑month R&D of $9.06 million, selling and marketing of $10.40 million, and G&A of $8.88 million, leading to a six‑month net loss of $28.0 million, up 15.2% from 2025.
Cash and cash equivalents were $15.15 million and marketable securities $15.27 million at June 30, 2026, with operating cash outflow of $23.23 million over six months. Management states there is substantial doubt about the company’s ability to continue as a going concern. InspireMD also received a Nasdaq minimum bid price deficiency notice and is pursuing equity, warrant exercises, partnerships and a post‑quarter workforce reduction expected to save about $9 million annually while it works to resolve the recall and advance multiple pivotal trials and FDA submissions.
InspireMD, Inc. reported a leadership change in its commercial organization. On July 23, 2026, the company notified Chief Commercial Officer Shane Gleason that his position has been eliminated. His last day of employment will be July 31, 2026. The update does not describe any successor or structural changes beyond the elimination of this role.
InspireMD, Inc. received a notice from Nasdaq on July 17, 2026 that its common stock no longer meets the minimum $1.00 per share bid price requirement for continued listing on The Nasdaq Capital Market, based on 30 consecutive business days from June 3 through July 16, 2026.
The stock continues to trade on Nasdaq under the symbol NSPR and the notice has no immediate effect. InspireMD has 180 calendar days, until January 13, 2027, to regain compliance by achieving a closing bid of at least $1.00 for at least ten consecutive business days, a period Nasdaq may extend at its discretion.
If compliance is not regained, the company may qualify for an additional 180-day period if other listing standards are met and it notifies Nasdaq of a plan to cure the deficiency, potentially including a reverse stock split. Otherwise, its common stock could become subject to delisting, with a right to appeal. InspireMD plans to monitor its share price and evaluate options but provides no assurance it will regain compliance.
InspireMD, Inc. reported that board member Raymond W. Cohen, a Class III director, has tendered his resignation from the board, effective July 1, 2026. He also serves on the company’s Audit Committee and Compensation Committee.
The company states that Mr. Cohen’s resignation is for personal considerations and is not due to any disagreement with InspireMD, its board, or management on operations, policies, or practices. The Nominating and Corporate Governance Committee plans to identify and evaluate candidates to fill the board vacancy created by his departure.
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.