Every 8-K that Inspiremd (NSPR) has filed with the SEC in the last 24 months is listed below, newest first, and each one links through to the document itself with the summary and the scores our analysis gives it.
A 8-K covers material events a company has to report between its quarterly reports, so if you follow NSPR and want that one kind of document rather than the whole filing history, this is the page to keep. The company's other filings, of every form, are on the full NSPR filings page.
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 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.
InspireMD, Inc. reported results of its 2026 annual stockholder meeting. Stockholders approved an amendment to the Amended and Restated Certificate of Incorporation increasing authorized common shares from 150,000,000 to 250,000,000, effective upon filing a Certificate of Amendment in Delaware on June 3, 2026.
As of April 10, 2026, there were 46,892,979 common shares outstanding, and 34,631,348 shares, or 73.85%, were present in person or by proxy, constituting a quorum. Stockholders re-elected Marvin Slosman, Raymond Cohen and Dan Dearen as Class 3 directors for three-year terms, approved the authorized share increase, and ratified Kesselman & Kesselman, a member of PricewaterhouseCoopers International Limited, as independent registered public accounting firm for the 2026 fiscal year.
InspireMD, Inc. reported that Board Chair Paul Stuka has decided not to seek reelection as a Class I director at the company’s 2027 Annual Meeting of Stockholders and plans to retire from the Board at that time.
The company states that his decision does not result from any disagreement regarding operations, policies, or practices. Stuka currently serves as Chair of the Board, Chair of the Compensation Committee, and as a member of the Audit and Nominating and Corporate Governance Committees, and he expects to continue in these roles until his term expires. The Nominating and Corporate Governance Committee plans to identify and evaluate suitable candidates as part of Board succession planning.
InspireMD reported strong growth for the first quarter of 2026, with revenue reaching $3.4 million, up 122% from $1.5 million a year earlier. U.S. revenue was $1.2 million, a 36% sequential increase, while international revenue rose 48% year over year to $2.2 million.
Despite this growth, the company recorded a net loss of $13.7 million, or $0.16 per share, as operating expenses climbed to $14.7 million to support U.S. commercialization. InspireMD booked an inventory impairment charge, but on an adjusted basis gross margin improved to 34.1% of revenue.
Operationally, the company received FDA IDE approval to initiate the CGUARDIANS III trial for its SwitchGuard neuro protection system in TCAR procedures and expects FDA decisions on its original CGuard delivery system in Q3 2026 and CGuard Prime 80 cm in H2 2026. Management also outlined expected reserves tied to the U.S. recall of CGuard Prime.
InspireMD filed an 8-K detailing a mix of product setback and regulatory progress. The company has initiated a voluntary U.S. recall of its CGuard Prime 135 cm carotid stent delivery system after controlled-launch experience showed technical success in procedures did not meet performance expectations. The CGuard stent implant itself is not included in the recall and continues in use.
Management highlighted strong demand, citing Q1 2026 global year-over-year unit sales growth of 53% and 34% quarter-over-quarter U.S. unit sales growth, but is withdrawing its prior full-year 2026 revenue guidance due to the temporary pause in U.S. commercialization while it awaits anticipated FDA approval of the original CGuard delivery system in the third quarter of 2026. InspireMD also expects FDA approval of the CGuard Prime 80 cm system for TCAR procedures in the second half of 2026 and is pursuing design improvements to the 135 cm system, with FDA approval anticipated in the first half of 2027.
Separately, the FDA has approved an Investigational Device Exemption for the CGUARDIANS III pivotal study of the SwitchGuard neuro protection system for use with the CGuard Prime 80 cm stent platform in TCAR procedures, supporting plans for a potential U.S. commercial launch of SwitchGuard in 2027 and expanding access to a TCAR market estimated at approximately 35,000 procedures annually in the United States.
InspireMD, Inc. entered a new Equity Distribution Agreement with BTIG, LLC allowing it to sell, from time to time at its option, up to $75,000,000 of common shares in an at-the-market offering under its existing Form S-3 registration.
BTIG will act as sales agent and may receive a commission of up to 3.0% of gross proceeds. InspireMD currently plans to use any net proceeds for operations, including research and development, sales and marketing, working capital and other general corporate purposes. On the same date, the company terminated its prior at-the-market equity distribution agreement with Piper Sandler, under which 1,361,519 shares had been sold, and incurred no termination penalties.
InspireMD reported strong 2025 revenue growth but widening losses as it invests in its U.S. launch. Total revenue rose to $9.0 million in 2025, up 28% from $7.0 million in 2024, with fourth quarter revenue of $3.1 million increasing 62% year over year.
Gross margin improved as higher‑margin U.S. sales grew, with Q4 gross profit reaching $1.2 million, or 37.5% of revenue, versus 24.1% a year earlier. However, full‑year operating expenses climbed to $52.3 million from $35.0 million, reflecting expanded U.S. commercial headcount and infrastructure.
Net loss widened to $48.8 million in 2025, compared with $32.0 million in 2024, even as cash and marketable securities increased to $54.2 million as of December 31, 2025 from $34.6 million a year earlier. For 2026, management expects revenue of $13 million to $15 million, implying approximately 45% to 65% growth over 2025.
InspireMD, Inc. reported that it has provided a notice of dismissal to Chief Operating Officer Andrea Tommasoli, who is employed by subsidiary InspireMD Ltd. under a French-law Employment Agreement dated November 2, 2020.
The dismissal is subject to a six-month notice period and compliance with French labor laws. Tommasoli is released from his duties effective April 1, 2026, but will continue to receive base salary through the end of the notice period and health and provident benefits under French law for up to 12 months.
He will also receive severance pay of approximately €61,000 gross plus accrued unused paid leave. Subject to applicable French law, his last day of employment is expected to be September 1, 2026.
InspireMD, Inc. filed an 8-K announcing it furnished a press release with financial and operating results and recent highlights for the three and nine months ended September 30, 2025. The materials were provided on November 4, 2025 and relate to performance through Q3 2025.
The company also furnished an updated investor presentation dated November 2025. Both items were submitted under Items 2.02 and 7.01 and are designated as “furnished,” not “filed,” under the Exchange Act. Exhibits include the press release (99.1), the presentation (99.2), and the cover page inline XBRL file (104).
InspireMD, Inc. reported a planned board transition, with longtime director Thomas J. Kester resigning effective September 16, 2025, and affirming that his departure was not due to any disagreement over company operations or policies.
The board appointed Danny Lee Dearen Jr. as a Class III director, chair of the audit committee, and member of the compensation committee, with a term through the 2026 annual meeting. He received equity awards valued at about $180,000, split 75% in restricted stock and 25% in options, vesting after one year or sooner if he is not renominated or reelected in 2026. In recognition of Kester’s service, the compensation committee accelerated his unvested equity, extended his option terms by two years, approved four additional quarters of director and committee fees, and granted additional stock and options totaling about $120,000.
InspireMD, Inc. updated its prior disclosure about board member Raymond W. Cohen. The company’s board has now appointed Mr. Cohen to serve on both the Audit Committee and the Compensation Committee, in addition to his existing role as a Class 3 director with a term running through the 2026 annual meeting.
InspireMD, Inc. filed an 8-K dated August 5, 2025 reporting that it issued a press release with financial and operating results for the three and six months ended June 30, 2025 (Item 2.02) and made an updated investor presentation available (Item 7.01).
The filing states the press release is attached as Exhibit 99.1 and the investor presentation as Exhibit 99.2, and that both are furnished (not "filed") under General Instruction B.2. The presentation is available on the company website at https://www.inspiremd.com/en/investors/. This 8-K does not include the underlying financial figures; readers must consult the attached exhibits for results.
InspireMD, Inc. (NSPR) has filed a Form 8-K dated July 9, 2025 to furnish a Regulation FD disclosure.
Under Item 7.01, the company states that it has issued a press release entitled “InspireMD Announces U.S. Commercial Launch of CGuard® Prime Carotid Stent System for the Prevention of Stroke.” The full press release is included as Exhibit 99.1, but its text is not reproduced in the filing. Management emphasizes that the information is being furnished, not filed, meaning it is excluded from Exchange Act Section 18 liability and will not be incorporated into other SEC filings unless specifically referenced.
The filing contains no financial statements, guidance, or transaction details. The exhibit list consists of:
- 99.1 – Press Release (July 9, 2025)
- 104 – Cover Page Interactive Data File
Beyond the announcement of the U.S. commercial launch of CGuard Prime—InspireMD’s carotid stent designed to reduce stroke risk—no additional quantitative or strategic information is provided.
InspireMD has received FDA Premarket Approval (PMA) for its CGuard Prime Carotid Stent System on June 23, 2025, marking a significant regulatory milestone. This approval follows their PMA application submitted on September 16, 2024.
Key developments include:
- FDA PMA approval for stroke prevention device
- Release of updated investor presentation available on company website
- Trading on Nasdaq Capital Market under symbol NSPR
The company issued a press release on June 24, 2025, announcing the approval. The filing includes two key exhibits: the press release and an updated investor presentation. This regulatory achievement potentially opens up the U.S. market for InspireMD's carotid stent system, representing a material development for the company's commercial prospects.