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Director Raymond W. Cohen resigns from InspireMD board effective July 1, 2026
Cohen resigned as Class III director and from Audit and Compensation Committees.
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InspireMD reports 100% acute device success, zero adverse events in CGUARDIANS II TCAR trial
Acute device success 100% (50/50 patients); no deaths, strokes, or MI at 30 days.
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InspireMD shareholders approve authorized share increase to 250M at annual meeting
Shareholders approved increase in authorized common shares from 150M to 250M (31,577,297 for, 3,009,107 against).
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Paul Stuka to retire as InspireMD Board Chair at 2027 Annual Meeting; not standing for reelection
Paul Stuka notified InspireMD on May 20, 2026, of his decision not to seek reelection as Class I director at the 2027 Annual Meeting.
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InspireMD Q1 revenue $3.4M (+122% YoY); voluntary recall of CGuard Prime 135 cm
Net loss $13.7M ($0.16/share) vs $11.2M loss a year ago; operating expenses rose to $14.7M.
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InspireMD recalls CGuard Prime 135 cm delivery system due to performance issues; withdraws FY2026 revenue guidance
Voluntary recall of CGuard Prime 135 cm delivery system in US; technical success not met. No safety issues for implanted stent.
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InspireMD enters $75M ATM equity facility with BTIG; terminates prior Piper Sandler ATM
Entered Equity Distribution Agreement with BTIG to sell up to $75M of common stock via ATM offering.
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InspireMD reports Q4 revenue $3.1M (+62% YoY); guides FY2026 rev $13-15M
Q4 revenue $3.1M, up 62% YoY; U.S. rev $0.9M (sequential +74%)
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InspireMD dismisses COO Andrea Tommasoli effective April 1, 2026
Andrea Tommasoli, COO, given notice of dismissal on February 27, 2026.
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InspireMD director Kathryn Arnold resigns; company awards ~$140k in accelerated equity and fees
Kathryn Arnold, Class III director, resigns effective Dec 31, 2025; no disagreement with company.
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InspireMD Q3 revenue record $2.5M (+39% YoY) as U.S. CGuard Prime launch gains traction
U.S. revenue of $497k marks first commercial quarter for CGuard Prime carotid stent system.
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InspireMD Appoints Dan Dearen to Board, Replacing Thomas Kester
Thomas Kester resigned as Class III director effective Sept. 16, 2025; no disagreement cited.
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InspireMD appoints Raymond Cohen to Audit and Compensation Committees
Raymond W. Cohen appointed to Audit Committee and Compensation Committee on September 7, 2025.
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InspireMD Q2 net loss widens to $13.2M ($0.26/share); revenue up 2.3% to $1.78M
Net loss of $13.2M ($0.26 per share) vs $7.9M loss ($0.22) in Q2 2024; operating expenses surged 55% to $13.3M.
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InspireMD raises $58M via PIPE and warrant exercise; appoints Ray Cohen to board
PIPE gross proceeds $40.1M: 16.6M shares/pre-funded warrants at $2.42/share; led by OrbiMed and Marshall Wace.
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InspireMD launches CGuard Prime carotid stent system in US after FDA PMA approval
U.S. commercial launch of CGuard Prime carotid stent system after FDA PMA approval.
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InspireMD receives FDA PMA approval for CGuard Prime carotid stent system; triggers $17.9M warrant tranche
FDA approved CGuard Prime carotid stent system on June 23, 2025 for stroke prevention in carotid artery stenosis.
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InspireMD receives CE Mark approval for CGuard Prime EPS under EU MDR
CE Mark approval under European Medical Device Regulation (MDR) for CGuard Prime Embolic Prevention System.
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InspireMD shareholders re-elect Berman and Ward, ratify auditors at 2025 annual meeting
Directors Berman and Ward re-elected as Class 2 directors: Berman 12,429,779 for, 248,915 withheld; Ward 12,447,235 for, 231,459 withheld; 7,800,113 broker non-votes each.
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InspireMD appoints Michael Lawless as CFO, succeeding Craig Shore
Michael Lawless appointed CFO effective on/before June 30, 2025; succeeds Craig Shore who served ~15 years.
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InspireMD Q1 net loss widens to $0.22/sh; FDA approval of CGuard Prime expected Q3 2025
Revenue $1.529M (+1.2% YoY); net loss $11.166M ($0.22/sh) vs $7.032M loss ($0.21/sh) in Q1 2024.
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InspireMD Q4 net loss widens to $9.2M; revenue up 11%; FDA approval for CGuard Prime expected H1 2025
Q4 revenue rose 10.7% YoY to $1.95M; gross profit fell 7.1% to $469K as COGS grew faster.
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InspireMD CFO Craig Shore to retire; successor search underway
Craig Shore, CFO for 15 years, will retire after successor appointed; he will assist transition.
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InspireMD enrolls first patient in CGUARDIANS II pivotal TCAR study for CGuard Prime
First patient enrolled by Dr. Patrick Muck at Good Samaritan Hospital (TriHealth, Cincinnati).
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InspireMD appoints medtech executive Scott R. Ward to Board of Directors
Scott R. Ward, former CEO of Cardiovascular Systems and Abbott leader, joins as Class II director.
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InspireMD Q3 revenue record $1.81M (+16.3% YoY); net loss $7.89M; submits PMA to FDA for CGuard Prime
Revenue record $1.81M, up 16.3% YoY; gross margin 22.9% down from 28.1% due to higher costs.
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InspireMD establishes Miami global HQ; anticipates U.S. launch of CGuard Prime in H1 2025
New global headquarters in Miami, Florida to support anticipated U.S. launch of CGuard Prime carotid stent system.
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FDA approves IDE for InspireMD's CGUARDIANS II pivotal study of CGuard Prime 80cm stent system
FDA approved IDE application for CGUARDIANS II pivotal study of CGuard Prime 80cm Carotid Stent System during TCAR procedures.
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InspireMD adopts 2024 Inducement Plan, reserves 2,200,000 shares for new employee awards
Compensation committee approved 2024 Inducement Plan on September 30, 2024.
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InspireMD submits PMA to FDA for CGuard Prime carotid stent; U.S. launch targeted H1 2025
PMA submission on Sept 16, 2024, seeks FDA marketing approval for CGuard Prime carotid stent system.
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InspireMD Q2 2024 revenue up 5.4% to $1.74M; net loss widens; positive CGuard trial data
Q2 2024 revenue $1.74M (+5.4% YoY); gross margin fell to 19.0% from 29.8% on higher costs.
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InspireMD completes full exercise of Series H warrants for $17.9M gross proceeds
Gross proceeds $17.9M; net proceeds $16.9M after fees.
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InspireMD posts updated investor presentation; content unavailable in filing excerpt
Company furnished an investor presentation dated June 2024 under Item 7.01 on June 13, 2024.
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InspireMD Announces Results of 2024 Annual Meeting of Stockholders
Stockholders re-elected Paul Stuka and Gary Rubin as Class 1 directors with 12,361,205 and 12,377,887 votes for, respectively.
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InspireMD enters $17M at-the-market equity distribution agreement with Piper Sandler
New ATM allows sale of up to $17M of common stock; Piper Sandler receives 3.0% commission on gross proceeds.
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InspireMD C-GUARDIANS trial shows 1.95% primary endpoint event rate; PMA filing planned H2 2024
Primary endpoint event rate of 1.95% through 12 months post-procedure, lowest reported for any carotid stent pivotal trial.
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InspireMD Q1 revenue up 22% to $1.51M; net loss widens to $7.0M ($0.21/sh)
Revenue $1.51M (+22% YoY); stent units sold 2,553 (+25.6% YoY).
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InspireMD amends CEO and CFO employment agreements to enhance change-in-control severance
CEO Marvin Slosman receives 24-month base salary severance plus 2x performance bonus on change-in-control termination.
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InspireMD's C-GUARDIANS 12-month abstract accepted for LINC 2024; prior 30-day DSMI 0.95%
Abstract of 12-month outcomes from C-GUARDIANS trial (316 patients, 24 sites) accepted for LINC 2024 (May 28-31, Leipzig).
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InspireMD Q4 revenue jumps 71.6% to $1.76M; net loss $0.16 per share
Record Q4 CGuard EPS revenue of $1.76M, up 71.6% YoY; 3,107 stents sold (+74.5%).
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InspireMD Receives CE Mark Recertification Under EU MDR for CGuard Stent System
CE Mark recertification under EU's new Medical Device Regulation (MDR) obtained.
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InspireMD receives U.S. patent for SwitchGuard NPS; IDE submission planned for 2024
U.S. Patent No. 11,844,893 issued for 'Shunts with Blood Flow Indicators' covering SwitchGuard NPS.
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InspireMD announces EFS agreement with Jacobs Institute for CGuard EPS in tandem lesion stroke patients
Agreement with Jacobs Institute to execute an Early Feasibility Study (EFS) of CGuard EPS for acute stroke with tandem lesions.
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InspireMD Q3 revenue +8.8% to $1.56M; CMS expands CAS coverage; trial results positive
Q3 revenue $1.556M (+8.8% YoY); gross margin 28.1% (vs 25.6% Q3 2022).
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InspireMD reports positive 30-day C-GUARDIANS trial results: 0.95% DSMI rate in 316 patients
DSMI (death, stroke, MI) rate of 0.95% through 30 days post-procedure in 316 high-risk carotid artery stenosis patients.
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CMS expands carotid stenting coverage to asymptomatic/standard-risk patients; InspireMD supports
CMS final NCD extends CAS coverage to asymptomatic and standard-risk patients, expanding addressable market.
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InspireMD reappoints Craig Shore as CFO; Kohen returns to VP role
Craig Shore reappointed as CFO, Secretary and Treasurer effective October 5, 2023.
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InspireMD shareholders approve officer liability limitation and private placement change of control
Stockholders re-elected Marvin Slosman, Thomas J. Kester, and Kathryn Arnold as Class 3 directors.
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InspireMD: C-Guardians 30-day results abstract accepted for VIVA23 presentation
Abstract of 30-day results from C-Guardians IDE trial accepted as late-breaking presentation at VIVA23 (Oct 30-Nov 2, Las Vegas) on Nov 1, 2023, by Dr. Chris Metzger.
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InspireMD reports Q2 revenue up 9.6% to $1.65M; secures up to $113.6M private placement
Closed transformational private placement: $42.2M upfront, up to $71.4M additional on milestone warrants.