Highest-materiality recent filing
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.
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.
Voluntary recall of CGuard Prime 135 cm delivery system in US; technical success not met. No safety issues for implanted stent.
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.
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%)
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.
InspireMD Appoints Dan Dearen to Board, Replacing Thomas Kester
Thomas Kester resigned as Class III director effective Sept. 16, 2025; no disagreement cited.
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.
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.
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.
FDA approved CGuard Prime carotid stent system on June 23, 2025 for stroke prevention in carotid artery stenosis.
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.
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.
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.
Q4 revenue rose 10.7% YoY to $1.95M; gross profit fell 7.1% to $469K as COGS grew faster.
InspireMD CFO Craig Shore to retire; successor search underway
Craig Shore, CFO for 15 years, will retire after successor appointed; he will assist transition.
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).
Revenue record $1.81M, up 16.3% YoY; gross margin 22.9% down from 28.1% due to higher costs.
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.
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.
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.
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.
InspireMD completes full exercise of Series H warrants for $17.9M gross proceeds
Gross proceeds $17.9M; net proceeds $16.9M after fees.
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.
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).
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%).
InspireMD Receives CE Mark Recertification Under EU MDR for CGuard Stent System
CE Mark recertification under EU's new Medical Device Regulation (MDR) obtained.
Agreement with Jacobs Institute to execute an Early Feasibility Study (EFS) of CGuard EPS for acute stroke with tandem lesions.
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).
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.
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.
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.
On May 20, 2026, Mr. Paul Stuka notified InspireMD, Inc. (the “Company”) of his decision to not seek reelection as a Class I director of the Board of Directors of the Company (the “Board”) at the Company’s 2027 Annual Meeting of Stockholders (the “2027 Annual Meeting”) and to retire from the Board.
On June 2, 2025, InspireMD, Inc. (the “ Company ”) appointed Michael Lawless as Chief Financial Officer of the Company, effective on or before June 30, 2025 (the “ Effective Date ”).
On the Effective Date, Mr. Lawless will succeed Craig Shore, whose employment as the Company’s Chief Financial Officer will be terminated simultaneous with Mr. Lawless’s appointment.
On November 25, 2024, the board of directors of InspireMD, Inc. (the “Board” and the “Company”, respectively) appointed Mr. Scott R. Ward as a Class II member of the Board, effective as of that date, with a term expiring at the Company’s 2025 annual meeting of stockholders.
Mr. Kohen will resume his role as the Company’s Vice President of Finance and Human Resources, effective as of the date of Mr. Shore’s reappointment.
On October 5, 2023, Mr. Shore was reappointed as the Chief Financial Officer, Secretary and Treasurer of the Company.
On July 20, 2023, the Board of Directors of InspireMD, Inc. (the “Company”) appointed Amir Kohen, the Company’s Vice President of Finance and Human Resources, to serve as of interim Chief Financial Officer, Secretary and Treasurer during the time that Craig Shore is out on medical leave.
On March 19, 2023, InspireMD, Inc. (the “Company”), announced that its Board of Directors (the “Board”) promoted Andrea Tommasoli to Chief Operating Officer of the Company, effective as of March 19, 2023.
Max materiality 0.90 · Median 0.62 · Most common event other_material