Welcome to our dedicated page for Inspiremd news (Ticker: NSPR), a resource for investors and traders seeking the latest updates and insights on Inspiremd stock.
InspireMD, Inc. (NSPR) is a medical device company whose news flow centers on its CGuard® Prime carotid stent system and proprietary MicroNet™ mesh technology for stroke prevention. Company press releases and SEC filings describe InspireMD as the developer of CGuard® Prime for the treatment of carotid artery stenosis, with a focus on making its products a standard approach in carotid stenting.
News about InspireMD often covers clinical milestones and peer-reviewed publications. For example, the company announced that results from its C-GUARDIANS pivotal trial of the CGuard® Prime carotid stent system were published in the Journal of the American College of Cardiology, with data showing low rates of disabling stroke or myocardial infarction through 30 days and low ipsilateral stroke rates through one year. InspireMD has also highlighted external clinical evidence such as the CREST-2 study in the New England Journal of Medicine, which it views as supportive of carotid artery stenting combined with medical therapy.
Investors following NSPR can also expect updates on regulatory and commercial developments. Recent filings report FDA PMA approval for the CGuard Prime Carotid Stent System in the United States and subsequent announcements of a U.S. commercial launch. Quarterly earnings releases describe the impact of CGuard Prime on revenue and provide commentary on procedure volumes and expansion of the company’s commercial team.
Additional news items include capital-raising transactions, such as private placements and warrant exercises, as well as changes in board composition and senior medical leadership. Together, these updates give readers insight into InspireMD’s clinical progress, regulatory status, commercialization efforts, and corporate governance. This page aggregates such NSPR news so readers can review the company’s key announcements in one place.
InspireMD (Nasdaq: NSPR) initiated a voluntary U.S. recall of the CGuard Prime 135 cm carotid stent delivery system on May 1, 2026, after a controlled launch showed technical performance below expectations.
The recall excludes the CGuard stent implant. The company withdrew full‑year 2026 revenue guidance and expects FDA approval for the original CGuard delivery system in Q3 2026 and redesigned CGuard Prime in H1 2027.
InspireMD (Nasdaq: NSPR) announced FDA approval of its Investigational Device Exemption (IDE) to start the CGUARDIANS III pivotal study of the SwitchGuard Neuro Protection System, including next‑generation enhancements for use with the CGuard Prime 80 cm stent in transcarotid artery revascularization (TCAR).
Co‑lead investigators from CGUARDIANS II will continue roles. The company targets a U.S. commercial launch of SwitchGuard in 2027, if approved. Clinical trial identifier: NCT07277296.
InspireMD (Nasdaq: NSPR) will release its first quarter 2026 financial results on Monday, May 4, 2026 and will host a conference call and webcast at 4:30 p.m. Eastern Time.
Interested parties must register for phone participation via the online form; webcast registration sends dial-in details and a personal PIN. A live audio webcast and archived recording will be available on the company Investors page.
InspireMD (NASDAQ: NSPR) will present at the 25th Annual Needham Virtual Healthcare Conference on April 14, 2026 at 12:45 PM ET. A live audio webcast and archived recording will be available on the company’s Investors page.
According to InspireMD, the presentation will cover recent corporate developments and provide an investor update.
InspireMD (Nasdaq: NSPR) reported Q4 2025 revenue of $3.1M (+62% YoY) and full-year 2025 revenue of $9.0M (+28% YoY). Gross margin improved to 37.5% in Q4. Full-year operating expenses rose to $52.3M. Cash and marketable securities totaled $54.2M as of Dec 31, 2025. Management provided 2026 revenue guidance of $13M–$15M (≈45%–65% growth).
Key operating progress includes U.S. launch traction for CGuard Prime, completion of C-GUARDIANS II enrollment, a PMA-S submission for TCAR, and a peer-reviewed publication in JACC.
InspireMD (Nasdaq: NSPR) will release its fourth quarter and full year 2025 financial results on Wednesday, March 18, 2026. The company will host a conference call and live webcast at 8:30 a.m. Eastern Time to discuss results and recent highlights.
A live audio webcast and archived recording will be available via the company Investors page, and participants are encouraged to register at least 15 minutes before the call.
InspireMD (Nasdaq: NSPR) announced that its Compensation Committee approved inducement grants totaling 36,118 restricted shares to one new non-executive employee, granted under the company's 2024 Inducement Plan with a grant date of January 14, 2026.
The awards were made outside the 2021 Equity Incentive Plan as an inducement material to the employee entering employment, in accordance with Nasdaq Listing Rule 5635(c)(4). The restricted stock vests over three years: one-third on the first anniversary and the remaining two-thirds in equal installments on the second and third anniversaries, subject to continued employment on each vesting date.
InspireMD (Nasdaq: NSPR) announced publication of the C-GUARDIANS pivotal trial in JACC reporting low adverse event rates for the CGuard® Prime MicroNet™ carotid stent. The trial showed a 30-day disabling stroke or myocardial infarction (DSMI) rate of 0.95% and a 1-year ipsilateral stroke rate of 1.93% in a cohort that included 25% symptomatic patients. No unexpected device-related adverse events were reported. InspireMD highlighted that results compare favorably with prior carotid stenting pivotal studies and said the device is FDA PMA-approved for treatment of carotid artery stenosis in the U.S.
InspireMD (Nasdaq: NSPR) welcomed publication of the CREST-2 trial in the New England Journal of Medicine on Nov 24, 2025, and presentation at SVIN and VEITH on Nov 21, 2025. CREST-2 found that adding carotid artery stenting (CAS) to medical therapy in patients with high-grade asymptomatic carotid stenosis significantly reduced the composite risk of perioperative stroke or death or ipsilateral stroke through 4 years versus intensive medical therapy alone.
The trial reported that carotid endarterectomy (CEA) did not provide a significant benefit vs medical therapy in a separate arm. InspireMD highlighted its CGuard platform, citing a 1.93% major adverse event rate through 12 months in its C-GUARDIANS trial and >b>65,000 global implants as supporting evidence.
InspireMD (Nasdaq: NSPR) announced inducement grants approved November 20, 2025, awarding a total of 122,054 restricted shares to eight new non-executive employees under the company’s 2024 Inducement Plan.
The grants were made outside the 2021 Equity Incentive Plan as permitted by Nasdaq Listing Rule 5635(c)(4) and vest over three years: one-third on the first anniversary and two equal installments on the second and third anniversaries, subject to continued employment.