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 develops and commercializes carotid stent systems built around its MicroNet stent platform for carotid artery disease and stroke prevention. News for NSPR centers on CGuard Prime and CGuard product commercialization, U.S. and international demand, FDA interactions, IDE approvals, pivotal studies for TCAR-related use, and product quality actions such as the CGuard Prime 135 cm delivery-system recall.
Company updates also cover quarterly financial results, hospital adoption and procedure experience, publications from C-GUARDIANS studies, investor conference participation, and capital-market communications tied to its Nasdaq-listed common stock.
InspireMD (Nasdaq:NSPR) approved inducement grants totaling 221,666 shares of restricted stock to a new non-executive employee, with a grant date of August 3, 2026. The awards were made outside the 2021 Equity Incentive Plan under InspireMD’s 2024 Inducement Plan, in line with Nasdaq Listing Rule 5635(c)(4).
The restricted stock vests in tranches: 56,666 shares in two equal installments on January 10, 2027 and 2028; 40,000 shares in three annual installments on January 16, 2027, 2028 and 2029; and 125,000 shares in three annual installments starting on the first anniversary of the grant date, all subject to continued employment.
InspireMD (Nasdaq: NSPR) appointed experienced commercial leader Kathleen (Kathy) Kennedy as Senior Vice President of Global Sales and Marketing, reporting to CEO Marvin Slosman. Kennedy brings over 30 years of medical device sales leadership, with deep expertise in carotid intervention and carotid stenting.
She previously supported the initial U.S. launch of CGuard Prime at InspireMD and returns with established relationships across vascular, neurovascular and cardiovascular physician communities, and health systems involved in carotid therapies. According to InspireMD, her appointment supports preparations for the potential U.S. approval, commercial relaunch and scaling of the CGuard platform, including CGuard Prime 80cm for TCAR procedures.
InspireMD (Nasdaq:NSPR) approved inducement grants of 91,161 restricted shares for six new non-executive employees under its 2024 Inducement Plan. These equity awards are granted outside the 2021 Equity Incentive Plan pursuant to Nasdaq Listing Rule 5635(c)(4).
The restricted stock vests over three years: one-third after the first anniversary, and the remaining two-thirds in equal installments on the second and third anniversaries, subject to the employees’ continued employment with InspireMD.
InspireMD (Nasdaq:NSPR) reported 30-day results from the CGUARDIANS II pivotal trial of its CGuard Prime 80 cm stent for TCAR procedures. In 50 patients, acute device success was 100%, with no deaths, strokes, myocardial infarctions, stent thrombosis, and complete stent patency in evaluable subjects.
The prospective, multi-center, single-arm study ran across 11 sites in high-risk patients using the FDA-cleared ENROUTE TCAR neuroprotection system. A PMA supplement for CGuard Prime 80 cm is under FDA review, with potential U.S. approval in H2 2026, targeting over 35,000 annual TCAR procedures.
InspireMD (Nasdaq:NSPR) enrolled the first patient in the CGUARDIANS III pivotal study of its SwitchGuard neuro protection system for use with the CGuard Prime 80 cm stent in TCAR procedures.
The prospective, multi-center, single-arm trial plans to enroll about 103 high-risk carotid stenosis patients.
InspireMD (Nasdaq: NSPR) will present at the Bank of America Securities 2026 Global Healthcare Conference on Wednesday, May 13, 2026 at 4:20 pm PT. A live audio webcast and archived recording will be available via the company’s Investors page at the provided investor website link.
InspireMD (Nasdaq: NSPR) reported Q1 2026 revenue of $3.4 million, up 122% year‑over‑year, with U.S. revenue of $1.2 million and international revenue of $2.2 million. Gross profit was $0.7 million (20.2% margin); adjusted gross profit was $1.2 million (34.1%) excluding a $0.5 million inventory impairment. Net loss was $13.7 million, or $0.16 per share. The company received FDA IDE approval for the CGUARDIANS III trial of SwitchGuard NPS for TCAR and expects FDA actions on CGuard delivery systems in Q3 and H2 2026. A voluntary recall of CGuard Prime 135 cm may affect short‑term availability and has expected reserves of ~$700k returns and ~$650k remediation.
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.