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InspireMD to Report Second Quarter 2024 Financial Results and Provide Corporate Business Update on Tuesday, August 6th
Newsfilter· 2024-07-30 11:00
-Conference call and webcast to be held at 8:30 a.m. EDT- Title: InspireMD Second Quarter 2024 Financial Results and Corporate Update Conference Call and Webcast Date: Tuesday, August 6th, 2024 Time: 8:30 a.m. ET Toll-Free: 1-800-445-7795 International: 1-785-424-1699 Conference ID: IMD2Q24 Conference Call Details: TEL AVIV, Israel, and MIAMI, July 30, 2024 (GLOBE NEWSWIRE) -- InspireMD, Inc. (NASDAQ:NSPR), developer of the CGuard™ Embolic Prevention Stent System (EPS) device for the treatment of Carotid Ar ...
InspireMD Announces Full Exercise of Series H Warrant Tranche for Gross Proceeds of $17.9 Million
Newsfilter· 2024-07-01 11:00
Series H warrants exercisable following release of positive outcomes results related to one-year follow-up from the Company's C-GUARDIANS pivotal trial. Participating warrant holders include Marshall Wace, OrbiMed, Rosalind, Nantahala, Soleus, Velan, and certain InspireMD Board members. Represents first of four milestone-driven warrant tranches pursuant to private placement financing of up to $113.6 million announced in May 2023. TEL AVIV, Israel and WESTIN, Fla., July 01, 2024 (GLOBE NEWSWIRE) -- InspireMD ...
InspireMD Announces Presentation of Positive One-Year Follow-Up Results from the C-GUARDIANS U.S. Investigational Device Exemption (IDE) Clinical Trial of CGuard at LINC 2024
Newsfilter· 2024-05-28 12:53
Data demonstrate lowest reported primary endpoint event rate of 1.95% through twelve months post-procedure for any carotid stent or embolic protection device pivotal trial Study results to support a Premarket Approval (PMA) application to FDA in H2 2024 U.S. commercial launch of the CGuard™ Prime Carotid Stent System anticipated in H1 2025, if approved TEL AVIV, Israel, and MIAMI, May 28, 2024 (GLOBE NEWSWIRE) -- InspireMD, Inc. (NASDAQ:NSPR), developer of the CGuard™ Embolic Prevention Stent System (EPS) f ...
InspireMD Announces Presentation of Positive One-Year Follow-Up Results from the C-GUARDIANS U.S. Investigational Device Exemption (IDE) Clinical Trial of CGuard at LINC 2024
globenewswire.com· 2024-05-28 12:53
Core Insights - InspireMD, Inc. announced positive one-year outcomes from the C-GUARDIANS IDE clinical trial for the CGuard™ Carotid Stent System, reporting the lowest primary endpoint event rate of 1.95% through twelve months post-procedure for any carotid stent or embolic protection device pivotal trial [1][2] - The company plans to submit a Premarket Approval (PMA) application to the FDA in the second half of 2024, with a U.S. commercial launch anticipated in the first half of 2025, pending approval [1][2] Clinical Trial Details - The C-GUARDIANS trial enrolled 316 patients across 24 sites in the U.S. and Europe from July 2021 to June 2023, focusing on patients with carotid artery stenosis at high risk for carotid endarterectomy [2][4] - The primary endpoint was a composite of major adverse events, including death, any stroke, or myocardial infarction through 30 days post-procedure, or ipsilateral stroke from day 31 to day 365 [5] - The trial confirmed extremely low rates of stroke, death, myocardial infarction, and target vessel revascularization, with 25% of participants being symptomatic [2][5] Technology and Market Position - InspireMD utilizes proprietary MicroNet® technology in its products, aiming to establish them as the industry standard for carotid stenting by providing superior acute results and durable, stroke-free long-term outcomes [6] - The company is enthusiastic about introducing both Carotid Artery Stenting (CAS) and Transcarotid Artery Revascularization (TCAR) solutions to serve a broad community of specialists in the carotid revascularization market [2]
InspireMD(NSPR) - 2024 Q1 - Quarterly Results
2024-05-14 11:10
Exhibit 99.1 InspireMD Reports First Quarter 2024 Financial Results and Provides Business Update - Generated first quarter 2024 CGuard EPS revenue of $1.51 million, an increase of 22.0% over the first quarter of 2023 - - Announced that an abstract detailing one-year outcomes from the C-GUARDIANS IDE clinical trial of CGuard™ Prime has been accepted for presentation at LINC 2024, to be held May 28-31 - - Named Patrick Geraghty, M.D. and Patrick Muck, M.D. as lead principal investigators for the Company's CGU ...
InspireMD(NSPR) - 2024 Q1 - Quarterly Report
2024-05-13 20:15
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended: March 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001-35731 InspireMD, Inc. (Exact name of registrant as specified in its charter) Delaware 26-2123838 (State or other jurisdiction ...
InspireMD(NSPR) - 2023 Q4 - Annual Results
2024-03-06 12:07
Exhibit 99.1 InspireMD Reports Fourth Quarter and Full-Year 2023 Financial Results and Provides Business Update - Record fourth quarter 2023 CGuard EPS revenue of $1.76 million increased 71.6% over fourth quarter 2022 - - Announced positive 30-day data from the Company's ongoing U.S. Investigational Device Exemption (IDE) clinical trial, C- GUARDIANS, designed to support U.S. approval of CGuard Prime - - Named Patrick Geraghty, M.D. and Patrick Muck, M.D. as lead principal investigators for the Company's C- ...
InspireMD(NSPR) - 2023 Q4 - Annual Report
2024-03-05 21:05
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 COMMISSION FILE NUMBER: 001-35731 InspireMD, Inc. (Exact name of registrant as specified in its charter) Delaware 26-2123838 (State or other jurisdiction of incorporation or organization) 4 Menor ...
InspireMD(NSPR) - 2023 Q3 - Quarterly Report
2023-11-06 21:05
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended: September 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001-35731 InspireMD, Inc. (Exact name of registrant as specified in its charter) Delaware 26-2123838 (State or other jurisdict ...
InspireMD(NSPR) - 2023 Q2 - Quarterly Report
2023-08-07 21:25
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended: June 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001-35731 InspireMD, Inc. (Exact name of registrant as specified in its charter) Delaware 26-2123838 (State or other jurisdiction o ...