MIAMI, Dec. 12, 2024 (GLOBE NEWSWIRE) -- InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention Stent System (EPS) for the prevention of stroke, today announced that Craig Shore, Chief Financial Officer, has decided to retire from the Company after a successor CFO is identified and appointed. Mr. Shore will remain as CFO until his successor is appointed and will assist in a smooth and orderly transition.... Read More

MIAMI, Dec. 09, 2024 (GLOBE NEWSWIRE) -- InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention Stent System (EPS) for the prevention of stroke, today announced that the first patient has been enrolled in the company’s CGUARDIANS II clinical trial evaluating its CGuard Prime Carotid Stent System in patients undergoing carotid artery stenting via the Transcarotid Artery Revascularization (TCAR) approach.... Read More

MIAMI, Nov. 25, 2024 (GLOBE NEWSWIRE) -- InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention Stent System (EPS) for the prevention of stroke, today announced the appointment of accomplished medical technology executive Scott R. Ward to its Board of Directors. Mr. Ward most recently served as Chief Executive Officer and President of Cardiovascular Systems, Inc. prior to its acquisition by Abbott (NYSE:... Read More

Submitted a Premarket Approval (PMA) application to the FDA seeking marketing approval of the CGuard Prime carotid stent system in the U.S. Announced approval of an IDE application to initiate the CGUARDIANS II pivotal study of the CGuard Prime carotid stent system for use during TCAR procedures Established its Headquarters in Miami, Florida, to optimally support the anticipated U.S. commercial launch of CGuard Prime in H1... Read More

MIAMI, Nov. 08, 2024 (GLOBE NEWSWIRE) -- InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Prime carotid stent system for the prevention of stroke, today announced that the Compensation Committee of InspireMD’s Board of Directors approved inducement grants to five new non-executive employees in the aggregate amount of 197,167 shares of restricted stock outside of InspireMD’s 2021 Equity Compensation Plan, with a grant... Read More

Conference call and webcast to be held at 8:30 a.m. EDT TEL AVIV, Israel and MIAMI, Nov. 04, 2024 (GLOBE NEWSWIRE) -- InspireMD, Inc . (Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention Stent System (EPS) device for the treatment of Carotid Artery Disease and stroke prevention, announced today it will report third quarter 2024 financial results on Tuesday, November 12 th , 2024, before the financial markets open.... Read More

MIAMI, Oct. 15, 2024 (GLOBE NEWSWIRE) -- InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention Stent System (EPS) for the prevention of stroke, today announced the establishment of its global headquarters in Miami, Florida. The new facility will ideally position the Company to support the anticipated U.S. launch and commercialization of the CGuard Prime carotid stent system in the first half of 2025, if... Read More

MIAMI, Oct. 07, 2024 (GLOBE NEWSWIRE) -- InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention Stent System (EPS) for the prevention of stroke, today announced that the U.S. Food and Drug Administration (FDA) has approved the company’s Investigational Device Exemption (IDE) Application to initiate the CGUARDIANS II pivotal study of its CGuard Prime 80cm Carotid Stent System during transcarotid... Read More

PMA based on overwhelmingly positive results from the pivotal C-GUARDIANS clinical study that were first presented at LINC 2024 in May U.S. commercial launch anticipated in H1 2025, if approved TEL AVIV, Israel and MIAMI, Sept. 16, 2024 (GLOBE NEWSWIRE) -- InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention Stent System (EPS) for the prevention of stroke, today announced that it has submitted a... Read More

Announced positive outcomes from the C-GUARDIANS IDE clinical trial of the CGuard™ Prime carotid stent system demonstrating a one-year primary endpoint event rate of 1.95%, the lowest for any carotid stent or embolic protection device pivotal trial On track to submit a Premarket Approval (PMA) application to the FDA this quarter Raised gross proceeds of $17.9 million from full exercise of Series H warrants triggered by... Read More

CGuard was the only investigational carotid stent approved by FDA for inclusion in the trials CREST-2 included 23 cases implanted with CGuard TEL AVIV, Israel and MIAMI, Aug. 05, 2024 (GLOBE NEWSWIRE) -- InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention Stent System (EPS) for the prevention of stroke, today congratulated the lead investigators on the completion of enrollment in the CREST-2 (Carotid... Read More

Conference call and webcast to be held at 8:30 a.m. EDT 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 Artery Disease and stroke prevention, announced today it will report second quarter 2024 financial results on Tuesday, August 6 th , before the financial markets open. Management... Read More

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... Read More

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,... Read More

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 CGUARDIANS II clinical... Read More

TEL AVIV, Israel and MIAMI, May 07, 2024 (GLOBE NEWSWIRE) -- InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention Stent System (EPS) device for the treatment of Carotid Artery Disease and stroke prevention, announced today it will report first quarter 2024 financial results on Tuesday, May 14 th , before the financial markets open. Management will host a conference call and webcast with the investment... Read More

TEL AVIV, Israel and MIAMI, April 03, 2024 (GLOBE NEWSWIRE) -- InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention Stent System (EPS) for the prevention of stroke, today announced that Marvin Slosman, Chief Executive Officer, will deliver a company update presentation at the 23rd Annual Needham Virtual Healthcare Conference, which is being held April 8-11, 2024. Presentation details: Date: Wednesday,... Read More

TEL AVIV, Israel and MIAMI, March 26, 2024 (GLOBE NEWSWIRE) -- InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention Stent System (EPS) for the prevention of stroke, today announced that an abstract of the one-year outcomes from its C-GUARDIANS IDE clinical trial of the CGuard™ Prime Carotid Stent System for the treatment of carotid artery stenosis has been accepted for presentation at the Leipzig... Read More

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-GUARDIANS II clinical trial of its... Read More

Conference call and webcast to be held at 8:30 a.m. EST TEL AVIV, Israel and MIAMI, Feb. 28, 2024 (GLOBE NEWSWIRE) -- InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention Stent System (EPS) device for the treatment of Carotid Artery Disease and stroke prevention, announced today it will report fourth quarter and full-year 2023 financial results on Wednesday, March 6 th , 2024, before the financial... Read More

TEL AVIV, Israel and MIAMI, Feb. 12, 2024 (GLOBE NEWSWIRE) -- InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention Carotid Stent System (EPS) for the prevention of stroke, today announced that the Company has appointed principal investigators (PIs) for its upcoming C-GUARDIANS II clinical trial of the SwitchGuard™ Neuroprotection System (NPS). Patrick Geraghty, M.D., professor of surgery and radiology,... Read More

TEL AVIV, Israel and MIAMI, Jan. 31, 2024 (GLOBE NEWSWIRE) -- InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention Carotid Stent System (EPS) for the prevention of stroke, today announced that it has received CE Mark recertification under the European Union’s new Medical Device Regulation (MDR) regulatory framework. MDR replaced the previous MDD framework, which had governed the approval and marketing... Read More

Appointment brings more than 30 years of medical technology general management and commercial leadership experience to the InspireMD team Reports inducement grant under NASDAQ listing rule 5635(c)(4) TEL AVIV, Israel and MIAMI, Jan. 03, 2024 (GLOBE NEWSWIRE) -- InspireMD (Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention Stent System (EPS) for the prevention of stroke, announced today the appointment of medical... Read More

TEL AVIV, Israel and MIAMI, Dec. 20, 2023 (GLOBE NEWSWIRE) -- InspireMD (Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention Stent System (EPS) for the prevention of stroke, announced today the issuance of U.S. Patent No. 11,844,893, titled, “Shunts with Blood Flow Indicators.” The patent covers key aspects of the company’s SwitchGuard™ Neuroprotection System (NPS) along with future features in development that are... Read More

TEL AVIV, Israel and MIAMI, Nov. 27, 2023 (GLOBE NEWSWIRE) -- InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention Stent System (EPS) for the prevention of stroke, today announced that the company has entered into a strategic agreement with the Jacobs Institute at the State University of New York at Buffalo, and Dr. Adnan Siddiqui, Vice-Chairman and Professor of Neurosurgery, to execute an Early... Read More

Presented positive 30-day follow-up results from the C-GUARDIANS U.S. Investigational Device Exemption (IDE) clinical trial demonstrating an overall major adverse events rate (DSMI) of 0.95% from procedure through 30 days at the Vascular InterVentional Advances Annual Meeting (VIVA23) Announced support for CMS’ final decision expanding coverage of CAS to include both asymptomatic and standard risk patients, significantly... Read More

TEL AVIV, Israel and MIAMI, Fla., Nov. 02, 2023 (GLOBE NEWSWIRE) -- InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention Stent System (EPS) for treatment of carotid artery disease and prevention of stroke, today announced that the Marvin Slosman, Chief Executive Officer, will participate in three upcoming investor conferences in November: Wolfe Research Healthcare Conference Wednesday, November 15,... Read More

TEL AVIV, Israel and MIAMI, Nov. 01, 2023 (GLOBE NEWSWIRE) -- InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention Stent System (EPS) for the prevention of stroke, today presented 30-day results from the C-GUARDIANS U.S. Investigational Device Exemption (IDE) clinical trial at the Vascular InterVentional Advances (VIVA) meeting, which is being held October 30 through November 2 in Las Vegas, NV. The... Read More

Conference call and webcast to be held at 8:30 a.m. EST TEL AVIV, Israel and MIAMI, Oct. 30, 2023 (GLOBE NEWSWIRE) -- InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention Stent System (EPS) device for the treatment of Carotid Artery Disease and stroke prevention, announced today it will report third quarter 2023 financial results on Monday, November 6 th , 2023, before the financial markets open.... Read More

Provides additional treatment options for patients and treating physicians; likely expands CAS addressable market Potentially accelerates conversion of carotid interventions from surgery (carotid endarterectomy) to minimally invasive CAS and TCAR procedures InspireMD advancing both CAS and TCAR stent delivery platforms along U.S. and E.U. regulatory pathways leveraging proven CGuard EPS stent system TEL AVIV, Israel and... Read More

Announces hiring of Patrick Verta, MD, as Executive VP of Clinical and Medical Affairs Cheryl Tal joins as VP of Quality Assurance and Regulatory Affairs Shane Gleason, current General Manager of North America & VP of Global Marketing, promoted to Chief Commercial Officer Reports Inducement Grant Under NASDAQ Listing Rule 5635(c)(4) TEL AVIV, Israel and MIAMI, Oct. 03, 2023 (GLOBE NEWSWIRE) -- InspireMD, Inc. (Nasdaq: NSPR),... Read More

TEL AVIV, Israel, and MIAMI, Aug. 31, 2023 (GLOBE NEWSWIRE) -- InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention Stent System (EPS) for the prevention of stroke, today announced that an abstract detailing upcoming 30-day results from its C-Guardians U.S. IDE clinical trial has been accepted for presentation as a late-breaking clinical trial at the Vascular InterVentional Advances Annual Meeting... Read More

Completed transformational private placement for up to $113.6 million, including $42.2 million upfront Completed enrollment in the C-Guardians US IDE trial; on track to announce primary and secondary endpoints and, if successful, submit PMA application in H2 2024 Generated Q2 2023 CGuard EPS revenue of $1.6 million, an increase of nearly 10% over Q2 2022 Management to host investor conference call today, August 8, at 8:30am... Read More

Conference call and webcast to be held at 8:30 a.m. EDT TEL AVIV, Israel and MIAMI, July 25, 2023 (GLOBE NEWSWIRE) -- InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention Stent System (EPS) device for the treatment of Carotid Artery Disease and stroke prevention, announced today it will report second quarter 2023 financial results on Tuesday, August 8th th , 2023, before the financial markets open.... Read More

Trial designed to support potential U.S. marketing approval of the CGuard™ Prime EPS stent system Study also included first-in-human cases treated with CGuard Prime CAS stent delivery platform Company anticipates study results and Premarket Approval (PMA) submission in H2 2024, potential U.S. approval in H1 2025 TEL AVIV, Israel, June 26, 2023 (GLOBE NEWSWIRE) -- InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™... Read More

TEL AVIV, Israel and MIAMI, May 18, 2023 (GLOBE NEWSWIRE) -- InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard ™ Embolic Prevention Stent System (EPS) for the prevention of stroke, today announced that, in connection with the appointment of Shane Gleason as General Manager of North America and VP of Global Marketing in February 2023, InspireMD granted Mr. Gleason 256,450 shares of restricted stock and stock options to... Read More

Completed transformational private placement for up to $113.6 million, including $42.2 million upfront Generated Q1 2023 CGuard EPS revenue of $1.2 million, an increase of 6.7% over Q1 2022 despite the temporary expiration of the Company’s CE Mark certification until mid-March Resumed shipments of CGuard EPS to CE Mark territories under the pre-existing Medical Device Directive (MDD) regulatory framework; Anticipates... Read More

Led by Marshall Wace with participation from OrbiMed, Rosalind, Nantahala, Soleus, Velan and certain InspireMD Board members $42.2 million financing upfront with up to an additional $71.4 million tied to exercise of milestone-driven warrants TEL AVIV, Israel and MIAMI, May 15, 2023 (GLOBE NEWSWIRE) -- InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention Stent System (EPS) for the prevention of stroke,... Read More

Conference call and webcast to be held at 8:30 a.m. EDT TEL AVIV, Israel, May 12, 2023 (GLOBE NEWSWIRE) InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention Stent System (EPS) device for the treatment of Carotid Artery Disease and stroke prevention, announced today that it will host its conference call and webcast to review first quarter 2023 financial and operating results on Tuesday, May 16 th ,... Read More

Conference call and webcast to be held at 8:30 a.m. EDT TEL AVIV, Israel, May 05, 2023 (GLOBE NEWSWIRE) -- InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention Stent System (EPS) device for the treatment of Carotid Artery Disease and stroke prevention, announced today it will now report first quarter 2023 financial results on Monday, May 15 th , 2023. Management will host a conference call and webcast... Read More

Procedure performed as part of the company’s ongoing CGuardians U.S. Investigational Device Exemption (IDE) trial designed to support potential U.S. marketing approval of the CGuard stent system CGuardians enrollment on track to be completed by the end of Q2 2023 TEL AVIV, Israel, May 01, 2023 (GLOBE NEWSWIRE) -- InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention Stent System (EPS) for the prevention... Read More

TEL AVIV, Israel, April 27, 2023 (GLOBE NEWSWIRE) -- InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention Stent System (EPS) device for the treatment of Carotid Artery Disease and stroke prevention, announced today it will report first quarter 2023 financial results on Tuesday, May 9 th , 2023, before the financial markets open. Management will host a conference call and webcast with the investment... Read More

2022 CGuard EPS revenue of $5.1 million increased 18.9% over 2021 Resumed shipments of CGuard EPS to CE Mark territories under the pre-existing Medical Device Directive (MDD) regulatory framework; Company anticipates re-certification under new Medical Device Regulation (MRD) framework in coming weeks Continued enrollment in the C-Guardian US IDE trial, with 20 sites currently enrolling patients; on track to complete... Read More

TEL AVIV, Israel, March 20, 2023 (GLOBE NEWSWIRE) -- InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention Stent System (EPS) for the prevention of stroke, today announced that it has promoted Andrea Tommasoli to Chief Operating Officer. Mr. Tommasoli formerly served as the Company’s Senior Vice President of Global Sales & Marketing since joining InspireMD in November 2020. “Andrea has been instrumental... Read More

Conference call and webcast to be held at 8:30 a.m. EDT TEL AVIV, Israel, March 02, 2023 (GLOBE NEWSWIRE) -- InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention Stent System (EPS) device for the treatment of Carotid Artery Disease and stroke prevention, announced today it will report fourth quarter and full-year 2022 financial results on Thursday, March 30, 2023, before the financial markets open.... Read More

TEL AVIV, Israel, Feb. 14, 2023 (GLOBE NEWSWIRE) -- InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention Stent System (EPS) for the prevention of stroke, today announced that it has hired medical device commercial veteran Shane Gleason as General Manager of North America and Vice President of Global Marketing. Mr. Gleason brings to InspireMD significant expertise in vascular interventions and a track... Read More