{"id":957292,"date":"2026-05-01T16:11:15","date_gmt":"2026-05-01T20:11:15","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/inspiremd-announces-fda-approval-of-investigational-device-exemption-application-for-cguardians-iii-pivotal-study-of-the-switchguard-neuro-protection-system\/"},"modified":"2026-05-01T16:11:15","modified_gmt":"2026-05-01T20:11:15","slug":"inspiremd-announces-fda-approval-of-investigational-device-exemption-application-for-cguardians-iii-pivotal-study-of-the-switchguard-neuro-protection-system","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/inspiremd-announces-fda-approval-of-investigational-device-exemption-application-for-cguardians-iii-pivotal-study-of-the-switchguard-neuro-protection-system\/","title":{"rendered":"InspireMD Announces FDA Approval of Investigational Device Exemption Application for CGUARDIANS III Pivotal Study of the SwitchGuard Neuro Protection System"},"content":{"rendered":"
\n

MIAMI, May 01, 2026 (GLOBE NEWSWIRE) — InspireMD, Inc. (Nasdaq: NSPR) (\u201cInspireMD\u201d or the \u201cCompany\u201d), developer of the CGuard\u00ae<\/sup> Prime carotid stent system for the prevention of stroke, today announced that the U.S. Food and Drug Administration (\u201cFDA\u201d) has approved the company\u2019s Investigational Device Exemption (\u201cIDE\u201d) Application to initiate the CGUARDIANS III pivotal study of its SwitchGuard neuro protection system (\u201cNPS\u201d), including next generation enhancements from our prior IDE approval for use with its CGuard Prime 80 cm stent platform, in transcarotid artery revascularization (\u201cTCAR\u201d) procedures.<\/p>\n

Patrick Geraghty, M.D., professor of surgery and radiology, section of vascular surgery at Washington University School of Medicine in St. Louis, MO, and Patrick Muck, M.D., program director and chief of vascular surgery at Good Samaritan Hospital in Cincinnati, OH, who previously led the CGUARDIANS II trial as co-lead investigators, will continue in the roles for the CGUARDIANS III trial.<\/p>\n

\u201cThe approval of our CGUARDIANS III IDE represents a meaningful advancement in our quest to offer the full TCAR tool kit leveraging our best-in-class CGuard Prime 80 cm stent platform for unmatched stroke prevention and carotid disease management,\u201d said Marvin Slosman, CEO of InspireMD. \u201cWe look forward to the efficient execution of this important study as we target U.S. commercial launch of the SwitchGuard NPS in 2027, if approved.\u201d<\/p>\n

For additional information: https:\/\/clinicaltrials.gov\/study\/NCT07277296<\/a><\/p>\n

\n About InspireMD, Inc.<\/strong>
\n
InspireMD seeks to utilize its proprietary MicroNet \u2122 mesh technology to make its products the industry standard for carotid stenting by providing outstanding acute results and durable, stroke-free long-term outcomes. InspireMD\u2019s common stock is quoted on Nasdaq under the ticker symbol NSPR. We routinely post information that may be important to investors on the Company\u2019s website. For more information, please visit www.inspiremd.com.<\/p>\n

\n Forward-looking Statements<\/strong>
\n
\n This press release contains \u201cforward-looking statements.\u201d Forward-looking statements include, but are not limited to, statements regarding InspireMD or its management team\u2019s expectations, hopes, beliefs, intentions or strategies regarding future events, future financial performance, strategies, expectations, competitive environment and regulation. Such statements may be preceded by the words \u201cintends,\u201d \u201cmay,\u201d \u201cwill,\u201d \u201cplans,\u201d \u201cexpects,\u201d \u201canticipates,\u201d \u201cprojects,\u201d \u201cpredicts,\u201d \u201cestimates,\u201d \u201caims,\u201d \u201cbelieves,\u201d \u201chopes,\u201d \u201cpotential\u201d, \u201cscheduled\u201d or similar words. <\/em>
\n Forward-looking statements are not guarantees of future performance, are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company\u2019s control, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with the Company\u2019s history of recurring losses and negative cash flows from operating activities, significant future commitments and the uncertainty regarding the adequacy of its liquidity to pursue its complete business objectives, and substantial doubt regarding its ability to continue as a going concern; the Company\u2019s need to raise additional capital to meet its business requirements in the future and such capital raising may be costly or difficult to obtain and could dilute out stockholders\u2019 ownership interests; the clinical development, commercialization and market acceptance of the Company\u2019s products; whether the clinical trial results for the Company\u2019s products will be predictive of real-world results; an inability to secure and maintain regulatory approvals for the sale of the Company\u2019s products; negative clinical trial results or lengthy product delays in key markets; the Company\u2019s ability to maintain compliance with the Nasdaq listing standards; the Company\u2019s ability to generate significant revenues from its products; estimates of the Company\u2019s expenses, future revenues, capital requirements and its needs for and ability to access sufficient additional financing, including any unexpected costs or delays in the ongoing commercial launch of its products; the Company\u2019s dependence on a single manufacturing facility and its ability to comply with stringent manufacturing quality standards and to increase production as necessary; the risk that the data collected from the Company\u2019s current and planned clinical trials may not be sufficient to demonstrate that its technology is an attractive alternative to other procedures and products; intense competition in the Company\u2019s industry, with competitors having substantially greater financial, technological, research and development, regulatory and clinical, manufacturing, marketing and sales, distribution and personnel resources than it does; entry of new competitors and products and potential technological obsolescence of the Company\u2019s products; inability to carry out research, development and commercialization plans; loss of a key customer or supplier; technical problems with the Company\u2019s research and products and potential product liability claims; product malfunctions; price increases for supplies and components; whether access to the Company\u2019s products is achieved in a commercially viable manner and whether its products receive adequate reimbursement by governmental and other third-party payers; the Company\u2019s efforts to successfully obtain and maintain intellectual property protection covering its products, which may not be successful; adverse federal, state and local government regulation, in the United States, Europe or Israel and other foreign jurisdictions; the fact that the Company conducts business in multiple foreign jurisdictions, exposing it to foreign currency exchange rate fluctuations, logistical and communications challenges, burdens and costs of compliance with foreign laws and political and economic instability in each jurisdiction; security, political and economic instability in the Middle East that could harm the Company\u2019s business, including due to the current security situation in Israel; current or future unfavorable economic and market conditions and adverse developments with respect to financial institutions and associated liquidity risk; and changes in tariffs, trade barriers, price and exchange controls and other regulatory requirements and the impact of such policies on the Company, its customers and suppliers, and the global economic environment. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company\u2019s filings with the Securities and Exchange Commission (SEC), including the Company\u2019s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Investors and security holders are urged to read these documents free of charge on the SEC\u2019s web site at http:\/\/www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise.<\/em>\n <\/p>\n

\n Investor Contacts:<\/strong>
\n
Jeff Warren
LifeSci Advisors
jwarren@lifesciadvisors.com<\/a>
investor-relations@inspiremd.com<\/a>\u00a0<\/strong><\/p>\n

\"\"
\n
\n \"\"\n <\/div>\n

<\/div>\n","protected":false},"excerpt":{"rendered":"

MIAMI, May 01, 2026 (GLOBE NEWSWIRE) — InspireMD, Inc. (Nasdaq: NSPR) (\u201cInspireMD\u201d or the \u201cCompany\u201d), developer of the CGuard\u00ae Prime carotid stent system for the prevention of stroke, today announced that the U.S. Food and Drug Administration (\u201cFDA\u201d) has approved the company\u2019s Investigational Device Exemption (\u201cIDE\u201d) Application to initiate the CGUARDIANS III pivotal study of its SwitchGuard neuro protection system (\u201cNPS\u201d), including next generation enhancements from our prior IDE approval for use with its CGuard Prime 80 cm stent platform, in transcarotid artery revascularization (\u201cTCAR\u201d) procedures. Patrick Geraghty, M.D., professor of surgery and radiology, section of vascular surgery at Washington University School of Medicine in St. Louis, MO, and Patrick Muck, M.D., program director and chief of vascular surgery at … <\/p>\n

Continue reading “InspireMD Announces FDA Approval of Investigational Device Exemption Application for CGUARDIANS III Pivotal Study of the SwitchGuard Neuro Protection System”<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[],"tags":[],"class_list":["post-957292","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"\nInspireMD Announces FDA Approval of Investigational Device Exemption Application for CGUARDIANS III Pivotal Study of the SwitchGuard Neuro Protection System - Market Newsdesk<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.marketnewsdesk.com\/index.php\/inspiremd-announces-fda-approval-of-investigational-device-exemption-application-for-cguardians-iii-pivotal-study-of-the-switchguard-neuro-protection-system\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"InspireMD Announces FDA Approval of Investigational Device Exemption Application for CGUARDIANS III Pivotal Study of the SwitchGuard Neuro Protection System - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"MIAMI, May 01, 2026 (GLOBE NEWSWIRE) — InspireMD, Inc. (Nasdaq: NSPR) (\u201cInspireMD\u201d or the \u201cCompany\u201d), developer of the CGuard\u00ae Prime carotid stent system for the prevention of stroke, today announced that the U.S. Food and Drug Administration (\u201cFDA\u201d) has approved the company\u2019s Investigational Device Exemption (\u201cIDE\u201d) Application to initiate the CGUARDIANS III pivotal study of its SwitchGuard neuro protection system (\u201cNPS\u201d), including next generation enhancements from our prior IDE approval for use with its CGuard Prime 80 cm stent platform, in transcarotid artery revascularization (\u201cTCAR\u201d) procedures. Patrick Geraghty, M.D., professor of surgery and radiology, section of vascular surgery at Washington University School of Medicine in St. Louis, MO, and Patrick Muck, M.D., program director and chief of vascular surgery at … Continue reading "InspireMD Announces FDA Approval of Investigational Device Exemption Application for CGUARDIANS III Pivotal Study of the SwitchGuard Neuro Protection System"\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.marketnewsdesk.com\/index.php\/inspiremd-announces-fda-approval-of-investigational-device-exemption-application-for-cguardians-iii-pivotal-study-of-the-switchguard-neuro-protection-system\/\" \/>\n<meta property=\"og:site_name\" content=\"Market Newsdesk\" \/>\n<meta property=\"article:published_time\" content=\"2026-05-01T20:11:15+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=MTAwMTE3OTQ4MiM0MDIzODUxMzkjMjE4NjI2Mg==\" \/>\n<meta name=\"author\" content=\"Newsdesk\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Newsdesk\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"5 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/inspiremd-announces-fda-approval-of-investigational-device-exemption-application-for-cguardians-iii-pivotal-study-of-the-switchguard-neuro-protection-system\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/inspiremd-announces-fda-approval-of-investigational-device-exemption-application-for-cguardians-iii-pivotal-study-of-the-switchguard-neuro-protection-system\\\/\"},\"author\":{\"name\":\"Newsdesk\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/#\\\/schema\\\/person\\\/482f27a394d4fda80ecb5499e519d979\"},\"headline\":\"InspireMD Announces FDA Approval of Investigational Device Exemption Application for CGUARDIANS III Pivotal Study of the SwitchGuard Neuro Protection System\",\"datePublished\":\"2026-05-01T20:11:15+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/inspiremd-announces-fda-approval-of-investigational-device-exemption-application-for-cguardians-iii-pivotal-study-of-the-switchguard-neuro-protection-system\\\/\"},\"wordCount\":1066,\"image\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/inspiremd-announces-fda-approval-of-investigational-device-exemption-application-for-cguardians-iii-pivotal-study-of-the-switchguard-neuro-protection-system\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/www.globenewswire.com\\\/newsroom\\\/ti?nf=MTAwMTE3OTQ4MiM0MDIzODUxMzkjMjE4NjI2Mg==\",\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/inspiremd-announces-fda-approval-of-investigational-device-exemption-application-for-cguardians-iii-pivotal-study-of-the-switchguard-neuro-protection-system\\\/\",\"url\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/inspiremd-announces-fda-approval-of-investigational-device-exemption-application-for-cguardians-iii-pivotal-study-of-the-switchguard-neuro-protection-system\\\/\",\"name\":\"InspireMD Announces FDA Approval of Investigational Device Exemption Application for CGUARDIANS III Pivotal Study of the SwitchGuard Neuro Protection System - 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(Nasdaq: NSPR) (\u201cInspireMD\u201d or the \u201cCompany\u201d), developer of the CGuard\u00ae Prime carotid stent system for the prevention of stroke, today announced that the U.S. Food and Drug Administration (\u201cFDA\u201d) has approved the company\u2019s Investigational Device Exemption (\u201cIDE\u201d) Application to initiate the CGUARDIANS III pivotal study of its SwitchGuard neuro protection system (\u201cNPS\u201d), including next generation enhancements from our prior IDE approval for use with its CGuard Prime 80 cm stent platform, in transcarotid artery revascularization (\u201cTCAR\u201d) procedures. Patrick Geraghty, M.D., professor of surgery and radiology, section of vascular surgery at Washington University School of Medicine in St. Louis, MO, and Patrick Muck, M.D., program director and chief of vascular surgery at … Continue reading \"InspireMD Announces FDA Approval of Investigational Device Exemption Application for CGUARDIANS III Pivotal Study of the SwitchGuard Neuro Protection System\"","og_url":"https:\/\/www.marketnewsdesk.com\/index.php\/inspiremd-announces-fda-approval-of-investigational-device-exemption-application-for-cguardians-iii-pivotal-study-of-the-switchguard-neuro-protection-system\/","og_site_name":"Market Newsdesk","article_published_time":"2026-05-01T20:11:15+00:00","og_image":[{"url":"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=MTAwMTE3OTQ4MiM0MDIzODUxMzkjMjE4NjI2Mg==","type":"","width":"","height":""}],"author":"Newsdesk","twitter_card":"summary_large_image","twitter_misc":{"Written by":"Newsdesk","Est. reading time":"5 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/inspiremd-announces-fda-approval-of-investigational-device-exemption-application-for-cguardians-iii-pivotal-study-of-the-switchguard-neuro-protection-system\/#article","isPartOf":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/inspiremd-announces-fda-approval-of-investigational-device-exemption-application-for-cguardians-iii-pivotal-study-of-the-switchguard-neuro-protection-system\/"},"author":{"name":"Newsdesk","@id":"https:\/\/www.marketnewsdesk.com\/#\/schema\/person\/482f27a394d4fda80ecb5499e519d979"},"headline":"InspireMD Announces FDA Approval of Investigational Device Exemption Application for CGUARDIANS III Pivotal Study of the SwitchGuard Neuro Protection System","datePublished":"2026-05-01T20:11:15+00:00","mainEntityOfPage":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/inspiremd-announces-fda-approval-of-investigational-device-exemption-application-for-cguardians-iii-pivotal-study-of-the-switchguard-neuro-protection-system\/"},"wordCount":1066,"image":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/inspiremd-announces-fda-approval-of-investigational-device-exemption-application-for-cguardians-iii-pivotal-study-of-the-switchguard-neuro-protection-system\/#primaryimage"},"thumbnailUrl":"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=MTAwMTE3OTQ4MiM0MDIzODUxMzkjMjE4NjI2Mg==","inLanguage":"en-US"},{"@type":"WebPage","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/inspiremd-announces-fda-approval-of-investigational-device-exemption-application-for-cguardians-iii-pivotal-study-of-the-switchguard-neuro-protection-system\/","url":"https:\/\/www.marketnewsdesk.com\/index.php\/inspiremd-announces-fda-approval-of-investigational-device-exemption-application-for-cguardians-iii-pivotal-study-of-the-switchguard-neuro-protection-system\/","name":"InspireMD Announces FDA Approval of Investigational Device Exemption Application for CGUARDIANS III Pivotal Study of the SwitchGuard Neuro Protection System - 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