InspireMD Announces FDA Approval for CGuard® Prime Carotid Stent System for the Prevention of Stroke
FDA Approval Announcement: InspireMD, Inc. has received FDA premarket application approval for its CGuard Prime Carotid Stent System, which is designed to prevent strokes and has shown the lowest major adverse event rates in pivotal trials.
Commercial Launch Plans: The approval triggers a financial milestone for the company, enabling an imminent U.S. launch of the CGuard Prime system, aimed at enhancing treatment options for patients with carotid artery disease.
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InspireMD Publishes Positive CREST-2 Data Confirming Efficacy of Carotid Stenting
- CREST-2 Study Results: InspireMD presented CREST-2 data at the SVIN Annual Meeting on November 21, 2025, showing that carotid artery stenting (CAS) significantly outperformed intensive medical management for patients with asymptomatic carotid stenosis. This finding provides crucial clinical evidence that could reshape treatment protocols for carotid disease.
- Clinical Trial Scale: The CREST-2 trial, independently conducted and NIH-sponsored, involved 155 centers globally with 1,245 patients randomized to the stenting group. Results indicated a significantly reduced risk of perioperative stroke or death over four years, underscoring the efficacy of stenting.
- Innovative Technology Advantage: InspireMD's CGuard®Prime stent demonstrated a record-low 1.93% major adverse event rate in the C-GUARDIANS trial, particularly among high-risk patients. This low event rate, combined with the positive CREST-2 results, reinforces the company's leadership in the carotid stenting market.
- Market Outlook: CEO Marvin Slosman stated that CREST-2 validates the superiority of combining stenting with medical management, indicating a shift towards an endovascular-first approach in vascular disease treatment. With growing recognition of effective treatments for asymptomatic carotid disease, InspireMD is poised for increased market share.
InspireMD to Attend the 37th Annual Healthcare Conference Hosted by Piper Sandler
Company Announcement: InspireMD, Inc. will participate in a fireside discussion at the Piper Sandler 37th Annual Healthcare Conference on December 3rd, 2025, at 12:30 pm ET.
Webcast Availability: A live audio webcast and replay of the discussion will be accessible on the company's website under the "Investor Calendar" section.
Product Focus: InspireMD is focused on its CGuard® Prime carotid stent system, which aims to prevent strokes using its proprietary MicroNet™ mesh technology.
Investor Information: InspireMD's common stock is traded on Nasdaq under the ticker symbol NSPR, and the company provides important updates for investors on its website.
InspireMD, Inc. Reports Wider Q3 Loss, Yet Surpasses Expectations
Earnings Report: InspireMD, Inc. reported a third-quarter loss of $12.71 million, or $0.17 per share, which is an increase from last year's loss of $7.89 million, or $0.16 per share.
Analyst Expectations: The company's loss was better than analysts' expectations, who had predicted a loss of $0.19 per share.
Revenue Growth: Revenue for the quarter rose by 39.2% to $2.52 million, up from $1.81 million in the same period last year.
Earnings Summary: Key figures include a loss of $12.71 million, an EPS of -$0.17, and revenue of $2.52 million compared to last year's figures.
InspireMD Names Peter Soukas as Chief Medical Officer
Appointment of Chief Medical Officer: InspireMD, Inc. has appointed Peter Soukas as Chief Medical Officer to enhance its carotid intervention tools, specifically the CGuard Prime carotid stent system.
Expertise and Experience: Soukas is a highly experienced vascular intervention specialist, serving as the Director of Vascular Medicine at The Miriam Hospital and has led numerous trials in carotid stenting and endovascular procedures.
Parkman Healthcare Increases Investment in InspireMD to Support Carotid Innovation
InspireMD's Growth: InspireMD, Inc. (NASDAQ:NSPR) has seen a 37.1% increase in institutional ownership by Parkman Healthcare Partners LLC, now holding nearly 3.82% of the company after acquiring 316,700 shares.
Company Developments: The Florida-based medical device company is enhancing its market position with new hires, including CFO Mike Lawless, and focuses on carotid artery treatments, while also being compared to AI stocks for investment potential.
Biobeat Technologies Appoints Raymond W. Cohen as Board Chairman
New Leadership Appointment: Biobeat Technologies Ltd has appointed Raymond W. Cohen as the Chairman of the Board of Directors to help advance their innovative medical technology.
Innovative Technology: The company has developed a wearable, cuff-less ambulatory blood pressure monitoring system that collects various physiological data and has received FDA clearance for its patch device.
Cohen's Experience: Mr. Cohen brings over 40 years of experience in the life sciences industry, having successfully led companies like Axonics, Inc. and SoniVie, Ltd., both of which achieved significant financial milestones.
Future Applications: Cohen sees potential applications for Biobeat's technology in renal denervation and long-term monitoring of patients post-cardiac procedures, aiming to transform patient monitoring practices.
InspireMD Publishes Positive CREST-2 Data Confirming Efficacy of Carotid Stenting
- CREST-2 Study Results: InspireMD presented CREST-2 data at the SVIN Annual Meeting on November 21, 2025, showing that carotid artery stenting (CAS) significantly outperformed intensive medical management for patients with asymptomatic carotid stenosis. This finding provides crucial clinical evidence that could reshape treatment protocols for carotid disease.
- Clinical Trial Scale: The CREST-2 trial, independently conducted and NIH-sponsored, involved 155 centers globally with 1,245 patients randomized to the stenting group. Results indicated a significantly reduced risk of perioperative stroke or death over four years, underscoring the efficacy of stenting.
- Innovative Technology Advantage: InspireMD's CGuard®Prime stent demonstrated a record-low 1.93% major adverse event rate in the C-GUARDIANS trial, particularly among high-risk patients. This low event rate, combined with the positive CREST-2 results, reinforces the company's leadership in the carotid stenting market.
- Market Outlook: CEO Marvin Slosman stated that CREST-2 validates the superiority of combining stenting with medical management, indicating a shift towards an endovascular-first approach in vascular disease treatment. With growing recognition of effective treatments for asymptomatic carotid disease, InspireMD is poised for increased market share.
InspireMD to Attend the 37th Annual Healthcare Conference Hosted by Piper Sandler
Company Announcement: InspireMD, Inc. will participate in a fireside discussion at the Piper Sandler 37th Annual Healthcare Conference on December 3rd, 2025, at 12:30 pm ET.
Webcast Availability: A live audio webcast and replay of the discussion will be accessible on the company's website under the "Investor Calendar" section.
Product Focus: InspireMD is focused on its CGuard® Prime carotid stent system, which aims to prevent strokes using its proprietary MicroNet™ mesh technology.
Investor Information: InspireMD's common stock is traded on Nasdaq under the ticker symbol NSPR, and the company provides important updates for investors on its website.
InspireMD, Inc. Reports Wider Q3 Loss, Yet Surpasses Expectations
Earnings Report: InspireMD, Inc. reported a third-quarter loss of $12.71 million, or $0.17 per share, which is an increase from last year's loss of $7.89 million, or $0.16 per share.
Analyst Expectations: The company's loss was better than analysts' expectations, who had predicted a loss of $0.19 per share.
Revenue Growth: Revenue for the quarter rose by 39.2% to $2.52 million, up from $1.81 million in the same period last year.
Earnings Summary: Key figures include a loss of $12.71 million, an EPS of -$0.17, and revenue of $2.52 million compared to last year's figures.
InspireMD Names Peter Soukas as Chief Medical Officer
Appointment of Chief Medical Officer: InspireMD, Inc. has appointed Peter Soukas as Chief Medical Officer to enhance its carotid intervention tools, specifically the CGuard Prime carotid stent system.
Expertise and Experience: Soukas is a highly experienced vascular intervention specialist, serving as the Director of Vascular Medicine at The Miriam Hospital and has led numerous trials in carotid stenting and endovascular procedures.
Parkman Healthcare Increases Investment in InspireMD to Support Carotid Innovation
InspireMD's Growth: InspireMD, Inc. (NASDAQ:NSPR) has seen a 37.1% increase in institutional ownership by Parkman Healthcare Partners LLC, now holding nearly 3.82% of the company after acquiring 316,700 shares.
Company Developments: The Florida-based medical device company is enhancing its market position with new hires, including CFO Mike Lawless, and focuses on carotid artery treatments, while also being compared to AI stocks for investment potential.
Biobeat Technologies Appoints Raymond W. Cohen as Board Chairman
New Leadership Appointment: Biobeat Technologies Ltd has appointed Raymond W. Cohen as the Chairman of the Board of Directors to help advance their innovative medical technology.
Innovative Technology: The company has developed a wearable, cuff-less ambulatory blood pressure monitoring system that collects various physiological data and has received FDA clearance for its patch device.
Cohen's Experience: Mr. Cohen brings over 40 years of experience in the life sciences industry, having successfully led companies like Axonics, Inc. and SoniVie, Ltd., both of which achieved significant financial milestones.
Future Applications: Cohen sees potential applications for Biobeat's technology in renal denervation and long-term monitoring of patients post-cardiac procedures, aiming to transform patient monitoring practices.
