InspireMD Initiates Voluntary Recall of CGuard Prime Stent
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 6 days ago
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Should l Buy NSPR?
InspireMD announced that, in consultation with the U.S. Food and Drug Administration, the company has initiated a voluntary recall in the U.S. for its CGuard Prime 135 cm carotid stent delivery system. "Concurrent with today's announcement, the Company is withdrawing its prior full year 2026 revenue guidance. Management believes this is the most prudent step given the impact of the temporary discontinuation of commercial activity in the U.S. pending the anticipated FDA approval of its original CGuard stent delivery system in the third quarter of 2026. Management intends to provide a full company update on this and other recent developments during its conference call for the results of the first quarter of 2026 on May 4," the company stated.
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Analyst Views on NSPR
Wall Street analysts forecast NSPR stock price to rise
1 Analyst Rating
1 Buy
0 Hold
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Moderate Buy
Current: 1.160
Low
5.00
Averages
5.00
High
5.00
Current: 1.160
Low
5.00
Averages
5.00
High
5.00
About NSPR
InspireMD, Inc. is a medical device company. The Company is focusing on the development and commercialization of its MicroNet stent platform technology for the treatment of vascular and coronary disease. Its MicroNet, a micron mesh sleeve, is wrapped over a stent to provide embolic protection in stenting procedures. Its CGuard carotid embolic prevention system (CGuard EPS) combines its MicroNet and a self-expandable nitinol stent in a single device for use in carotid artery applications. Its MGuard Prime Embolic Protection System (MGuard Prime EPS) is marketed for use in patients with acute coronary syndromes, notably acute myocardial infarction (heart attack) and saphenous vein graft coronary interventions (bypass surgery). It markets and sells MGuard Prime EPS, a bare-metal cobalt-chromium based stent, for the treatment of coronary disease in the European Union. It is also developing a neurovascular flow diverter (NGuard), which is an endovascular device.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
InspireMD Reports Q1 2026 Earnings with 120% Revenue Growth Amid FDA Challenges
- Significant Revenue Growth: InspireMD reported Q1 2026 revenue of $3.4 million, reflecting over 120% growth compared to the previous year, indicating strong market performance despite facing FDA regulatory challenges.
- Commercialization Pause: The company has decided to pause the commercialization of the CGuard Prime 135 delivery system, a proactive measure not related to product safety, which is expected to impact short-term revenue and led to the withdrawal of the full-year 2026 revenue guidance.
- FDA Approval Outlook: Management anticipates FDA approval for the original CGuard delivery system in Q3 2026, which, if successful, will lay the groundwork for the company's recovery in the U.S. market, while the approval of the CGuard Prime 80 system is also underway, potentially doubling the addressable market in the U.S.
- Financial Impact Warning: Due to the commercialization pause, the company expects to recognize approximately $700,000 in customer return reserves and $650,000 in inventory impairment and remediation costs in Q2, highlighting the financial pressures faced while navigating regulatory challenges.
See More
InspireMD Initiates New Trial and Recalls Product
- FDA Approval for New Trial: InspireMD announced that its SwitchGuard Neuro-Protection System's CGUARDIANS III pivotal study has received FDA approval, with hopes to launch in the U.S. by 2027, marking a significant advancement in the company's TCAR solution offerings.
- Product Recall: The company has initiated a voluntary recall of its CGuard Prime 135 cm carotid stent delivery system due to failure to meet technical performance expectations during a controlled commercial launch, although there are no safety concerns for patients with the implanted stent.
- Withdrawal of Financial Guidance: InspireMD has withdrawn its full-year 2026 revenue guidance due to the pause in U.S. sales of the 135 cm version while awaiting FDA approval, with management stating this is a prudent response to the temporary discontinuation of commercial activity.
- Market Reaction: Despite facing challenges, InspireMD's stock surged 30% following the FDA approval announcement, reflecting investor optimism regarding the new trial, although the stock has fallen 56% over the past 12 months.
See More
InspireMD Receives FDA Approval to Initiate CGUARDIANS III Trial
- FDA Approval for New Trial: InspireMD announced that it has received FDA approval to initiate the CGUARDIANS III trial, aimed at evaluating its SwitchGuard neuro protection system in carotid revascularization procedures, marking a significant advancement in the field of stroke prevention.
- Clinical Research Leadership: The CGUARDIANS III trial will be led by Dr. Patrick Geraghty and Dr. Patrick Muck, who previously directed the CGUARDIANS II trial, ensuring the professionalism and effectiveness of the study, thereby enhancing the reliability of clinical data.
- Market Launch Plans: The company plans to launch the SwitchGuard NPS in 2027, pending approval, which will provide a more comprehensive toolkit for carotid disease management, further solidifying its competitive position in the medical device market.
- Commitment to Technological Innovation: InspireMD is committed to utilizing its proprietary MicroNet™ mesh technology to establish its products as the industry standard for carotid stenting, delivering outstanding acute results and durable, stroke-free long-term outcomes, demonstrating the company's strong commitment to technological innovation.
See More
INSPIREMD INC - RECALL DUE TO CGUARD PRIME 135 CM TECHNICAL PERFORMANCE FALLING SHORT OF EXPECTATIONS
Technical Performance Recall: The CGUARD PRIME 135 CM has not met performance expectations, leading to a recall.
Impact on Stakeholders: The recall may affect users and stakeholders who rely on the product's performance.
See More
InspireMD to Announce Q1 Earnings on May 4th
- Earnings Announcement: InspireMD (NSPR) is set to release its Q1 2023 earnings on May 4th before market open, with a consensus EPS estimate of -$0.18, reflecting an 18.2% year-over-year improvement, indicating a potential trend towards profitability.
- Revenue Growth Expectations: The anticipated revenue for Q1 is $2.7 million, representing a significant 76.5% year-over-year increase, showcasing InspireMD's strong performance in market demand and product sales, which may lay a foundation for future financial stability.
- Performance Exceeding Expectations: Over the past year, InspireMD has beaten EPS estimates 25% of the time and revenue estimates 100% of the time, demonstrating the company's reliability in financial forecasting and bolstering market confidence.
- Future Outlook: InspireMD targets $13 million to $15 million in revenue for 2026 as CGuard Prime gains traction in the U.S. market, which is expected to further drive company growth and enhance competitive positioning.
See More
Purcell & Lefkowitz LLP Investigates InspireMD for Potential Fiduciary Breaches
- Investigation Background: Purcell & Lefkowitz LLP is investigating InspireMD, Inc. to determine whether the company's directors breached their fiduciary duties in recent corporate actions, which could impact shareholder rights.
- Shareholder Rights Protection: The investigation focuses on safeguarding shareholder interests, and shareholders of InspireMD are encouraged to visit the firm's website for more information about their rights and options.
- Commitment to Legal Services: Purcell & Lefkowitz LLP is dedicated to representing shareholders nationwide who are victims of securities fraud, breaches of fiduciary duty, and other corporate misconduct, demonstrating a strong commitment to protecting shareholder rights.
- Free Consultation Opportunity: The firm offers no-cost or obligation consultations, allowing shareholders to contact attorneys via email or phone to learn more about the case, thereby enhancing shareholder confidence in the legal process.
See More
InspireMD Reports Q1 2026 Earnings with 120% Revenue Growth Amid FDA Challenges
- Significant Revenue Growth: InspireMD reported Q1 2026 revenue of $3.4 million, reflecting over 120% growth compared to the previous year, indicating strong market performance despite facing FDA regulatory challenges.
- Commercialization Pause: The company has decided to pause the commercialization of the CGuard Prime 135 delivery system, a proactive measure not related to product safety, which is expected to impact short-term revenue and led to the withdrawal of the full-year 2026 revenue guidance.
- FDA Approval Outlook: Management anticipates FDA approval for the original CGuard delivery system in Q3 2026, which, if successful, will lay the groundwork for the company's recovery in the U.S. market, while the approval of the CGuard Prime 80 system is also underway, potentially doubling the addressable market in the U.S.
- Financial Impact Warning: Due to the commercialization pause, the company expects to recognize approximately $700,000 in customer return reserves and $650,000 in inventory impairment and remediation costs in Q2, highlighting the financial pressures faced while navigating regulatory challenges.
See More
InspireMD Initiates New Trial and Recalls Product
- FDA Approval for New Trial: InspireMD announced that its SwitchGuard Neuro-Protection System's CGUARDIANS III pivotal study has received FDA approval, with hopes to launch in the U.S. by 2027, marking a significant advancement in the company's TCAR solution offerings.
- Product Recall: The company has initiated a voluntary recall of its CGuard Prime 135 cm carotid stent delivery system due to failure to meet technical performance expectations during a controlled commercial launch, although there are no safety concerns for patients with the implanted stent.
- Withdrawal of Financial Guidance: InspireMD has withdrawn its full-year 2026 revenue guidance due to the pause in U.S. sales of the 135 cm version while awaiting FDA approval, with management stating this is a prudent response to the temporary discontinuation of commercial activity.
- Market Reaction: Despite facing challenges, InspireMD's stock surged 30% following the FDA approval announcement, reflecting investor optimism regarding the new trial, although the stock has fallen 56% over the past 12 months.
See More
InspireMD Receives FDA Approval to Initiate CGUARDIANS III Trial
- FDA Approval for New Trial: InspireMD announced that it has received FDA approval to initiate the CGUARDIANS III trial, aimed at evaluating its SwitchGuard neuro protection system in carotid revascularization procedures, marking a significant advancement in the field of stroke prevention.
- Clinical Research Leadership: The CGUARDIANS III trial will be led by Dr. Patrick Geraghty and Dr. Patrick Muck, who previously directed the CGUARDIANS II trial, ensuring the professionalism and effectiveness of the study, thereby enhancing the reliability of clinical data.
- Market Launch Plans: The company plans to launch the SwitchGuard NPS in 2027, pending approval, which will provide a more comprehensive toolkit for carotid disease management, further solidifying its competitive position in the medical device market.
- Commitment to Technological Innovation: InspireMD is committed to utilizing its proprietary MicroNet™ mesh technology to establish its products as the industry standard for carotid stenting, delivering outstanding acute results and durable, stroke-free long-term outcomes, demonstrating the company's strong commitment to technological innovation.
See More
INSPIREMD INC - RECALL DUE TO CGUARD PRIME 135 CM TECHNICAL PERFORMANCE FALLING SHORT OF EXPECTATIONS
Technical Performance Recall: The CGUARD PRIME 135 CM has not met performance expectations, leading to a recall.
Impact on Stakeholders: The recall may affect users and stakeholders who rely on the product's performance.
See More
InspireMD to Announce Q1 Earnings on May 4th
- Earnings Announcement: InspireMD (NSPR) is set to release its Q1 2023 earnings on May 4th before market open, with a consensus EPS estimate of -$0.18, reflecting an 18.2% year-over-year improvement, indicating a potential trend towards profitability.
- Revenue Growth Expectations: The anticipated revenue for Q1 is $2.7 million, representing a significant 76.5% year-over-year increase, showcasing InspireMD's strong performance in market demand and product sales, which may lay a foundation for future financial stability.
- Performance Exceeding Expectations: Over the past year, InspireMD has beaten EPS estimates 25% of the time and revenue estimates 100% of the time, demonstrating the company's reliability in financial forecasting and bolstering market confidence.
- Future Outlook: InspireMD targets $13 million to $15 million in revenue for 2026 as CGuard Prime gains traction in the U.S. market, which is expected to further drive company growth and enhance competitive positioning.
See More
Purcell & Lefkowitz LLP Investigates InspireMD for Potential Fiduciary Breaches
- Investigation Background: Purcell & Lefkowitz LLP is investigating InspireMD, Inc. to determine whether the company's directors breached their fiduciary duties in recent corporate actions, which could impact shareholder rights.
- Shareholder Rights Protection: The investigation focuses on safeguarding shareholder interests, and shareholders of InspireMD are encouraged to visit the firm's website for more information about their rights and options.
- Commitment to Legal Services: Purcell & Lefkowitz LLP is dedicated to representing shareholders nationwide who are victims of securities fraud, breaches of fiduciary duty, and other corporate misconduct, demonstrating a strong commitment to protecting shareholder rights.
- Free Consultation Opportunity: The firm offers no-cost or obligation consultations, allowing shareholders to contact attorneys via email or phone to learn more about the case, thereby enhancing shareholder confidence in the legal process.
See More
