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InspireMD Recalls CGuard Prime Delivery System, Pauses U.S. Launch

Story Highlights
  • InspireMD voluntarily recalled its CGuard Prime 135 cm U.S. delivery system after subpar technical performance, while affirming the safety and continued use of its CGuard stent implant and pausing commercialization to implement design enhancements.
  • The company withdrew its 2026 revenue guidance due to the temporary halt of U.S. commercial activity, even as it reports strong global sales growth and pursues FDA approvals for its original CGuard system and TCAR-focused CGuard Prime 80 cm platform to expand its market.
  • Looking for the best stocks to buy? Follow the recommendations of top-performing analysts.
InspireMD Recalls CGuard Prime Delivery System, Pauses U.S. Launch

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InspireMD ( (NSPR) ) has provided an update.

InspireMD, Inc., a developer of carotid stent systems to prevent stroke, has built its CGuard portfolio around its proprietary MicroNet mesh technology and has recorded strong demand, with global unit sales rising 53% year over year and U.S. unit sales up 34% in the first quarter of 2026. The company aims to expand its addressable market through indications in both carotid artery stenting and transcarotid artery revascularization procedures.

On May 1, 2026, InspireMD initiated a voluntary U.S. recall of its CGuard Prime 135 cm carotid stent delivery system after its controlled launch showed technical performance below expectations, though the CGuard stent implant itself remains unaffected and continues to be used globally. The company has paused U.S. commercialization of this delivery system, withdrawn its full-year 2026 revenue guidance due to the temporary disruption, and is pursuing regulatory approvals for its original CGuard delivery system and CGuard Prime 80 cm platform to support future growth in both CAS and TCAR markets.

The most recent analyst rating on (NSPR) stock is a Buy with a $6.00 price target. To see the full list of analyst forecasts on InspireMD stock, see the NSPR Stock Forecast page.

Spark’s Take on NSPR Stock

According to Spark, TipRanks’ AI Analyst, NSPR is a Neutral.

The score is held back primarily by weak financial quality—widening operating losses and persistently worsening negative cash flow—despite revenue growth and a low-leverage balance sheet. Technical signals also remain bearish with the stock below key moving averages, while corporate updates are directionally positive on U.S. commercialization and regulatory progress but do not offset the cash-burn and trend risks.

To see Spark’s full report on NSPR stock, click here.

More about InspireMD

InspireMD, Inc. is a medical device company focused on stroke prevention through carotid artery stenting, developing the CGuard Prime carotid stent system based on its proprietary MicroNet mesh technology. The company targets making its CGuard platform an industry standard for carotid interventions, with its shares listed on Nasdaq under the ticker NSPR.

Average Trading Volume: 41,985

Technical Sentiment Signal: Sell

Current Market Cap: $55.33M

See more insights into NSPR stock on TipRanks’ Stock Analysis page.

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