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MIAMI - InspireMD, Inc. (Nasdaq: NSPR), a medical device company with a market capitalization of $76.6 million, has received CE Mark approval under the European Medical Device Regulation for its CGuard Prime EPS carotid stent system, according to a press release issued Friday. According to InvestingPro data, the company maintains a strong liquidity position with a current ratio of 4.36x.
The CGuard Prime stent system, designed for the prevention of stroke, incorporates the company’s proprietary MicroNet mesh technology that aims to trap debris against vessel walls to prevent plaque prolapse and embolization.
Marvin Slosman, CEO of InspireMD, called the certification "a major milestone" that allows for commercial launch across current CE-marked markets. The company also plans to launch the same platform in the United States later this year, pending FDA approval.
The CGuard system is designed to widen narrowed carotid arteries in patients at high risk for surgical complications who need less invasive treatment. According to the company, the device combines the largest open-cell frame of available carotid stents with the smallest mesh pore size.
InspireMD describes the CGuard system as providing "lasting protection demonstrated beyond five years" for patients requiring carotid stenting procedures.
The company’s stock is traded on the Nasdaq under the ticker symbol NSPR.
The approval represents a regulatory step forward for InspireMD as it seeks to expand its commercial presence in the carotid stenting market.
In other recent news, InspireMD reported its first-quarter 2025 earnings, revealing mixed results. The company exceeded expectations with an earnings per share (EPS) of -$0.22, surpassing the forecasted -$0.31. However, revenue fell short at $1.53 million, below the anticipated $1.79 million, raising investor concerns. Piper Sandler adjusted its price target for InspireMD to $4.00 from $4.50, maintaining an Overweight rating despite the revenue miss and timeline adjustments for FDA approvals. InspireMD has revised its FDA approval timeline for the CGuard Prime stent to the third quarter of 2025, with the SwitchGuard TCAR system’s U.S. launch now expected in 2026. Meanwhile, the company appointed Michael Lawless as its new Chief Financial Officer, effective by June 30, 2025, as part of its strategic leadership changes. Lawless is set to receive a grant of restricted stock and options under InspireMD’s 2024 Inducement Plan, which will vest over three years. Despite the delays, Piper Sandler remains optimistic about InspireMD’s progress toward U.S. approval and commercialization, highlighting potential value creation in the next 12 to 18 months.
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