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MIAMI - InspireMD, Inc. (NASDAQ:NSPR) announced Wednesday the commercial launch of its CGuard Prime carotid stent system in the United States following FDA premarket application approval. According to InvestingPro data, the company maintains a strong liquidity position with a current ratio of 4.36x, indicating robust short-term financial stability.
The device, designed for stroke prevention, features a dual-layer design combining an open-cell frame with a small mesh pore size. According to the company, the system includes MicroNet technology, a bio-stable mesh made from a single polyethylene terephthalate strand that traps plaque against vessel walls, and SmartFit technology that eliminates the need for tapered versions.
"Our U.S. commercial launch marks a pivotal milestone in InspireMD’s expansion history, having already secured double-digit market share across more than 30 countries," said Marvin Slosman, Chief Executive Officer of InspireMD.
Dr. D. Chris Metzger, System Vascular Chief at OhioHealth, who has used the system in clinical trials and practice, stated, "CGuard’s unique design makes a real difference in addressing the complexities of carotid artery disease, offering enhanced embolic protection without compromising deliverability."
Alan Levine, Chairman and CEO of Ballad Health, noted his organization’s involvement from the first C-GUARDIANS enrollments in 2021 through the first commercial case.
The CGuard Prime is marketed as providing embolic protection demonstrated beyond five years, according to the company’s press release statement.
InspireMD develops products utilizing its proprietary MicroNet mesh technology and trades on the Nasdaq under the ticker symbol NSPR.
In other recent news, InspireMD reported its first-quarter 2025 earnings, revealing a mixed performance with earnings per share (EPS) of -$0.22, surpassing the forecast of -$0.31, while revenue fell short of expectations at $1.53 million against a projected $1.79 million. The U.S. Food and Drug Administration granted premarket approval for InspireMD’s CGuard Prime Carotid Stent System, following the C-GUARDIANS pivotal trial, which showed low major adverse event rates. This approval activates a warrant tranche from a May 2023 financing agreement, potentially bringing in $17.9 million. Additionally, InspireMD received CE Mark approval for the CGuard Prime stent system in Europe, allowing for commercial expansion in CE-marked markets.
InspireMD also announced the appointment of Michael Lawless as its new Chief Financial Officer, who will start by June 30, 2025. Piper Sandler adjusted its price target for InspireMD to $4.00 from $4.50, maintaining an Overweight rating despite delays in FDA approval timelines for the CGuard Prime stent. The firm remains optimistic about InspireMD’s progress and potential value creation. InspireMD is preparing for the U.S. launch of the CGuard Prime stent, now anticipated in the third quarter of 2025, with further developments expected in 2026.
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