InspireMD NSPR recently announced that it has submitted a Premarket Approval (PMA) application to the FDA seeking marketing approval for the CGuard Prime carotid stent system in the United States.

NSPR’s quest for U.S. approval of its next-generation CGuard Prime stent, which offers best-in-class clinical outcomes to treat carotid artery disease and stroke prevention, has advanced significantly with the submission of the PMA application to the FDA.

Upon successful marketing approval of the CGuard Prime carotid stent system in the United States, the company is likely to launch the product in the first half of 2025 commercially. The stent system is expected to contribute significantly to boosting the top-line growth of the company.

However, shares of NSPR have lost 2.23% in the pre-market session on Sept. 17.

More on NSPR’s PMA Application

The PMA application is based on the overwhelmingly positive one-year data from the company’s C-GUARDIANS pivotal clinical trial that was presented at the Leipzig Interventional Course (LINC) 2024 in May. The C-GUARDIANS clinical trial evaluated the safety and efficacy of CGuard for the treatment of carotid artery stenosis. The study enrolled 316 patients across 24 trial sites in the United States and Europe.

The C-GUARDIANS results showed a primary endpoint major adverse event rate of 1.95% through 12 months post-procedure, the lowest such event rate reported for any carotid stent or embolic protection device pivotal trial to date.

More on NSPR’s CGuard EPS & Recent Developments

The CGuard Embolic Prevention Carotid Stent System (EPS) is a novel mesh carotid stent designed to improve patient safety by offering continuous embolic support. By trapping potential emboli against the arterial wall, CGuard EPS preserves external carotid artery perfusion and avoids late and peri-procedural embolization.

In May, NSPR presented the C-GUARDIANS U.S. pivotal trial positive study data. On the second-quarter earnings call, management commented that it expects to commence enrollment in C-GUARDIANS II in the back half of 2024. The company anticipates FDA approval of the company’s C-Guard stent for integration with SILK’s neuroprotection system in the second half of 2025. Additionally, NSPR continues to expect approval for its SwitchGuard TCAR system in the first half of 2026.

Favorable Industry Prospects for NSPR

Per a report by Grand View Research, the carotid artery stents market size was estimated to be $559.7 million in 2021 and is projected to witness a CAGR of 3% during the 2022-2030 period.

Given the market potential, NSPR’s CGuard Prime carotid stent system is likely to provide a boost to the company’s business.

Price Performance of NSPR Stock

In the past six months, NSPR’s shares have gained 18.4% compared with the industry’s 2.2% rise. The S&P 500 has increased 9.3% in the same time frame.

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NSPR’s Zacks Rank & Stocks to Consider

NSPR carries a Zacks Rank #4 (Sell) at present.

Some better-ranked stocks in the broader medical space are Universal Health Service UHS, Quest Diagnostics DGX and ABM Industries ABM. While Universal Health Service currently sports a Zacks Rank #1 (Strong Buy), Quest Diagnostics and ABM Industries carry a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Universal Health Service has an estimated long-term growth rate of 19%. UHS’ earnings surpassed estimates in each of the trailing four quarters, the average surprise being 14.58%.

The company has gained 41.1% so far this year compared with the industry's 34.8% growth.

Quest Diagnostics has an estimated long-term growth rate of 6.20%. DGX’s earnings surpassed estimates in each of the trailing four quarters, the average surprise being 3.31%.

The company’s shares have gained 3.7% so far this year compared with the industry’s 10.2% growth.

ABM Industries’ earnings surpassed estimates in each of the trailing four quarters, delivering an average surprise of 7.34%.

ABM's shares have risen 24.1% so far this year compared with the industry’s 11.9% growth.

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