InspireMD, Inc. NSPR recently announced its receipt of CE Mark recertification under the European Union’s (EU) new Medical Device Regulation (MDR) regulatory framework.
The CE Mark certification under the MDR regulatory framework replaces the previous MDR framework, which controlled the approval and marketing of medical devices in the EU until May 2021.
Price Performance
For the past six months, NSPR’s shares have declined 8.7% against the industry’s growth of 1.5%. The S&P 500 increased 9.6% in the same time frame.
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More on the News
With the official recertification of the CE Mark under MDR, the company is likely to proceed with the establishment of the CGuard Embolic Prevention Carotid Stent System (EPS) as the standard care for carotid artery revascularization. The company also looks forward to advancing new products using the pathway provided by MDR.
The company is making good progress on the Premarket Approval Application (PMA) for the C-GUARDIANS U.S. IDE study. It anticipates receiving the primary endpoint results in mid-2024, and in the second half of 2024, the company is likely to submit the final module of the PMA application to the FDA.
InspireMD is also looking forward to achieving important goals, such as getting the CGuard Prime EPS stent approved in the United States in the first half of 2025.
More on CGuard EPS
With its innovative mesh carotid stent, the CGuard EPS aims to enhance patient safety by providing long-term embolic support.
With CGuard EPS, possible emboli are trapped against the arterial wall, preserving perfusion to the external carotid artery and preventing peri-procedural and late embolization.
Industry Prospects
Per a report by Grand View Research, the global carotid artery stents market, which was valued at $559.7 million in 2021, is expected to witness growth rate of 3.0% from 2023-2030.
The primary driver expected to propel the market growth is the increasing prevalence of cardiovascular diseases, including stroke, ischemic stroke, and transient ischemic attack. These conditions are driving demand for carotid artery stenting treatments that require stents.
InspireMD, Inc. Price
InspireMD, Inc. price | InspireMD, Inc. Quote
Zacks Rank & Stocks to Consider
NSPR carries a Zacks Rank #3 (Hold) at present.
Some better-ranked stocks to consider in the broader medical space are Universal Health Services UHS, Integer Holdings Corporation ITGR and Acadia Healthcare ACHC.
Universal Health Services, carrying a Zacks Rank #2 (Buy) at present, has an estimated growth rate of 4.4% for 2024. UHS’s earnings surpassed estimates in all the trailing four quarters, delivering an average surprise of 5.47%. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
UHS’s shares have gained 1.9% in the past six months against the industry’s 5% decline.
Integer Holdings, presently carrying a Zacks Rank of 2, has an estimated long-term growth rate of 15.8%. ITGR’s earnings surpassed estimates in each of the trailing four quarters, delivering an average surprise of 11.9%.
Integer Holdings’ shares have rallied 43.5% in the past year against the industry’s 3.7% decline.
Acadia Healthcare, carrying a Zacks Rank of 2 at present, has an estimated long-term growth rate of 10.4%. ACHC’s long-term earnings are expected to grow at 11.2%.
Acadia’s shares have gained 11.7% in the past six months against the industry’s decline of 5%.
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