InspireMD Launches CGuard Prime Carotid Stent System in the U.S.

InspireMD, Inc. NSPR recently announced the official commercial launch of the CGuard Prime Carotid Stent System in the United States, following its premarket application approval from the FDA. This milestone marks a critical step in bringing InspireMD’s next-generation stroke prevention technology to U.S. physicians and patients, addressing the urgent need for safer and more effective treatment of carotid artery disease.

CGuard Prime features the company’s proprietary MicroNet mesh technology, engineered to provide sustained embolic protection while promoting plaque healing. With a refined delivery system and enhanced deployment accuracy, CGuard Prime builds on the success of its predecessor, aiming to reduce periprocedural and long-term stroke risks. The U.S. launch not only reinforces InspireMD’s clinical footprint but also sets the stage for broader adoption in global stroke prevention strategies.

Likely Trend of NSPR Stock Following the News

Following the announcement, the company's shares traded flat until yesterday’s closing. Shares have lost 7.6% in the year-to-date period compared with the industry’s 9.2% decline. The S&P 500 has gained 5.9% in the same time frame.

The U.S. launch of the CGuard Prime Carotid Stent System is a major commercial inflection point for NSPR, positioning the company to tap into the sizable U.S. carotid stenting market with a differentiated, FDA-approved technology. Backed by strong clinical trial data, this launch is expected to drive meaningful revenue growth, expand market share, and enhance the company’s competitive positioning in stroke prevention solutions.

NSPR currently has a market capitalization of $74.4 million. It has an earnings yield of 1.45%, higher than the industry’s negative 2.88%. In the last reported quarter, NSPR delivered an earnings surprise of 5.85%.

More on the CGuard Prime Carotid Stent System

The CGuard Prime Carotid Stent System is engineered to significantly reduce both early and late risks of embolism during carotid artery procedures. It works by trapping potential emboli against the arterial wall while maintaining blood flow through the external carotid artery.

The system’s design integrates three core technologies — a dual-layer structure that combines the largest open-cell frame with the smallest mesh pore size available, the MicroNet mesh made from a single 20 μm polyethylene terephthalate strand that seals thrombus and plaque to prevent embolization, and SmartFit technology that ensures consistent apposition to vessel walls without the need for tapered versions. These features aim to provide effective embolic protection while simplifying deployment for physicians.

CGuard Prime’s U.S. commercial launch follows years of international adoption, with InspireMD already holding double-digit market share across more than 30 countries. The company has assembled a dedicated commercial team with strong industry experience and relationships to support this next phase of growth.

Clinicians who have used the device, including those involved in the C-GUARDIANS clinical trial, highlight its ability to address the complexities of carotid artery disease while maintaining deliverability. The Ballad Health team played a key role in the product's development lifecycle, from early trial enrolment to the first commercial use, reflecting a strong commitment to advancing stroke prevention technologies in clinical practice.

Favorable Industry Prospects for NSPR

Per a report by Precedence Research, the global stroke diagnostic and therapeutic market size was estimated at $38.98 billion in 2024 and is anticipated to reach around $83.91 billion by 2034, expanding at a CAGR of 7.96% from 2025 to 2034.

The rising prevalence of ischemic stroke among the geriatric population has boosted growth of the stroke diagnostic and therapeutic market.

NSPR’s Zacks Rank & Key Picks

Currently, NSPR carries a Zacks Rank #3 (Hold).

Some better-ranked stocks in the broader medical space are Hims & Hers Health, Inc. HIMS, Cencora, Inc. COR and Integer Holdings Corporation ITGR.

Hims & Hers, carrying a Zacks Rank #2 at present, has an estimated long-term growth rate of 36.5%. HIMS’ earnings surpassed estimates in two of the trailing four quarters, missed once and met in the other, the average surprise being 19.6%. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Hims & Hers’ shares have surged 99.2% compared with the industry’s 37.1% growth in the past year.

Cencora, carrying a Zacks Rank of 2 at present, has an estimated long-term growth rate of 12.8%. COR’s earnings surpassed estimates in each of the trailing four quarters, the average surprise being 6%.

Cencora’s shares have rallied 23.9% against the industry’s 16.9% decline in the past year.

Integer Holdings, carrying a Zacks Rank of 2 at present, has an estimated long-term growth rate of 18.4%. ITGR’s earnings surpassed estimates in three of the trailing four quarters and missed once, the average surprise being 2.8%.

Integer Holdings’ shares have gained 4.9% against the industry’s 13% decline in the past year.

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This article originally published on Zacks Investment Research (zacks.com).

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