InspireMD Inc. NSPR recently announced the first patient enrolment in the company’s CGUARDIANS II clinical trial. The trial evaluates NSPR’s CGuard Prime Carotid Stent System in patients undergoing carotid artery stenting via the Transcarotid Artery Revascularization (TCAR) approach.

CGUARDIANS II is a prospective, multi-center, single-arm pivotal study that aims to enroll a minimum of 50 evaluable patients. This study aims to evaluate the acute device success and technical success of the CGuard Prime when used in conjunction with an FDA-cleared TCAR neuro-protection system in patients at high risk for adverse events from carotid endarterectomy.

Likely Trend of NSPR Stock Following the News

Following the announcement, shares of the company closed flat at $3.14 on Tuesday. In the year-to-date period, NSPR shares have gained 11.7% compared with the industry’s 6.4% growth. The S&P 500 increased 27.2% in the same time frame.

Meanwhile, NSPR currently has a market capitalization of $81.64 million.

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More on NSPR’s CGuard Prime Carotid Stent System

The CGuard Prime Carotid Stent by InspireMD is designed to prevent strokes in patients with carotid artery disease. The stent features InspireMD's proprietary MicroNet technology, which offers embolic protection, reducing the risk of stroke during carotid artery stenting. This device uses a neuroprotection system for patients at high risk of complications from conventional carotid endarterectomy. It has shown positive clinical outcomes, including a low major adverse event rate in trials, which enhances its appeal for use in critical carotid interventions.

In October, the company announced FDA premarket approval for its CGuard Prime Carotid stent system. This approval allows the company to market its carotid stent system in the U.S. market for treating carotid artery stenosis (CAS), a condition that increases the risk of stroke. The approval was based on the impressive clinical trial results of the CGuard stent system, which demonstrated strong efficacy and safety in preventing stroke during carotid revascularization procedures. The study's primary endpoint was the occurrence of major adverse events, including stroke, death, myocardial infarction and target vessel revascularization. Over a one-year follow-up period, the trial demonstrated a major adverse event rate of 1.95%, the lowest reported for any carotid stent or embolic protection device in a pivotal trial.

The CGuard Prime Carotid Stent system is optimized for TCAR procedures, offering a less invasive alternative to traditional carotid artery surgery. This system’s advanced neuroprotective features ensure that patients with high risk for carotid endarterectomy have a safe and effective treatment option. The CGuard’s design minimizes the risk of complications and the need for future revascularization procedures, making it a valuable addition to InspireMD’s product portfolio.

With the FDA’s premarket approval, InspireMD is well-positioned to expand its presence in the U.S. market. The FDA approval of the CGuard Prime system and plans for a U.S. commercial launch in 2025 signal a promising future for InspireMD’s global growth.

Also, The Jacobs Institute is conducting a Sponsor Investigator study of patients ≥ 18 years old to establish safety and preliminary effectiveness in treating extracranial stenosis with the CGuard Prime Carotid Stent in an acute ischemic stroke setting.

Favorable Industry for NSPR

Per a report by Grand View Research, the global carotid artery stents market size was valued at $559.7 million in 2021 and is anticipated to witness a CAGR of 3.0% from 2022 to 2030.

The rising prevalence of cardiovascular diseases, such as stroke, ischemic stroke, and transient ischemic attack, is driving demand for carotid artery stenting procedures that require stents, which is the major factor anticipated to fuel the market growth.

NSPR’s Zacks Rank & Stocks to Consider

NSPR carries a Zacks Rank #3 (Hold) at present.

Some better-ranked stocks from the medical industry are Masimo MASI, AngioDynamics ANGO and Globus Medical GMED.

Masimo, sporting a Zacks Rank #1 (Strong Buy) at present, has an estimated growth rate of 10.4% for 2025. You can see the complete list of today’s Zacks #1 Rank stocks here.

MASI’s earnings surpassed estimates in each of the trailing four quarters, delivering an average surprise of 17.10%. Masimo’s shares have risen 37.2% year to date compared with the industry’s 6.7% growth.

AngioDynamics, carrying a Zacks Rank #2 (Buy) at present, has an estimated growth rate of 38.2% for 2025. ANGO’s earnings surpassed estimates in three of the trailing four quarters and missed once, delivering an average surprise of 31.71%.

AngioDynamics’ shares have lost 8.9% year to date against the industry’s 6.7% growth.

Globus Medical, carrying a Zacks Rank of 2 at present, has an estimated long-term growth rate of 12.7%. GMED’s earnings surpassed estimates in each of the trailing four quarters, delivering an average surprise of 12.1%. Its shares have risen 56.5% year to date compared with the industry’s 6.7% growth.

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