InspireMD, Inc, developer of the CGuard Prime carotid stent system for the prevention of stroke, today announced the official commercial launch of the CGuard Prime carotid stent system in the U.S., following its premarket application (PMA) approval from the U.S. Food and Drug Administration (FDA).

InspireMD公司是用于预防中风的CGuard Prime颈动脉支架系统的开发者，今天宣布在美国正式推出CGuard Prime颈动脉支架系统，此前该系统已获得美国食品药品监督管理局（FDA）的上市前申请（PMA）批准。

The CGuard Prime was engineered specifically to minimize both early and late embolism risk by effectively trapping potential emboli against the arterial wall while preserving external carotid artery perfusion. This innovative device features three key advantages: First, a dual layer design that combines the largest open-cell frame with the smallest mesh pore size available.

CGuard Prime 专门设计用于通过有效地将潜在的栓子固定在动脉壁上，同时保持颈外动脉的灌注，从而最大限度地降低早期和晚期栓塞风险。该创新装置具有三个关键优势：第一，双层设计，结合了最大的开孔支架和最小的网孔尺寸。

Second, the MicroNet™, a bio-stable mesh crafted from a single 20 μm Polyethylene Terephthalate (PET) strand that traps and seals thrombus and plaque against the vessel wall to prevent embolization. Third, SmartFit™ technology eliminates the need for tapered versions while ensuring precise vessel wall apposition..

其次，MicroNet™ 是一种由单根 20 微米的聚对苯二甲酸乙二醇酯（PET）丝线编织而成的生物稳定网，能够将血栓和斑块固定并密封在血管壁上，防止栓塞。第三，SmartFit™ 技术无需使用锥形版本，同时确保与血管壁的精确贴合。

“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. “We’ve spent the past year meticulously preparing for this moment, assembling a world-class commercial team comprised of industry veterans with deep expertise and longstanding relationships.

“我们美国市场的商业启动标志着InspireMD扩张历史上的一个关键里程碑，我们已经在30多个国家获得了两位数的市场份额，” InspireMD首席执行官马文·斯洛斯曼表示。“我们过去一年一直在精心准备这一时刻，组建了一支由行业资深人士组成的世界级商业团队，他们拥有深厚的专业知识和长期的合作关系。”

Backed by this all-star team and a robust operational infrastructure, we are poised to execute a highly impactful U.S. launch. We’re incredibly grateful to everyone who contributed to making this possible and couldn’t be more excited about the road ahead.”.

在全明星团队和强大的运营基础设施的支持下，我们准备执行一次高影响力的美国发布。我们非常感谢所有为此做出贡献的人，对未来的道路充满无比的期待。

“Treating patients with the CGuard Prime system is incredibly meaningful, both personally, for the advancement of innovation at OhioHealth, and for the field of carotid intervention as a whole,” said Dr. D. Chris Metzger, System Vascular Chief at OhioHealth. “CGuard’s unique design makes a real difference in addressing the complexities of carotid artery disease, offering enhanced embolic protection without compromising deliverability.

“使用CGuard Prime系统治疗患者具有深远的意义，无论是对我个人、俄亥俄健康医疗系统的创新进步，还是对整个颈动脉介入领域而言都是如此，”俄亥俄健康医疗系统血管主管D. Chris Metzger博士说道。“CGuard的独特设计在应对颈动脉疾病的复杂性方面产生了真正的差异，提供了增强的栓塞保护，同时没有影响其可操作性。”

My experience using the system—both in clinical trials and now in practice—reinforces how much demand there is for safer, less invasive alternatives, particularly for patients at higher risk of stroke. This technology represents an important advancement in how we approach stroke prevention in the U.S.”.

我使用该系统的经验——无论是在临床试验中还是现在在实践中——都印证了对于更安全、更少侵入性的替代方案有多么大的需求，特别是对于中风风险较高的患者。这项技术代表了我们在美国如何应对中风预防方面的重要进步。

“Our team at Ballad Health is thrilled to have contributed to the journey of this novel next generation carotid device. From initiating the first C-GUARDIANS enrollments in 2021 and leading enrollment throughout the trial to supporting the first commercial case by Dr. Chris Metzger, we have been a crucial contributor to the full life cycle of this technology to date.

“我们在Ballad Health的团队为能参与到这个新一代颈动脉装置的研发历程中感到非常激动。从2021年启动首个C-GUARDIANS注册，到在整个试验过程中主导注册，并支持Chris Metzger博士完成首个商业案例，我们迄今为止在这项技术的整个生命周期中都发挥了关键作用。

Our efforts reflect the commitment of the Ballad Health System to advancing innovation to improve patient care and offering the latest in medical breakthrough technologies,” shared Alan Levine, Chairman and CEO, Ballad Health..

我们的努力反映了Ballad健康系统致力于推动创新以改善患者护理，并提供最新的医疗突破技术，”Ballad Health的董事长兼首席执行官Alan Levine表示。

About CGuard Prime

关于CGuard Prime

The CGuard Prime Carotid Stent System is a novel mesh-covered carotid stent designed to improve patient safety through sustained embolic protection. CGuard Prime combines the largest open-cell frame of available carotid stents with the smallest mesh pore size, preventing plaque protrusion through the stent, for lasting embolic protection demonstrated beyond five years..

CGuard Prime颈动脉支架系统是一种新型的覆网颈动脉支架，旨在通过持续的栓塞保护来提高患者的安全性。CGuard Prime结合了现有颈动脉支架中最大的开孔框架和最小的网孔尺寸，防止斑块通过支架突出，从而提供超过五年的持久栓塞保护。

About InspireMD, Inc.

关于InspireMD公司

InspireMD seeks to utilize its proprietary MicroNet mesh technology to make its products the industry standard for carotid stenting by providing outstanding acute results and durable, stroke-free long-term outcomes. InspireMD’s common stock is quoted on Nasdaq under the ticker symbol NSPR.

InspireMD力求利用其专有的MicroNet网状技术，通过提供出色的急性治疗效果和持久的、无中风的长期疗效，使其产品成为颈动脉支架手术的行业标准。InspireMD的普通股在纳斯达克以股票代码NSPR进行报价。

We routinely post information that may be important to investors on our website. For more information, please visit www.inspiremd.com.

我们经常在我们的网站上发布可能对投资者重要的信息。欲了解更多信息，请访问 www.inspiremd.com。

Forward Looking Statements

前瞻性声明

This press release contains “forward-looking statements.” Forward-looking statements include, but are not limited to, statements regarding InspireMD or its management team’s expectations, hopes, beliefs, intentions or strategies regarding future events, future financial performance, strategies, expectations, competitive environment and regulation, including potential U.S.

本新闻稿包含“前瞻性声明”。前瞻性声明包括但不限于关于InspireMD或其管理团队对未来的期望、希望、信念、意图或策略的声明，涉及未来事件、未来财务表现、策略、预期、竞争环境和监管，包括潜在的美国市场。

commercial launch and expectations regarding the exercise of any warrants. Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential”, “scheduled” or similar words. Forward-looking statements are not guarantees of future performance, are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the company’s control, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements.

商业发布以及关于任何认股权证行使的预期。这些声明可能前缀为“打算”、“可能”、“将”、“计划”、“预计”、“预期”、“项目”、“预测”、“估计”、“目标”、“相信”、“希望”、“潜力”、“预定”或类似词语。前瞻性声明并非对未来业绩的保证，基于某些假设，并受多种已知和未知风险及不确定性的影响，其中许多超出公司的控制范围，无法预测或量化，因此，实际结果可能与这些前瞻性声明所明示或暗示的内容存在重大差异。

Such risks and uncertainties include, without limitation, risks and uncertainties associated with our history of recurring losses and negative cash flows from operating activities; substantial doubt about our ability to continue as a going concern; significant future commitments and the uncertainty regarding the adequacy of our liquidity to pursue our complete business objectives; our need to raise additional capital to meet our business requirements in the future and such capital raising may be costly or difficult to obtain and could dilute out stockholders’ ownership interests; market acceptance of our products; an inability to secure and maintain regulatory approvals for the sale of our products; negative clinical trial results or lengthy pr.

此类风险和不确定性包括但不限于：我们历史上持续亏损和经营活动产生的负现金流相关的风险和不确定性；对我们能否持续经营存在重大怀疑；未来重大承诺以及对我们流动性是否足以实现全部商业目标的不确定性；我们需要筹集额外资金以满足未来的业务需求，而此类融资可能成本高昂或难以获得，并可能稀释股东的股权；市场对我们产品的接受程度；无法确保并维持产品销售所需的监管批准；临床试验结果不佳或试验周期过长。

Investor Contacts:

投资者联系人：

Webb Campbell

韦伯·坎贝尔

Gilmartin Group LLC

吉尔马丁集团有限责任公司

[email protected]

[email protected]

[email protected]

[email protected]

Source: globenewswire.com

来源：globenewswire.com