InspireMD, Inc. developer of the CGuard Prime Carotid Stent System for the prevention of stroke, today announced that the U.S. Food and Drug Administration (FDA) has granted premarket application (PMA) approval of the CGuard Prime Carotid Stent System in the United States.

InspireMD, Inc. 是预防中风的 CGuard Prime 颈动脉支架系统的开发商，今天宣布美国食品药品监督管理局 (FDA) 已授予 CGuard Prime 颈动脉支架系统在美国的上市前申请 (PMA) 批准。

The PMA approval is backed by best-in-class evidence from the Company’s C-GUARDIANS pivotal trial, first presented at the Leipzig Interventional Course (LINC) in May 2024. The study, which enrolled 316 patients across 24 sites in the United States and Europe, evaluated the safety and efficacy of CGuard Prime for treating carotid artery stenosis.

PMA的批准得到了公司C-GUARDIANS关键试验的最佳证据支持，该试验于2024年5月在莱比锡介入课程（LINC）上首次发布。这项研究在美国和欧洲的24个地点招募了316名患者，评估了CGuard Prime治疗颈动脉狭窄的安全性和有效性。

CGuard Prime demonstrated the lowest 30-day (0.95%) and 1-year (1.93%) primary endpoint major adverse event rates of any pivotal study of carotid intervention..

CGuard Prime 在颈动脉干预的任何关键研究中，展示了最低的30天（0.95%）和1年（1.93%）主要终点主要不良事件发生率。

“The C-GUARDIANS clinical trial provides strong scientific evidence to support the neuro-protective benefits of the next generation MicroNet™ mesh technology of the CGuard Prime Carotid Stent System and results are consistent with the large body of evidence from outside of the United States with this device,” said Dr.

“C-GUARDIANS 临床试验为 CGuard Prime 颈动脉支架系统的下一代 MicroNet™ 网状技术的神经保护益处提供了强有力的科学证据，结果与美国以外使用该设备的大量证据一致，”博士说道。

D. Chris Metzger, System Vascular Chief at OhioHealth. “As U.S. Primary Investigator for this pivotal IDE trial, I am proud of the scientific rigor and integrity of the data, which demonstrates the lowest event rates (stroke, death and MI to 30 days and ipsilateral stroke at 1 year) ever reported in any trial of carotid revascularization.

D. Chris Metzger，俄亥俄健康系统的首席血管外科医生。“作为这一关键IDE试验的美国首席研究员，我为数据的科学严谨性和完整性感到自豪，这些数据展示了颈动脉血运重建试验中报告的最低事件率（30天内的中风、死亡和心肌梗死，以及1年内的同侧中风）。”

These excellent results were in patients who were at high risk for carotid endarterectomy, a quarter of whom were symptomatic. CGuard Prime now offers an important frontline, proven technology for treatment of United States patients with obstructive carotid artery disease, and continued benefits to patients worldwide.”.

这些优秀的结果出现在那些接受颈动脉内膜切除术的高风险患者中，其中四分之一的患者出现症状。CGuard Prime 现在为治疗美国阻塞性颈动脉疾病患者提供了一种重要的前线、经过验证的技术，并继续为全球患者带来益处。”

“I am proud to announce the PMA approval of CGuard Prime, our best-in-class carotid stent system. This is a pivotal milestone for the Company after many years of commitment to bringing this innovative stent platform to patients in the United States,” said Marvin Slosman, Chief Executive Officer of InspireMD.

“我很自豪地宣布，我们的最佳颈动脉支架系统CGuard Prime获得了PMA批准。这是公司多年来致力于将这一创新支架平台带给美国患者的里程碑式成就，”InspireMD首席执行官马文·斯洛斯曼表示。

“The significance of CGuard Prime to the shift toward less invasive carotid artery revascularization is tremendous. Our approval marks a true breakthrough in the treatment of carotid disease. Our innovation is built around the protective MicroNet mesh barrier providing durable protection and preventing post procedural events, a unique and next generation advancement in the carotid field.

“CGuard Prime 对向微创颈动脉血运重建的转变意义重大。我们的批准标志着颈动脉疾病治疗领域的一项真正突破。我们的创新围绕提供持久保护并防止术后事件的 MicroNet 网状屏障，这是颈动脉领域独特且新一代的进步。”

With over 65,000 implants sold to date and studies in over 2,000 patients, CGuard Prime offers an established and tested advancement to patient care. We are grateful to the many who have contributed to this approval, including all of our trial investigators and investors. We look forward to making this technology available to all who can benefit with an immediate and aggressive U.S.

迄今为止，CGuard Prime 已售出超过 65,000 个植入物，并在 2,000 多名患者中进行了研究，为患者护理提供了经过验证和测试的进步。我们感谢所有为此批准做出贡献的人，包括所有的试验研究人员和投资者。我们期待通过立即且积极的美国市场推广，将这项技术提供给所有可以受益的患者。

launch.”.

启动。”

The Company’s announcement of FDA approval of the CGuard Prime Carotid Stent System triggers the second of four milestone-driven warrant tranches pursuant to the private placement financing of up to $113.6 million announced in May 2023. Gross proceeds from this warrant tranche are expected to be $17.9M if exercised in full.

公司宣布CGuard Prime颈动脉支架系统获得FDA批准，触发了2023年5月宣布的高达1.136亿美元私募融资中的第二个由里程碑驱动的认股权证部分。如果该认股权证部分全部行使，预计总收益为1790万美元。

Proceeds, if any, will be used to support the imminent commercial launch of the CGuard Prime Carotid Stent System in the United States, initiating new regulatory pathways for advanced applications of our CGuard stent platform, and developing new products, while at the same time continuing to develop our business outside of the United States.

如果有收益，将用于支持CGuard Prime颈动脉支架系统在美国即将进行的商业发布，开启我们CGuard支架平台高级应用的新监管途径，开发新产品，同时继续拓展我们在美国以外的业务。

Warrant holders include Marshall Wace, OrbiMed, Rosalind, Nantahala, Soleus, Velan, and certain InspireMD Board members..

认股权证持有人包括Marshall Wace、OrbiMed、Rosalind、Nantahala、Soleus、Velan以及某些InspireMD董事会成员。

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 C-GUARDIANS

关于C-GUARDIANS

The C-GUARDIANS clinical trial evaluated the safety and efficacy of the CGuard Carotid Stent System for the treatment of carotid artery stenosis. The study enrolled 316 patients across 24 trial sites in the United States and Europe.

C-GUARDIANS 临床试验评估了 CGuard 颈动脉支架系统治疗颈动脉狭窄的安全性和有效性。该研究在美国和欧洲的 24 个试验点招募了 316 名患者。

The trial included both symptomatic and asymptomatic patients undergoing carotid artery stenting (CAS). The primary endpoint includes the composite of the following: incidence of the following major adverse events: death (all‐ cause mortality), all stroke, or myocardial infarction (DSMI) through 30‐days post‐index procedure, based on the Clinical Events Committee (CEC) adjudication or ipsilateral stroke from 31‐365-day follow‐up, based on CEC adjudication.

该试验包括接受颈动脉支架置入术 (CAS) 的有症状和无症状患者。主要终点包括以下复合终点：根据临床事件委员会 (CEC) 裁定，术后30天内全因死亡率、所有卒中或心肌梗死 (DSMI) 的主要不良事件发生率，以及根据CEC裁定的术后31至365天随访期间的同侧卒中。

The performance goal was considered to have been met if the upper bound of the two-sided 95% confidence interval calculated from the observed primary endpoint rate is <11.6% and the p-value is <0.025..

如果根据观察到的主要终点率计算得出的双侧 95% 置信区间的上限小于 11.6%，且 p 值小于 0.025，则认为已达成性能目标。

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. We routinely post information that may be important to investors on our website.

InspireMD旨在利用其专有的MicroNet网格技术，通过提供卓越的短期结果和持久的、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上市，股票代码为NSPR。我们通常会在我们的网站上发布可能对投资者重要的信息。

For more information, please visit www.inspiremd.com..

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或其管理层对未来的期望、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。此类声明可能前缀为“打算”、“可能”、“将”、“计划”、“预计”、“预期”、“预测”、“估计”、“目标”、“相信”、“希望”、“潜力”、“预定”或类似词语。前瞻性声明并非未来表现的保证，基于某些假设，并受制于各种已知和未知的风险与不确定性，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表达或暗示的内容有重大差异。

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；未来的重要承诺及对我们流动性是否足以实现全部业务目标的不确定性；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，并可能稀释股东的权益；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：

Craig Shore

克雷格·肖尔

Chief Financial Officer

首席财务官

InspireMD, Inc.

启明医疗公司

888-776-6804

888-776-6804

[email protected]

电子邮件地址

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]

电子邮件地址

Source: globenewswire.com

来源：globenewswire.com