SOLANA BEACH, Calif., March 19, 2024 (GLOBE NEWSWIRE) -- ClearPoint Neuro, Inc. (Nasdaq: CLPT) (the “Company”), a global device, cell, and gene therapy-enabling company offering precise navigation to the brain and spine, today congratulates its partner PTC Therapeutics, Inc. on completion of its BLA submission to the U.S.

加利福尼亚州索拉纳海滩，2024年3月19日（环球通讯社）--ClearPoint Neuro，Inc.（纳斯达克：CLPT）（以下简称“公司”）是一家全球设备、细胞和基因治疗公司，能够提供精确的大脑和脊柱导航，今天祝贺其合作伙伴PTC Therapeutics，Inc.完成向美国提交的BLA。

Food and Drug Administration (FDA) for the approval of Upstaza™ (eladocagene exuparvovec), an investigational treatment for AADC Deficiency. If approved, Upstaza™ would become the first therapy to treat AADC Deficiency in the United States..

美国食品和药物管理局（FDA）批准Upstaza™（eladocagene exuparvovec），这是一种针对AADC缺乏症的研究性治疗方法。如果获得批准，Upstaza™将成为美国第一种治疗AADC缺乏症的疗法。。

“AADC Deficiency is a devastating rare pediatric movement disorder that causes significant developmental delays and autonomic symptoms starting from birth. Patients with AADC deficiency are at a high risk of death in the first decade of life,” stated Jeremy Stigall, Chief Business Officer at ClearPoint Neuro.

ClearPoint Neuro首席商务官杰里米·斯蒂格尔（Jeremy Stigall）表示：“AADC缺乏症是一种毁灭性的罕见儿科运动障碍，从出生开始就会导致严重的发育迟缓和自主神经症状。AADC缺乏症患者在生命的头十年中有很高的死亡风险。”。

“The Upstaza™ BLA is the first filing for FDA approval of a treatment that addresses this devastating condition. Through our partnership with PTC, we are demonstrating our commitment to drive progress for the AADC Deficiency community.”.

“Upstaza™BLA是FDA批准治疗这种破坏性疾病的第一份申请。通过我们与PTC的合作，我们正在证明我们致力于推动AADC缺乏症社区的进步。”。

About aromatic L-amino acid decarboxylase (AADC) deficiency

关于芳香族L-氨基酸脱羧酶（AADC）缺乏症

AADC deficiency is a fatal, rare genetic disorder that typically causes severe disability and suffering from the first months of life, affecting every aspect of life – physical, mental and behavioral. The suffering of children with AADC deficiency may be exacerbated by episodes of distressing seizure-like oculogyric crises causing the eyes to roll up in the head, frequent vomiting, behavioral problems, and difficulty sleeping..

AADC缺乏症是一种致命的罕见遗传疾病，通常会导致严重残疾，并在生命的最初几个月遭受痛苦，影响生活的方方面面-身体，心理和行为。AADC缺乏症儿童的痛苦可能会因令人痛苦的癫痫样眼病发作而加剧，导致眼睛在头部卷起，频繁呕吐，行为问题和睡眠困难。。

The lives of affected children are severely impacted and shortened. Ongoing physical, occupational and speech therapy, and interventions, including surgery, also are often required to manage potentially life-threatening complications such as infections, severe feeding and breathing problems.

受影响儿童的生命受到严重影响并缩短。通常还需要进行持续的物理，职业和言语治疗以及包括手术在内的干预措施，以管理潜在的危及生命的并发症，例如感染，严重的进食和呼吸问题。

About the SmartFlow® Cannula

关于SmartFlow®套管

With over 7,000 cannulas sold to date, SmartFlow is the only co-labeled device to gain approval by a regulatory agency for delivery of an approved gene therapy to the brain. The industry-leading cannula is used by many of ClearPoint Neuro’s 50+ pharmaceutical, academic, and biotech partners to bypass the blood brain barrier and deliver therapeutics to regions of interest using Convection Enhanced Delivery (CED) under direct image guidance.

迄今为止，SmartFlow已售出7000多个插管，是唯一获得监管机构批准的联合标记设备，用于向大脑提供经批准的基因疗法。ClearPoint Neuro的50多家制药、学术和生物技术合作伙伴使用业界领先的插管绕过血脑屏障，并在直接图像引导下使用对流增强递送（CED）将治疗药物传递到感兴趣的区域。

The SmartFlow Cannula has 510(k) clearance from the FDA for use in the United States for the aspiration of cerebrospinal fluid or injection of the chemotherapy drug Cytarabine into the ventricles. It has also been CE marked to deliver approved fluids into the brain and for aspiration of cerebrospinal fluid, and holds regulatory clearance for clinical use in Israel and Brazil.

SmartFlow套管已获得FDA 510（k）的许可，可在美国用于吸入脑脊液或将化疗药物阿糖胞苷注射到心室。它还被CE标记为将批准的液体输送到大脑和吸入脑脊液，并在以色列和巴西获得临床使用的监管许可。

SmartFlow is utilized in approved clinical and preclinical studies for various research and drug trials..

SmartFlow用于各种研究和药物试验的批准临床和临床前研究。。

About ClearPoint Neuro

关于ClearPoint Neuro

ClearPoint Neuro is a device, cell, and gene therapy-enabling company offering precise navigation to the brain and spine. The Company uniquely provides both established clinical products as well as pre-clinical development services for controlled drug and device delivery. The Company’s flagship product, the ClearPoint Neuro Navigation System, has FDA clearance and is CE-marked.

ClearPoint Neuro是一家设备、细胞和基因治疗公司，能够为大脑和脊柱提供精确的导航。该公司独特地提供既定的临床产品以及临床前开发服务，以控制药物和设备的交付。该公司的旗舰产品ClearPoint神经导航系统已获得FDA批准，并带有CE标志。

ClearPoint Neuro is engaged with healthcare and research centers in North America, Europe, Asia, and South America. The Company is also partnered with the most innovative pharmaceutical/biotech companies, academic centers, and contract research organizations, providing solutions for direct CNS delivery of therapeutics in pre-clinical studies and clinical trials worldwide.

ClearPoint Neuro与北美、欧洲、亚洲和南美的医疗保健和研究中心合作。该公司还与最具创新性的制药/生物技术公司、学术中心和合同研究组织合作，为全球临床前研究和临床试验中直接中枢神经系统提供治疗方案。

To date, thousands of procedures have been performed and supported by the Company’s field-based clinical specialist team, which offers support and services to our customers and partners worldwide. For more information, please visit www.clearpointneuro.com..

迄今为止，该公司基于现场的临床专家团队已经执行并支持了数千个程序，该团队为全球客户和合作伙伴提供支持和服务。有关更多信息，请访问www.clearpointeuro.com。。

Forward-Looking Statements

前瞻性声明

This press release contains forward-looking statements within the context of the federal securities laws, which may include the Company’s expectation for the future market of its products and services, and other performance and results. These forward-looking statements are based on management’s current expectations and are subject to the risks inherent in the business, which may cause the Company's actual results to differ materially from those expressed in or implied by forward-looking statements.

本新闻稿包含联邦证券法范围内的前瞻性声明，其中可能包括公司对其产品和服务未来市场的预期以及其他业绩和结果。这些前瞻性陈述基于管理层当前的预期，并受到业务固有风险的影响，这可能导致公司的实际结果与前瞻性陈述中表达或暗示的结果存在重大差异。

Particular uncertainties and risks include those relating to: global and political instability, supply chain disruptions, labor shortages, and macroeconomic and inflationary conditions; future revenue from sales of the Company’s products and services; the Company’s ability to market, commercialize and achieve broader market acceptance for new products and services offered by the Company; the ability of our biologics and drug delivery partners to achieve commercial success, including their use of the Company’s products and services in their delivery of therapies; the Company’s expectations, projections and estimates regarding expenses, future revenue, capital requirements, and the availability of and the need for additional financing; the Company’s ability to obtain additional funding to support its research and development programs; the ability of the Company to manage the growth of its business; the Company’s ability to attract and retain its key employees; and risks inherent in the research, development, and regulatory approval of new products.

具体的不确定性和风险包括：全球和政治不稳定、供应链中断、劳动力短缺以及宏观经济和通货膨胀状况；公司产品和服务的未来销售收入；公司对公司提供的新产品和服务进行营销、商业化和获得更广泛市场认可的能力；我们的生物制剂和药物输送合作伙伴取得商业成功的能力，包括他们在提供治疗时使用公司的产品和服务；公司对费用、未来收入、资本要求以及额外融资的可用性和需求的预期、预测和估计；公司获得额外资金以支持其研发计划的能力；公司管理其业务增长的能力；公司吸引和留住关键员工的能力；以及新产品的研究、开发和监管批准所固有的风险。

More detailed information on these and additional factors that could affect the Company’s actual results are described in the “Risk Factors” section of the Company’s Annual Report on Form 10-K for the year ended December 31, 2023, wh.

有关这些因素以及可能影响公司实际业绩的其他因素的更多详细信息，请参见公司截至2023年12月31日年度报告表10-K中的“风险因素”部分。

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/d375ef5e-925f-4976-8bb2-63f3e90871a3

有关此公告的照片，请访问https://www.globenewswire.com/NewsRoom/AttachmentNg/d375ef5e-925f-4976-8bb2-63f3e90871a3

Contact:

联系人：

Media Contact:

媒体联系人：

Jacqueline Keller, Vice President of Marketing

市场营销副总裁杰奎琳·凯勒

(888) 287-9109 ext. 4

（888）287-9109分机4

info@clearpointneuro.com

info@clearpointneuro.com

Investor Relations:

投资者关系：

Danilo D’Alessandro, Chief Financial Officer

首席财务官Danilo D'Alessandro

(888) 287-9109 ext. 3

（888）287-9109分机3

ir@clearpointneuro.com

ir@clearpointneuro.com

ClearPoint Neuro

ClearPoint神经

ClearPoint Neuro Navigation Platform for Drug Delivery

用于药物输送的ClearPoint神经导航平台