/PRNewswire/ -- Anuncia Medical, Inc. ('Anuncia'), a pioneering company in CSF management and neurocritical care, has received Breakthrough Device Designation from the FDA for its ReFlow® EVD, an innovative solution for external ventricular drains (EVDs) used to manage brain swelling and elevated intracranial pressure.

/PRNewswire/ -- 专注于脑脊液管理与神经重症监护的先锋企业 Anuncia Medical, Inc.（“Anuncia”）宣布，其创新的外部脑室引流（EVD）解决方案 ReFlow® EVD 获得了美国食品药品监督管理局（FDA）的突破性医疗器械认定。该设备用于管理脑肿胀和颅内压升高。

This milestone expands Anuncia's breakthrough portfolio, complementing the ReFlow® System Mini, a first-generation device with up to six years of clinical success, and the ReFlow® Mini Flusher, already transforming hydrocephalus care in its early U.S. rollout by enabling noninvasive, at-home CSF flow maintenance and reducing the need for costly revision surgeries.

这一里程碑扩展了Anuncia的突破性产品组合，补充了第一代设备ReFlow® System Mini（具有长达六年的临床成功经验）以及ReFlow® Mini Flusher，后者在早期美国推出时已经通过实现无创、家庭化的脑脊液流动维护，减少了对昂贵翻修手术的需求，正在变革脑积水护理。

With ReFlow® EVD, Anuncia is advancing both acute and long-term CSF management, driving innovation, and expanding strategic opportunities in neurocritical care..

通过ReFlow® EVD，Anuncia正在推动急性及长期脑脊液管理的创新，并在神经重症监护领域拓展战略机遇。

ReFlow® EVD: Advancing ICU Care and Patient Outcomes

ReFlow® EVD：提升ICU护理与患者疗效

EVDs are placed in more than 100,000 cases annually in the U.S. to relieve elevated intracranial pressure. The ReFlow® EVD is the first device of its kind to provide a noninvasive, manual flushing mechanism designed to restore and maintain cerebrospinal fluid (CSF) flow. By reducing the risk of occlusions, it helps prevent prolonged ICU stays, additional neurosurgical procedures, and costly EVD replacements.

每年在美国有超过10万例放置EVD以缓解颅内压升高的情况。ReFlow® EVD是首个提供非侵入性手动冲洗机制的设备，旨在恢复和维持脑脊液（CSF）流动。通过降低堵塞风险，它有助于防止延长ICU住院时间、额外的神经外科手术以及昂贵的EVD更换。

Unlike traditional flushing methods that require a neurosurgeon, ReFlow® EVD can be operated by nurses noninvasively during routine patient checks, seamlessly integrating into existing workflows to improve efficiency and reduce costs..

与需要神经外科医生的传统冲洗方法不同，ReFlow® EVD可以在日常患者检查时由护士非侵入性操作，无缝融入现有工作流程，提高效率并降低成本。

'This regulatory milestone highlights the broader impact of our ReFlow® innovation beyond hydrocephalus management,' said

“这一监管里程碑突显了我们的ReFlow®创新在脑积水管理之外的更广泛影响，”

Elsa Chi Abruzzo

艾尔莎·基·阿布鲁佐

, CEO and President of Anuncia Medical. 'We continue to hear from neurosurgeons, nurses, patients, and families that ReFlow's simple, seconds-long manual flush helps prevent blockages—improving outcomes and providing peace of mind. Expanding our ReFlow portfolio reinforces our commitment to advancing neurocritical care and patient well-being.'.

，Anuncia Medical的首席执行官兼总裁。“我们不断从神经外科医生、护士、患者和家属那里听到，ReFlow简单、数秒的手动冲洗有助于防止堵塞——改善结果并提供安心。扩展我们的ReFlow产品组合，进一步巩固了我们对推进神经重症监护和患者福祉的承诺。”

Driving Innovation in Hydrocephalus Treatment

推动脑积水治疗的创新

The Flinn Foundation has awarded Anuncia a meaningful grant through its Bioscience Entrepreneurship Program to support post-FDA clearance studies of the ReFlow® Mini Flusher. Led by Dr.

弗林基金会通过其生物科学创业计划授予Anuncia一项重要资助，以支持ReFlow® Mini Flusher的FDA批准后研究。该研究由博士领导。

Jason Hauptman

杰森·哈普特曼

(Phoenix Children's Hospital) and Dr.

（凤凰城儿童医院）和博士。

Anthony Avellino

安东尼·阿维利诺

(HonorHealth Medical Group), the research aims to improve care and generate clinical evidence for hydrocephalus patients at high risk for shunt occlusion, including those affected by Coccidioidomycosis (Cocci) Meningitis, a serious complication of Valley Fever and regional health concern.

（HonorHealth医疗集团），该研究旨在改善护理并为高风险脑积水患者（包括那些受到球孢子菌病（Cocci）脑膜炎影响的患者）生成临床证据，球孢子菌病脑膜炎是河谷热的严重并发症，也是区域健康问题。

'This grant allows us to generate the high-quality, prospective clinical data needed for broader commercial adoption, further cementing

“这项资助使我们能够生成高质量的前瞻性临床数据，推动更广泛的商业应用，进一步巩固

Arizona

亚利桑那州

as a leader in neurosurgical excellence,' said Dr.

作为神经外科卓越的领导者，博士说道。

Anthony M. Avellino

安东尼·M·阿维利诺

, neurosurgeon and Chief Medical Officer of HonorHealth Medical Group – Specialty Care. 'By partnering with Dr.

，神经外科医生，HonorHealth医疗集团专科护理部首席医疗官。“通过与Dr.合作，

Jason Hauptman

杰森·豪普特曼

, Chief of Neurosurgery at Phoenix Children's, we are advancing hydrocephalus care while showcasing

，凤凰城儿童医院神经外科主任，我们在推进脑积水治疗的同时展示

Arizona's

亚利桑那州的

world-class institutions as a national model.'

世界级机构作为国家模范。

While demand for CSF management technologies is high in developed nations, access to hydrocephalus care in low-resource settings remains a far greater challenge. In Sub-Saharan Africa, bacterial meningitis often leads to post-infectious hydrocephalus, yet many children lack access to life-saving treatment.

虽然发达国家对脑脊液管理技术的需求很高，但在资源匮乏的地区获得脑积水治疗仍然是一个更大的挑战。在撒哈拉以南非洲，细菌性脑膜炎常常导致感染后脑积水，但许多儿童无法获得挽救生命的治疗。

To help bridge this gap, Anuncia has partnered with NeuroKids.org, founded by pioneering neurosurgeon Dr. .

为了帮助弥合这一差距，Anuncia 与由先锋神经外科医生 Dr. 创立的 NeuroKids.org 合作。

'Anuncia Medical's revolutionary ReFlow device has the power to provide peace of mind to parents and patients living with hydrocephalus,' said

“Anuncia Medical公司革命性的ReFlow装置能够为患有脑积水的父母和患者带来安心。”

Derek Johnson

德里克·约翰逊

, Chief Executive Officer of NeuroKids.org. 'NeuroKids is proud to partner with Anuncia Medical to bring this technology to some of the most vulnerable populations living in

NeuroKids.org的首席执行官表示：“NeuroKids很荣幸能与Anuncia Medical合作，将这项技术带给一些最脆弱的人群，他们生活在

, as patients in rural U.S. communities and underserved regions also face significant barriers. With an estimated 30 million people worldwide affected by hydrocephalus, access to effective treatment remains a critical challenge. Early data from its U.S. commercial rollout suggest ReFlow® may help prevent catheter blockages, potentially reducing emergency surgeries—an especially critical benefit where neurosurgical care is limited.

，因为美国农村社区和服务不足地区的患者也面临重大障碍。 全世界估计有3000万人受到脑积水的影响，获得有效治疗仍然是一个关键挑战。 美国商业推广的早期数据表明，ReFlow® 可能有助于防止导管堵塞，从而可能减少紧急手术，这一益处在神经外科护理有限的地方尤为重要。

Through partnerships and innovation, Anuncia is building a strong body of clinical evidence to support additional regulatory claims and expanded reimbursement, driving broader adoption and integration of ReFlow® into the standard of care for hydrocephalus treatment..

通过合作与创新，Anuncia正在构建强有力的临床证据体系，以支持更多的监管声明和扩大报销范围，推动ReFlow®在脑积水治疗标准中的广泛应用和整合。

About Anuncia Medical, Inc.

关于Anuncia Medical公司

Anuncia Medical is an early-stage commercial company redefining CSF management and neurocritical care with innovative therapeutic and monitoring solutions—from hospital to home. Our Breakthrough Device Designated technologies, including the ReFlow® EVD and ReFlow® Mini Flusher, provide noninvasive, cost-effective solutions to restore CSF flow and reduce complications in hydrocephalus and neurocritical care patients.

Anuncia Medical是一家处于早期阶段的商业公司，通过创新的治疗和监测解决方案重新定义脑脊液管理和神经重症监护——从医院到家庭。我们获得突破性设备指定的技术，包括ReFlow® EVD和ReFlow® Mini Flusher，提供非侵入性、经济高效的解决方案，以恢复脑脊液流动并减少脑积水和神经重症患者并发症。

We are also developing remote monitoring systems to improve real-time patient management and long-term outcomes, driving the next generation of lifesaving neurocritical innovations..

我们还在开发远程监测系统，以改善实时患者管理和长期疗效，推动下一代挽救生命的神经重症创新技术。