/PRNewswire/ -- Revalesio, a clinical-stage biopharmaceutical company developing treatments for acute and chronic neurological disorders, today announced that the U.S. Food and Drug Administration has granted Fast Track designation to RNS60, its lead investigational therapy, for the treatment of acute ischemic stroke.

/PRNewswire/ -- 临床阶段生物制药公司Revalesio今日宣布，美国食品和药物管理局（FDA）已授予其主要研究性疗法RNS60快速通道资格，用于治疗急性缺血性中风。该公司专注于开发针对急性和慢性神经系统疾病的治疗方法。

This designation is intended to accelerate the development and review of RNS60, which could fill a major gap in stroke care by protecting brain tissue even after blood flow is restored with standard procedures and medications..

这一指定旨在加速RNS60的开发和审查，它可能通过在标准手术和药物恢复血流后仍然保护脑组织，填补中风治疗中的一个重大空白。

Stroke is a leading cause of long-term disability and the second leading cause of death worldwide.

中风是长期残疾的主要原因之一，也是全球第二大死亡原因。

While advances in endovascular thrombectomy have improved outcomes for some patients, a large percentage continue to experience permanent neurological deficits due to brain tissue damage sustained even after blood flow is restored. No FDA-approved therapies currently exist to protect the brain during or after reperfusion..

虽然血管内血栓切除术的进步改善了一些患者的预后，但很大一部分患者在血流恢复后仍因脑组织损伤而遭受永久性神经功能缺损。目前尚无FDA批准的疗法能够在再灌注期间或之后保护大脑。

RNS60 is an oxygen-supersaturated saline intended to support mitochondria activity, increase cellular resilience, modulate inflammation and protect at-risk brain tissue following ischemic injury. Revalesio is currently preparing to initiate RESTORE, a Phase 3 trial that will evaluate the safety and efficacy of RNS60 in a broader population of stroke patients eligible for endovascular therapy.

RNS60是一种氧超饱和盐水，旨在支持线粒体活动、增强细胞适应性、调节炎症并保护缺血性损伤后的脑组织。Revalesio目前正准备启动RESTORE，这是一项三期临床试验，将评估RNS60在更广泛的符合血管内治疗条件的中风患者中的安全性和有效性。

The Fast Track designation was granted based on the Phase 2 RESCUE trial and a supportive preclinical data package..

基于2期RESCUE试验和一个支持性的临床前数据包，快速通道资格获得授予。

'The Fast Track designation underscores the urgent need for new treatments that go beyond restoring blood flow to actually protect brain tissue and preserve neurological function,' said Dr.

“快速通道资格凸显了对新疗法的迫切需求，这些疗法不仅仅是恢复血流，而是真正保护脑组织并保留神经功能，”博士表示。

Jordan Dubow

乔丹·杜博

, Chief Medical Officer of Revalesio. 'We believe RNS60 represents a fundamentally different approach to stroke care, and this designation reinforces the importance of advancing it as quickly as possible.'

Revalesio的首席医疗官表示：“我们认为RNS60代表了一种从根本上不同的中风护理方法，这一认定进一步强调了尽快推进其发展的重要性。”

About FDA Fast Track Designation

关于FDA快速通道指定

The FDA's Fast Track program is designed to facilitate the development and expedite the review of therapies that treat serious or life-threatening conditions and have the potential to address unmet medical needs. Programs granted Fast Track designation benefit from more frequent interactions with the FDA, eligibility for Accelerated Approval and Priority Review, and the option to submit a New Drug Application on a rolling basis..

FDA的快速通道计划旨在促进治疗严重或危及生命状况的疗法的开发，并加快对其审查，这些疗法有潜力满足未满足的医疗需求。获得快速通道资格的项目可以更频繁地与FDA互动，有资格获得加速批准和优先审查，并可以选择滚动提交新药申请。

About RNS60

关于RNS60

RNS60 is a proprietary, oxygen-enriched saline with demonstrated cytoprotective, anti-inflammatory, and mitochondrial-supportive properties. The treatment is being developed as an adjunctive therapy for acute ischemic stroke and in other neurological conditions, such as ALS and Alzheimer's Disease. The company is preparing to launch a Phase 3 clinical trial of RNS60 in acute ischemic stroke based on promising Phase 2 data showing reduced brain tissue loss, improved functional outcomes, and shorter hospital stays in patients treated within 24 hours of stroke onset..

RNS60 是一种专利的富氧盐水，具有细胞保护、抗炎和线粒体支持特性。该疗法正在开发作为急性缺血性中风和其他神经系统疾病（如肌萎缩侧索硬化症和阿尔茨海默病）的辅助治疗。基于二期临床试验数据的良好结果，该公司正准备启动 RNS60 在急性缺血性中风中的三期临床试验，数据显示，在中风发作后 24 小时内接受治疗的患者脑组织损失减少、功能结果改善且住院时间缩短。

About Revalesio

关于Revalesio

Revalesio is a clinical-stage pharmaceutical company with a vision to change the future of treatment for acute and chronic neurological disorders. The company's lead clinical program for RNS60 is ischemic stroke with additional programs in ALS and other neurological disorders. The company's pioneering technology, founded in fluid physics, modulates fundamental mechanisms involved with proper cellular function to slow disease progression and improve quality of life..

Revalesio是一家处于临床阶段的制药公司，其愿景是改变急性及慢性神经系统疾病治疗的未来。该公司RNS60的主要临床项目针对缺血性中风，同时还有ALS及其他神经系统疾病的项目。公司基于流体物理学的开创性技术，调控与细胞正常功能相关的基本机制，以延缓疾病进展并改善生活质量。