RNS-60

TACOMA, Wash., July 31, 2025 /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. 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. Stroke is a leading cause of long-term disability and the second leading cause of death worldwide.i 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. 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. The Fast Track designation was granted based on the Phase 2 RESCUE trial and a supportive preclinical data package. "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. Jordan Dubow, 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." About FDA Fast Track Designation 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. About 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. About 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. Media: Lori Murray [email protected] i Feigin VL, Stark BA, Johnson CO, et al. Global, regional, and national burden of stroke and its risk factors, 1990–2019: a systematic analysis. Lancet Neurol. 2021 Oct;20(10):795–820. doi: 10.1016/S1474-4422(21)00252-0 SOURCE Revalesio Corporation WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Trial met primary endpoints of similar rates of serious adverse events (SAEs) and fewer deaths observed with RNS60 versus placebo Statistically significant reduction in infarct growth (brain tissue loss) – a secondary endpoint – in patients treated with RNS60 adjunct to endovascular thrombectomy Results support advancement of RNS60 to Phase 3 TACOMA, Wash., July 21, 2025 /PRNewswire/ -- Revalesio, a clinical-stage biopharmaceutical company developing treatments for acute and chronic neurological disorders, today announced the peer-reviewed publication of results from its RESCUE Phase 2 clinical trial evaluating RNS60 as an adjunctive treatment in patients with acute ischemic stroke. The paper, titled "Randomized, Proof-of-Concept Trial (RESCUE) of RNS60 as an Adjunct Therapy in Acute Ischemic Stroke," appears in the journal Stroke. RESCUE is the first randomized, double-blind, placebo-controlled clinical trial to evaluate RNS60 in patients (n=82) with large vessel occlusion, or blockage in one of the brain's main arteries, undergoing endovascular thrombectomy (EVT), a standard of care procedure to remove blood clots from the brain. RNS60 is a proprietary, oxygen-supersaturated saline formulation intended to support mitochondria, increase cellular resilience and modulate inflammation following ischemic injury. The RESCUE trial met its primary endpoints of similar rates of SAEs (33.3%, 25.0% and 28.6%) and fewer deaths (6.7%, 8.3% and 14.3%) across RNS60 0.5 mL/kg/h, RNS60 1.0 mL/kg/h, and placebo, respectively. RNS60 also demonstrated a statistically significant 47% reduction in infarct growth (brain tissue loss) – a secondary endpoint – at 48 hours in patients treated with RNS60 at 1.0 mL/kg/h compared to placebo (p<0.05). "Stroke remains the number one cause of disability worldwide, resulting in a substantial global economic burden. The ability to safely deliver a cytoprotective treatment adjunct to EVT would be transformative," said Marc Fisher, M.D., Neurologist Beth Israel Deaconess Medical Center, Harvard Medical School, and former World Stroke Organization President. "The RESCUE trial lays the foundation for a new treatment paradigm in stroke care, where more patients may benefit from effective intervention beyond the narrow window of traditional reperfusion therapies." Revalesio is preparing to launch the RESTORE study, a Phase 3 clinical trial evaluating RNS60 at 1.0 mL/kg/h in a broader population of stroke patients. "The publication of these results in a respected peer-reviewed journal underscores the strength of our Phase 2 proof of concept data and highlights the urgent need for new treatment options in acute ischemic stroke," said Jordan Dubow, M.D., Chief Medical Officer at Revalesio. "We are preparing to launch our Phase 3 RESTORE trial to evaluate RNS60 in a larger population and move closer to delivering a meaningful new option for stroke patients." About 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. About 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. For more information, please visit revalesio.com and engage with us on LinkedIn. Media: Lori Murray [email protected] SOURCE Revalesio Corporation WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED