Aruna Bio, Inc.

Neural Stem Cell Extracellular Vesicle Treatment for Traumatic Brain Injury - Project Summary/abstract Traumatic Brain Injury (TBI) Is a Universal Health Concern and Is Known as a “silent Epidemic”. Each Year in America, 2.53 Million Patients Visit the Emergency Department After Suffering a Tbi of Which 56,800 Die and Over 288,000 Require Hospitalization, Rehabilitation Programs, and Long-term Supportive Care. Although the Primary Tbi Event Is Typically Acute, Subsequent Secondary Injury Responses (neuroinflammation) and Chronic Tissue Loss Often Result in Functional Deficits That Last a Lifetime. Presently, There Are No Neuroprotective or Regenerative Food and Drug Administration Approved Tbi Treatments. Aruna Bio Has Recently Developed a Novel Neuroprotective and Regenerative Neural Stem Cell Extracellular Vesicle (NSC Ev) Product Called AB126™ That May Be Used to Treat Tbi. AB126™ Has Demonstrated Multimodal Therapeutic Efficacy in Divergent Species (aged Mouse, Rat, Pig) and Neural Injury Models (tbi, Stroke). in Tbi Rodent Models, AB126™ Reduced Lesion Sizes, Enhanced Endogenous Neurogenesis and Angiogenesis, and Rapidly Attenuated Motor Function Impairments. Large Animal Testing Has Been Repeatedly Identified by Academic, Industry, and Government Agencies as a Key De-risking Step in Tbi Therapeutic Development. to This End, This Proposal Outlines Fda Enabling Studies in a Pig Controlled Cortical Impact Tbi Model Using Clinically Relevant Assessment Tools to Evaluate the Efficacy and Safety of AB126™ as a Treatment for Tbi. the Successful Completion of This Study Will Provide Key Information Pertaining to AB126™ Dosage, Therapeutic Effects on Tbi Pathophysiology (edema, Hemorrhage) and Functional Outcomes, Toxicity, and Potential Adverse Side Effects That Will Serve as the Basis for an Ind Submission and Future Clinical Trials.