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Latest Patent to Complement Issued Claims on Viral Inhibition, Adaptive Immune Stimulation, and Brain Protection/Regeneration ELK CITY, Idaho--(BUSINESS WIRE)-- Therapeutic Solutions International, Inc. (TSOI), a clinical-stage stem cell and immunotherapy company, announced today the granting of a patent covering the ability of QuadraMune® and similar compositions, to stimulate natural killer (NK) cell activity in patients with COVID-19. NK cells are the first line of defense against viruses and cancers1. The Company was previously awarded by the United States Patent and Trademark Office the following QuadraMune® related patents: Patent #11,229,674, covering inhibition of the immune suppressing enzyme indolamine 2,3 dioxygenase2. It is published that this enzyme plays a fundamental role in immune suppression by cancer3, as well as numerous viruses including SARS-CoV-2, the causative agent of COVID-194. Patent #11,266,707, “Nutraceuticals for the prevention, inhibition, and treatment of SARS-CoV-2 and associated COVID-19”5. Patent #11,504,410, covering use of QuadraMune® and its derivatives for protecting and restoring brain function after neurological damage, including Long COVID6. Patent #11759495, covering upregulation of T regulatory cells for suppression of suicidal ideation7. “In addition to this important validation from the USPTO, the fact that the ingredients in QuadraMune® have been reported by institutions such as Johns Hopkins University to suppress SARS-CoV-2 is strongly encouraging,” said Famela Ramos, Vice President of Business Development for the Company. “Our Company is driven by a desire to address unmet medical needs, whether it is through developing state of the art stem cell and gene therapies, or science-backed nutraceuticals,” said Timothy Dixon, President, and CEO of the Company. “The importance of NK cells in protecting the body against cancer and viruses is well known, the fact that this can be performed using a low-cost nutraceutical approach has implications in both oncology and virology.” About Therapeutic Solutions International, Inc. Therapeutic Solutions International is focused on immune modulation for the treatment of several specific diseases. The Company's corporate website is . 1 Cerwenka and Lanier. Natural killer cells, viruses and cancer. Nat Rev Immunol. 2001 Oct;1(1):41-9. 2 3 Ricuitti et al. Targeting indoleamine-2,3-dioxygenase in cancer: Scientific rationale and clinical evidence. Pharmacol Ther. 2019 Apr:196:105-116. 4 Guo et al. Indoleamine 2,3-dioxygenase (IDO)-1 and IDO-2 activity and severe course of COVID-19. J Pathol. 2022 Mar;256(3):256-261. 5 6 7 8 Johns Hopkins University Publishes Efficacy of QuadraMune™ Ingredient Sulforaphane at Inhibiting Coronavirus in Laboratory Studies | BioSpace

Studies presented at World Congress of Pediatric Cardiology and Cardiac Surgery show Etiometry’s clinical intelligence platform supports efficient escalation and safe de-escalation decisions to enhance patient outcomes and reduce length of stay BOSTON--(BUSINESS WIRE)-- Etiometry, the leader in clinical decision-support software, shares exciting new study results from ten hospitals, including Boston Children’s Hospital, Children’s of Alabama, Children’s National Hospital and St. Louis Children’s Hospital, that demonstrate the significant impact its platform has on outcomes for critically ill patients. Physician researchers presented their findings at the World Congress of Pediatric Cardiology and Cardiac Surgery (WCPCCS) in Washington, D.C. on Monday, Aug. 28, 2023. Key data highlights include: Etiometry utilization reduced time on mechanical ventilation by 22% and decreased hospital length of stay in these patients by 19%. Etiometry utilization reduced time on vasoactive medications by 18%. Etiometry’s Hyperlactatemia Index provides early warning for elevated lactic acid, alerting the care team to potentially impaired oxygen delivery. The studies utilized Etiometry’s FDA-cleared Risk Analytics, Automated Clinical Pathways and Quality Improvement App to address pressing challenges in critical care settings, which are often the most complex and expensive units in the hospital. Etiometry’s Risk Analytics provide an individualized assessment of the patient’s condition, bringing attention to patients who need it most and revealing insight into the cause of potential deterioration or improvement to a patient's state. When paired with the platform’s Clinical Pathway Automation, care teams can achieve the elusive balance of individualized and standardized care to support quality initiatives like ICU liberation. Mechanical Ventilation Management Extubation failure is associated with significant morbidity, including prolonged total ventilation time and longer hospital length of stay. Extubation readiness trials (ERTs) are used to guide clinicians when a patient is ready to extubate, and these manual workflows are cumbersome for staff. Etiometry automates this process, providing clinicians with alerts when a patient is eligible for an ERT, and automatically tracks performance throughout the spontaneous breathing trial. The study presented at WCPCCS analyzed before and after deployment of Etiometry’s automated ERT pathway on patients undergoing cardiopulmonary bypass surgery and found that using Etiometry reduced time on mechanical ventilation by 22%. Study Title: Automated Extubation Readiness Tool is Associated with Improved Outcomes Following Pediatric Cardiac Surgery 747 patients were included in the analysis Research led by Santiago Borasino MD, MPH, Donald M. James Chair in Pediatric Cardiac Critical Care Medicine, Professor of Pediatrics, and Section Head of Pediatric Cardiac Critical Care Medicine, Division of Cardiology, University of Alabama at Birmingham, and Medical Director, Cardiovascular Intensive Care Unit, of Children’s of Alabama Weaning of Vasoactive Medications Vasoactive medication is crucial for hemodynamic management after cardiac surgery, but its use carries risks of complications and requires close monitoring and individual patient management for appropriate care de-escalation. Until now, there have been no clinical trials exploring the use of algorithms in the safe de-escalation of care. Etiometry’s IDO2 Index™, a non-invasive algorithm that predicts the probability of inadequate oxygen delivery, was paired with Etiometry’s clinical pathway automation capability to evaluate its potential to prompt earlier weaning of vasoactive medication support. The findings reveal the new automated standardized workflow in Etiometry informed data-driven decisions leading to an 18% reduction of time with vasoactive infusions. Study Title: Use of a Risk Analytic Algorithm to Inform Weaning from Vasoactive Medication in Patients Following Pediatric Cardiac Surgery 851 patients enrolled Research led by Joshua Salvin, MD, MPH, Pediatric Cardiac Intensivist, Attending, Department of Cardiology of Boston Children’s Hospital and Associate Professor of Pediatrics, Harvard Medical School Early Warning of Hyperlactatemia Pediatric patients after cardiac surgery are predisposed to develop low cardiac output syndrome. Serum lactate is a well-defined marker of inadequate systemic oxygen delivery which can be a major risk for organ failure. Researchers utilized Etiometry’s HLA Index™ to monitor inadequate perfusion and identify risk of HLA or hyperlactatemia (elevated lactic acid). Etiometry’s HLA Index showed a strong positive association with elevated lactic acid, providing the bedside clinician with an early, non-invasive warning of impaired oxygen delivery. Study Title: A Near Real Time Risk Analytics Algorithm Predicts Elevated Lactate Levels in Pediatric Cardiac Critical Care Patients: 3,496 enrolled patients compared to 58,168 lactic acid test results Research led by Ahmed M. Asfari, MD, MSHA, Pediatric Cardiologist, Cardiac Critical Care at Children’s of Alabama and Assistant Professor, University of Alabama at Birmingham “We’re grateful to the physician researchers who’ve utilized our platform and our superb team of data scientists, engineers and clinical specialists to tackle key challenges of a stressful, high-acuity environment, such as the ICU. The data are compelling, especially in terms of how our clinical intelligence can enhance patient care,” said Shane Cooke, CEO of Etiometry. “We look forward to supporting many more research and quality improvement initiatives.” Etiometry continues to expand its capabilities. This year, the company announced two software releases with several customer-driven enhancements, achieved two FDA clearances for its risk algorithms and continues to enable collaboration among clinicians to support standardization of care with automated clinical pathways. “Through our tools, automated reporting and support, we are committed to not only deploying our clinical decision support system technology into care, but equally important - enabling the measurement of their performance,” said Evan Butler, Co-founder of Etiometry and Chief Operating Officer. “These studies are a testament to the unique capability we can provide our ICUs.” Through Thursday, Aug. 31, WCPCCS attendees have the opportunity to engage in person with Etiometry’s experts, delve into the platform’s functionalities and experience live demonstrations that showcase its transformative potential. Those not in attendance can request an online demo at Etiometry.com/GetYourView. About Etiometry Founded in 2010, Etiometry is the leader in clinical decision-support software designed to help clinicians in the intensive care setting make data-based decisions regarding their patients’ care and treatment. The company’s technologies provide valuable clinical insight and analysis to support early recognition of subtle changes in patients’ conditions to avoid complications and speed recovery. Etiometry has nine FDA clearances and four Health Canada approvals and CE markings. With roots in pediatric ICUs, Etiometry is utilized by some of the world’s top academic medical centers as well as leading children’s hospitals ranked by US News and World Report and Newsweek. Etiometry is committed to improving patient outcomes, increasing clinical efficiency, and lowering the cost of care through the more effective use of data. The Etiometry Platform is the only critical care software solution that reveals deep insights into patient physiology, helping critical care teams deliver standardized and individualized care - and provides the ability to automate care escalation and de-escalation decisions. It is designed to facilitate the use of all available data to support the anticipation and management of the dynamic condition of patients requiring intensive care. To learn more, visit .

The IVCO2 index is displayed as a digital readout on Etiometry’s software platform that clinicians can refer to between blood gas tests to keep an eye out for signs of hypercapnia. The index increases in tandem with the risk of inadequate carbon dioxide ventilation—offering a prediction of whether a patient’s partial pressure of carbon dioxide will cross into the danger zone above 50 mmHg. Nearly four years after securing its initial clearance from the FDA, an algorithm designed to watch for signs of hypercapnia in children in intensive care has broadened its scope. The IVCO2 Index was developed by Etiometry and named for its goal of detecting the inadequate ventilation of carbon dioxide. It uses artificial intelligence to monitor real-time patient data, sending out an alert if carbon dioxide levels are on track to rise too high in a mechanically ventilated patient, potentially leading to hypercapnic respiratory failure. The AI algorithm was first cleared by the FDA at the end of 2019, with the agency’s go-ahead to monitor for hypercapnia risk in patients between the ages of 29 days and 12 years who weigh at least two kilograms and are on ventilators in an intensive care unit. That indication was slightly expanded last year, allowing the algorithm to be used from the day a patient was born. Now, the technology’s brief has stretched even further, as Etiometry announced this week that the IVCO2 Index can now be used on newborns in the neonatal ICU who weigh under two kilograms. Etiometry said its algorithm can help circumvent some of the current difficulties of monitoring this tiny and especially fragile patient population with standard tools like arterial blood gas testing and transcutaneous monitoring. The IVCO2 index is displayed as a digital readout on Etiometry’s software platform that clinicians can refer to between blood gas tests to keep an eye out for signs of hypercapnia. The index increases in tandem with the risk of inadequate carbon dioxide ventilation—offering a prediction of whether a patient’s partial pressure of carbon dioxide will cross into the danger zone above 50 mmHg. “The IVCO2 Index is a first-of-its-kind algorithm that increases the ability to detect hypercapnia risk without needing additional hardware attached to these fragile patients,” Dimitar Baronov, Etiometry’s chief technology officer, said in the announcement. “It allows clinicians to prioritize care for patients who need it most.” The latest FDA clearance is Etiometry’s ninth since its 2010 founding and its second this year alone. In January, the Boston-based company marked its first foray into older populations in the U.S. as its long-standing IDO2 Index was cleared by the FDA to detect the risk of inadequate oxygen delivery in adult patients in the ICU. The IDO2 Index has been available for use in pediatric populations in the U.S. since 2016. Like the IVCO2 index, it’s digitally displayed on the Etiometry platform and works by using AI to analyze the vast amounts of patient data continuously collected in the ICU around the clock. In this case, however, the algorithm looks for instances in which the amount of oxygen in a patient’s blood is dropping, with an aim of sending out an alert before it reaches the hypoxic respiratory failure phase.