Amnesia, Anterograde

Research validates the efficacy and accuracy of its digital solutions designed to detect early indicators of cognitive impairment BOSTON, March 5, 2025 /PRNewswire/ -- Linus Health has announced that it has hit a major milestone with over 145 peer-reviewed studies conducted and authored by leaders and staff from the company and its affiliates. Since 2019, Linus Health and its affiliates have published 72 peer-reviewed publications and delivered 75 scientific presentations at academic conferences. Linus Health is revolutionizing brain health with trusted, science-driven solutions, delivering a comprehensive, end-to-end strategy that supports early detection, intervention, and continuous care across all settings. The majority of the published research features investigations and validations of the efficacy and accuracy of various elements and solutions within the Linus Health platform designed to promote brain health, detect early indicators of cognitive impairment, and predict the risk of Alzheimer's disease and other forms of dementia. To date, Linus Health has completed more than 40 clinical trials and 25 validation studies and has filed 33 patents supporting its technology, which is available in 18 languages. "These landmark achievements reflect Linus Health's unwavering dedication to scientific validation as we scale and enhance our offerings and capabilities," said Linus Health Co-Founder and Chief Medical Officer Alvaro Pascual-Leone, MD, PhD. "This is a bench to bedside commitment, ensuring that we are at the forefront of advancing brain health within both life sciences and healthcare." A sampling of some of the most noteworthy recent studies published by Linus Health clinicians and researchers includes: The Journal of Alzheimer's Disease, November 2024: Detecting functional impairment with the Digital Clock and Recall. Linus Health Digital Clock and Recall (DCR™) assessment delivers a clinically meaningful evaluation of functional impairment and accurately identifies which patients require more comprehensive care, such as advanced diagnostic testing, specialist referrals, and care partner support. Scientific Reports, September 2024: Digital speech hearing screening using a quick novel mobile hearing impairment assessment: an observational correlation study. The authors concluded that Linus Health's digital hearing screening tool quickly, efficiently, and accurately identifies early signs of speech hearing impairment compared to lengthier audiometric tests. Frontiers in Neurology, June 2024: Towards a lifelong personalized brain health program: empowering individuals to define, pursue, and monitor meaningful outcomes. The article describes a technology-enabled, scalable approach to guide clinical decisions and outcome evaluations about brain health that effectively incorporate patients' treatment priorities. Alzheimer's & Dementia: Diagnosis, Assessment, & Disease Monitoring, February 2024: Clinical classification of memory and cognitive impairment with multimodal digital biomarkers. The article demonstrates the great utility of multimodal assessment with the DCR for identifying verbal memory impairment as confirmed by the Rey Auditory Verbal Learning Test (RAVLT). Alzheimer's Research & Therapy, January 2024: Digital Clock and Recall is superior to the Mini‑Mental State Examination for the detection of mild cognitive impairment and mild dementia. Results of a clinical trial show that the DCR outperforms the most commonly used paper-based assessment in detecting early mild cognitive impairment and mild dementia and with less ethnic bias. Research Strength Matches Company Growth Meanwhile, Linus Health continues to expand and diversify the company while raising awareness of its capabilities through awards and high-profile speaking engagements. Acquisitions. Since 2020, Linus Health has completed four acquisitions. Most recently, it acquired Aural Analytics, a leader in clinical-grade speech analytics, and Together Senior Health, a brain health company delivering evidence-based solutions for individuals with cognitive decline due to Alzheimer's disease and related dementias. In 2022, it acquired Kinesis Health Technologies, a leader in physical function assessment for older adults; and in 2020, it acquired Digital Cognition Technologies, a leader in digital cognitive assessment. Awards. Linus Health has earned numerous prestigious digital health and technology awards over the years. Most recently, Linus Health was named one of Fierce Healthcare's Fierce 15 of 2025, an annual special report highlighting innovative and creative private healthcare companies striving to change the world by changing the healthcare industry. Linus Health was also named the "Best in Class" winner in the Digital Health Hub Foundation's Digital Health Awards 2024 in the Longevity category. The awards recognize companies that "hold the promise of transforming healthcare systems by improving access, efficiency, quality of care, patient outcomes, and addressing cost challenges," according to its founders. Speaking Engagements. John Showalter, MD, MSIS, chief strategy officer of Linus Health, was invited to discuss breakthroughs in the early detection of dementia at the HLTH Event 2024 in Las Vegas. Participating in the "Brainiacs" panel, Showalter explained how primary care physicians and neurologists can leverage innovative digital tools that can make early detection of mild cognitive impairment, the precursor of dementia, as routine as any other preventive screening. In 2024, Ali Jannati, MD, PhD, director of cognitive science at Linus Health, presented the company's latest research on concurrent identification of cognitive impairment and likely amyloid-beta status on PET using the DCR in a featured research panel at the Alzheimer's Association International Conference (AAIC) in Philadelphia. Stina Saunders, PhD, personalized medicine lead at Linus Health, delivered an AAIC presentation focusing on the company's electronic person-specific outcome measure tool. In addition, Linus Health scientists delivered 10 poster presentations at AAIC. More than 14,000 attendees joined the world's largest dementia conference for its robust scientific program. Linus Health leaders were also invited to deliver 4 unique poster presentations at the 17th annual Clinical Trials on Alzheimer's Disease conference in Madrid, Spain. The global conference attracts over 2,000 leading experts onsite and online to discuss the latest therapeutic advances in Alzheimer's disease. "Our many achievements and growing industry recognition reflect an emerging consensus that the best clinical pathway to help more people prevent the progression of dementia and other forms of cognitive impairment is through promotion of brain health, prevention of disease, early detection, and evidence-based lifestyle modifications," said Linus Health Co-Founder and CEO David Bates, PhD. "Our learnings, as well as those of our peers, will continue to inform our solution development in the coming years as we look forward to helping more patients achieve optimal outcomes and a higher quality of life." About Linus Health Linus Health is a Boston-based digital health company focused on transforming brain health for people across the world. By advancing how we detect and address cognitive and brain disorders – leveraging cutting-edge neuroscience, clinical expertise, and artificial intelligence – our goal is to enable a future where people can live longer, happier, and healthier lives with better brain health. Linus Health's digital cognitive assessment platform delivers a proven, practical means of enabling early detection; empowers providers with actionable clinical insights; and supports individuals with personalized action plans. We are proud to partner with leading healthcare delivery organizations, research institutions, and life sciences companies to accelerate more proactive intervention and personalized care in brain health. To learn more about our practical solutions for proactive brain health®, visit or follow us on LinkedIn. Media Contact Tara Stultz (Amendola for Linus Health) 440-225-9595 [email protected] SOURCE Linus Health WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

SARASOTA, Fla., June 27, 2024 (GLOBE NEWSWIRE) -- Oragenics, Inc. (NYSE American: OGEN), a company focused on developing unique, intranasal pharmaceuticals for the treatment of neurological disorders, today announced it has completed a prototype of its automated intranasal device for use in concussed patients who are initially confused, dazed or unconscious in the acute phase of injury. Oragenics’ lead drug candidate, ONP-002, is a new chemical entity (NCE) designed to target the brain through delivery into the nasal cavity and onward to the brain. A Phase II study is being designed to analyze the effectiveness of ONP-002 on blood biomarkers and patient-reported outcomes of concussed patients. Loss of consciousness along with acute memory impairment are linked to prolonged post-concussion symptoms and poor clinical outcomes. Oragenics’ breath-propelled device requires the patient to administer ONP-002 into the nose. Concussed patients with an acute altered mental state may not be capable of following these instructions. Oragenics intends to use its breath-propelled device in the planned Phase II trial, which calls for multiple days of treatment. However, for those patients who have a loss of consciousness or altered mental status early on, the current automated prototype is being developed for their initial treatment by medical staff during the period in which they may struggle to follow directions for blowing. “We are excited about this new automated technology as it allows us to treat the full range of concussive injuries. Both devices offer advantages and can deliver our nanoparticle powder. Given the early mental alterations many concussed patients experience, we aim to provide them the best drug delivery route to improve their clinical outcomes,” stated Michael Redmond, President at Oragenics. Approximately 10% of concussed patients lose consciousness, while many others experience an immediate altered mental state, with short-term memory loss and confusion. Both loss of consciousness and acute memory impairment are linked to prolonged post-concussion symptoms and poor clinical outcomes. Concussion is an unmet medical need. There are an estimated 69 million concussions annually reported worldwide. Common causes of concussion include falls, motor vehicle accidents, and contact sports. Other neurological disorders, including Alzheimer’s Disease, Parkinson’s Disease, and Chronic Traumatic Encephalopathy (CTE), have been linked to concussion. Post-concussion symptomology is linked to long-term disability and occurs in as high as 20% of concussed patients. About Oragenics Forward-Looking Statements This communication contains “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, including without limitation statements regarding the ability of the Company to timely and successfully undertake Phase II clinical trial using its novel drug-device combination for the treatment of mild Traumatic Brain Injury. These forward-looking statements are based on management’s beliefs and assumptions and information currently available. The words "believe," "expect," "anticipate," "intend," "estimate," "project" and similar expressions that do not relate solely to historical matters identify forward-looking statements. Investors should be cautious in relying on forward-looking statements because they are subject to a variety of risks, uncertainties, and other factors that could cause actual results to differ materially from those expressed in any such forward-looking statements. These factors include, but are not limited to: the Company’s ability to advance the development of its product candidates, including the neurology assets, under the timelines and in accord with the milestones it projects; the Company’s ability to raise capital and obtain funding, non-dilutive or otherwise, for the development of its product candidates; the regulatory application process, research and development stages, and future clinical data and analysis relating to its product candidates, including any meetings, decisions by regulatory authorities, such as the FDA and investigational review boards, whether favorable or unfavorable; the Company’s ability to obtain, maintain and enforce necessary patent and other intellectual property protection; the nature of competition and development relating to concussion treatments; the Company’s expectations as to the outcome of preclinical studies and clinical trials and the potential benefits, activity, effectiveness and safety of its product candidates including as to administration, transmission, manufacturing, storage and distribution; and general economic and market conditions and risks, as well as other uncertainties described in our filings with the U.S. Securities and Exchange Commission. All information set forth is as of the date hereof unless otherwise indicated. You should consider these factors in evaluating the forward-looking statements included and not place undue reliance on such statements. We do not assume any obligation to publicly provide revisions or updates to any forward-looking statements, whether as a result of new information, future developments or otherwise, should circumstances change, except as otherwise required by law. Oragenics, Inc. Janet Huffman, Chief Financial Officer 813-286-7900 jhuffman@oragenics.com Investor Relations: Rich Cockrell CG Capital 404-736-3838 ogen@cg.capital

A research team has revealed the link between the frequency of sleep apnea events during the rapid-eye-movement stage and the severity of verbal memory impairment in older adults at risk for Alzheimer's disease. Verbal memory refers to the cognitive ability to retain and recall information presented through spoken words or written text and is particularly vulnerable to Alzheimer's. A research team led by the University of California, Irvine has revealed the link between the frequency of sleep apnea events during the rapid-eye-movement stage and the severity of verbal memory impairment in older adults at risk for Alzheimer's disease. Verbal memory refers to the cognitive ability to retain and recall information presented through spoken words or written text and is particularly vulnerable to Alzheimer's. The study, recently published online in the journal Alzheimer's Research & Therapy, discovered a specific correlation between the severity of sleep apnea -- when breathing pauses while an individual is sleeping -- and diminished cognition. Higher ratios during REM compared to non-REM stages were associated with worse memory performance. "Our findings identified the specific features of sleep apnea that are associated with memory, which is important because clinically, events occurring during REM sleep are often overlooked or minimized," said co-corresponding author Bryce Mander, UC Irvine associate professor of psychiatry & human behavior. "Most hours of sleep are non-REM, so the overall averages of apnea severity can look much lower than what is typically observed during REM sleep. This means that someone at risk can be misdiagnosed and undertreated because current evaluation standards are not focused on sleep-stage-specific apnea severity." "Furthermore," said co-corresponding author Ruth Benca, professor and chair of psychiatry and behavioral medicine at Wake Forest University School of Medicine, "we found that women are more likely to have a greater proportion of their apneic events in REM sleep in comparison to men, which could potentially be contributing to their greater risk for Alzheimer's disease." The study involved 81 middle-aged and older adults from the Wisconsin Alzheimer's Disease Research Center with heightened risk factors, of whom 62 percent were female. Participants underwent polysomnography -- a comprehensive test that records brain waves, eye movements, muscle activity, blood oxygen levels, heart rate and breathing during sleep -- and verbal memory assessments. Results showed apnea events during REM to be a critical factor contributing to verbal memory decline, especially among individuals with a genetic predisposition to Alzheimer's and those with a parental history of the disease. "Our findings highlight the intricate relationship among sleep apnea, memory function and Alzheimer's risk," Mander said. "Identifying and addressing REM-specific events are crucial for developing proactive, personalized approaches to assessment and treatment that are tailored to individual sleep patterns." The team also included lead author Kitty K. Lui, a graduate student in the San Diego State University/University of California, San Diego joint doctoral program in clinical psychology, and faculty and graduate students from UC Irvine, UC San Diego, the Wisconsin Alzheimer's Disease Research Center and the University of Kentucky. This work was supported by the National Institute on Aging under grants R56 AG052698, R01 AG027161, R01 AG021155, ADRC P50 AG033514, R01 AG037639 and K01 AG068353; by the National Institutes of Health's Ruth L. Kirschstein National Research Service Award F31 AG048732; and by the National Center for Advancing Translational Sciences' Clinical and Translational Science Awards Program under grant UL1TR000427.