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Tonix Pharmaceuticals drug TNX-102 SL gets FDA ok for US Department of Defense funded trial

Tonix Pharmaceuticals

Tonix Pharmaceuticals CEO Dr. Seth Lederman joined Steve Darling from Proactive to share significant news regarding the company's latest development: the clearance of the Investigational New Drug application by the U.S. Food and Drug Administration for the Phase 2 investigator-initiated OASIS trial. This trial aims to evaluate the efficacy of TNX-102 SL in reducing the severity of acute stress reaction and the frequency of acute stress disorder and post traumatic stress disorder. Dr. Lederman explained that the trial is sponsored by The University of North Carolina Institute for Trauma Recovery and is supported by a substantial 3 million dollar grant from the U.S. Department of Defense. The primary objective of the trial is to assess the safety and efficacy of TNX-102 SL in mitigating adverse posttraumatic neuropsychiatric effects among patients who present to the emergency department following a motor vehicle collision. The trial is expected to enroll approximately 180 trauma survivors across various emergency department study sites throughout the United States. Participants will be randomly assigned to receive either TNX-102 SL 5.6 mg or a placebo for a two-week course. Notably, there is currently a lack of medication available at or near the point-of-care to effectively address the needs of patients suffering from traumatic events and support their long-term health. This development underscores Tonix Pharmaceuticals' commitment to addressing unmet medical needs in the field of trauma recovery and psychiatric disorders. With the initiation of the OASIS trial, the company aims to contribute to the advancement of treatment options for individuals experiencing acute stress reactions and related neuropsychiatric sequelae following traumatic events. Contact Details Proactive Investors +1 604-688-8158 na-editorial@proactiveinvestors.com

February 28, 2024 06:56 AM Eastern Standard Time

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Tonix Pharmaceuticals' Fibromyalgia Trial Shows Promising Results in Webinar Presentation

Tonix Pharmaceuticals

Tonix Pharmaceuticals CEO Dr. Seth Lederman joined Steve Darling from Proactive to share positive Phase 3 data on Tonmya, also known as TNX-102 SL, for the management of fibromyalgia, and discussed the company's plans to file for FDA approval in the second half of 2024. Dr. Lederman highlighted that Tonmya, a centrally acting, non-opioid, non-addictive bedtime medication, showed promising results in the RESILIENT Phase 3 study. The study met its pre-specified primary endpoint by significantly reducing daily pain compared to placebo in participants with fibromyalgia. Additionally, significant improvements were observed in key secondary endpoints related to sleep quality, fatigue reduction, and overall fibromyalgia symptoms and function. Based on these positive results, Tonix Pharmaceuticals plans to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in the second half of 2024 for Tonmya for the management of fibromyalgia. The company hosted a webinar featuring key opinion leaders in fibromyalgia, highlighting the significance of the trial results. Interested individuals can access the webinar through Tonix Pharmaceuticals' website or the accompanying press release. Led by renowned experts like Professor Leslie Arnold and Professor Dan Clau, the webinar offers valuable insights into the treatment landscape for fibromyalgia. Tonix Pharmaceuticals remains committed to advancing innovative solutions for fibromyalgia and improving patient outcomes. Contact Details Proactive Investors +1 604-688-8158 na-editorial@proactiveinvestors.com

February 28, 2024 06:54 AM Eastern Standard Time

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TRUE Addiction & Behavioral Health: Elevating Standards of Care in Murfreesboro, Tennessee

TRUE Addiction & Behavioral Health

TRUE (Transforming Roots Unto Eternity) Addiction & Behavioral Health proudly announces its grand opening in Murfreesboro, Tennessee for individuals seeking comprehensive addiction and behavioral health services. Founded by Benjamin Dobbs, the facility stems from the urgent need for elevated standards of care in substance abuse and mental health treatment across the greater Nashville area. TRUE offers a spectrum of services addressing substance abuse, mental health disorders, and gambling and process addiction. Recent statistics underline the critical need for such services. According to the National Institute on Drug Abuse (NIDA), approximately 20.4 million adults in the United States battled a substance use disorder in 2019, with only about 10.3% receiving the specialized treatment they needed. Furthermore, NIDA indicates a concerning trend of increased drug overdose deaths with 92,000 fatalities recorded in 2020. Dobbs emphasizes, “As a leading substance abuse and mental health treatment facility, we are committed to delivering the highest quality care and fostering lasting recovery. Through evidence-based best practices and client-centered care, we equip individuals with the tools for transformation. Our approach delves into core beliefs, values, and connections, ensuring comprehensive support tailored to each client’s needs and fostering results-driven progress.” Programs offered: Partial hospitalization program (PHP): Intensive and structured care for individuals, ideal for those needing support beyond outpatient therapy without 24-hour hospitalization. Intensive outpatient program (IOP): Structured therapy and support while individuals continue living at home or in a supportive environment. Sober living homes: Structured housing offering additional accountability through drug tests and curfews, often utilized alongside PHP and IOP. Treatment services used in programs include: Cognitive Behavioral Therapy (CBT): Proven effective for various disorders, including depression, anxiety, and substance use issues. Dialectical Behavioral Therapy (DBT): Focused on managing emotions and relationships, particularly beneficial for addiction and self-harm. Holistic Therapy: Addressing physical, emotional, mental, and spiritual well-being for balanced development and coping skills. 12-Step Facilitation and Relapse Prevention: Customized aftercare plans and techniques to prevent relapse and sustain recovery. Additionally, TRUE plans to enhance community engagement among the clients with the upcoming opening of a 3,500-square-foot community center this spring. The center will feature a cafe, a 50-person meeting area, a meditation and yoga room, a lounge area, and a gaming area with ping pong, a pool table, and cornhole. These amenities are designed to aid in the healing process, promoting relaxation and stress reduction in clients between therapy sessions, as well as improving their comfort and ability to concentrate during therapy. TRUE Addiction & Behavioral Health in Murfreesboro, Tennessee, is dedicated to delivering compassionate and personalized care to individuals facing addiction and mental health challenges. Unlike standardized approaches, TRUE devises tailored treatment plans, equipping clients with the tools needed for lasting recovery. It stands as the only facility in Tennessee offering outpatient care for both mental health and substance abuse. For more information about programs and scheduling tours, visit https://trueaddictionbh.org/. Contact Details R Public Relations Madison Baber +1 210-213-2426 madison@rprfirm.com Company Website https://trueaddictionbh.org/

February 27, 2024 01:31 PM Eastern Standard Time

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Express Gene Molecular Diagnostics Laboratory Receives Accreditation from the College of American Pathologists

ExpressGene Lab

The Accreditation Committee of the College of American Pathologists (CAP) has awarded accreditation to Express Gene Molecular Diagnostics Laboratory (Express Gene Lab), following a comprehensive on-site inspection by CAP inspectors, who are experienced professionals in pathology and laboratory medicine. This accreditation is a testament to Express Gene's adherence to the highest standards of quality and risk management, contributing significantly to enhanced patient outcomes. Express Gene Lab, was informed of this prestigious global recognition and praised for the laboratory's commitment to excellence in its services. Express Gene Lab is now among the elite group of over 8,000 CAP-accredited facilities worldwide. Express Gene Lab Team expressed their enthusiasm: "Achieving CAP accreditation is a monumental milestone for Express Gene Lab. It underscores our dedication to providing the highest quality of laboratory services and our commitment to patient care. This accreditation affirms our relentless pursuit of excellence and our unwavering commitment to the health and safety of our patients." The CAP accreditation process is rigorous, involving detailed scrutiny of the laboratory’s procedures, records, quality control measures, staff qualifications, equipment, facilities, safety protocols, and overall management. This evaluation ensures adherence to the latest best practices in laboratory medicine.. Express Gene Lab takes immense pride in this achievement, which reflects our pathology and laboratory medicine team's hard work and dedication to high-quality patient care. About the College of American Pathologists: The CAP is the world’s largest organization of board-certified pathologists and a leading provider of laboratory accreditation and proficiency testing programs. It serves patients, pathologists, and the public by promoting excellence in pathology and laboratory medicine globally. For more information, visit CAP.org and follow the stories of pathologists making a difference in patient care at yourpathologist.org. Rooted in pathologist expertise, CAP collaborates with laboratories globally to enhance the quality of laboratory medicine, aiming for operational excellence, diagnostic confidence, and superior patient care About Express Gene Molecular Diagnostics Laboratory Express Gene Lab is at the forefront of molecular diagnostics, offering a comprehensive suite of genetic testing services designed to provide insightful and actionable health information. Our state-of-the-art laboratory is equipped with advanced technology to ensure accuracy and reliability across all tests, including pharmacogenomics, cancer risk assessment, neurogenetic disorders, and prenatal screenings. At Express Gene Lab, we are committed to making genetic testing accessible and understandable, empowering individuals and healthcare providers to make informed decisions about health and treatment strategies. Our team of expert geneticists, pathologists, and laboratory technicians work diligently to uphold the highest standards of quality and confidentiality. With a patient-centric approach, we strive to deliver not just results, but also the support and resources needed to navigate genetic health. Express Gene Lab is proud to be an accredited facility by the College of American Pathologists (CAP), reflecting our dedication to excellence in laboratory services. For Press Inquires: AlphaBull (800) 530-0412 www.Pubcowire.com For more information about our services or to request a testing kit, please visit our website www.expressgene.me/collection or contact us directly. Our customer service team is available to answer any questions and assist with your genetic testing needs. At Express Gene Lab, your health is our priority, and we are dedicated to providing you with the highest level of service and care. Contact Details ExpressGene Lab Lab Direct +1 786-250-3419 info@expressgene.us Company Website https://www.expressgene.us

February 27, 2024 12:54 PM Eastern Standard Time

PathAI Launches New Pathologist-Centric Features on AISight to Enable Efficient Case Review through Intelligent Case Prioritization and Real-Time Multi-Institutional Collaboration

PathAI

PathAI, Inc., a leading AI-powered precision pathology company, today announced the availability of two new features on the AISight digital pathology image management system – an Intelligent Caselist and AISight Live. AISight is a cloud-based platform that serves as a central hub for case management, image management, and best-in-class artificial intelligence to enable efficient end-to-end digital pathology workflows. The latest AISight enhancements represent PathAI’s ongoing commitment to empowering pathologists with cutting-edge solutions that improve pathology assessment and laboratory operations and lay the groundwork for broader implementation of AI tools in pathology. AISight Live includes a suite of features to optimize real-time collaboration for a variety of use cases, and its Sync view allows users to follow one another as they navigate the slide – providing real-time case review and interaction with users remotely. An AISight Live Participants list allows users to invite other pathologists for ‘over the shoulder’ and multi-headed scope review/consults, live tumor boards, educational seminars and training, and anonymized viewing to mask PHI if necessary. “The AISight Live collaboration suite marks a significant leap in optimizing remote interactions amongst pathologists,” says Eric Walk, PathAI Chief Medical Officer. “This feature holds immense promise in enhancing collaborative efforts, fostering knowledge exchange, driving resident education, and ultimately improving collaboration through efficient and dynamic pathology workflows.” The Intelligent Caselist features an information-rich data table and three filterable charts, providing pathologists and lab personnel a more streamlined view of their case workload, and allowing for embedded AI to assist in case prioritization. “We’re confident that the AISight Live and the Intelligent Caselist features will simplify pathology workflows and speed up the more tedious tasks – such as case prioritization,” said Pete Romanowich, PathAI Vice President of Program Management and Platform Product. “These features will streamline and optimize pathologist workflows, providing pathologists more time to operate at the top of their license and focus their attention where it matters most.” The AISight platform was created with input from hundreds of pathologists from dozens of institutions, and its launch, and enhancements, underpins all the work PathAI does to support pathologists, biopharma partners and those in the academic research community. AISight Live and the Intelligent Caselist are another critical step in PathAI’s quest to improve patient outcomes with AI-powered pathology. PathAI launched AISight as an IMS in September 2023. Many leading anatomic pathology laboratories ranging from reference laboratories, to independent laboratories and academic medical centers are now using AISight. To learn more about AISight, PathAI’s Image Management System, join our next webinar on February 29, for a live demo of the latest AISight enhancements and an overview of our 2024 product roadmap. AISight is For Research Use Only. Not for use in diagnostic procedures. About PathAI PathAI is the only AI-focused technology company to provide comprehensive precision pathology solutions from wet lab services to algorithm deployment for clinical trials and laboratory use. Rigorously trained and validated with data from more than 15 million annotations, its AI-powered models can be leveraged to optimize the analysis of pathology samples to improve efficiency and accuracy of pathology interpretation, as well as to better gauge therapeutic efficacy and accelerate drug development for complex diseases. For more information, please visit www.pathai.com. PathAI is headquartered in Boston, MA, and manages a CAP/CLIA-certified diagnostics clinical laboratory (formerly known as Poplar Healthcare) – one of the country’s largest anatomic pathology labs – in Memphis, TN. For more information, please visit www.pathai.com. Contact Details SVM Public Relations and Marketing Communications Maggie Naples +1 401-490-9700 pathai@svmpr.com Company Website https://www.pathai.com/

February 27, 2024 10:00 AM Eastern Standard Time

Vaping: Know the Truth: Youth Vaping Prevention & Resources to Quit

YourUpdateTV

A video accompanying this announcement is available at: https://youtu.be/LXqBkJ5imDA E-cigarette use remains a public health threat among youth and young adults with more than 2.1 million middle and high schoolers currently using e-cigarettes, according to the 2023 National Youth Tobacco Survey. Nearly one in four students surveyed use e-cigarettes vape every day or nearly daily, underscoring the highly addictive nature of nicotine, which is harmful to developing brains. It doesn’t stop there. A recent study revealed that teen cannabis use has increased by 245% over the past two decades and approximately 15% of high school seniors who have ever used cannabis become daily or near daily users. On February 5th, a media tour was conducted featuring Amy Taylor, Chief of Community Engagement for Truth Initiative and teachers who use the Vaping: Know the truth curriculum. Vaping: Know the truth is a free, comprehensive digital curriculum designed to empower students by giving them the facts about the health dangers of e-cigarettes and providing resources for youth who vape to quit and made available to schools by leading social impact education innovator, EVERFI. Truth Initiative also recently added two new lessons to the Vaping: Know the truth curriculum to equip students with knowledge about the health effects of vaping cannabis. The new cannabis-focused lessons equip students with knowledge regarding cannabis in vaping products, including short- and long-term health effects, consequences, and risks. Since its launch, more than one million students across the country have actively engaged with the curriculum. It is a self-led interactive online course with peer-to-peer instruction. It was developed as part of Truth Initiative’s proven-effective and nationally recognized truth youth public education campaign. In addition to encouraging students to live vape-free lives, Vaping: Know the truth offers resources to help young people who are currently using e-cigarettes to quit through truth’s first-of-its-kind text message youth quit vaping program This is Quitting, which is already helping more than 700,000 youth and young adults on their journeys to quit. The curriculum also has suggested resources available for young people looking to quit cannabis. For more information, visit TRUTHINITIATIVE.ORG/VAPING-CURRICULUM Contact Details YourUpdateTV +1 212-736-2727 yourupdatetv@gmail.com

February 26, 2024 12:25 PM Eastern Standard Time

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Clearmind Medicine receives Patent Approval in China for treatment of binge behaviours

Clearmind Medicine Inc

Clearmind Medicine Inc CEO Dr. Adi Zuloff-Shani joined Steve Darling from Proactive to announce a significant milestone for the company: the granting of divisional patent approval by the China National Intellectual Property Administration (CNIPA). This latest patent approval solidifies Clearmind's patent protection for its flagship molecule and further establishes its extensive intellectual property (IP) protection in the psychedelic space. Clearmind's IP portfolio now encompasses fifteen utility patent families, including patents and applications with method of use and composition of matter claims. This includes 24 pending patent applications and 27 granted patents in key jurisdictions such as the US, Europe, China, and India. The company's robust IP portfolio positions it as a leader in the development of innovative treatments in the psychedelic field. Dr. Zuloff-Shani provided insights into Clearmind's flagship molecule, MEAI, which has shown promise in reducing the desire to consume alcoholic beverages while inducing a slight euphoric, alcohol-like experience. This treatment targets Alcohol Use Disorder, a prevalent condition characterized by an individual's inability to control their alcohol consumption despite negative consequences. MEAI also holds potential in addressing binge drinking, offering hope for individuals struggling with this harmful addiction. Clearmind plans to commence clinical trials for alcohol use disorder, expand their IP portfolio, and explore M E's potential in treating obesity. With collaborations with esteemed institutions like Johns Hopkins and Yale, Clearmind aims to revolutionize addiction treatment and offer innovative solutions to societal challenges. Stay tuned for their exciting developments in 2024. Contact Details Proactive North America Proactive North America +1 604-688-8158 NA-editorial@proactiveinvestors.com

February 26, 2024 10:37 AM Eastern Standard Time

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Cardiff Lexington CEO Alex Cunningham Discusses Healthcare Growth Strategy

Cardiff Lexington Corporation

Cardiff Lexington CEO Alex Cunningham joined Steve Darling from Proactive to discuss the company's transformation into an acquisition-oriented healthcare firm with a focus on orthopedic surgery centers. Cardiff Lexington's revenue primarily stems from bodily injury and general liability insurance coverages, providing insulation from pricing downsides associated with Medicare and Medicaid. Cunningham emphasized the unique accounts receivable structure of the company, along with its focus on uninsured coverages, which contribute to maintaining high collectability rates. He also highlighted the increasing demand for orthopedic services driven by an aging population, positioning Cardiff Lexington for growth in this market. The company's recent financial performance showed significant increases in revenue, net earnings, and assets, reflecting its strategic focus and operational efficiency. Looking ahead to 2024, Cardiff Lexington plans to continue its expansion through acquisitions, market expansion initiatives, and strategic partnerships. Furthermore, Cunningham mentioned the company's plans to release its 10k in early March and pursue an uplift to a major exchange in 2024, with a clear focus on enhancing shareholder value and achieving strategic growth objectives. Contact Details Proactive North America Proactive North America +1 604-688-8158 NA-editorial@proactiveinvestors.com

February 26, 2024 10:32 AM Eastern Standard Time

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IQ-AI advances glioblastoma clinical trial, eyes phase two in 2025

IQ-AI Ltd

Dr Jennifer Connelly, MD, the Principal Investigator (PI) of the IQ-AI Limited sponsored phase one clinical trial that is being conducted at the Medical College of Wisconsin, joined Proactive's Stephen Gunnion with a positive update from its treatment for recurring glioblastoma patients. Connelly explained that glioblastoma, the most common malignant brain tumour, significantly impacts brain function, highlighting the importance of clinical trials to improve patient quality of life. The trial, opened nearly two years ago, investigates gallium maltolate, an oral medication showing promise in preclinical studies and animal models for efficacy against tumour cells. This phase focuses on drug tolerance, with patients reporting ease of use compared to traditional treatments and the ability to maintain normal daily activities. An expanded access programme (EAP), also known as compassionate use, has been launched by IA-AI subsidiary Imaging Biometric to allow wider access to gallium maltolate across the country, benefiting patients unable to travel to the Medical College of Wisconsin. The EAP, approved by the FDA, aims to collect additional safety and toxicity data, contributing to the trial's findings and supporting the progression towards a phase two clinical trial. The next milestone, by the end of 2024, involves concluding the phase one trial, determining the maximum tolerated dose, and preparing for the phase two trial slated for 2025, focusing on safety and beginning to evaluate efficacy. Contact Details Proactive UK Proactive UK +44 20 7989 0813 UKEditorial@proactiveinvestors.com

February 26, 2024 09:51 AM Eastern Standard Time

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