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Adia Nutrition Inc. Supports Heroes and Their Families with TRICARE In-Network Application, Advancing Regenerative Care Through Adia Med
Newsfile· 2025-07-23 13:45
Core Insights - Adia Nutrition Inc. is advancing its regenerative care offerings by filing to become an in-network provider with TRICARE, which serves approximately 9.5 million beneficiaries, including active-duty service members and their families [2][5] - The company anticipates approval as a United Healthcare provider by August 1, 2025, which will further enhance its healthcare access initiatives [2][5] - Adia Med aims to secure TRICARE in-network provider status by August 31, 2025, tapping into a program that disbursed $50.6 billion for medical treatments in FY2019 [2][3] Company Developments - Adia Med plans to offer innovative regenerative treatments such as Umbilical Cord Blood Stem Cell therapies, Autologous Hematopoietic Stem Cell Transplantation, and Therapeutic Plasma Exchange, targeting conditions like Multiple Sclerosis and joint pain [3][5] - The filing with TRICARE complements Adia Med's progress with United Healthcare, where the company has begun submitting patient insurance claims, indicating near-final integration into the healthcare system [5] - By securing in-network status with both TRICARE and United Healthcare, Adia Med will join a select group of providers recognized for clinical excellence and compliance, enhancing patient care and insurance reimbursement opportunities [5][6] Market Positioning - The strategic move to join TRICARE's network is expected to make advanced regenerative therapies more accessible and affordable for military personnel and their families, aligning with the company's mission to revolutionize healthcare accessibility [3][5] - Adia Nutrition Inc. operates with a dual focus on premium organic supplements and leading-edge stem cell therapies, positioning itself as a key player in the healthcare and wellness industry [6]
Creative Medical Technology Holdings Receives Notice of Allowance for the Prevention and/or Treatment of Type 1 Diabetes Using Modulated Immune Cells
Globenewswire· 2025-07-17 13:15
Group 1 - Creative Medical Technology Holdings, Inc. has received a Notice of Allowance for a U.S. patent related to the treatment of Type 1 Diabetes, which will be effective until at least 2040 [1][4] - The patent supports a cell-based immunotherapy approach using the ImmCelz product, which involves supercharged T regulatory cells derived from patients with Type 1 Diabetes [2][5] - Type 1 Diabetes is characterized by the immune system attacking insulin-producing beta cells in the pancreas, leading to insulin deficiency [3] Group 2 - The CEO of Creative Medical emphasizes that the use of ImmCelz represents regenerative immunotherapy and highlights the ongoing CREATE-1 clinical trial focused on Type 1 Diabetes [4] - The ImmCelz platform reprograms a patient's immune cells with optimized cell-free factors, enhancing their regenerative properties for potential treatment of various conditions [5][6] - Creative Medical is a clinical-stage biotechnology company specializing in regenerative medicine solutions across multiple indications, including pain management and neurology [6]
CollPlant Appoints Collagen Biomaterials Expert as New Head of North America Commercial Operations
Prnewswire· 2025-07-14 11:00
Core Viewpoint - CollPlant Biotechnologies has appointed Bowman Bagley as Vice President, Commercial North America, to enhance its growth strategy and market presence for rhCollagen products [1][2]. Company Overview - CollPlant is focused on regenerative and aesthetic medicine, utilizing non-animal-derived recombinant human collagen (rhCollagen) for its products [5]. - The company aims to innovate in areas such as 3D bioprinting, tissue repair, and medical aesthetics [5]. Leadership Appointment - Bowman Bagley will oversee the commercial strategy, including sales, marketing, and logistics for CollPlant's rhCollagen-based products in North America [1][2]. - Bagley has extensive experience in collagen-based biomaterials and has held leadership roles in sales and product development [2][3]. Strategic Goals - The appointment of Bagley is expected to accelerate the growth of CollPlant's bioinks portfolio and expand rhCollagen sales in both research markets and strategic collaborations [2]. - The company has previously entered into a significant agreement with Allergan for dermal and soft tissue fillers, indicating a strong market position [6].
Bonus Biogroup Appoints Renowned Cell Therapy Leader, Professor Edwin M. Horwitz, MD, PhD, to its Advisory Board
Globenewswire· 2025-07-14 11:00
Core Insights - Bonus Biogroup has appointed Professor Edwin M. Horwitz to its Advisory Board to strengthen its scientific leadership as it progresses toward Phase 3 clinical trials for its therapies BonoFill and MesenCure [1][2][3] Company Overview - Bonus Biogroup is a late-stage biotechnology company focused on immunomodulatory and regenerative mesenchymal stem cells (MSC) to develop innovative tissue engineering and cell therapy solutions [1][7] - The company aims to create effective and safe therapies for common and severe conditions with limited treatment options, ensuring broad accessibility through cost-effective solutions [7] Key Products BonoFill - BonoFill is an autologous tissue-engineered live human bone graft designed for treating large or nonhealing bone defects, with a 90% success rate in Phase 2 trials [4] - The company plans to initiate a Phase 3 study for BonoFill in 2026, targeting a total addressable market (TAM) of approximately $25.0 billion in the U.S. by 2030 [4] MesenCure - MesenCure is an allogeneic cell therapy aimed at treating inflammation and tissue damage, with a Phase 2 trial showing a 68% reduction in mortality for COVID-19 pneumonia patients [6] - The FDA has cleared an IND application for MesenCure, allowing the company to proceed with a Phase 3 clinical trial, with a market potential of approximately $9.4 billion in the U.S. by 2030 [6] Leadership and Expertise - Professor Horwitz brings over three decades of experience in cell therapy, clinical hematology, and oncology, enhancing the company's commitment to scientific excellence and innovation [2][3] - He has authored over 210 scientific publications, significantly influencing global research and therapeutic development in cell therapy [3] Intellectual Property - Bonus Biogroup holds a strong intellectual property portfolio with six patent families, including 71 granted patents and 10 pending applications across multiple countries [8]
Creative Medical Technology Holdings Receives Notice of Allowance for ImmCelz™ for Treatment of Heart Failure and/or Post Infarct Pathological Remodeling
Globenewswire· 2025-07-11 12:01
Core Insights - Creative Medical Technology Holdings, Inc. has received a Notice of Allowance for a U.S. patent related to treating heart failure and post-infarct pathological remodeling using its ImmCelz product, with the patent expected to be effective until at least 2040 [1][2]. Group 1: Patent and Product Details - The patent covers treatment for patients at risk of or already experiencing heart failure, utilizing the proprietary ImmCelz product [2]. - The total addressable market for heart failure treatment in the U.S. exceeds five million patients, with an additional six million patients suffering from chronic chest pain who may benefit from the ImmCelz product [2]. - ImmCelz is administered through an ultra-minimally invasive outpatient procedure [2]. Group 2: Company Strategy and Technology - The CEO of Creative Medical emphasized that the Notice of Allowance enhances the company's intellectual property portfolio and reflects the potential of its cell-based technology for developing therapies across various indications [3]. - The ImmCelz platform involves reprogramming a patient's immune cells outside the body with optimized cell-free factors before re-injecting them, which is believed to enhance their regenerative properties [4]. - Creative Medical is focused on pioneering regenerative medicine solutions across multiple indications, including pain management, neurology, and urology [5].
Longeveron® Announces Completion of Enrollment of Pivotal Phase 2b Clinical Trial Evaluating Laromestrocel as a Treatment for Hypoplastic Left Heart Syndrome (HLHS)
Globenewswire· 2025-06-24 10:30
Core Insights - Longeveron Inc. has completed full enrollment of the Phase 2b clinical trial (ELPIS II) for laromestrocel, targeting Hypoplastic Left Heart Syndrome (HLHS) [1][2] - The trial aims to evaluate laromestrocel as a potential adjunct treatment for HLHS, with top-line results expected in Q3 2026 [1][5] - Laromestrocel has received multiple FDA designations, including Orphan Drug, Fast Track, and Rare Pediatric Disease designations, indicating its potential significance in addressing unmet medical needs [4][5] Company Overview - Longeveron is a clinical stage biotechnology company focused on developing regenerative medicines, with laromestrocel as its lead investigational product [9] - The company is pursuing treatments for HLHS, Alzheimer's disease, and aging-related frailty, with laromestrocel being an allogeneic mesenchymal stem cell therapy [9] Clinical Trial Details - ELPIS II enrolled 40 pediatric patients across twelve leading treatment institutions, with primary endpoints including survival at 12 months and changes in right ventricular ejection fraction [2][3] - The trial builds on the success of ELPIS I, which reported 100% transplant-free survival at five years for patients treated with laromestrocel [3][6] Market Potential - The U.S. market potential for laromestrocel in treating HLHS is estimated to be up to $1 billion, highlighting the significant unmet medical need in this area [5] - If successful, the company could be eligible for a Priority Review Voucher (PRV), which can expedite the review process for future drug applications [7] Regulatory Status - The FDA has confirmed that ELPIS II is a pivotal trial, and positive results could lead to a Biological License Application (BLA) submission for full approval [4][5] - The Rare Pediatric Disease PRV program is currently facing uncertainty, but recent legislative efforts may extend its availability [7]
Home Run! Adia Med of Winter Park's AHCA Triumph Brings Insurance-Covered Healing to Patients
Newsfile· 2025-06-16 13:00
Core Insights - Adia Nutrition, Inc. has received full approval from the Agency for Health Care Administration (AHCA) for its clinic, Adia Med of Winter Park, allowing it to accept insurance for treatments [2][4][5] - This approval positions Adia Med as a leading provider of innovative therapies, including Autologous Hematopoietic Stem Cell Transplantation (aHSCT) for Multiple Sclerosis and other autoimmune conditions [4][6] - The clinic aims to enhance patient access to life-changing treatments by advocating for insurance coverage, thereby reducing financial barriers [5][6] Company Overview - Adia Nutrition, Inc. is a publicly traded company focused on revolutionizing healthcare through innovative regenerative medicine and nutritional supplements [7] - The company operates two main divisions: a supplement division offering premium organic supplements and a medical division specializing in advanced stem cell therapies [7] - Adia Med of Winter Park opened in January 2025 and is designed to provide personalized regenerative treatments [6][7] Market Context - The approval by AHCA allows Adia Nutrition to enter the $4.9 trillion healthcare insurance market, enhancing its growth potential [6] - By accepting insurance, the company can better serve patients and expand its reach within the healthcare sector [5][6]
Global Longevity Summit 2025: Spotlight on Dr. Steve Horvath, New Advisory Board Members, and Early Registration Opportunity
Globenewswire· 2025-06-12 15:00
Core Insights - The Global Longevity Summit is set to take place from October 28–30, 2025, at the Genolier Innovation Hub in Geneva, Switzerland, focusing on advancements in aging science and human performance [3][5] - Dr. Steve Horvath, a biogerontologist and epigenetic researcher, will be the keynote speaker and will receive the 2025 Global Longevity Award for his work on the epigenetic clock [2][3] - The event will feature 300 global leaders from healthcare, science, business, and capital, emphasizing the theme "Mastering the Aging Clock: The Science of Longevity" [3][4] Event Details - The Summit will include discussions on epigenetics, regenerative medicine, AI-powered health optimization, and precision intervention strategies [3] - New members have been appointed to the Scientific and Professional Advisory Board, enhancing the event's multidisciplinary approach [4] - Early registration is encouraged due to rising demand, with ticket prices set to increase on July 1 [5] Participation Information - The Global Longevity Summit is an invitation-only event, requiring participant approval for qualified professionals and executives in the longevity ecosystem [6][7] - Interested participants can apply for access through the official website [6]
Cryoport Completes CRYOPDP Divestiture and Commences Strategic Partnership with DHL Group
Prnewswire· 2025-06-12 12:00
Core Insights - Cryoport, Inc. has completed the divestiture of its specialty courier business, CRYOPDP, to DHL Group for approximately $200 million in cash [1][4] - A strategic partnership has been established between Cryoport and DHL to enhance supply chain services in the global life sciences and healthcare sector [2][3] Financial Impact - The divestiture provides a significant capital infusion, improving Cryoport's growth trajectory and positioning the company for sustainable, long-term profitability [4] Strategic Focus - The partnership with DHL is expected to enhance Cryoport's capabilities in the Asia Pacific and EMEA regions, allowing for targeted services in response to market demand [3] - Cryoport aims to intensify its focus on advancing its Life Science Services platform, particularly in the regenerative medicine market [3] Company Overview - Cryoport is a leader in temperature-controlled supply chain solutions for the life sciences, emphasizing regenerative medicine [5] - The company offers a comprehensive suite of services designed to minimize risk and maximize reliability across the temperature-controlled supply chain [5]
Capricor Therapeutics Announces Key Regulatory Updates for its Duchenne Muscular Dystrophy Program
Globenewswire· 2025-06-11 13:25
Core Insights - Capricor Therapeutics has successfully completed the FDA Pre-License Inspection for its manufacturing facility in San Diego for Deramiocel, its lead cell therapy candidate for Duchenne Muscular Dystrophy (DMD) [1][5] - The inspection resulted in a Form 483 with several observations related to quality systems and documentation practices, but no material changes to the cGMP process were required [1][5] - The FDA Advisory Committee meeting is scheduled for July 30, 2025, with a PDUFA action date for the Biologics License Application (BLA) set for August 31, 2025 [2][5] Company Overview - Capricor Therapeutics is focused on developing cell and exosome-based therapeutics for rare diseases, with Deramiocel being a key product in late-stage development for DMD [7] - The company has received Orphan Drug Designation from both the FDA and EMA for Deramiocel, which is supported by RMAT and ATMP designations [5][6] - Capricor has entered into an exclusive commercialization agreement for Deramiocel in the U.S. and Japan with Nippon Shinyaku Co., Ltd., pending regulatory approval [9] Product Information - Deramiocel (CAP-1002) consists of allogeneic cardiosphere-derived cells (CDCs) that have shown immunomodulatory and anti-fibrotic effects in preserving muscle function in DMD [4][7] - DMD is a severe genetic disorder affecting approximately 15,000-20,000 individuals in the U.S., characterized by progressive muscle weakness and inflammation [3][4] - The pathophysiology of DMD involves impaired dystrophin production, leading to muscle cell damage and heart failure, which is the leading cause of death in DMD patients [3]