Rion Co., Ltd.

ROCHESTER, Minn.--( BUSINESS WIRE )--RION, a clinical-stage regenerative medicine company pioneering exosome-based therapeutics, today announced the appointment of five distinguished leaders to its Advisory Board. These new advisors bring decades of expertise in their respective fields, ranging from orthopedic & plastic surgery to infectious diseases, military medicine, biomanufacturing and government health strategy, further positioning RION as a leader in innovative regenerative medicine. “We are thrilled to welcome this esteemed group of experts to our team,” said Dr. Atta Behfar, Co-Founder of RION. “Their exceptional track records in clinical practice, biomanufacturing, public health leadership, and scientific innovation will play a crucial role as we continue to advance our groundbreaking platform technology and bring transformative regenerative therapies to patients worldwide.” Advisory Board Members: James B. Peake, M.D . Dr. James Peake, a retired Lieutenant General and former U.S. Army Surgeon General, brings a wealth of experience from his military career and public service as the Secretary of the U.S. Department of Veterans Affairs under President George W. Bush. Dr. Peake has commanded Army medical facilities worldwide and played a pivotal role in shaping healthcare delivery for veterans. His leadership continues in the private sector, where he contributes to the advancement of healthcare strategy at CGI. Raquel C. Bono, M.D., MBA, FACS A board-certified trauma surgeon and retired Vice Admiral, Dr. Raquel Bono made history as the first woman and Asian-American to hold a three-star admiral rank in the U.S. Navy’s medical field. As Director of the Defense Health Agency, she oversaw management of all 55 military treatment facilities and more than 300 associated clinics. Before that, from 2013 to 2015, she served as the 11th chief of the Navy Medical Corps. Dr. Bono’s extensive leadership roles include board membership at Humana and healthcare consulting, shaping value-based care strategies in both military and civilian healthcare systems. Steven L. Moran, M.D. Dr. Moran is a Professor of Plastic Surgery and Orthopedic Surgery at Mayo Clinic, Rochester, and staff surgeon at the Shrine Clinic for Sick Children in Minneapolis. He is the former Chairman of the Division of Plastic Surgery at Mayo Clinic, Dr. Moran is now the Surgical Director of the Mayo Clinic’s vascularized composite tissue allotransplant program. His renowned expertise spans wrist surgery, congenital hand surgery, and microsurgical reconstruction of the upper extremity. With over 375 peer-reviewed publications, numerous book chapters, and edited textbooks, Dr. Moran is recognized globally for his research in tissue engineering and regenerative medicine. Andrew Omidvar, Ph.D. Dr. Andrew Omidvar, Vice President of Government R&D at Philips Healthcare, leads large-scale healthcare innovation programs, including government partnerships with BARDA and the Gates Foundation. His strategic expertise in securing billion-dollar funding for transformative healthcare solutions and his leadership at MITRE and Motorola make him an invaluable asset to RION’s advisory team. Steve Reed, Ph.D. A leading expert in infectious disease research and vaccine development, as well as drug delivery methods, Dr. Steve Reed is the co-founder and CEO of HDT Bio. Dr. Reed has a long history of impactful contributions, including developing the first defined vaccines for tuberculosis, leishmaniasis, and leprosy. His work has garnered over $140 million in grants, and his career includes founding key biotech companies such as Corixa Corporation and Immune Design Corp., both of which transformed cancer and infectious disease therapeutics. About RION RION emerged out of the Mayo Clinic after two decades of research and innovation, in the Van Cleve Cardiac Regenerative Medicine Program, leading to the discovery that the driving force behind tissue repair was exosome signaling. Located in Rochester, MN, RION is internationally recognized for its pioneering advancements in isolating and mass-producing platelet-derived regenerative exosomes into shelf stable PEP™. RION is advancing its proprietary biologic PEP™ platform in multiple clinical trials in various therapeutic areas, including wound healing, cardiology, and orthopedics.

ROCHESTER, MN, USA I September 10, 2024 I RION, at the forefront of exosome innovation and therapeutic application, has officially commenced a Phase 1b study aimed at assessing the efficacy and safety of Purified Exosome Product™ (PEP™), its exclusive exosome regenerative therapeutic, for the management knee osteoarthritis (Knee OA). Each year, Knee OA affects approximately 364 million people worldwide and is associated with over one million hospitalizations annually in the U.S., primarily for total joint replacement. Knee OA represents a substantial burden on U.S. public and private healthcare systems, with estimates ranging from $5.7 billion to $15 billion in cost 2 . This trial serves as a key component of RION’s broader efforts aimed at developing regenerative therapies in areas of unmet clinical need and chronic disease, such as Knee OA. This is the first FDA approved trial evaluating therapeutic exosomes in the orthopedic space. RION’s Phase 1b trial represents a significant step forward in the development of a regenerative biologic for Knee OA. This open label, randomized, multi-center study will involve 24 patients across the United States. Patients will receive single intra-articular injections of PEP™ in escalating doses and followed for safety and signals of efficacy. Peer-reviewed in vitro data found RION’s PEP™ is an efficient chondroprotective and regenerative agent by enhancing proliferation, attenuating apoptosis and modulating inflammation. Further, a preclinical study in a validated animal model of post-traumatic osteoarthritis confirmed the potential efficacy of PEP™ combined with Hyaluronic Acid in support of RION’s osteoarthritis clinical program 3 . A positive outcome in the Phase 1b trial will pave the way for future studies with PEP™ in Knee OA followed by the submission of a Biologics License Application (BLA). “The progress we’ve made in advancing PEP™, reflects our deep commitment to developing powerful exosome therapies that unleash the body’s ability to heal from within,” said Dr. Atta Behfar, Co-founder of RION. “Not only will this study address a critical unmet need in knee osteoarthritis, but it serves as a pivotal moment for RION. From manufacturing to therapeutic innovation, we have been able to disrupt barriers in scaling and application of exosome therapies. With focus on disrupting paradigms that drive up the cost of biologics-based technology, we are establishing exosomes as a new generation of therapies endowed with the potential to truly transform the way we treat complex and chronic diseases. Guided by the FDA, RION is committed to bringing exosome-based therapies to patients as quickly and safely as possible to transform the management of this debilitating condition​​​​.” About RION RION was born out of the Mayo Clinic after two decades of research and innovation, in the Van Cleve Cardiac Regenerative Medicine Program, leading to the discovery that the driving force behind tissue repair was exosome signaling. RION, located in Rochester, MN, is internationally recognized for its pioneering advancements in isolating and mass-producing platelet-derived regenerative exosomes into shelf stable PEP™. RION is rewriting the regenerative medicine playbook. Our cutting-edge proprietary biomanufacturing platform crafts the future of regenerative therapy, unlocking the penitential within these tiny cellular messengers. RION’s regenerative PEP™ technology will be integral to the therapeutic exosome revolution. About PEP™ RION’s Purified Exosome Product™ (PEP™) is a shelf stable product in a lyophilized powder derived from human platelets that contains stabilized platelet-derived regenerative exosomes. PEP™ is an exosome therapeutic that is designed to promote cell growth and formation of new blood vessels, while also reducing inflammation and protecting cells. RION and its scientific collaborators have performed extensive research showing the potential of PEP™ to heal a wide array of damaged tissue. The company is currently evaluating PEP™ in preclinical and clinical studies for several indications. As our efforts in wound healing advance, multiple IND-enabling efforts in musculoskeletal, cardiovascular disease, pulmonary disease, women’s health disorders and drug delivery are creating solutions where current standards of care cannot address unmet clinical needs. About Knee Osteoarthritis Osteoarthritis is by far the most common form of arthritis, affecting more than 32.5 million Americans and more than 350 million individuals worldwide 4 . About half of knees with ACL injuries develop osteoarthritis within 5 to 15 years. 78 million Americans are projected to have osteoarthritis by the year 2040 5 . Symptomatic knee osteoarthritis is particularly prevalent and disabling, with 40% of men and 47% of women developing knee osteoarthritis in their lifetimes 6 . The burden of osteoarthritis is enormous, and the need for treatments that reduce pain and attendant disability for persons with osteoarthritis is critical. RION’s journey is paved with unwavering determination. We seek to break the cycle of pain, loss, and economic burden through application of PEP™, our pioneering regenerative exosome technology. We will remain undeterred in our pursuit to have PEP™ become the first exosome biologics therapy to be approved for the treatment of Knee Osteoarthritis. References SOURCE : RION

ROCHESTER, Minn.--(BUSINESS WIRE)-- RION, a clinical-stage regenerative medicine company at the forefront of exosome therapeutics, announced today the first subject was dosed in the Phase 2 clinical trial with its novel product, known as Purified Exosome Product™ (PEP™). This event marks a pivotal milestone in evaluating PEP™ as an innovative treatment for chronic conditions such as Diabetic Foot Ulcers (DFUs). PEP was administered to the first subject as part of a 40-subject Phase 2A study. The Phase 2A study is a multi-center, prospective, open-label, and randomized study to evaluate the safety and efficacy of topically applied PEP. The objective of the study is to compare subjects treated with PEP versus Standard of Care for up to 12 weekly applications (NCT06319287). Annually, DFUs affect an estimated 18.6 million individuals globally1, leading to significant morbidity and economic stress on healthcare systems, with treatment costs in the U.S. alone reaching approximately $13 billion2. PEP™ features a polyvalent mode of action critical for tissue healing in patients suffering with DFUs. “Dosing the first subject in the Phase 2 trial represents a key clinical advancement of our lead program and is an important moment for both the company and the field of exosome science,” said Dr. Atta Behfar, Co-founder of RION. “With the Phase 2 effort, Rion has established key advances in exosome manufacturing and scaling, while cementing its commitment to revolutionizing the treatment of chronic wounds. This pioneering exosome therapy is a testament to the potential of PEP™ to radically improve advanced wound care paradigms and patient outcomes.” A positive Phase 2 trial outcome has the potential to pave the way for a pivotal study followed by the submission of a Biologics License Application (BLA) laying the foundation for PEP™ to address a significant unmet medical need in the realm of diabetic wound care. About RION RION was born out of Mayo Clinic after two decades of research and innovation. RION is located in Rochester, MN and is internationally recognized for its pioneering advancements in isolating and mass-producing platelet-derived regenerative exosomes into shelf stable PEP™. RION is rewriting the regenerative medicine playbook. Our cutting-edge proprietary biomanufacturing platform crafts the future of regenerative therapy, unlocking the potent secrets within these tiny cellular messengers. RION’s regenerative PEP™ technology will be integral to the therapeutic exosome revolution. About PEP™ RION's Purified Exosome Product™ (PEP™) is a shelf stable product in a lyophilized powder derived from human platelets that contains stabilized platelet-derived regenerative exosomes. Discovered by the Mayo Clinic Van Cleve Cardiac Regenerative Medicine Program, PEP™ is an exosome therapeutic that is designed to promote cell growth and formation of new blood vessels, while also reducing inflammation and protecting cells. RION and its scientific collaborators have performed extensive research showing the potential of PEP™ to heal a wide array of damaged tissue. The company is currently evaluating PEP™ in preclinical and clinical studies for several indications. While our focus remains on wound healing, multiple IND-enabling efforts in musculoskeletal, cardiovascular disease, pulmonary disease and women’s health disorders are creating new solutions where current standards of care cannot address unmet clinical needs. About Diabetic Foot Ulcers (DFU) Diabetic Foot Ulcers (DFUs) are a severe and common complication of diabetes, characterized by wounds on the feet that are slow to heal and susceptible to infection. DFUs significantly impact the quality of life due to pain, reduced mobility, and the potential for amputation. Approximately 15-25% of people with diabetes will develop a DFU in their lifetime3. Alarmingly, around 14-24% of these cases result in amputation4. Furthermore, every three and a half minutes in the US5, there is an amputation due to DFU, highlighting the severity of this condition. The management of DFUs is challenging, with many patients experiencing recurrent ulcers. Additionally, DFU patients face a high mortality rate, with about 40% succumbing to the condition6. The economic burden of DFUs is substantial, imposing significant costs on healthcare systems, from direct treatment expenses to indirect costs related to loss of productivity and long-term disability. References Armstrong DG, Tan TW, Boulton AJM, Bus SA. Diabetic Foot Ulcers: A Review. JAMA. 2023 Jul 3;330(1):62-75. doi: 10.1001/jama.2023.10578. PMID: 37395769; PMCID: PMC10723802. Rice JB, Desai U, Cummings AK, Birnbaum HG, Skornicki M, Parsons NB. Burden of diabetic foot ulcers for medicare and private insurers. Diabetes Care. 2014;37(3):651-8. doi: 10.2337/dc13-2176. Epub 2013 Nov 1. Erratum in: Diabetes Care. 2014 Sep;37(9):2660. PMID: 24186882. Yazdanpanah L, Shahbazian H, Nazari I, Arti HR, Ahmadi F, Mohammadianinejad SE, Cheraghian B, Hesam S. Incidence and Risk Factors of Diabetic Foot Ulcer: A Population-Based Diabetic Foot Cohort (ADFC Study)-Two-Year Follow-Up Study. Int J Endocrinol. 2018 Mar 15;2018:7631659. doi: 10.1155/2018/7631659. PMID: 29736169; PMCID: PMC5875034. Liao X, Li SH, El Akkawi MM, Fu XB, Liu HW, Huang YS. Surgical amputation for patients with diabetic foot ulcers: A Chinese expert panel consensus treatment guide. Front Surg. 2022 Nov 8;9:1003339. doi: 10.3389/fsurg.2022.1003339. PMID: 36425891; PMCID: PMC9679004. Amputation Prevention Alliance. (n.d.). Amputation prevention alliance. Amputation Prevention Alliance | ADA. Jeyaraman K, Berhane T, Hamilton M, Chandra AP, Falhammar H. Mortality in patients with diabetic foot ulcer: a retrospective study of 513 cases from a single Centre in the Northern Territory of Australia. BMC Endocr Disord. 2019 Jan 3;19(1):1. doi: 10.1186/s12902-018-0327-2. PMID: 30606164; PMCID: PMC6318899.