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)..

明尼苏达州罗切斯特市（商业新闻短讯）--处于外泌体治疗前沿的临床阶段再生医学公司RION今天宣布，第一个受试者在第二阶段临床试验中服用了其新产品，称为Purified exosome product™（PEP™）。本次活动标志着评估PEP™作为糖尿病足溃疡（DFUs）等慢性病的创新治疗方法的关键里程碑。。

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)..

作为40名受试者2A期研究的一部分，对第一名受试者施用PEP。2A期研究是一项多中心，前瞻性，开放标签和随机研究，旨在评估局部应用PEP的安全性和有效性。这项研究的目的是比较接受PEP治疗的受试者与标准治疗的受试者每周最多12次（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..

DFUs每年影响全球约1860万人1，导致医疗保健系统的严重发病率和经济压力，仅在美国，治疗费用就达到约130亿美元2。PEP™具有多价作用模式，对患有DFUs的患者的组织愈合至关重要。。

“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.

RION联合创始人Atta Behfar博士说：“在第二阶段试验中给第一个受试者服用药物代表了我们lead项目的关键临床进展，对公司和外泌体科学领域来说都是一个重要时刻。”。“通过第二阶段的努力，Rion在外泌体制造和结垢方面取得了关键进展，同时巩固了其对彻底改变慢性伤口治疗的承诺。

This pioneering exosome therapy is a testament to the potential of PEP™ to radically improve advanced wound care paradigms and patient outcomes.”.

这种开创性的外泌体疗法证明了PEP™从根本上改善先进伤口护理模式和患者预后的潜力。”。

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.

积极的2期试验结果有可能为关键研究铺平道路，然后提交生物制剂许可证申请（BLA），为PEP™奠定基础，以解决糖尿病伤口护理领域尚未满足的重大医疗需求。

About RION

关于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™.

经过二十年的研究和创新，里翁出生于梅奥诊所。RION位于明尼苏达州罗切斯特，因其在分离和大量生产血小板衍生的再生外泌体到货架稳定的PEP™方面的开创性进展而获得国际认可。

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..

里恩正在改写再生医学剧本。我们的尖端专有生物制造平台开创了再生疗法的未来，解开了这些微小细胞信使的强大秘密。RION的再生PEP™技术将成为治疗性外泌体革命的组成部分。。

About PEP™

关于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纯化的Exosome Product™（PEP™）是一种冻干粉末中的货架稳定产品，该粉末来自人血小板，其中含有稳定的血小板衍生的再生外泌体。由Mayo Clinic Van Cleve心脏再生医学计划发现，PEP™是一种外泌体治疗剂，旨在促进细胞生长和新血管的形成，同时减轻炎症和保护细胞。

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..

RION及其科学合作者进行了广泛的研究，显示了PEP™治愈各种受损组织的潜力。该公司目前正在临床前和临床研究中评估PEP™的几种适应症。虽然我们的重点仍然是伤口愈合，但在肌肉骨骼疾病，心血管疾病，肺部疾病和女性健康疾病方面的多项IND努力正在创造新的解决方案，目前的护理标准无法满足未满足的临床需求。。

About Diabetic Foot Ulcers (DFU)

关于糖尿病足溃疡（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.

糖尿病足溃疡（DFU）是糖尿病的一种严重且常见的并发症，其特征是脚部伤口愈合缓慢且易感染。DFUs由于疼痛，行动不便和截肢的可能性而显着影响生活质量。大约15-25%的糖尿病患者会在一生中发展成DFU 3。

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.

令人担忧的是，这些病例中约有14-24%会导致截肢4。此外，在US5中，每三分钟半就会有一次DFU截肢，突显了这种情况的严重性。DFUs的管理具有挑战性，许多患者经历了复发性溃疡。此外，DFU患者的死亡率很高，约有40%死于这种情况6。

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..

DFUs的经济负担很重，给医疗保健系统带来了巨大的成本，从直接治疗费用到与生产力损失和长期残疾相关的间接成本。。

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