ReTendon: development of a novel tendon repair device that accelerates healing and reduces re-rupture of tendons

本项目的目的是 ** 开发一种新型肌腱修复医疗器械，以改善肌腱损伤患者的健康状况 **。肌腱损伤可能会严重致残，通常需要进行康复时间长和医疗费用高的手术。最常见的需要手术修复的肌腱损伤类型是：屈肌（手）：英国每年约18，000例手术跟腱（脚）：英国每年约62，000例肩袖手术：英国每年约9，000例每10万人的手术数量与国外相似。高达四分之一的肌腱手术由于瘢痕组织的形成而无法达到满意的效果，而瘢痕组织的效果不如原始肌腱。在20到5分之一的修复肌腱（取决于断裂的肌腱）可能会再次断裂，需要进一步的手术。ReTendon开发了一种新型肌腱修复医疗器械，它在缝合在一起的肌腱末端之间建立了一座桥梁。我们的设备可以使肌腱更自然地重建，具有肌腱愈合更快，更强的潜力，它还可以减少肌腱在手术后断裂，减少再次手术的成本和康复时间以及患者的休假时间。我们的初步研究表明，我们的设备是安全的，有可能改善肌腱修复。我们还建立了生产工艺，并证明了生产稳定和无菌产品的能力。这项受专利保护的工作借鉴了英国曼彻斯特大学的突破性研究，并将由英国公司ReTendon Limited进一步开发和商业化。这个早期项目的目的是创建完整的技术和商业数据包，使ReTendon能够获得以下产品：在投资和监管（MHRA）批准的第一个人体临床试验。该项目的合作伙伴是Retendon有限公司（铅，普罗克特）和曼彻斯特大学（卡特梅尔），由现有的团队，专家分包商和临床顾问的支持。该团队拥有生物学、工程学、工业和临床实践方面的必要专业知识，可以交付上述项目。我们预计，该项目的完成将实现首次人体临床试验;成功的试验将使该平台技术适用于多种肌腱损伤、韧带损伤，并具有兽医应用范围。该项目将为ReTendon成为软组织修复领域的全球领导者奠定基础，改善患者的治疗效果，并从英国的新研究中创造商业影响。

The aim of this project is to **develop a novel tendon repair medical device that improves health outcomes in patients with tendon injuries**.Tendon injuries can be severely disabling to patients, often requiring an operation with long rehabilitation times and high healthcare costs.The most common types of tendon injuries that require surgical repair are:Flexor (hand): ~18,000 operations/year in UKAchilles (foot): ~ 62,000 operations/year in UKRotator cuff (shoulder): ~9,000 operations/year in UKThe number of operations per 100,000 people are similar abroad.Up to 1 in 4 tendon operations do not achieve satisfactory results due to the formation of scar tissue that works less well than the original tendon. Between 1 in 20 and 1 in 5 of repaired tendons (dependent on which tendon was broken) can break again requiring further operations.ReTendon has developed a novel tendon repair medical device, which builds a bridge between the ends of sown-together tendons. Our device enables tendons to re-build more naturally, with a potential for tendons to heal faster and more strongly, it also reduces tendons from breaking after operation, reducing reoperation costs and the length of rehabilitation and time off work for patients.Our initial research demonstrates that our device is safe and is likely to improve tendon repair. We have also established manufacturing processes and demonstrated the ability to manufacture a stable and sterile product.This patent-protected work draws on breakthrough UK research at the University of Manchester and will be further developed and commercialised by UK company ReTendon Limited.The aim of this early-stage project is to create the complete technical and commercial data package required to enable ReTendon to obtain follow-on investment and regulatory (MHRA) approval for a first clinical trial in humans.The project partners are ReTendon Ltd (Lead, Proctor) and the University of Manchester (Cartmell), supported by an existing team, expert subcontractors and clinical advisors. This team has the necessary expertise in biology, engineering, industrial and clinical practice to deliver the above project.We anticipate that completion of this project will enable a first in human clinical trial; a successful trial will then enable this platform technology to be adapted for multiple tendon injuries, ligament injuries and has scope for veterinary applications. The project will provide a basis for ReTendon to become a global leader in soft tissue repair, improving patient outcomes and creating commercial impact from novel UK research.