Regenity Biosciences, a global leader in regenerative medicine and Linden Capital Partners portfolio company, today announced that it has received FDA 510(k) clearance to market RejuvaKnee™, a minimally invasive collagen-based meniscal implant indicated for use in the reinforcement and repair of soft tissue injuries of the meniscus..

再生医学领域的全球领导者Regenity Biosciences和林登资本合作伙伴投资组合公司今天宣布，它已获得FDA 510（k）批准上市RejuvaKnee™，这是一种基于胶原蛋白的微创半月板植入物，用于加固和修复半月板的软组织损伤。。

Regenity Biosciences Receives 510(k) Clearance for RejuvaKnee™

Regenity Biosciences获得RejuvaKnee™510（k）许可

RejuvaKnee™ allows for a more complete recovery by facilitating the regeneration of the native meniscal tissue instead of cutting or replacing it. In a 12-month animal study that examined biochemical and biomechanical attributes and histology for tissue growth, RejuvaKnee™ demonstrated that in three months, the regenerated meniscus is able to withstand full weight bearing, and the knee returns to normal range of motion1.

RejuvaKnee™通过促进天然半月板组织的再生而不是切割或替换它，可以实现更完全的恢复。在一项为期12个月的动物研究中，该研究检查了组织生长的生化和生物力学属性以及组织学，RejuvaKnee™证明，在三个月内，再生的半月板能够承受全部负重，膝盖恢复正常运动范围1。

These results are superior to that of meniscectomy and allograft transplantation. Neovascularization and tissue histology also demonstrated healthy tissue regeneration with RejuvaKnee™ achieving nearly five times more tissue growth than the standard of care. Meniscectomy can offer high short-term clinical success rates but can frequently lead to follow-on meniscectomy or predisposition for osteoarthritis2,3, as opposed to RejuvaKnee™, which is designed to elongate the life of a knee that has been impacted by meniscal injury..

这些结果优于半月板切除术和同种异体移植。新血管形成和组织组织学也证明了健康的组织再生，RejuvaKnee™的组织生长比标准护理高近五倍。半月板切除术可以提供较高的短期临床成功率，但经常会导致后续半月板切除术或骨关节炎的易感性2,3，而RejuvaKnee™旨在延长受半月板损伤影响的膝盖的寿命。。

'The FDA clearance of RejuvaKnee™ represents a turning point in the meniscal repair market and marks an exciting innovation milestone for Regenity as a global leader in regenerative medicine solutions,' said Shawn McCarthy, CEO of Regenity Biosciences. 'The pre-clinical animal study data supports our confidence that RejuvaKnee™ will deliver results by facilitating significant tissue regeneration and balanced implant resorption.

Regenity Biosciences首席执行官肖恩·麦卡锡（ShawnMcCarthy）说：“美国食品和药物管理局（FDA）批准RejuvaKnee™是半月板修复市场的一个转折点，标志着Regenity作为再生医学解决方案全球领军者的一个激动人心的创新里程碑。”临床前动物研究数据支持我们的信心，即RejuvaKnee™将通过促进显着的组织再生和平衡的植入物吸收来提供结果。

As the only FDA-cleared regenerative implant device for meniscal repair on the market, this is a game changer for the industry given it will be indicated for a significant portion of the more than one million meniscectomies that are performed each year in the United States. With this innovation, our 60th 510(k) approval, we are further expanding the Regenity product portfolio that we bring to our commercial partners to improve patient outcomes.'.

作为市场上唯一获得FDA批准的半月板修复再生植入装置，这将改变该行业的游戏规则，因为它将在美国每年进行的100多万次半月板切除术中占据重要地位。通过这项创新，即我们第60次510（k）批准，我们正在进一步扩大我们为商业合作伙伴带来的再生产品组合，以改善患者的预后。”。

RejuvaKnee™ is a natural bovine-derived collagen implant that facilitates host tissue ingrowth and repair of damaged or injured meniscal tissue. In human cadaver studies, Regenity, in partnership with a panel of key opinion leaders in sports medicine, demonstrated the application and ease of use for arthroscopic implantation using a wide range of instrumentation currently available on the market.'Many complex meniscus tears are currently treated with a partial resection for symptomatic relief, but with the significant risk of increased contact pressures and more rapid progression of arthritis.

RejuvaKnee™是一种天然的牛源胶原植入物，可促进宿主组织向内生长并修复受损或受伤的半月板组织。在人体尸体研究中，Regenity与运动医学领域的关键意见领袖小组合作，展示了使用市场上现有的各种仪器进行关节镜植入的应用和易用性。”目前，许多复杂的半月板撕裂都采用部分切除术治疗，以缓解症状，但接触压力增加和关节炎进展更快的风险很大。

RejuvaKnee provides a scaffold for the patient to regenerate their own meniscal tissue for these defects. Favorable incorporation of the scaffold can not only offer symptomatic relief, but also has the potential to reduce osteoarthritis and quality of life over time for patients. I am very encouraged by the results of these animal and cadaveric studies for what could be a transformative treatment and alternative to meniscectomy,' said Dr.

RejuvaKnee为患者提供了一个支架，可以为这些缺陷再生自己的半月板组织。支架的良好结合不仅可以缓解症状，而且有可能随着时间的推移降低患者的骨关节炎和生活质量。。

Asheesh Bedi, MD, Clinical Professor at the University of Chicago, Chief Medical Officer for the NBPA, and Vice Chair of Research and Innovation at NorthShore/Endeavor Health System.Based on the volume of eligible meniscectomies that are performed in the United States each year, the market potential for this device is currently estimated at more than $900 million.

Asheesh Bedi，医学博士，芝加哥大学临床教授，NBPA首席医学官，NorthShore/Endeavor Health System研究与创新副主席。。

Regenity is currently exploring opportunities via a strategic partner to commercialize the device in the United States.About Regenity BiosciencesRegenity Biosciences, a Linden Capital Partners portfolio company, is a leading global developer and manufacturer of bioresorbable technologies to repair and regenerate natural tissue and bone for a variety of markets including dental, spine, o.

Regenity目前正在通过战略合作伙伴探索在美国将该设备商业化的机会。关于Regenity BiosciencesRegenity Biosciences，一家林登资本合作伙伴投资组合公司，是全球领先的生物可吸收技术开发和制造商，可修复和再生天然组织和骨骼，适用于牙科、脊柱、口腔等多种市场。