/PRNewswire/ -- Hyalex Orthopaedics, a privately held medical device company developing joint preservation technologies based on the transformative HYALEX

/PRNewswire/ -- Hyalex Orthopaedics是一家私人持有的医疗设备公司，致力于基于变革性HYALEX技术开发关节保护技术。

HYDROSURF materials platform, today announced that the U.S. Food and Drug Administration (FDA) has approved the company's supplemental Investigational Device Exemption (IDE) application for its cutting-edge Freestyle Knee Implant. This approval paves the way for Hyalex to expand its Early Feasibility Study (EFS) into a pivotal clinical trial of its novel knee implant technology, supporting the company's continued efforts to bring this next-generation orthopedic solution to patients in need..

HYDROSURF材料平台今日宣布，美国食品和药物管理局（FDA）已批准该公司为其前沿的Freestyle膝关节植入物提交的补充研究性器械豁免（IDE）申请。这一批准为Hyalex将其早期可行性研究（EFS）扩展为针对其新型膝关节植入技术的关键临床试验铺平了道路，支持公司继续努力将这一下一代骨科解决方案带给有需要的患者。

Hyalex's Freestyle Knee Implant is designed to enable patients suffering from cartilage damage and early osteoarthritis of the femoral condyle(s) to regain an active lifestyle. The planned pivotal trial, which will be conducted at leading orthopedic centers across

Hyalex的自由式膝关节植入物旨在帮助遭受软骨损伤和股骨髁早期骨关节炎的患者重新获得积极的生活方式。计划中的关键试验将在领先的骨科中心进行。

the United States

美国

and

和

Europe

欧洲

, will evaluate the safety and effectiveness of the device in restoring mobility and improving patient outcomes. Study investigators intend to enroll a diverse patient population that currently has limited treatment options.

，将评估该设备在恢复行动能力和改善患者预后方面的安全性和有效性。研究者计划招募目前治疗选择有限的多样化患者群体。

'This FDA approval validates the rigorous research and development behind our Freestyle Knee Implant and propels us into the next phase of clinical evaluation,' said

“这一FDA的批准证实了我们Freestyle膝关节植入物背后严谨的研发工作，并推动我们进入临床评估的下一阶段，”

Carl Vause

卡尔·沃斯

, chief executive officer of Hyalex. 'We are committed to advancing orthopedic care by delivering innovative solutions that address the unmet needs of cartilage gap patients, which is estimated to represent a

Hyalex首席执行官表示：“我们致力于通过提供创新解决方案来推动骨科护理的发展，以满足软骨间隙患者未被满足的需求，这估计代表一个..."

$2 billion

20亿美元

market in the US alone.'

仅美国市场。

The planned pivotal trial will build upon promising clinical results seen by surgeons who have been involved in Hyalex's EFS of the Freestyle Knee Implant, including the study's national principal investigator,

计划中的关键试验将基于参与 Hyalex 的 Freestyle 膝关节植入物早期可行性研究 (EFS) 的外科医生所看到的有希望的临床结果，包括该研究的全国主要研究者。

Sabrina Strickland

萨布丽娜·斯特里克兰

, M.D., of Hospital for Special Surgery.

医学博士，来自特种外科医院。

'In our early clinical evaluations, the HYALEX Freestyle Knee Implant demonstrated exceptional promise in mimicking natural joint mechanics and helping patient's return to their active lifestyle,' said Dr. Strickland. 'The ability to help these patients, who have limited options today, could significantly impact the future treatment of chondral and osteochondral defects in the knee.'.

斯特里克兰博士说：“在我们早期的临床评估中，HYALEX Freestyle膝关节植入物在模拟自然关节力学和帮助患者恢复积极生活方式方面展现了卓越的潜力。帮助这些目前选择有限的患者的能力，可能会对膝关节软骨和骨软骨缺损的未来治疗产生重大影响。”

About Hyalex Orthopaedics

关于Hyalex骨科

Hyalex is a privately held medical device company headquartered in

Hyalex 是一家总部位于

Lexington, MA

马萨诸塞州列克星敦

, developing transformational joint preservation technologies for diseased and damaged joints. The HYALEX

，开发用于病变和受损关节的变革性关节保留技术。HYALEX

HYDROSURF materials platform is protected by more than 17 patents and trademarks worldwide. The HYALEX Freestyle Knee system has received Investigational Device Exemption (IDE) approval from the United States Food and Drug Administration for a clinical trial in

HYDROSURF材料平台受到全球17项以上专利和商标的保护。HYALEX Freestyle膝关节系统已获得美国食品药品监督管理局（FDA）颁发的研究设备豁免（IDE），以进行临床试验。