WARSAW, Ind., May 02, 2024 (GLOBE NEWSWIRE) -- OrthoPediatrics Corp. (“OrthoPediatrics”) (NASDAQ: KIDS), a company focused exclusively on advancing the field of pediatric orthopedics, today announced it has received the “Breakthrough Device” Designation from the Food and Drug Administration (“FDA”) for its new eLLi surgical device, an implant designed to address severe pathology associated with Early Onset Scoliosis (EOS), which can be associated with thoracic insufficiency, a potentially life-threatening condition.

华沙，印第安纳州，2024年5月2日（环球通讯社）--OrthoPediatrics Corp.（“OrthoPediatrics”）（纳斯达克股票代码：KIDS），一家专注于推进儿科骨科领域的公司，今天宣布其新的eLLi手术装置获得了美国食品和药物管理局（“FDA”）的“突破装置”称号，该植入物旨在解决与早发性脊柱侧弯（EOS）相关的严重病理问题，该病可能与胸廓功能不全有关，这是一种潜在的危及生命的疾病。

eLLi aims to provide a non-invasive means of extending the growing rods that provides increased force, enhanced mechanical reliability, and superior distraction precision, while also addressing safety concerns associated with current technology. eLLi will allow surgeons a new alternative to address deformity of the growing spine with an advanced technology that will complement our efforts to build a platform of EOS technologies.

eLLi旨在提供一种非侵入性的方法来延长生长棒，从而提供更大的力，增强的机械可靠性和更高的分心精度，同时还解决了与当前技术相关的安全问题。eLLi将为外科医生提供一种新的替代方案，通过先进的技术来解决日益增长的脊柱畸形，这将补充我们构建EOS技术平台的努力。

We are proud to have an expert design team comprised of surgeons who have dedicated their careers to treating these unique patients..

我们很自豪拥有一支由外科医生组成的专家设计团队，他们致力于治疗这些独特的患者。。

According to the FDA, the Breakthrough Devices Program is a voluntary program for certain medical devices and device-led combination products that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. The Breakthrough Program is intended to help patients have more timely access to medical devices by expediting their development, assessment, and review, while preserving the statutory standards for premarket approval, 510(k) clearance, and De Novo marketing authorization, consistent with the Agency’s mission to protect and promote public health..

据美国食品和药物管理局（FDA）称，突破性设备计划是针对某些医疗设备和设备主导的组合产品的自愿计划，这些产品可以更有效地治疗或诊断危及生命或不可逆转的衰弱疾病或病症。该突破计划旨在通过加快医疗器械的开发、评估和审查，帮助患者更及时地获得医疗器械，同时保持上市前批准、510（k）许可和从头上市授权的法定标准，符合该机构保护和促进公共健康的使命。。

David Bailey, OrthoPediatrics’ President & CEO, commented, “Receiving the Breakthrough Device designation from the FDA is a great achievement for our team. This innovative product will be a great addition to our suite of products for pediatric patients with Scoliosis and represents our commitment to continuous innovation and advancing healthcare for children all over the world.

整形外科总裁兼首席执行官大卫·贝利（DavidBailey）评论道：“获得美国食品和药物管理局（FDA）的突破性设备称号对我们的团队来说是一项巨大的成就。这种创新产品将是我们为脊柱侧弯儿科患者提供的一系列产品的重要补充，代表着我们对不断创新和推进全球儿童医疗保健的承诺。

I’m incredibly proud of my colleagues for all the work they are doing to deliver novel technologies to our surgeon customers and the KIDS they treat!”.

我为我的同事们所做的一切感到无比骄傲，他们正在为我们的外科医生客户和他们治疗的孩子们提供新技术！”。

About OrthoPediatrics Corp.

关于OrthoPediatrics Corp。

Founded in 2006, OrthoPediatrics is an orthopedic company focused exclusively on advancing the field of pediatric orthopedics. As such it has developed the most comprehensive product offering to the pediatric orthopedic market to improve the lives of children with orthopedic conditions. OrthoPediatrics currently markets 71 products that serve three of the largest categories within the pediatric orthopedic market.

骨科成立于2006年，是一家专注于推进儿科骨科领域的骨科公司。因此，它为儿科骨科市场开发了最全面的产品，以改善患有骨科疾病的儿童的生活。骨科目前销售71种产品，服务于儿科骨科市场中最大的三个类别。

This product offering spans trauma and deformity, scoliosis, and sports medicine/other procedures. OrthoPediatrics’ global sales organization is focused exclusively on pediatric orthopedics and distributes its products in the United States and over 70 countries outside the United States. For more information, please visit www.orthopediatrics.com..

该产品涵盖创伤和畸形、脊柱侧弯和运动医学/其他程序。骨科全球销售组织专注于儿科骨科，并在美国和美国以外的70多个国家销售其产品。有关更多信息，请访问www.orthopediatrics.com。。

Investor Contact

投资者联系人

Philip Trip Taylor

菲利普·特里普·泰勒

Gilmartin Group

吉尔马丁集团

philip@gilmartinir.com

philip@gilmartinir.com

415-937-5406

415-937-5406