LEWISVILLE, Texas--(BUSINESS WIRE)--Orthofix Medical Inc. (NASDAQ:OFIX), a leading global spine and orthopedics company, today announced the full U.S. commercial launch and successful completion of the first cases with the Galaxy Fixation Gemini™ system. The latest in the Galaxy product line, this stable external fixation system is provided in several sterile procedure kit configurations as a quick off-the-shelf solution for treating fractures that result from trauma in the lower and upper limbs..

德克萨斯州刘易斯维尔-（商业线）-全球领先的脊柱和骨科公司Orthofix Medical Inc.（纳斯达克股票代码：OFIX）今天宣布美国完整的商业推出并成功完成Galaxy Fixation Gemini的首例病例™ 系统。Galaxy产品系列的最新产品，这种稳定的外固定系统以多种无菌手术套件配置提供，作为治疗下肢和上肢创伤引起的骨折的快速现成解决方案。。

“In trauma settings, it is critical that we respond quickly to manage the damage to the impacted limb,” said Dr. Evengy Dyskin, Clinical Assistant Professor of Orthopaedics, University of Buffalo, in Buffalo, NY. “The all-inclusive nature of the sterile kits eliminates spatial constraints, enabling application in a trauma bay or intensive care unit setting, which would not be possible with a traditional pin-to-bar system.”.

“在创伤环境中，我们必须迅速应对受影响肢体的损伤，”纽约州布法罗市布法罗大学骨科临床助理教授Evengy Dyskin博士说。“无菌套件的包容性消除了空间限制，可以在创伤室或重症监护病房环境中应用，这在传统的针对杆系统中是不可能的。”。

Sterile kits eliminate the need for sterilization of trays which takes an average of 139 minutes1 to process and adds cost to healthcare facilities. Sterilization of trays also results in increased operating room (OR) delays and costs due to packaging, restocking and tray contamination. Average cost to a facility for OR delays related to tray contamination is $1,0811 which can be avoided through the use of prepacked sterile kits..

无菌套件消除了对托盘进行灭菌的需要，托盘平均需要139分钟1才能处理并增加医疗设施的成本。托盘的灭菌还导致由于包装，补货和托盘污染而导致手术室（OR）延迟和成本增加。与托盘污染有关的设施或延误的平均成本为10811美元，可以通过使用预先包装的无菌试剂盒来避免。。

In particular, the Galaxy Fixation Gemini ankle kit is the only pin-to-bar system with specific clamps available in a sterile kit configuration giving surgeons more efficient solutions in lower extremity trauma situations where time is an important factor. The ankle kit, developed specifically to meet the needs of U.S.

特别是，Galaxy Fixation Gemini脚踝套件是唯一具有特定夹具的针对杆系统，采用无菌套件配置，可为外科医生在时间是重要因素的下肢创伤情况下提供更有效的解决方案。脚踝套件，专门为满足美国的需求而开发。

surgeons, includes a double multiscrew clamp to facilitate rapid insertion of tibial half-pins and is complemented by the foot support and first metatarsal sterile kits when a more robust construct is desired. It is estimated that ankle fractures occur in 187 per 100,000 persons per year in the U.S.2.

外科医生包括一个双多重夹钳，以便于快速插入胫骨半针，并在需要更坚固的构造时由脚支撑和第一跖骨无菌套件补充。据估计，美国每年每10万人中有187人发生踝关节骨折。

“We are excited to expand our external fixation offerings in the U.S. for trauma through the introduction of the Galaxy Fixation Gemini System in several sterile packed configurations,” said Kim Elting, President of Global Orthopedics. “This streamlined pin-to-bar configuration is the latest example of our leadership in sterile kit solutions, which improve OR efficiencies and meaningfully decrease costs for the hospital and also for our business.”.

全球骨科总裁Kim Elting说：“我们很高兴通过在几种无菌包装配置中引入Galaxy fixation Gemini系统来扩展我们在美国的创伤外固定产品。“这种简化的针对棒配置是我们在无菌套件解决方案中领导的最新实例，它可以提高OR效率并有意义地降低医院和我们业务的成本。”。

Orthofix further expanded its sterile kit offerings with the global launch of the CalcFix Plus Calcaneal Minifixator™ System earlier this year. The CalcFix Plus represents the latest version of the original CalcFix Fixator device designed to treat calcaneal fractures using a more minimally invasive external fixation approach compared with internal fixation and includes updates to the design that reduce the number of operative steps to apply..

随着CalcFix Plus Calcanal Minifixator的全球推出，Orthofix进一步扩展了其无菌套件产品™ 系统今年早些时候。CalcFix Plus代表了原始CalcFix固定器装置的最新版本，与内固定相比，采用更微创的外固定方法治疗跟骨骨折，并包括对设计的更新，以减少应用的手术步骤数量。。

The Galaxy Fixation Gemini and the CalcFix Plus Systems add to Orthofix’s extensive portfolio of over 50 sterile kit procedural solutions available globally and demonstrate Orthofix’s continued investment in providing off-the-shelf solutions to meet the needs in the acute trauma, military and humanitarian crisis settings..

Galaxy Fixation Gemini和CalcFix Plus系统增加了Orthofix在全球范围内提供的50多种无菌套件程序解决方案的广泛组合，并展示了Orthofix在提供现成解决方案方面的持续投资，以满足急性创伤，军事和人道主义危机环境中的需求。。

Those attending the AOFAS Annual Meeting in Louisville, KY Sept. 20-22 can learn more about the Galaxy Fixation Gemini System and the CalcFix Plus Calcaneal Minifixator System by visiting booth 613.

那些参加肯塔基州路易斯维尔AOFAS年会的人可以通过访问613号展位了解更多关于银河系固定双子座系统和CalcFix Plus跟骨微型固定器系统的信息。

1 Ly JA, Wang WL, et al. Arch Bone Jt Surg, 2022 May; 10(5): 420-425.

1 Ly JA，王WL，等。Arch Bone Jt Surg，2022年5月；10（5）:420-425。

2 Source (SmartTrack, 2023).

2来源（SmartTrack，2023）。

About Orthofix

关于Orthofix

On January 5, 2023, Orthofix and SeaSpine merged to form a leading global spine and orthopedics company with a comprehensive portfolio of biologics, innovative spinal hardware, bone growth therapies, specialized orthopedic solutions, and a leading surgical navigation system. Its products are distributed in approximately 68 countries worldwide..

2023年1月5日，Orthofix和SeaSpine合并成为全球领先的脊柱和骨科公司，拥有全面的生物制剂，创新脊柱硬件，骨生长疗法，专业骨科解决方案和领先的手术导航系统。其产品分布在全球约68个国家。。

The Company is headquartered in Lewisville, Texas and has primary offices in Carlsbad, CA, with a focus on spine and biologics product innovation and surgeon education, and Verona, Italy, with an emphasis on product innovation, production, and medical education for orthopedics. The combined Company’s global R&D, commercial and manufacturing footprint also includes facilities and offices in Irvine, CA, Toronto, Canada, Sunnyvale, CA, Wayne, PA, Olive Branch, MS, Maidenhead, UK, Munich, Germany, Paris, France and Sao Paulo, Brazil.

该公司总部设在德克萨斯州路易斯维尔，在加利福尼亚州卡尔斯巴德设有主要办事处，专注于脊柱和生物制品产品创新和外科医生教育，以及意大利维罗纳，重点关注骨科产品创新，生产和医学教育。该联合公司的全球研发，商业和制造业足迹还包括位于加拿大多伦多欧文，加拿大桑尼维尔，加利福尼亚州韦恩，宾夕法尼亚州橄榄分公司，MS，Maidenhead，英国，慕尼黑，德国，法国巴黎的设施和办事处。巴西圣保罗。

A new name for the combined entity will be announced at a future date; the Company will continue to operate as Orthofix until said announcement..

合并实体的新名称将在未来公布；公司将继续作为Orthofix运营，直至宣布。。

Forward-Looking Statements

前瞻性声明

This news release may include forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended. In some cases, you can identify forward-looking statements by terminology such as “may,” “will,” “should,” “expects,” “plans,” “anticipates,” “believes,” “estimates,” “projects,” “intends,” “predicts,” “potential,” “continue” or other comparable terminology.

本新闻稿可能包括1934年“证券交易法”第21E条（经修订）和1933年“证券法”第27A条（经修订）含义内的前瞻性陈述。在某些情况下，您可以通过诸如“可能”，“将会”，“应该”，“期望”，“计划”，“预期”，“相信”，“估计”，“项目”，“意图”，“预测”，“潜力，“继续”或其他可比较的术语。

Orthofix cautions you that statements included in this news release that are not a description of historical facts are forward-looking statements that are based on the Company’s current expectations and assumptions. Each forward-looking statement contained in this news release is subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statement.

Orthofix提醒您，本新闻稿中包含的不描述历史事实的陈述是基于公司当前期望和假设的前瞻性陈述。本新闻稿中包含的每个前瞻性声明都存在风险和不确定性，可能导致实际结果与此类声明所表达或暗示的结果大不相同。

Applicable risks and uncertainties include, among others: the ability of newly launched products to perform as designed and intended and to meet the needs of surgeons and patients, including as a result of the lack of robust clinical validation; and the risks identified under the heading “Risk Factors” in Orthofix Medical Inc.’s Annual Report on Form 10-K for the fiscal year ended December 31, 2022, which was filed with the Securities and Exchange Commission (SEC) on March 6, 2023.

适用的风险和不确定性包括：新推出的产品按设计和预期执行并满足外科医生和患者需求的能力，包括由于缺乏强有力的临床验证；以及Orthofix Medical Inc.在2022年12月31日结束的财政年度10-K年度报告“风险因素”标题下确定的风险，该报告于3月6日提交给证券交易委员会（SEC），2023年。

The Company’s public filings with the Securities and Exchange Commission are available at www.sec.gov. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date when made. Orthofix does not intend to revise or update any forward-looking statement set forth in this news release to reflect events or circumstances arising after the date hereof, except as may be required by law..

本公司向证券交易委员会提交的公开文件可在www.sec.gov上查阅。警告您不要过分依赖前瞻性声明，这些声明仅在发布之日起生效。Orthofix不打算修改或更新本新闻稿中规定的任何前瞻性声明，以反映本协议签署之日以后发生的事件或情况，除非法律可能要求。。