SAN DIEGO--(BUSINESS WIRE)--Tandem Diabetes Care, Inc. (NASDAQ: TNDM), a leading insulin delivery and diabetes technology company, today announced the United States commercial launch of its new Tandem Mobi, the world’s smallest, durable automated insulin delivery system for people living with diabetes.* The company has begun taking orders and shipping to eligible customers in the United States..

圣地亚哥--（商业新闻短讯）--领先的胰岛素输送和糖尿病技术公司Tandem Diabetes Care，Inc.（纳斯达克：TNDM）今天宣布在美国商业推出其全球最小的Tandem Mobi，为糖尿病患者提供耐用的自动胰岛素输送系统。*该公司已开始接受订单并向美国合格客户发货。。

Tandem Mobi is a new way for people living with diabetes to experience the life-changing benefits of Control-IQ technology, the same technology that helped make Tandem the #1 recommended pump brand.1 The Control-IQ advanced hybrid closed-loop automated insulin delivery feature, cleared for use by people with type 1 diabetes age 6 and up, predicts and helps prevent high and low blood sugar, and has demonstrated improved time in range throughout the day and night in numerous controlled clinical trials and real-world studies.2-4.

Tandem Mobi是糖尿病患者体验Control-IQ技术改变生活益处的一种新方法，该技术有助于Tandem成为#1推荐的泵品牌。1 Control-IQ高级混合闭环自动胰岛素输送功能可供6岁及以上的1型糖尿病患者使用，可预测并帮助预防高血糖和低血糖，并且在许多对照临床试验和现实世界研究中证明了白天和晚上的时间范围有所改善.2-4。

“This tiny, wearable pump exceeded the expectations of users from an early access program, and we are thrilled to begin offering this exciting new technology to more people in the diabetes community,” said John Sheridan, president and chief executive officer. 'With this launch, we are executing on our strategy to offer a differentiated portfolio of durable insulin pumps, providing choice, along with new options in wearability.”.

总裁兼首席执行官约翰·谢里登（JohnSheridan）表示：“这种小巧的可穿戴泵超出了早期接入计划用户的期望，我们很高兴开始向糖尿病社区的更多人提供这种令人兴奋的新技术。”通过这次发布，我们正在执行我们的战略，提供耐用胰岛素泵的差异化组合，提供选择，以及可穿戴性的新选择。”。

Key Tandem Mobi System Features:

串联Mobi系统的关键功能：

Impressively Small – Less than half the size of the t:slim X2 insulin pump and small enough to fit in the coin pocket of a pair of jeans

令人印象深刻的小-不到t的一半大小：纤细的X2胰岛素泵，足够小，可以放在牛仔裤的硬币口袋中

Wearability Like Never Before – Can be worn almost anywhere, giving users greater discretion, comfort, and options for how they manage their diabetes:

前所未有的可穿戴性–几乎可以在任何地方佩戴，让用户在如何管理糖尿病方面拥有更大的判断力、舒适度和选择：

Wear it on-body with a lightweight adhesive sleeve (sold separately)

用轻质粘合套将其佩戴在车身上（单独出售）

Clip it discreetly to clothing

小心地夹在衣服上

Slip it into a pocket

把它塞进口袋

Infusion Set Options – Compatible with all existing Tandem-branded infusion sets manufactured by Convatec, including a new 5-inch tubing option made just for Tandem Mobi. Infusion sets allow users to temporarily disconnect from their pump for convenience and provide the flexibility of more than 30 mix-and-match infusion site and tubing length combinations..

输液器选件–与Convatec生产的所有现有串联品牌输液器兼容，包括专为串联Mobi设计的新型5英寸输液管选件。输液器允许用户暂时断开泵的连接，以方便使用，并提供30多种混合匹配输液部位和管长组合的灵活性。。

Tandem Mobi Mobile App – Full iOS mobile control through a user’s compatible iPhone5

Tandem Mobi移动应用程序–通过用户兼容的iPhone5实现iOS全方位移动控制

Sensor Compatibility – Compatible with the Dexcom G6 Continuous Glucose Monitoring (CGM) System. Additional CGM sensor integrations are planned, including Dexcom G7 in the second quarter of 2024, followed by integration with the Abbott FreeStyle Libre 3 sensor.

传感器兼容性–与Dexcom G6连续血糖监测（CGM）系统兼容。计划进行额外的CGM传感器集成，包括2024年第二季度的Dexcom G7，然后与雅培FreeStyle Libre 3传感器集成。

#1 Rated1 Control-IQ Technology – Uses values from a Dexcom G6 CGM to predict glucose levels 30 minutes ahead and automatically adjust insulin, if needed, to help prevent highs and lows

#1 Rated1 Control IQ技术-使用Dexcom G6 CGM的值提前30分钟预测血糖水平，并在需要时自动调整胰岛素，以帮助预防高血糖和低血糖

Clear 200-unit cartridge – Allows users to see their remaining insulin level

清晰的200单位墨盒–允许用户查看其剩余的胰岛素水平

Water-Resistant – The pump is water-resistant to a depth of 8 feet (2.4 meters) for up to 2 hours (IP28 rating)

防水–泵在8英尺（2.4米）深度内防水长达2小时（IP28等级）

Flexible Pump Control – The Tandem Mobi system has a physical button that allows users to deliver a bolus of insulin without their iPhone.

灵活的泵控制–串联Mobi系统有一个物理按钮，允许用户在不使用iPhone的情况下推注胰岛素。

Advanced Technology – Uses modern wireless charging and is capable of remote software updates6

先进技术–使用现代无线充电，并能够进行远程软件更新6

Accessing the Tandem Mobi System

访问串联Mobi系统

Orders will be processed on a first come, first served basis, with initial shipments to users who meet specific eligibility requirements, including use of the Dexcom G6 CGM to access automated insulin delivery features. The Tandem Customer Care team is available now to help determine eligibility and potential timing of pump shipments for customers.

订单将以先到先得的方式处理，初始发货给符合特定资格要求的用户，包括使用Dexcom G6 CGM访问自动胰岛素输送功能。Tandem客户服务团队现在可以帮助确定客户的泵装运资格和潜在时间。

People living with diabetes interested in the Tandem Mobi system can start the order process at: www.tandemdiabetes.com/mobi..

对串联Mobi系统感兴趣的糖尿病患者可以在以下网站开始订购流程：www.tandemdeabetes.com/Mobi。。

About Tandem Diabetes Care

关于串联糖尿病护理

Tandem Diabetes Care, a global insulin delivery and diabetes technology company, manufactures and sells advanced automated insulin delivery systems that reduce the burden of diabetes management, while creating new possibilities for patients, their loved ones, and healthcare providers. The Company’s pump portfolio features the Tandem Mobi system and the t:slim X2 insulin pump, both of which feature Control-IQ advanced hybrid closed-loop technology.

Tandem Diabetes Care是一家全球胰岛素输送和糖尿病技术公司，生产和销售先进的自动胰岛素输送系统，可减轻糖尿病管理的负担，同时为患者及其亲人和医疗保健提供者创造新的可能性。该公司的泵产品组合采用串联Mobi系统和t:slim X2胰岛素泵，两者均采用Control-IQ高级混合闭环技术。

Tandem Diabetes Care is based in San Diego, California. For more information, visit tandemdiabetes.com..

Tandem Diabetes Care位于加利福尼亚州圣地亚哥。有关更多信息，请访问tandemdiabetes.com。。

Follow Tandem Diabetes Care on X @tandemdiabetes; use #tslimX2 #TandemMobi and #TandemDiabetes.

遵循X@tandemdiabetes的串联糖尿病护理；使用#tslimX2#TandemMobi和#tandemmeties。

Follow Tandem Diabetes Care on Facebook at www.facebook.com/TandemDiabetes.

关注Facebook上的串联糖尿病护理，网址为www.Facebook.com/tandemdeabetes。

Follow Tandem Diabetes Care on LinkedIn at https://www.linkedin.com/company/tandemdiabetes.

在LinkedIn上关注串联糖尿病护理https://www.linkedin.com/company/tandemdiabetes.

© 2024 Tandem Diabetes Care, Inc. All rights reserved. Tandem Diabetes Care, the Tandem logo, Control-IQ, t:slim X2, and Tandem Mobi are either registered trademarks or trademarks of Tandem Diabetes Care, Inc. in the United States and/or other countries. Dexcom, Dexcom G6, Dexcom G7, and any related logos and design marks are either registered trademarks or trademarks of Dexcom, Inc.

©2024 Tandem Diabetes Care，Inc.保留所有权利。Tandem Diabetes Care、Tandem徽标、Control IQ、t:slim X2和Tandem Mobi是Tandem Diabetes Care，Inc.在美国和/或其他国家/地区的注册商标或商标。Dexcom、Dexcom G6、Dexcom G7以及任何相关徽标和设计标记均为Dexcom，Inc.的注册商标或商标。

in the United States and/or other countries. FreeStyle, Libre, and related brand marks are marks of Abbott and used with permission. iPhone is a trademark of Apple Inc., registered in the U.S. and other countries. All other third-party marks are the property of their respective owners..

在美国和/或其他国家。FreeStyle、Libre和相关品牌标志是雅培的标志，经许可使用。iPhone是Apple Inc.在美国和其他国家注册的商标。所有其他第三方标记均为其各自所有者的财产。。

Responsible Use of Control-IQ technology

负责任地使用控制智商技术

Control-IQ technology does not prevent all highs and lows. Users must still bolus for meals and actively manage their diabetes. Visit tandemdiabetes.com/responsible-use for additional important safety information.

控制智商技术并不能阻止所有的高低。用户仍然必须在进餐时推注，并积极管理他们的糖尿病。有关其他重要安全信息，请访问tandemdeabetes.com/responsible-use。

*As of Feb., 2024. Data on file, Tandem Diabetes Care.

*截至2024年2月。档案数据，串联糖尿病护理。

1. dQ&A US Diabetes Connections Patient Panel Report; Net Promoter Score; Q1 2019-Q3 2023: P.49.

1.dQ＆A美国糖尿病连接患者小组报告；净启动子得分；2019年第1季度至2023年第3季度：第49页。

2. All published clinical trials and real-world studies of Control-IQ technology to date are based on use of Dexcom G6 CGM with the Tandem t:slim X2 insulin pump.

迄今为止，所有已发表的临床试验和控制智商技术的现实世界研究都是基于使用Dexcom G6 CGM和串联t:slim X2胰岛素泵。

3. Breton MD, Kovatchev BP. One year real-world use of the Control-IQ advanced hybrid closed-loop technology. Diabetes Technol Ther. 2021;23(9):601-608. Doi: 10.1089/dia.2021.0097.

布雷顿医学博士，科瓦切夫BP。一年的实际使用控制智商先进的混合闭环技术。糖尿病技术。2021年；23（9）：601-608。内政部：10.1089/dia.2021.0097。

4. Beck RW, Kanapka LG, Breton MD, et al. A Meta-Analysis of Randomized Trial Outcomes for the t:slim X2 Insulin Pump with Control-IQ Technology in Youth and Adults from Age 2 to 72. Diabetes Technol Ther. 2023 May;25(5):329-342. doi: 10.1089/dia.2022.0558.

4.Beck RW，Kanapka LG，Breton MD等。对2至72岁青少年和成人使用控制智商技术的t:slim X2胰岛素泵随机试验结果的荟萃分析。糖尿病技术。2023年5月；25（5）：329-342。内政部：10.1089/dia.2022.0558。

5. The mobile app requires a compatible iPhone model and operating system (sold separately). Only available to pump users who reside in the United States.

移动应用程序需要兼容的iPhone型号和操作系统（单独出售）。仅适用于居住在美国的泵用户。

6. Future updates for all or some of Tandem’s products may not be developed and may not be offered everywhere and would be subject to applicable regulatory approvals. Software updates are only available to customers who are in warranty at the time they update their pump. Additional training may be required to access certain software updates.

6.Tandem所有或部分产品的未来更新可能不会开发，也可能不会在任何地方提供，并将获得适用的监管批准。软件更新仅适用于在更新泵时处于保修期的客户。访问某些软件更新可能需要额外的培训。

Charges may apply. Tandem may discontinue select software and features over time at its discretion..

可能会收取费用。Tandem可能会自行决定停止选择软件和功能。。

Important Safety Information

重要安全信息

RX ONLY. Indications for Use: Tandem Mobi system: The Tandem Mobi insulin pump with interoperable technology (the pump) is intended for the subcutaneous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin. The pump is able to reliably and securely communicate with compatible, digitally connected devices, including automated insulin dosing software, to receive, execute, and confirm commands from these devices.

仅接收。使用适应症：串联Mobi系统：具有可互操作技术的串联Mobi胰岛素泵（泵）旨在以设定和可变速率皮下输送胰岛素，用于治疗需要胰岛素的人的糖尿病。该泵能够与兼容的数字连接设备（包括自动胰岛素给药软件）可靠安全地通信，以接收、执行和确认来自这些设备的命令。

The pump is intended for single patient, home use and requires a prescription. The pump is indicated for use in individuals 6 years of age and greater. Control-IQ technology: Control-IQ technology is intended for use with compatible integrated continuous glucose monitors (iCGM, sold separately) and alternate controller enabled (ACE) pumps to automatically increase, decrease, and suspend delivery of basal insulin based on iCGM readings and predicted glucose values.

该泵适用于单身患者，家庭使用，需要处方。该泵适用于6岁及以上的个人。Control-IQ技术：Control-IQ技术旨在与兼容的集成连续血糖监测仪（iCGM，单独出售）和替代控制器启用（ACE）泵一起使用，以根据iCGM读数和预测的葡萄糖值自动增加，减少和暂停基础胰岛素的输送。

It can also deliver correction boluses when the glucose value is predicted to exceed a predefined threshold. Control-IQ technology is intended for the management of Type 1 diabetes mellitus in persons 6 years of age and greater. Control-IQ technology is intended for single patient use. Control-IQ technology is indicated for use with NovoLog or Humalog U-100 insulin..

当预测葡萄糖值超过预定阈值时，它还可以提供校正推注。Control-IQ技术旨在管理6岁及以上人群的1型糖尿病。Control-IQ技术旨在供单个患者使用。Control-IQ技术适用于NovoLog或Humalog U-100胰岛素。。

WARNING: Control-IQ technology should not be used by anyone under the age of 6 years old. It should also not be used in patients who require less than 10 units of insulin per day or who weigh less than 55 pounds.

警告：6岁以下的人不应使用Control IQ技术。它也不应该用于每天需要少于10单位胰岛素或体重低于55磅的患者。

Control-IQ technology is not indicated for use in pregnant women, people on dialysis, or critically ill patients. Do not use Control-IQ technology if using hydroxyurea. Users of a Tandem insulin pump and Control-IQ technology must use the insulin pump, CGM, and all other system components in accordance with their respective instructions for use; test blood glucose levels as recommended by their healthcare provider; demonstrate adequate carb-counting skills; maintain sufficient diabetes self-care skills; see healthcare provider(s) regularly; and have adequate vision and/or hearing to recognize all functions of the pump, including alerts, alarms, and reminders.

控制智商技术不适用于孕妇、透析患者或重症患者。如果使用羟基脲，请勿使用Control-IQ技术。串联胰岛素泵和Control-IQ技术的用户必须根据各自的使用说明使用胰岛素泵、CGM和所有其他系统组件；按照医疗保健提供者的建议测试血糖水平；展示足够的碳水化合物计数技能；保持足够的糖尿病自我护理技能；定期咨询医疗保健提供者；并具有足够的视觉和/或听觉来识别泵的所有功能，包括警报、警报和提醒。

The Tandem pump and the CGM transmitter and sensor must be removed before MRI, CT, or diathermy treatment. Visit tandemdiabetes.com/safetyinfo for additional important safety information..

在进行MRI、CT或透热治疗之前，必须拆除串联泵、CGM发射器和传感器。有关其他重要的安全信息，请访问tandemdeabetes.com/safetyinfo。。

Forward-looking Statements

前瞻性声明

This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements relate to, among other things, the anticipated integrations of the Tandem Mobi insulin pump with the Dexcom G7 and Abbott Freestyle Libre 3 CGM sensors.

本新闻稿包含经修订的《1933年证券法》第27A节和经修订的《1934年证券交易法》第21E节所指的“前瞻性声明”。这些前瞻性陈述涉及串联Mobi胰岛素泵与Dexcom G7和Abbott Freestyle Libre 3 CGM传感器的预期集成。

These statements are subject to numerous risks and uncertainties, including the risks associated with the research and development process generally, such as the design, testing, and validation in compliance with the applicable regulatory and legal requirements in the markets that we serve as well as our ability to market, scale, and maintain the systems, personnel, and infrastructure necessary to support these integrations.

这些声明受到许多风险和不确定性的影响，包括与研发过程相关的风险，例如根据我们服务的市场中适用的监管和法律要求进行的设计、测试和验证，以及我们营销、规模和维护系统、人员、，以及支持这些集成所必需的基础设施。

These and other risks are identified and described in greater detail under the “Risk Factors” heading of our most recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and other documents filed with the Securities and Exchange Commission. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release.

这些风险和其他风险在我们最新的10-K表年度报告、10-Q表季度报告以及向美国证券交易委员会提交的其他文件的“风险因素”标题下进行了更详细的识别和描述。提醒读者不要过度依赖这些前瞻性声明，这些声明仅在本发布之日起生效。

Actual results could differ materially from those anticipated or projected in the forward-looking statements. Tandem undertakes no obligation to update or review any forward-looking statement in this press release because of new information, future events, or other factors..

实际结果可能与前瞻性声明中的预期或预测结果存在重大差异。由于新信息、未来事件或其他因素，Tandem没有义务更新或审查本新闻稿中的任何前瞻性声明。。