GERMANTOWN, Md. & PARSIPPANY, N.J.--(BUSINESS WIRE)--Senseonics Holdings, Inc. (NYSE American: SENS), a medical technology company focused on the development and manufacturing of long-term, implantable continuous glucose monitoring (CGM) systems for people with diabetes and Ascensia Diabetes Care, a global diabetes care company, today announced that the US Food and Drug Administration (FDA) has cleared the next-generation Eversense® 365 CGM system for people with Type 1 and Type 2 diabetes aged 18 years and older.

医学技术公司Senseonics Holdings，Inc.（纽约证券交易所美国代码：SENS），专注于为糖尿病患者开发和制造长期植入式连续血糖监测（CGM）系统，以及全球糖尿病护理公司Ascensia diabetes Care，今天宣布，美国食品和药物管理局（FDA）已经为18岁及以上的1型和2型糖尿病患者批准了下一代Eversense®365 CGM系统。

Eversense 365 is the world’s first One Year CGM system, representing a significant breakthrough in diabetes technology and management..

Eversense 365是世界上第一个为期一年的CGM系统，代表着糖尿病技术和管理的重大突破。。

“The approval of Eversense 365 represents a significant leap in CGM innovation. Extending sensor longevity to a full year, coupled with seamless device connectivity and a high level of accuracy, provides both freedom and peace of mind to patients living with diabetes,” said Tim Goodnow, PhD, President and Chief Executive Officer of Senseonics.

Senseonics总裁兼首席执行官蒂姆·古德诺（TimGoodnow）博士说：“Eversense 365的批准标志着CGM创新的重大飞跃。将传感器寿命延长一年，再加上无缝设备连接和高精度，为糖尿病患者提供了自由和平和的心态。”。

“Eversense 365 was ‘designed for real life’ and is optimally suited to help people with diabetes increase time in range of desired glucose levels and lower A1c. The delivery of the world’s first 365 day sensor is a seminal event for Senseonics and we’re excited to bring it to people with diabetes.”.

“Eversense 365是‘为现实生活而设计的’，最适合帮助糖尿病患者在所需的血糖水平和降低A1c的范围内增加时间。世界上第一个365天传感器的交付对Senseonics来说是一个开创性的事件，我们很高兴能将其带给糖尿病患者。”。

“Managing diabetes can be stressful and it is important for technology to disrupt life as little as possible to limit this burden,” said Brian Hansen, President of CGM at Ascensia Diabetes Care, a subsidiary of PHC Holdings Corporation (TSE 6523). “Eversense 365 allows people with diabetes to focus on living their lives, rather than managing the limitations that many experience with short-term CGMs.

PHC控股公司（TSE 6523）子公司Ascensia diabetes Care的CGM总裁布莱恩·汉森（BrianHansen）表示：“管理糖尿病可能会有压力，重要的是技术要尽可能少地中断生活，以限制这种负担。”。“Eversense 365允许糖尿病患者专注于生活，而不是管理许多短期CGM的局限性。

We are very excited about Senseonics’ ability to once again bring true innovation to the CGM space and are working closely with our partner to make Eversense 365 commercially available as soon as possible. In parallel, our partnership discussions with various pump manufacturers continue to progress, as we look to leverage Eversense 365’s unique potential to simplify life with integrated automated insulin delivery (AID) systems.”.

我们对Senseonics再次为CGM领域带来真正创新的能力感到非常兴奋，并正在与我们的合作伙伴密切合作，尽快使Eversense 365商业化。与此同时，我们与各泵制造商的合作伙伴关系讨论继续取得进展，因为我们希望利用Eversense 365的独特潜力，通过集成的自动胰岛素输送（AID）系统简化生活。”。

Eversense 365 is supporting people with diabetes to live life uninterrupted, as a fully-implantable, long-term CGM option that is highly-differentiated from short-term CGMs:

Eversense 365支持糖尿病患者不间断地生活，这是一种完全植入式的长期CGM选项，与短期CGM有很大区别：

Longest lasting CGM: The only CGM with a 365-day sensor means no frequent sensor changes, and only one insertion and one “Day 1” every year, compared to every 10-14 days with short-term CGM systems

持续时间最长的CGM：只有365天传感器的CGM意味着没有频繁的传感器更换，每年只有一次插入和一次“第一天”，而短期CGM系统则是每10-14天一次

Most dependable CGM: Sensor survivability across 12 months reduces the burden of data interruptions from frequent short-term CGM sensor failures or changes1, 2, 3

最可靠的CGM：传感器在12个月内的生存能力减少了频繁的短期CGM传感器故障或更改导致的数据中断负担1、2、3

No more wasted sensors: A tiny sensor that rests comfortably under the skin means that it cannot be knocked off, minimizing the inconvenience and cost of regular replacements

不再浪费传感器：一个舒适地放置在皮肤下的微小传感器意味着它不能被拆除，从而最大限度地减少了定期更换的不便和成本

Alerts that can be trusted: Exceptional accuracy consistently for one year4 and almost no false alerts from compression lows during the night5

可以信任的警报：一年内始终保持异常准确4，夜间几乎没有来自压缩低点的错误警报5

Maximum comfort: A gentle silicone-based adhesive that can be changed daily and causes almost no skin reactions6

最大舒适度：一种温和的硅胶基粘合剂，可以每天更换，几乎不会引起皮肤反应6

More freedom: The only CGM with a removable transmitter which can be easily taken on and off† without wasting a sensor or adding a warm up period

更自由： 唯一一款带有可拆卸发射器的 CGM，可方便地打开和关闭†，而不会浪费传感器或增加预热时间

Improved discretion: On-body vibration alerts keep patients notified even when their mobile phone is out of sight

改进了判断力：即使手机不在视线范围内，身体振动警报也能让患者得到通知

Ascensia expects to initiate the US launch of Eversense 365 US in the fourth quarter of 2024, with work ongoing to transition coverage availability in order to facilitate immediate access to as many users as possible.

Ascensia预计将于2024年第四季度在美国推出Eversense 365 US，目前正在努力转换覆盖率，以方便尽可能多的用户立即访问。

Eversense 365 has been cleared as an integrated CGM (iCGM) system, indicating that it can integrate with compatible medical devices, including insulin pumps as part of an automated insulin delivery (AID) system. Eversense 365 is exceptionally well suited to address common limitations7 of AID systems and the companies are advancing partnership discussions with various pump manufacturers..

Eversense 365已被批准为集成CGM（iCGM）系统，表明它可以与兼容的医疗设备集成，包括胰岛素泵，作为自动胰岛素输送（AID）系统的一部分。Eversense 365非常适合解决AID系统的常见限制7，这些公司正在推进与各泵制造商的合作伙伴关系讨论。。

1 Senseonics. (2024) Eversense 365 User Guide.

1感官。（2024）Eversense 365用户指南。

2 Abbott. (2024) Freestyle Libre 3 User Guide ART49385-001 Rev. A 04/24

。（2024）自由泳3用户指南ART49385-001修订版A 04/24

3 Dexcom (2024) G7 User Guide AW00078-10 Rev 003 MT-00078-10

3 Dexcom（2024）G7用户指南AW00078-10 Rev 003 MT-00078-10

4 Data on file

4存档数据

5 Christiansen MP, Klaff LJ, Brazg R, et al. A Prospective Multicenter Evaluation of the Accuracy of a Novel Implanted Continuous Glucose Sensor: PRECISE II. Diabetes Technol Ther. 2018;20(3):197-206. doi:10.1089/dia.2017.0142

5 Christiansen MP，Klaff LJ，Bragg R等。新型植入式连续葡萄糖传感器准确性的前瞻性多中心评估：PRECISE II。糖尿病技术。2018年；20（3）：197-206。内政部：10.1089/dia.2017.0142

6 Deiss, D. et al. (2020). Real-world safety of an implantable continuous glucose sensor over multiple cycles of use: A post-market registry study. Diabetes Technology & Therapeutics, 22(1), 48–52.

6 Deiss，D.等人（2020年）。植入式连续葡萄糖传感器在多个使用周期内的真实世界安全性：上市后注册研究。糖尿病技术与治疗学，22（1），48-52。

7 Sherr JL, Heinemann L, Fleming GA, et al. Automated insulin delivery: benefits, challenges, and recommendations. A Consensus Report of the Joint Diabetes Technology Working Group of the European Association for the Study of Diabetes and the American Diabetes Association. Diabetologia. 2023;66(1):3-22.

7 Sherr JL，Heinemann L，Fleming GA等。自动胰岛素输送：益处，挑战和建议。欧洲糖尿病研究协会和美国糖尿病协会联合糖尿病技术工作组的共识报告。糖尿病。2023年；。

doi:10.1007/s00125-022-05744-z.

doi:10.1007/s00125-022-05744-z。

About Senseonics

关于Senseonics

Senseonics Holdings, Inc. ('Senseonics') is a medical technology company focused on the development and manufacturing of glucose monitoring products designed to transform lives in the global diabetes community with differentiated, long-term implantable glucose management technology. Senseonics' CGM systems Eversense® 365 and Eversense® E3 include a small sensor inserted completely under the skin that communicates with a smart transmitter worn over the sensor.

Senseonics Holdings，Inc.（“Senseonics”）是一家医疗技术公司，专注于开发和制造血糖监测产品，旨在通过差异化的长期植入式血糖管理技术改变全球糖尿病社区的生活。Senseonics的CGM系统Eversense®365和Eversense®E3包括一个完全插入皮肤下的小型传感器，该传感器与传感器上佩戴的智能变送器通信。

The glucose data are automatically sent every 5 minutes to a mobile app on the user's smartphone..

葡萄糖数据每5分钟自动发送到用户智能手机上的移动应用程序。。

About Eversense

关于Eversense

The Eversense® Continuous Glucose Monitoring (CGM) Systems are indicated for continually measuring glucose levels for up to 365 days for Eversense® 365 and 180 days for Eversense® E3 in persons with diabetes age 18 and older. The systems are indicated for use to replace fingerstick blood glucose (BG) measurements for diabetes treatment decisions.

Eversense®连续血糖监测（CGM）系统适用于连续测量18岁及以上糖尿病患者的Eversense®365天和Eversense®E3 180天的血糖水平。该系统用于替代用于糖尿病治疗决策的手指血糖（BG）测量。

Fingerstick BG measurements are still required for calibration primarily one time per week after day 14 for Eversense® 365 and one time per day after day 21 for Eversense® E3, and when symptoms do not match CGM information or when taking medications of the tetracycline class. The sensor insertion and removal procedures are performed by a health care provider.

对于Eversense®365，在第14天之后每周一次校准，对于Eversense®E3，在第21天之后每天一次校准，并且当症状与CGM信息不匹配或服用四环素类药物时，仍然需要手指棒BG测量。传感器的插入和拆卸程序由医疗保健提供者执行。

The Eversense CGM Systems are prescription devices; patients should talk to their health care provider to learn more. For important safety information, see https://www.eversensediabetes.com/safety-info/..

Eversense CGM系统是处方设备；患者应该与他们的医疗保健提供者交谈以了解更多信息。有关重要的安全信息，请参阅https://www.eversensediabetes.com/safety-info/..

About Ascensia Diabetes Care

关于Ascensia糖尿病护理

Ascensia Diabetes Care is a global company focused entirely on helping people with diabetes. Our mission is to empower those living with diabetes through innovative solutions that simplify and improve their lives. We are home to the world-renowned CONTOUR® portfolio of blood glucose monitoring systems and the exclusive global distribution partner for the Eversense® Continuous Glucose Monitoring Systems from Senseonics.

Ascentia Diabetes Care是一家全球性公司，专注于帮助糖尿病患者。我们的使命是通过创新的解决方案来简化和改善糖尿病患者的生活。我们拥有世界知名的CONTOUR®血糖监测系统组合，也是Senseonics Eversense®连续血糖监测系统的独家全球分销合作伙伴。

These products combine advanced technology with user-friendly functionality to help people with diabetes manage their condition and make a positive difference to their lives. As a trusted partner in the diabetes community, we collaborate closely with healthcare professionals and other partners to ensure our products meet the highest standards of accuracy, precision and reliability, and that we conduct our business compliantly and with integrity..

这些产品将先进的技术与用户友好的功能相结合，帮助糖尿病患者管理自己的病情，并对他们的生活产生积极影响。作为糖尿病界值得信赖的合作伙伴，我们与医疗保健专业人员和其他合作伙伴密切合作，以确保我们的产品达到准确性、精确度和可靠性的最高标准，并确保我们以合规和诚信的方式开展业务。。

Ascensia is a member of PHC Group and was established in 2016 through the acquisition of Bayer Diabetes Care by PHC Holdings Corporation. Ascensia products are sold in more than 100 countries. Ascensia has around 1,400 employees and operations in 29 countries.

Ascensia是PHC集团的成员，于2016年通过PHC控股公司收购拜耳糖尿病护理公司成立。Ascensia产品销往100多个国家。Ascensia在29个国家拥有约1400名员工和业务。

About PHC Holdings Corporation

关于PHC控股公司

PHC Holdings Corporation (TSE 6523) is a global healthcare company with a mission of contributing to the health of society through healthcare solutions that have a positive impact and improve the lives of people. Its subsidiaries (referred to collectively as PHC Group) include PHC Corporation, Ascensia Diabetes Care Holdings AG, Epredia Holdings Ltd., LSI Medience Corporation, Mediford Corporation, and Wemex.

PHC控股公司（TSE 6523）是一家全球医疗保健公司，其使命是通过具有积极影响并改善人们生活的医疗保健解决方案为社会健康做出贡献。其子公司（统称为PHC集团）包括PHC Corporation、Ascensia Diabetes Care Holdings AG、Epredia Holdings Ltd.、LSI Medience Corporation、Mediford Corporation和Wemex。

Together, these companies develop, manufacture, sell and service solutions across diabetes management, healthcare solutions, life sciences and diagnostics. PHC Group’s consolidated net sales in FY2023 were JPY 353.9 billion with global distribution of products and services in more than 125 countries..

这些公司共同开发、制造、销售和服务糖尿病管理、医疗保健解决方案、生命科学和诊断领域的解决方案。2023财年，PHC集团的综合净销售额为3539亿日元，产品和服务在全球125多个国家分布。。

www.phchd.com

www.phchd.com

©2024 Ascensia Diabetes Care Holdings AG. All right reserved. Ascensia, the Ascensia Diabetes Care logo and Contour are trademarks and/or registered trademarks of Ascensia Diabetes Care Holdings AG.

。Ascensia、Ascensia Diabetes Care徽标和Contour是Ascensia Diabetes Care Holdings AG的商标和/或注册商标。