LifePlus, a Silicon Valley startup redefining personal health monitoring, today announced the clinical validation of LifeLeaf®, the world’s first non-invasive and cuffless wearable for continuous glucose and blood pressure tracking. The device, tested in global multi-center trials including Mayo Clinic, AMCR Clinic – San Diego, CA, Cleveland Clinic – Abu Dhabi, and Hospital Sebarang Jaya – Penang, Malaysia, delivers real-time insights without needles, invasive sensors, or cuffs, setting a new standard in scalable, preventive care management..

LifePlus是一家重新定义个人健康监测的硅谷初创公司，今天宣布了其产品LifeLeaf®的临床验证，这是全球首款无创、无袖带的连续血糖和血压追踪可穿戴设备。该设备在全球多中心试验中进行了测试，包括梅奥诊所、AMCR诊所（加利福尼亚州圣地亚哥）、克利夫兰诊所（阿布扎比）以及马来西亚槟城的Sebarang Jaya医院，无需针头、侵入式传感器或袖带即可提供实时数据，为可扩展的预防性护理管理树立了新标准。

LifeLeaf delivers clinically validated performance without the usual barriers of needles, cuffs, or cost,” said Dr. Samuel J. Asirvatham and Dr. Narayan G. Kowlgi of Cardiovascular Medicine, Mayo Clinic, Rochester, MN. “By making blood pressure and glucose monitoring effortless and non-invasive, it drives better patient adherence, which is crucial for managing chronic conditions like hypertension and diabetes.

“LifeLeaf 提供了经过临床验证的性能，且无需常见的针头、袖带或高昂成本，”明尼苏达州罗切斯特梅奥诊所心血管医学部的塞缪尔·J·阿西尔瓦萨姆博士和纳拉扬·G·科瓦利博士表示。“通过让血压和血糖监测变得轻松且无创，它提高了患者的依从性，这对于管理高血压和糖尿病等慢性病至关重要。”

This scalable solution has a strong potential to transform care models globally by enabling proactive, patient-friendly disease management.”.

这种可扩展的解决方案具有强大的潜力，可以通过实现积极的、以患者为中心的疾病管理来改变全球的护理模式。

Global Dataset

全局数据集

LifePlus has collected and analyzed over 70,000 paired multi-biomarker datapoints from more than 500 human subjects across 14 countries and 4 continents. “This robust dataset spans a wide range of demographics—including skin tone, age, gender, and BMI—supporting the development of proprietary signal processing and highly generalizable, multi-biomarker advanced AI/ML algorithms and models,” said Ben Mbouombouo, Chief Operating Officer and Product GM of LifePlus..

LifePlus 已从横跨 14 个国家和 4 个大洲的 500 多名人类受试者身上收集并分析了超过 70,000 个配对的多生物标志物数据点。LifePlus 首席运营官兼产品总经理 Ben Mbouombouo 表示：“这一强大的数据集涵盖了广泛的 demographics，包括肤色、年龄、性别和 BMI，为开发专有的信号处理技术以及高度通用的多生物标志物先进 AI/ML 算法和模型提供了支持。”

Clinical Results

临床结果

LifePlus has already conducted multiple clinical studies to demonstrate clinical validation for LifeLeaf. The most recent results of its performance vs BGM for glucose monitoring are scheduled to be showcased at the upcoming American Diabetes Association (ADA) Meeting, June 20-23, 2025. Earlier, LifeLeaf’s performance vs CGM was shared at the Advanced Technology and Treatment for Diabetes (ATTD) meeting in 2023.

LifePlus已经进行了多项临床研究，以证明LifeLeaf的临床有效性。其最新的血糖监测性能与BGM的对比结果将于2025年6月20日至23日举行的美国糖尿病协会（ADA）会议上展示。此前，LifeLeaf与CGM的性能对比数据已在2023年的糖尿病先进技术与治疗（ATTD）会议上分享。

LifePlus also published clinical validation results for blood pressure in the European Society of Hypertension meeting in 2023. Please see key highlights below:.

LifePlus 还在 2023 年欧洲高血压学会会议上发布了关于血压的临床验证结果。请参见以下关键亮点：。

Glucose Monitoring

血糖监测

In head-to-head studies, LifeLeaf achieved an impressive 10.8% MARD against BGM references1 and 8.5% MARD against Dexcom G62 for a target dynamic range of 70-250 mg/dL, demonstrating non-invasive glucose monitoring is not only possible, but viable and scalable for real-world use.

在头对头研究中，LifeLeaf 相较于BGM参考值达到了令人印象深刻的10.8% MARD，相较于Dexcom G6则为8.5% MARD，目标动态范围为70-250 mg/dL，证明了无创血糖监测不仅可行，而且在现实世界中是切实可行并可扩展的。

LifeLeaf attained a low 2% outlier rate1 in blinded continuous glucose monitoring studies, comparable with invasive alternatives and underscoring its clinical reliability.

LifeLeaf 在盲法连续血糖监测研究中达到了较低的 2% 离群率，与侵入式替代方案相当，凸显了其临床可靠性。

Blood Pressure

血压

The cuffless blood pressure feature of LifeLeaf demonstrated impressive accuracy, with a mean difference ± standard deviation of –0.02 ± 12.5 mmHg for systolic and 0.03± 8.4 mmHg for diastolic measurements3 for a supported dynamic range of 90/55-170/110 mmHg, validated across multiple clinical studies and real-world settings..

LifeLeaf的无袖带血压功能展示了令人印象深刻的准确性，收缩压的平均差±标准差为–0.02 ± 12.5 mmHg，舒张压为0.03 ± 8.4 mmHg，支持的动态范围为90/55-170/110 mmHg，并在多项临床研究和真实场景中得到验证。

LifeLeaf collected indefinite long-term blood pressure data as opposed to traditional ambulatory monitors, offering continuous, real-world views. LifePlus is engaged with the world’s leading clinicians to establish a new longitudinal metric for assessing arterial stiffness that may better predict long-term effects of hypertension and related cardiovascular outcomes..

LifeLeaf收集了比传统动态血压监测仪更长期的不定期血压数据，提供持续的真实世界视角。LifePlus正与全球领先的临床医生合作，建立一种新的纵向指标，用于评估动脉硬化状况，这可能更好地预测高血压及其相关心血管结果的长期影响。

LifeLeaf is unique because it does not require needles, cuffs, or calibration as current solutions do. It is 70% more cost-effective over a 12-month period and supports effortless daily use, which is critical for maintaining a high degree of patient adherence and delivering preventive insights.

LifeLeaf 的独特之处在于它不需要像现有解决方案那样使用针头、袖带或校准。它在 12 个月内的成本效益高出 70%，并支持轻松的日常使用，这对于保持高度的患者依从性和提供预防性洞察至关重要。

“The results presented at ADA this year show that LifeLeaf has the potential to provide accurate data, without invasiveness or complexity,” said Dr. Timothy S. Bailey of Headlands Research – AMCR Clinic, Escondido, CA, and Dr. Jerome S. Fischer of MDRequest, San Antonio, TX. “This kind of non-invasive monitoring is uniquely poised to improve patient adherence and enable earlier detection – two critical factors in managing chronic conditions.”.

“今年在ADA上展示的结果表明，LifeLeaf有潜力提供准确的数据，且无需侵入性或复杂性，”加利福尼亚州埃斯孔迪多Headlands Research – AMCR诊所的蒂莫西·S·贝利博士和德克萨斯州圣安东尼奥MDRequest的杰罗姆·S·费舍尔博士说道。“这种非侵入性监测方式独特地有助于提高患者的依从性并实现更早的检测——这是管理慢性病的两个关键因素。”

Upcoming Global Clinical Trials

即将到来的全球临床试验

LifePlus is now initiating additional longitudinal outcome studies for LifeLeaf across Asia, Europe, Middle East and North America, focusing on prediabetic and hypertensive populations. The goal: to prove that continuous, passive monitoring can lead to earlier interventions and measurable reductions in chronic disease incidence..

LifePlus目前正于亚洲、欧洲、中东和北美地区针对LifeLeaf开展额外的纵向结果研究，重点关注糖尿病前期和高血压人群。其目标是：证明持续、被动的监测可以带来更早的干预，并显著降低慢性病的发生率。

“We’re incredibly encouraged by the clinical validation at world-class institutions like Mayo Clinic and Cleveland Clinic,” said Dr. Alodeep Sanyal, co-founder and CEO of LifePlus. “It confirms what we have believed from the beginning: that non-invasive, AI-powered monitoring can be reliable and scalable.

“我们得到了梅奥诊所和克利夫兰诊所等世界级机构的临床验证，这让我们备受鼓舞，”LifePlus 的联合创始人兼首席执行官阿尔德普·桑亚尔博士表示。“这证实了我们从一开始就相信的观点：非侵入式、人工智能驱动的监测可以既可靠又可扩展。”

The growing global interest from healthcare providers, partners and investors reaffirms that we are at the forefront of a major shift in how we manage and prevent chronic disease.”.

“医疗保健提供者、合作伙伴和投资者日益增长的全球兴趣再次表明，我们在管理和预防慢性疾病的方式上正处于重大转变的前沿。”

With global spending on diabetes and cardiovascular care projected to exceed $1.5 trillion annually by 2030, the market is primed for solutions that go beyond reactive treatment. LifeLeaf is the first clinically validated solution of its kind in this space, targeting a $100B+ total addressable market..

到2030年，全球在糖尿病和心血管护理上的支出预计每年将超过1.5万亿美元，市场正为超越被动治疗的解决方案做好准备。LifeLeaf是该领域首个经过临床验证的同类解决方案，目标市场规模超过1000亿美元。

To learn more about partnership, pilot opportunities, or investment in LifeLeaf’s clinically validated platform, visit www.lifeplus.ai.

要了解更多关于合作、试点机会或对LifeLeaf临床验证平台的投资信息，请访问www.lifeplus.ai。

Footnotes

脚注

Improved accuracy of a fully non-invasive continuous glucose monitor in a diverse population. T. Bailey et al. American Diabetes Association (ADA) Annual Meeting 2025.

T. Bailey 等。在多样化人群中提高了完全无创连续血糖监测仪的准确性。美国糖尿病协会 (ADA) 2025年年会。

The feasibility of non-invasive continuous glucose monitoring with the novel LifeLeaf wristwatch and platform. T. Bailey et al. Advanced Technology and Treatment in Diabetes (ATTD) Annual Meeting 2023.

新型LifeLeaf腕表及平台进行无创连续血糖监测的可行性。T. Bailey 等。2023年糖尿病先进技术与治疗（ATTD）年会。

The feasibility of cuffless, non-occlusive blood pressure assessments using the novel LifeLeaf wristwatch and platform. European Society of Hypertension (ESH) Annual Meeting 2023.

使用新型LifeLeaf手表和平台进行无袖带、非阻塞性血压评估的可行性。2023年欧洲高血压学会（ESH）年会。

About LifePlus

关于LifePlus

LifePlus is committed to transforming how people manage and improve their health. At the heart of our innovation is LifeLeaf®, the world’s first non-invasive, effortless, wrist-worn medical device and platform for continuous, real-time remote patient monitoring. Powered by AI, this technology empowers individuals with real-time insights into their vital health parameters, enabling proactive health management, early intervention, and seamless information sharing with loved ones and care teams.

LifePlus致力于改变人们管理和改善健康的方式。我们创新的核心是LifeLeaf®，这是全球首款非侵入式、无需操作、佩戴于手腕的医疗设备和平台，可实现持续、实时的远程患者监测。该技术由人工智能驱动，为个人提供实时的生命健康参数洞察，助力主动健康管理、早期干预，并与亲人和护理团队实现无缝信息共享。

Designed for the billions worldwide at risk of chronic diseases, LifePlus is redefining everyday health monitoring with comfort, continuity, and confidence..

面向全球数十亿面临慢性病风险的人群设计，LifePlus 正在通过舒适性、连续性和信心重新定义日常健康监测。

Contacts

联系人

Media Contact:

媒体联系人:

Kat Aronofsky

凯特·阿罗诺夫斯基

[email protected]

[email protected]

(+1) 339-222-9219

(+1) 339-222-9219

Source: businesswire.com

来源：businesswire.com