LifePlus Establishes Global Clinical Validation for First-of-Its-Kind Non-Invasive Glucose and Cuffless BP Monitoring Device and Platform

Business Wire

23-06-2025

SAN JOSE, Calif.--(BUSINESS WIRE)-- 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.
LifeLeaf delivers clinically validated performance without the usual barriers of needles, cuffs, or cost.
Share
'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. This scalable solution has a strong potential to transform care models globally by enabling proactive, patient-friendly disease management.'
Global Dataset
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.
Clinical Results
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 also published clinical validation results for blood pressure in the European Society of Hypertension meeting in 2023. Please see key highlights below:
Glucose Monitoring
In head-to-head studies, LifeLeaf achieved an impressive 10.8% MARD against BGM references 1 and 8.5% MARD against Dexcom G6 2 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.
LifeLeaf attained a low 2% outlier rate 1 in blinded continuous glucose monitoring studies, comparable with invasive alternatives and underscoring its clinical reliability.
Blood Pressure
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 measurements 3 for a supported dynamic range of 90/55-170/110 mmHg, validated across multiple clinical studies and real-world settings.
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 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.
'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.'
Upcoming Global Clinical Trials
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.
'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. 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.'
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.
To learn more about partnership, pilot opportunities, or investment in LifeLeaf's clinically validated platform, visit www.lifeplus.ai.
Footnotes
1. 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.
2. 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.
3. The feasibility of cuffless, non-occlusive blood pressure assessments using the novel LifeLeaf wristwatch and platform. European Society of Hypertension (ESH) Annual Meeting 2023.
About 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. Designed for the billions worldwide at risk of chronic diseases, LifePlus is redefining everyday health monitoring with comfort, continuity, and confidence.