A new cardiovascular research ecosystem
Visits capture moments.
Prolaio captures life.
Traditional clinical trials measure moments. Prolaio measures everything in between, turning homes into trial sites and continuous heart data into robust clinical insights.
80% of cardiovascular drug trials fail to clear Phase 2.Source: BIO Clinical Development Success Rates, 2011–2020 ↗
We built something different.
For decades, cardiovascular research has relied on site visits, large cohort analysis, and fragmented data insights. The result: slower, riskier, and more expensive trials.
Prolaio takes a more modern approach to cardiovascular research. We run multi-modal, real-world data through our intelligence engine that turns raw signals into clinical insights. This faster, leaner, more precise clinical trial ecosystem helps move cardiovascular care forward.
In collaboration with
Continuous
Participant Data
Move beyond episodic site visits with continuous, real-world cardiovascular data across diverse populations.
Adaptive Trial
Intelligence
Detect risk, variability, and participant changes earlier with predictive analytics.
Clinically Robust
Endpoints
Generate meaningful insights from smaller cohorts using FDA-cleared digital biomarkers, field-tested across real studies with more on the way.
Synced
Blood Pressure Cuff
- Average BP: 128/82 mmHg
- Morning BP: 135/85 mmHg
- Evening BP: 124/79 mmHg
- BP variability: 6.2%
- 30-day systolic trend: -2.3 mmHg
- Pulse pressure: 46 mmHg
Taken: 7:48 AM · Daily reading
Synced
ECG Patch
- Heart rate (24-hr avg): 63 bpm
- HRV: 42 ms
- Respiratory rate: 14 breaths/min
- Sleep: 6h 42m
- Steps: 7,840/day
Last synced 2 minutes ago · Worn 6h 14m today
Synced
Cardiobracelet
- Resting HR: 58 bpm
- Daytime HR avg: 64 bpm
- Pulse rate variability: 38 ms
- SpO2: 97%
Last synced 2 minutes ago · Worn 6h 14m today
One ecosystem for every stage of your trial.
A connected research infrastructure—continuous data capture, validated analytics, and clinical-grade evidence—that sharpens with every study.
Medical-grade wearables add continuous, real-world participant data to any trial design.
- Recruitment & enrollment
- 24/7 real-world data capture
- Wider population reach
Pattern matching, deep learning, and predictive analytics turn raw signals into clinical insight.
- Clinically validated measures
- FDA-cleared biomarkers
- AI-powered algorithms
Validated digital biomarkers and high-density data insights enable faster, more precise action.
- Clinical trial reporting dashboards
- Near real-time study visibility
- Rapid signal detection
-
40+
Proven algorithms
-
7
FDA-cleared algorithms
-
4M+
Hours of on-body patient data on one of the largest curated datasets
-
22+
Countries served
Digital biomarkers validated and ready for your trial.
Digital biomarkers turn everyday signals from medical-grade wearables into regulatory-grade measures of cardiovascular clinical research. Choose from our library of trial-ready markers, or we’ll develop a new one for your study.
A growing library of biomarkers.
Explore the full library — case studies, validation data, and the science behind every biomarker.
FDA-CLEARED
Multivariate Change Index
Heart failure (HF), hypertrophic cardiomyopathy (HCM), coronary artery disease (CAD), aortic stenosis, pulmonary arterial hypertension.
FDA-CLEARED
AFib Burden
Atrial fibrillation, stroke risk, HF.
FDA-CLEARED
Blood Pressure
Hypertension, HF, CAD, chronic kidney disease (CKD), CVOTs.
FDA-CLEARED
Heart Rate
Multi-indication, safety monitoring, cardiovascular outcomes trials (CVOTs).
VALIDATED
Asleep Probability
Sleep quality, circadian rhythm, HF, stress.
FDA-CLEARED
Respiration Rate
HF, pulmonary arterial hypertension (PAH), COPD, sepsis, sleep disorders.
FDA-CLEARED
QRS Complex
Cardiac conduction, arrhythmia detection, HF, cardiovascular outcomes trials (CVOTs).
VALIDATED
Gross Activity
Physical activity, recovery, cardiovascular outcomes trials (CVOTs).
VALIDATED
Steps
Mobility, functional capacity, COPD, cardiovascular outcomes trials (CVOTs).
Biomarker spotlight
eVO2peak: CPET-level cardiopulmonary insight
An FDA-cleared digital biomarker that measures cardiopulmonary functional capacity. Early changes in eVO2peak predict clinical outcomes in heart failure.
How it works:
- Traditionally: peak VO2 is measured through CPET, a gold-standard test that requires specialized resources and a strenuous exercise protocol.
- With eVO2peak: peak VO2 is estimated from ECG and vital-sign dynamics during activities of daily living (ADL). No strenuous activity is required of the patient.
Completed
Treadmill CPET
- Peak VO2: 18.4 mL/kg/min
- Anaerobic threshold: 11.2 mL/kg/min
- Peak HR: 138 bpm
- RER: 1.14
Single in-clinic session · 11 min
In clinic peak VO2 derived from traditional cardiopulmonary test (CPET)
Synced
Cardiobracelet
- Resting HR: 58 bpm
- Daytime HR avg: 64 bpm
- Pulse rate variability: 38 ms
- SpO2: 97%
Last synced 2 minutes ago · Worn 3h today
Daily Life eVO2peak biomarkers from medical-grade wearables
The intelligence behind Prolaio.
Every novel biomarker moves through the same data pipeline powered by our AI-based algorithms and clinical validation process.
Inputs
Capturing more than just heart rate.
Multimodal data from wearables, patient-reported inputs, and EHR via Prolaio’s My Data Program—raw ECG and PPG waveforms sensitive enough to catch what others miss.
Intelligence
Machine learning, made for cardiology.
Clinical trial intelligence that flags signal and risk early—tested and validated head-to-head against clinical gold standard on one of the largest curated cardiovascular datasets.
Outputs
Regulatory-ready clinical insights.
Continuous digital biomarkers from at-home wearable signals—an FDA-cleared estimate of peak VO2, plus AFib burden and other cardiovascular measures—delivered as dashboards and structured data.
Why this matters
Built for adaptive trials to get to commercial trials faster.
For sponsors, this means continuous, validated endpoints that surface signal and risk earlier, so you can adapt protocols mid-study, run leaner cohorts, keep a trial from failing, and reach approval and commercialization sooner.
Real-world data collected at scale.
Built around your protocol, Prolaio can run the remote parts of your data capture, or scale into whatever your trial needs. That means flexible support across decentralized enrollment of pre-screened U.S. participants, nurse-assisted eConsent, and wearable logistics. Research-quality data, without adding work for your team.
Weight scale, smartphone, ECG patch, cardiobracelet, blood pressure monitor
Medical-grade wearables and devices.
Customize a kit to your protocol, or start from one of three ready-to-ship configurations.
Clinical history, medications, visits, procedures
Unified EHR and clinical records.
A single digital record, paired with device streams, gives a more complete picture of health.
Track every step of your study.
The Clinical Trial Reporting Dashboard tracks adherence, data quality, and key metrics across your entire study. See the tool in action below.
1 OF 5
Study Snapshot
Get a near real-time snapshot of your study performance, enrollment, scale, and engagement at a glance.
Hear from research groups, doctors, and partners.
My patients have found the system included in the OCORO study to be empowering and helpful to them. It gives them access to their own biometric data and a clearer window into patterns they maybe wouldn’t otherwise see day to day. For many, that visibility alone is empowering — it helps them feel more engaged with and informed about their own heart health.
Jeffrey B. Geske, MD
Cardiologist, Professor of Medicine
Mayo Clinic Rochester
The tools clinicians rely on shouldn’t stay locked in clinics. When everyone has access to the technology, research and care improves for everyone.
Dr. Greg Kurio
Cardiologist
Prolaio’s Head of Developmental Services
Principal Investigator for OCORO
We believe in patient empowerment. We believe that includes education — about our condition in general, and about how our condition may fit into the bigger picture for others like us. That’s where Prolaio comes in. Through the OCORO Heart Study, we’re able to contribute our data toward research studying how proactive data collection may improve our understanding of heart conditions over time. That knowledge could one day help patients and cardiologists identify patterns earlier and shape better treatments in the future. To us, that’s what empowerment means — not just being informed, but actively participating in the research that could change outcomes for the next patient.
Bethany & Hannah Keime
Cardiomyopathy Patients
Founders of the HeartCharged Patient Community
Research begins with patients. The data collected through this study will help advance our understanding of heart disease and accelerate the development of tomorrow’s therapies.
Greg Ruf
Executive Director
DCM Foundation
GCAC
My grandfather died of a heart attack at 35 and my father has dealt with heart issues his entire adult life. Despite doing everything “right”, I didn’t escape the genetic lottery. That’s exactly why I’m thrilled to participate in research that can help people like me and families like mine.
Kelley
Participant
OCORO Heart Study
Too much of cardiac care still waits for a crisis before taking action: a fainting spell, a troubling heart rhythm, or worse. Research into continuous, proactive monitoring is exactly the kind of shift the cardiac community needs to see more of.
Walker Frahm
CEO
Sudden Arrhythmia Death Syndrome Foundation
Foundation for Inherited Arrhythmias
Better health starts with knowing what’s happening inside your own body. Better healthcare starts when more of us contribute to better science. Prolaio’s at-home study makes both easier. This moves us toward how everyday healthcare should work. Count me in.
Juhan
Participant
OCORO Heart Study
Ways to partner with us.
Whether you’re adapting a traditional trial, outsourcing real-world study execution, or monitoring patients after discharge, Prolaio helps you capture continuous cardiovascular data without adding operational burden.