Prolaio
Prolaio is a cardiovascular clinical intelligence company that uses FDA-cleared AI algorithms and continuous wearable monitoring to provide pharma/biotech sponsors, healthcare providers, and patients with real-world heart data and clinical research services, now operating under Kardigan following its November 2025 acquisition.
- Company typePrivate
- Founded2022
- HeadquartersScottsdale, United States
- Headcount51–100
- GTM typeB2B
- OfferingSoftware
What Prolaio does
Prolaio is a cardiovascular clinical intelligence company that develops an AI-based platform integrating wearable sensor data with proprietary analytics to support pharmaceutical and biotech clinical development. Its core product, the Prolaio Clinical Intelligence Platform, continuously collects high-density data — including ECG, pulse, respiration, and activity — from clinical-grade wearables and applies FDA-cleared algorithms, including the eVO2peak cardiopulmonary measure and a Digital Twin personalization engine, to generate cardiovascular function insights correlated with standard clinical assessments. The company also operates the OCORO Heart Study, a national, all-remote observational study enrolling US adults with diagnosed heart conditions for up to five years of longitudinal monitoring.
The company serves three customer segments: pharmaceutical and biotech sponsors running cardiovascular trials (primary segment), healthcare providers and cardiologists using remote patient monitoring, and individual patients contributing data through the OCORO study. Its revenue model is enterprise sales-led, with subscription/recurring clinical research services for sponsors, platform licensing for researchers, and data and analytics licensing arrangements. The company has accumulated 4M+ hours of on-body patient data across 22+ countries, holds 20+ issued patents, and operates under 7 FDA-cleared algorithms alongside ISO 13485:2016 and MDSAP certifications.
In November 2025 Prolaio was acquired by Kardigan, a cardiovascular therapeutics company also co-founded by Tassos Gianakakos. The acquisition integrates Prolaio's clinical intelligence platform and CV data asset with Kardigan's three late-stage drug programs, positioning the combined entity to embed continuous real-world data and AI-driven patient identification across the drug-development lifecycle. Headquartered in Chicago, IL with 11-50 employees, Prolaio continues to operate the OCORO Heart Study and clinical research services under the Kardigan umbrella.
Prolaio firmographics
Firmographics- Name
- Prolaio
- Legal name
- Prolaio Inc.
- Website
- https://prolaio.com
- Company type
- Private
- Founded year
- 2022
- Operating status
- Acquired
- Headcount range
- 51–100 employees
- Short description
- Prolaio is a cardiovascular clinical intelligence company that uses FDA-cleared AI algorithms and continuous wearable monitoring to provide pharma/biotech sponsors, healthcare providers, and patients with real-world heart data and clinical research services, now operating under Kardigan following its November 2025 acquisition.
- Ownership category
- akta.pro rank
Prolaio industry classification
Industry- Product category
- Cardiovascular Clinical Intelligence Platform
- NAICS
- Analytical Laboratory Instrument Manufacturing (334516), Medical and Diagnostic Laboratories (62151)
- SIC
- Laboratory Analytical Instruments (3826), In Vitro & In Vivo Diagnostic Substances (2835)
- akta.pro primary industry
- AI/ML Platforms for Drug Discovery & Experiment Optimization (HLAGAJAO)
- akta.pro secondary industries
- Cardiology Telemedicine Platforms (HLALAGAB), Preventive Cardiology & Lipidology (HLAKABAF), Imaging & Cardiac Safety Core Labs (ECOG/EEG/ECG) (HLAGAAAJ)
Keywords
Where Prolaio is headquartered
LocationHeadquarters
- HQ city
- Scottsdale
- HQ country
- United States
- HQ region
- North America
Offices1 record
Markets served
Prolaio business model
Business model- GTM type
- B2B
- Offering type
- Software
- Cost components
- Technology or R&D, Personnel, Operations, Marketing or Sales, Others
Revenue model
- Clinical Research Services: Prolaio provides clinical intelligence services to pharmaceutical and biotech companies conducting cardiovascular clinical trials, enabling patient identification, enrollment optimization, and continuous data collection throughout trial intervals.
- Platform Access for Researchers: Licensing of the Prolaio platform to clinical researchers for longitudinal data collection, real-world evidence generation, and trial optimization.
- Data and Analytics Licensing: Access to Prolaio's extensive cardiovascular data set and advanced analytics to enhance drug development processes, as demonstrated by the Kardigan acquisition.
Go-to-market motion3 records
Distribution channels3 records
Marketing channels5 records
Prolaio product offering
Product offeringCore offering
Prolaio provides a cardiovascular clinical intelligence platform that integrates continuous high-density data from clinical-grade wearable sensors with proprietary AI-based algorithms. The platform supports pharmaceutical and biotech companies conducting cardiovascular clinical trials through patient identification, enrollment optimization, real-world evidence generation, and predictive analytics. Key capabilities include FDA-cleared algorithms such as eVO2peak and a Digital Twin machine-learning technology for predicting heart-failure decompensation.
Product overview
Prolaio is a cardiovascular clinical intelligence company offering a unified platform combining continuous wearable monitoring, AI-powered analytics, and clinical research services. The core Prolaio Clinical Intelligence Platform integrates medical insights and data analytics designed to improve cardiovascular clinical development. The company operates the OCORO Heart Study, a national observational registry that collects continuous cardiovascular data from participants using wearable devices including ECG patches and CardioWatch. Key technology offerings include eVO2peak, an FDA-cleared algorithm for remote cardiopulmonary assessment, and Digital Twin machine learning technology for predicting heart failure decompensation. The platform collects over 4 million hours of on-body patient data across 22+ countries, powered by 20+ issued patents and 7 FDA-cleared algorithms.
Differentiator
Problem solved
Functional benefit
Brands
- OCORO Heart Study: A national, observational heart study designed to help researchers understand how heart conditions behave over time, using wearable devices and secure digital tools.
- eVO2peak
Products and services
- Prolaio Clinical Intelligence Platform
Quantifiable outcome
- Detection of impending heart-failure decompensation approximately 6.5 days before symptom onset
- +1 more outcomes
Companies that use Prolaio
Customer profileNamed customers3 records
Segments3 records
Ideal customer profiles3 records
Prolaio technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
AI capability5 records
Feature5 records
Prolaio partnerships and signals
Strategic signalPartnerships
One partnership is on record.
- KardiganflagshipKardigan acquired Prolaio in November 2025 to create a pioneering heart health company with integrated cardiovascular data and therapeutics platform. The acquisition grants Kardigan access to Prolaio's extensive CV data set and advanced analytics to improve patient identification and trial enrollment for its three late-stage cardiovascular drug programs. Tassos Gianakakos, co-founder of both companies, leads the combined entity. Note: This is an acquisition relationship where Prolaio became part of Kardigan.
Scale indicators7 records
Recent moves6 records
Expansion highlights6 records
Prolaio competitors and assessment
Company assessmentDirect peers
- iRhythm Technologies: iRhythm's Zio long-term continuous ECG monitoring patch and AI-backed arrhythmia detection compete head-to-head with Prolaio's ECG patch-based continuous monitoring platform. Both serve clinicians and clinical trial sponsors with wearable cardiac monitoring and analytics.
- AliveCor: AliveCor offers consumer and clinical ECG products (KardiaMobile) with AI-based cardiac arrhythmia detection, overlapping with Prolaio's continuous ECG and AI analytics approach for cardiovascular monitoring.
- Eko Health: Eko combines digital stethoscopes with AI-based cardiac analysis (including FDA-cleared algorithms) for clinicians and clinical research, mirroring Prolaio's combination of FDA-cleared algorithms and continuous cardiac data capture.
- HeartFlow: HeartFlow applies AI to cardiovascular imaging and analytics for clinical decision support and is sold into cardiology workflows. Like Prolaio, it is an AI-driven cardiovascular clinical intelligence company with FDA-cleared technology.
Broad incumbents
- Preventice Solutions (Boston Scientific): Preventice, now part of Boston Scientific, provides ambulatory ECG and cardiac monitoring services, competing with Prolaio's wearable-based continuous monitoring but operating as part of a much larger device and services portfolio.
- Philips (BioTel / Cardiac Monitoring): Philips offers cardiac monitoring, ECG, and clinical research services through its connected care and BioTel heritage businesses. It competes with Prolaio in continuous ambulatory monitoring and clinical trial support, but as one segment within a broad medtech portfolio.
- Tempus Labs: Tempus provides AI-driven precision medicine data and analytics infrastructure to pharma and providers, including for clinical trial design and real-world evidence. It overlaps with Prolaio's platform as a clinical intelligence layer for pharma-sponsored research, though across multiple therapeutic areas.
- Verily (Alphabet): Verily builds clinical research platforms, wearable sensors, and real-world evidence infrastructure for life sciences companies. It competes with Prolaio in continuous wearable data and clinical trial analytics, backed by Alphabet-scale resources.
- Hillrom / Baxter (Bardy Diagnostics heritage): Bardy Diagnostics (acquired by Hillrom, now part of Baxter) developed the CAM patch for continuous ambulatory ECG, directly overlapping with Prolaio's ECG patch-based continuous monitoring technology.
Emerging players
- CardioSignal: CardioSignal develops smartphone- and wearable-based AI analytics for cardiac function, with overlapping technology approach to Prolaio's continuous monitoring and Digital Twin-style analytics, though earlier stage and more consumer-facing.
Market position
Strengths5 records
Weaknesses5 records
Competitive moat5 records
Key risks6 records
Key highlights7 records
Customer concentration
Prolaio social profiles
Digital presenceProlaio compliance and trust
Trust signalCompliance4 records
Prolaio financial estimates
Financial estimateRevenue estimate
Valuation estimate
Prolaio leadership team
Management profileNumber of profiles
Profiles11 records
Prolaio funding detail
Funding detailFunding overview
Funding rounds1 record
Investors
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
Prolaio M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about Prolaio
What does Prolaio do?
Prolaio provides a cardiovascular clinical intelligence platform that integrates continuous high-density data from clinical-grade wearable sensors with proprietary AI-based algorithms. The platform supports pharmaceutical and biotech companies conducting cardiovascular clinical trials through patient identification, enrollment optimization, real-world evidence generation, and predictive analytics. Key capabilities include FDA-cleared algorithms such as eVO2peak and a Digital Twin machine-learning technology for predicting heart-failure decompensation.
Is Prolaio a public or private company?
Prolaio is a private company. It is classified as corporate owned and is currently acquired.
When was Prolaio founded?
Prolaio was founded in 2022. It employs 51 to 100 people.
Where is Prolaio based?
Prolaio is headquartered in Scottsdale, United States, in the North America region.
How does Prolaio make money?
Three revenue lines are on record. Clinical Research Services are the primary driver. The others are platform Access for Researchers and data and Analytics Licensing.
Who are Prolaio's main competitors?
Direct peers on record are iRhythm Technologies, AliveCor, Eko Health and HeartFlow. Broad incumbents are Preventice Solutions (Boston Scientific), Philips (BioTel / Cardiac Monitoring), Tempus Labs, Verily (Alphabet) and Hillrom / Baxter (Bardy Diagnostics heritage). CardioSignal is listed as an emerging player.
Does Prolaio have an API?
No public API is recorded for Prolaio.
What industry is Prolaio in?
Prolaio's product category is Cardiovascular Clinical Intelligence Platform. Its primary akta.pro industry code is HLAGAJAO, AI/ML Platforms for Drug Discovery & Experiment Optimization, with a secondary code of HLALAGAB, Cardiology Telemedicine Platforms. Its NAICS code is 334516 and its SIC code is 3826.