Koneksa Health

What Koneksa Health does

Koneksa Health Inc., founded in 2013 and headquartered at One World Trade Center in New York, is a private healthcare data analytics company that builds multimodal clinical data infrastructure for biopharmaceutical drug development. Its core offering, the Koneksa Platform, is a sensor-agnostic, regulatory-aligned platform that integrates connected wearables, mobile applications, and traditional clinical outcome assessments into unified data pipelines, enabling sponsors to capture continuous, patient-centric digital endpoints across therapeutic areas including neuroscience, oncology, respiratory, Parkinson's disease, and rare diseases. The company has supported 50+ clinical programs and holds three granted patents covering movement analysis, step/stride accuracy, and integrated multi-sensor health monitoring, with peer-reviewed scientific publications underpinning endpoint validity for FDA and EMA submissions.

The business operates a B2B enterprise model selling primarily to large and mid-size biopharmaceutical companies, supplemented by engagements with academic medical centers, contract research organizations, and biotech firms such as Sanofi, Takeda, Merck, Regeneron, Amicus Therapeutics, Verily, and Cambridge Cognition. Revenue is generated through subscription-based SaaS access to the platform, professional services for protocol design, device provisioning, biometrics, and regulatory consulting, and data licensing/syndication partnerships (notably a Parkinson's disease data syndication with Merck covering 10,000+ participants). Pricing is quote-based, structured around annual or multi-year contracts.

In June 2026, Koneksa expanded its product surface with Lodestar™, an intelligent submission software that connects 10 workflow steps from EDC ingest through eCTD Module 5.3 assembly, built to 21 CFR Part 11 and GAMP 5 standards. The company maintains GDPR, CCPA, and EU-US Data Privacy Framework compliance, and its quality and privacy programs are led by a dedicated VP. Leadership combines clinical research, biostatistics, ML, and regulatory expertise, and the company is led by recently appointed CEO David T. Lynch, PhD.

Name

Koneksa Health

Legal name

Koneksa Health Inc.

Website

https://koneksahealth.com

Company type

Private

Founded year

2013

Operating status

Operating

Headcount range

51–100 employees

Short description

Koneksa Health builds multimodal clinical data infrastructure for biopharmaceutical sponsors, combining wearables, mobile apps, and validated digital endpoints into a regulatory-aligned SaaS platform plus Lodestar™ submission software, serving enterprise pharma, biotech, and academic researchers across 50+ clinical programs.

Ownership category

akta.pro rank

Product category

Clinical Trial Technology

NAICS

Scientific Research and Development Services (5417), Computer Systems Design Services (541512), Other Computer Related Services (541519)

SIC

Services-Prepackaged Software (7372), Services-Commercial Physical & Biological Research (8731)

akta.pro primary industry

Clinical Trial Informatics (EDC/CTMS/eCOA/eTMF) (HLAGAJAM)

akta.pro secondary industries

Regulatory Submissions & Clinical Content Management (eCTD/Publishing) (HLACAOAN), Site & Investigator Platforms (Site Payments, Feasibility, Activation) (HLACAOAJ)

Keywords

• Digital biomarker platform
• Clinical trial technology
• Healthcare data analytics
• Wearable health monitoring
• Regulatory submission software

Headquarters

HQ city

New York

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Software

Cost components

Personnel, Technology or R&D, Operations, Marketing or Sales, Infrastructure

Revenue model

1. SaaS Platform Subscription: Subscription-based access to Koneksa's digital biomarker platform, including data collection infrastructure, analytics tools, and endpoint validation services. Recurring revenue model with annual or multi-year contracts with pharmaceutical clients.
2. Professional Services: Implementation, consulting, and support services for deploying digital biomarker solutions in clinical trials. Includes protocol design, device provisioning, data management, and regulatory consulting.
3. Data Licensing: Licensing of de-identified, aggregated data insights and benchmark data derived from clinical trial operations. Supports pharmaceutical research beyond individual trial engagements.

Pricing tiers

Go-to-market motion3 records

Distribution channels2 records

Marketing channels4 records

Core offering

Koneksa Health provides a multimodal clinical data platform that combines connected wearables, mobile applications, and traditional clinical outcome assessments to capture and analyze digital biomarkers for use in pharmaceutical clinical trials. The company sells the Koneksa Platform and Lodestar™ intelligent submission software as core products, supported by professional services for advanced modeling, biometrics, data science, data engineering, and digital measurement framework design. Their solutions enable biopharma sponsors to deploy validated, regulatory-accepted digital endpoints across therapeutic areas including neuroscience, oncology, Parkinson's disease, respiratory, and rare diseases.

Product overview

Koneksa Health offers a multimodal clinical data platform for clinical development, combining the core Koneksa Platform with Lodestar™ intelligent submission software. The platform enables remote, patient-centric data collection via wearables and mobile technology, integrating traditional biomarkers and digital biomarkers through services including Advanced Modeling & Analysis, Biometric Services, Data Science, Data Syndication & IP, Data Engineering & Processing, and the Digital Measurement Framework. The portfolio supports clinical trials across neuroscience, oncology, respiratory, rare diseases, and Parkinson's disease, with validated digital endpoints designed for regulatory confidence.

Differentiator

Problem solved

Functional benefit

Brands

• Lodestar: Intelligent submission software that unifies the clinical submission pipeline from EDC to eCTD, connecting every step of the clinical submission pipeline into a single, continuously validated, 21 CFR Part 11 audit-trailed workflow supporting FDA and EMA submissions.

Products and services

• Koneksa Platform A sensor-agnostic, flexible SaaS platform supporting regulatory-aligned evidence generation for clinical trials. Enables remote, patient-centric data collection via wearables and mobile technology, integrating traditional and digital biomarkers for analysis, export, and new signal discovery. Designed for biopharmaceutical sponsors conducting clinical research.
• Lodestar™ First Intelligent Submission Software for clinical trials that connects every step of the submission pipeline into a single, continuously validated, 21 CFR Part 11 audit-trailed workflow supporting FDA and EMA submissions. Sequences 10 connected workflow steps from EDC ingest through eTMF push, with AI-assisted human-approved processes at each step. Built to GAMP 5 standards across more than 20 therapeutic areas.
• Advanced Modeling & Analysis Services

Quantifiable outcome

• Supported over 50 clinical programs across multiple therapeutic areas
• +2 more outcomes

Named customers7 records

Segments3 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

AI capability4 records

Feature4 records

Partnerships

Ten partnerships are on record, tiered core and minor.

• MerckcoreStrategic or Co-development Partner · 1 January 2020Collaboration on digital measures for Parkinson's disease research. Partnership includes data syndication for Parkinson's disease study involving 10,000+ participants. Joint work on developing and validating digital endpoints for neurological disorders.
• RegeneroncoreStrategic or Co-development PartnerKH007 study collaboration focused on movement disorder assessment using Koneksa's proprietary digital biomarker technology. Regeneron utilized Koneksa's validated endpoints for clinical trial outcome measurement.
• Michael J. Fox FoundationcoreStrategic or Co-development PartnerCollaboration on Parkinson's disease research, bringing together foundation funding, patient community access, and Koneksa's digital biomarker technology for objective measurement of disease progression.
• VerilycoreStrategic or Co-development PartnerPartnership on Parkinson's disease risk prediction research. Combines Verily's technology platform and data capabilities with Koneksa's digital biomarker expertise for longitudinal monitoring and risk assessment.
• Einstein College of MedicineminorStrategic or Co-development PartnerAcademic research collaboration on digital biomarker validation and clinical endpoint development in collaboration with Einstein College of Medicine researchers.
• Northwestern UniversityminorStrategic or Co-development PartnerResearch collaboration with Northwestern University researchers on digital biomarker development and validation methodologies.
• Oregon Health and Science UniversityminorStrategic or Co-development PartnerAcademic partnership for digital biomarker research and clinical validation studies conducted with OHSU investigators.
• University of RochesterminorStrategic or Co-development PartnerCollaboration with University of Rochester researchers on Parkinson's disease research and digital biomarker development, leveraging the university's expertise in movement disorders.
• Syneos HealthminorChannel Partner/ Reseller/ DistributorChannel partnership following acquisition of Illigo Health by Syneos. Koneksa's digital biomarker solutions offered as part of Syneos' decentralized trial and clinical development services.
• SSI StrategyminorImplementation/ SI/ Consulting PartnerConsulting partnership for regulatory strategy and implementation support for digital biomarker solutions in clinical trials.

Scale indicators3 records

Recent moves6 records

Expansion highlights6 records

Broad incumbents

• Medidata Solutions (Dassault Systèmes): Operates Rave EDC, eCOA, and decentralized trial solutions widely used in pharma clinical research. Directly comparable to Koneksa's Koneksa Platform and Lodestar (EDC-to-eCTD submission) capabilities but at significantly larger scale with broader portfolios.
• IQVIA: Global CRO and clinical technology provider with EDC, eCOA, decentralized trial, and real-world evidence capabilities. Competes with Koneksa across both biomarker analytics and the broader clinical trial technology stack.

Direct peers

• Clario: Provides scientific-led clinical trial technology including wearable-based digital endpoints, eCOA, and cardiac safety services. Closest pure-play competitor to Koneksa's validated digital endpoint and wearable analytics offering for pharma sponsors.
• Science 37 (now part of eMed): Decentralized clinical trial platform integrating wearable data, telehealth, and remote assessments. Comparable to Koneksa's patient-centric, remote data collection approach for clinical research.
• Medable: Decentralized and hybrid trial platform enabling eCOA, ePRO, telehealth, and connected device integration. Overlaps with Koneksa's digital biomarker and remote patient data capture offerings for biopharma.
• ActiGraph: Specializes in wearable actigraphy devices and analytics for clinical research, including validated endpoints in neurology and rare disease. Directly competes in the wearable digital biomarker space Koneksa serves.
• VivoSense: Develops and validates digital clinical outcome assessments using wearable sensors, focused on regulatory-grade endpoints. Closely comparable to Koneksa's validated digital endpoint thesis and pharma customer base.
• AiCure: Uses AI and computer vision on mobile devices to assess patient behavior and adherence in clinical trials. Overlaps with Koneksa's digital measurement and patient-centric data capture capabilities.

Emerging players

• Evidation Health: Operates a direct-to-participant health data platform and conducts decentralized research with pharma partners. Comparable in multimodal wearable data and predictive modeling for clinical research use cases.
• Cambridge Cognition: Specializes in cognitive assessment tools for clinical trials in CNS disorders. Already partners with Koneksa and addresses an overlapping neuroscience-focused customer base with complementary digital endpoint technology.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat6 records

Key risks6 records

Key highlights7 records

Customer concentration

• Xx.com/koneksa
• YouTubeyoutube.com/channel/UC1vlfNNZkMickBcRt_iDoOw
• LinkedInlinkedin.com/company/koneksa-health/posts/?feedView=all

Compliance4 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles13 records

Funding overview

Funding rounds6 records

Investors13 records

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Koneksa Health