Kelyon

What Kelyon does

Kelyon is a privately held Italian digital health company founded in 2008 and headquartered in Naples, with additional offices in Rome and Cardiff (UK, via wholly owned Kelyon Ltd. established in 2018). The company develops certified Software Medical Devices with CE marking and digital health platforms aimed at the prevention, diagnosis, treatment, and monitoring of chronic and complex diseases — primarily in oncology, rare diseases (e.g., disorders of sex development), parenteral nutrition, and increasingly antibiotic resistance. Its technology stack combines Artificial Intelligence, Machine Learning, and Deep Learning to produce decision support models that pair patient health information with clinical guidelines, deployed through a portfolio that includes the Libria clinical data platform and disease-specific tools such as I-DSD, RAS AKTIVE, BRAF LAB, RASBRAF QUALITY, Tirnet, Rational, MOIRA, and ADRE. Kelyon operates under an extensive regulatory and quality apparatus — ISO 9001, ISO 13485, ISO 27001 (with ISO 27017 and ISO 27018 cloud extensions), GDPR, EU MDR, and IVDR compliance — with cloud infrastructure on AWS.

Kelyon's commercial model is enterprise B2B, selling custom digital health solutions, Software Medical Devices, and ongoing support services directly to pharmaceutical companies, healthcare organizations, and research institutions. Its named client base includes major pharma multinationals (Pfizer, AstraZeneca, Merck, Boehringer Ingelheim, GSK, Alexion, Roche) alongside academic and clinical institutions (Università degli Studi di Napoli Federico II, University of Glasgow, Swansea University, Tampere University, IDI-IRCCS, AIOM, FBK). The company states that over 50% of revenue is generated outside Italy, reflecting its international footprint across Europe and select Oceanian markets. The company is founder-led (CEO Gaetano Cafiero, CTO Stefano Tagliaferri), has not disclosed external funding rounds, and has been recognized multiple times at the AboutPharma Digital Awards (2014 finalist, 2015, 2016, and 2024 winner), positioning it as a niche, regulated digital health vendor rather than a venture-backed scale-up.

Name

Kelyon

Legal name

Kelyon Srl

Website

https://kelyon.com

Company type

Private

Founded year

2008

Operating status

Operating

Headcount range

11–50 employees

Short description

Kelyon is a privately held Italian digital health vendor founded in 2008 that builds CE-marked Software Medical Devices and AI-enabled decision support platforms for pharmaceutical companies, healthcare organizations, and research institutions, primarily in oncology and complex chronic diseases.

Ownership category

akta.pro rank

Product category

Digital Health Software

NAICS

Computer Systems Design and Related Services (54151), Custom Computer Programming Services (541511), Professional, Scientific, and Technical Services (54)

SIC

Surgical & Medical Instruments & Apparatus (3841), Services-Health Services (8000)

akta.pro primary industry

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

akta.pro secondary industries

eCOA/ePRO/eDiary & Patient-Facing Data Collection (HLACAOAB), Connected Therapeutics & Smart Drug Delivery Monitoring (HLACAFAL)

Keywords

• Software medical devices
• Digital health platforms
• Clinical decision support
• Healthcare data science
• Patient registry systems

Headquarters

HQ city

Napoli

HQ country

Italy

HQ region

Europe

Offices3 records

Markets served

GTM type

B2B

Offering type

Software

Cost components

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

Revenue model

1. Digital Health Solutions and Software Medical Devices: Kelyon provides certified digital solutions including Software Medical Devices with CE marking for prevention, diagnosis, treatment and monitoring of chronic and complex diseases. Revenue is generated through project-based development and ongoing support services for pharmaceutical companies, healthcare organizations and research institutions.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels6 records

Core offering

Kelyon designs, develops, and delivers certified Software Medical Devices (CE-marked) and e-Health web/mobile applications for the prevention, diagnosis, treatment, and monitoring of chronic and complex diseases. Its portfolio spans clinical data management platforms (Libria), disease registries (I-DSD), molecular diagnostic decision-support systems (Tirnet, BRAF LAB, RAS AKTIVE, RASBRAF QUALITY), oncology therapeutic pathway platforms (Rational), patient-facing telemonitoring apps (MOIRA), and enterprise care-management solutions (ADRE), built using AI, Machine Learning, and Deep Learning technologies.

Product overview

Kelyon offers a comprehensive Digital Health and Digital Medicine portfolio comprising Software Medical Devices with CE marking and digital projects. The core offering includes Libria (clinical data management platform), I-DSD (international disorders of sex development registry), and multiple diagnostic decision support platforms (Tirnet, BRAF LAB, RAS AKTIVE, RASBRAF QUALITY, Rational). The company also provides patient-facing solutions (MOIRA for parenteral nutrition support), enterprise digital solutions (ADRE for residential care), and additional products (Flora, AntiMO, uSTAS, Telma, Gyno). These products are built on a Quality Management System certified to ISO 9001, ISO 13485, and ISO 27001 standards with cloud infrastructure on AWS.

Differentiator

Problem solved

Functional benefit

Products and services

• Libria Platform for clinical data collection, management and analysis enabling healthcare professionals to create patient registries, manage clinical trials, and develop predictive models, with features for data collection, trend analysis, advanced analytics export, and reporting. Targeted at healthcare organizations, research institutions, and pharmaceutical companies.
• I-DSD Web-based Software Medical Device providing access to an international registry of disorders of sex development (DSD), supporting healthcare professionals with clinical case information integration and data consultation. Targeted at clinicians and academic researchers (deployed for University of Glasgow).
• Tirnet Web-based Software Medical Device simplifying access to molecular diagnostic tests on thyroid FNA (fine needle aspiration), enabling NRAS and BRAF mutation testing through a Hub-Spoke model that connects professionals and laboratories for diagnosis and treatment of nodular thyroid disease. Targeted at clinicians and pathology laboratories.
• BRAF LAB Web-based Software Medical Device simplifying tests for BRAF gene mutation determination for colorectal cancer treatment, enabling Italian oncology centers to connect with qualified molecular diagnostic laboratories through a Hub-Spoke model. Targeted at oncologists and molecular diagnostic laboratories.
• RAS AKTIVE Web-based Software Medical Device simplifying KRAS gene mutation testing for colorectal cancer treatment, connecting Italian oncology centers with molecular diagnostic laboratories through a Hub-Spoke model. Targeted at oncologists and molecular diagnostic laboratories.
• RASBRAF QUALITY Multilingual web-based Software Medical Device supporting a quality control program for identification of biomarkers relevant for colorectal cancer and melanoma treatment, monitoring quality assurance processes of analysis centers performing KRAS, NRAS, and BRAF mutation analysis. Targeted at medical-scientific associations (deployed for AIOM).
• Rational Digital platform supporting oncologists in choosing optimal therapeutic pathways based on NGS (next-generation sequencing) test results, functioning as a network for personalized medicine with access to actionable mutations in cancer patients. Targeted at oncologists and clinical decision-makers.
• MOIRA Web and mobile digital solution supporting patients on parenteral nutrition with central venous catheter (CICC) and their caregivers, featuring telemonitoring, online training, televisit, and 24/7 messaging for care management. Targeted at patients, caregivers, and clinical nutrition teams.
• ADRE Digital solution supporting healthcare staff in RSA (residential care facilities) for assistance and monitoring of residents, maximizing efficiency in service delivery through a modular platform enabling team interaction and information sharing. Targeted at residential care facility operators.
• AntiMO Digital platform for antibiotic resistance management, helping clinicians choose the most effective therapy. Targeted at infectious disease specialists, microbiologists, and antimicrobial stewardship programs (deployed with IDI-IRCCS).
• Gyno Software Medical Device for gynecological applications. Targeted at healthcare organizations and gynecological care providers.
• Flora Digital health solution for specialized healthcare applications. Targeted at healthcare professionals and patient care programs.
• uSTAS Digital health solution for specialized healthcare applications. Targeted at healthcare providers.
• Telma Digital health solution for specialized healthcare applications. Targeted at healthcare providers.

Quantifiable outcome

• Reduced diagnostic turnaround times through Hub-Spoke platform models for molecular testing
• +1 more outcomes

Named customers14 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 capability6 records

Feature3 records

Partnerships

Six partnerships are on record, tiered core and minor.

• FBK (Fondazione Bruno Kessler)coreStrategic or Co-development PartnerStrategic alliance for artificial intelligence in healthcare. Kelyon and FBK formed a partnership to advance AI applications in the healthcare sector, combining Kelyon's digital health expertise with FBK's research capabilities.
• IDI-IRCCScoreStrategic or Co-development PartnerCollaboration on the AntiMO platform for fighting antibiotic resistance. IDI-IRCCS and Kelyon partner to develop digital solutions for antimicrobial resistance management.
• iCAMPUS ConsortiumminorStrategic or Co-development PartnerKelyon is a founding member of the iCAMPUS consortium, an ICT innovation and research consortium in Campania region aimed at creating a research and innovation hub.
• ICT Professionals NetworkminorStrategic or Co-development PartnerNetwork of 5 IT engineering companies including Kelyon, MDP, Protom Group, SMS Engineering, and Tecnosoft for collaborative business development.
• Danone/NutriciaminorStrategic or Co-development PartnerNon-conditional contribution to MOIRA project for patient nutrition monitoring solutions.
• Aziende Senza Frontiere (MSF Support)minorOthersKelyon supports Medici Senza Frontiere (Doctors Without Borders) as part of Corporate Social Responsibility activities.

Scale indicators4 records

Recent moves8 records

Expansion highlights6 records

Direct peers

• ArisGlobal: ArisGlobal delivers life sciences R&D technology including clinical trial and safety/regulatory platforms used by similar pharma customers; the AI/ML decision support and SaMD positioning overlaps with Kelyon's digital medicine focus.
• Medidata (Dassault Systèmes): Medidata's Rave EDC, eCOA and CTMS suite is the category leader in clinical trial informatics and competes head-on with Kelyon's Libria, I-DSD registry and clinical decision support offerings to large pharma sponsors.
• Castor EDC: Castor EDC offers a cloud-based clinical data platform with EDC, ePRO/eCOA and decentralized trial capabilities, directly competing with Kelyon's Libria platform and patient-facing data collection tools for pharma and academic sponsors.
• OpenClinica: OpenClinica provides EDC and eClinical platform functionality used by pharma and academic research, comparable in scope to Kelyon's Libria clinical trial and registry infrastructure.
• Veeva Systems: Veeva's clinical and medical suite (Vault CDB, Vault EDC, Vault CTMS) targets the same global pharma accounts that Kelyon serves, with overlapping capabilities in clinical data, study build and post-market evidence.

Emerging players

• ThoughtSphere: ThoughtSphere provides clinical analytics and trial performance software for sponsors and CROs, comparable in being a niche digital health platform targeting clinical operations data and decision support like Kelyon.
• Arithmos: Arithmos is an Italy-based eClinical and life sciences consulting firm supporting EDC, CDISC and regulated software delivery for pharma - a regional peer comparable in size, geography and service offering to Kelyon's clinical software business.

Broad incumbents

• Oracle Health Sciences (Clinical One): Oracle's Clinical One platform unifies EDC, RTSM and clinical trial workflows for large pharma sponsors, competing with Kelyon's Libria and registry offerings at the enterprise end of the market.
• IQVIA (Clinical & Technology Solutions): IQVIA combines CRO scale with the E360, Inform and Site Suite clinical technology portfolio, serving the same global pharma and biotech customer base as Kelyon while competing on integrated trials and real-world evidence.
• DXC Technology (Healthcare & Life Sciences): DXC's life sciences practice delivers clinical development, regulatory and safety platforms to pharma, broadly overlapping with Kelyon's clinical informatics and SaMD services for enterprise pharma clients.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

• Xx.com/kelyon
• YouTubeyoutube.com/@kelyon
• Facebookfacebook.com/kelyonsrl
• LinkedInlinkedin.com/company/kelyon
• Instagraminstagram.com/kelyonofficial

Compliance9 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles10 records

Subsidiaries1 record

Funding overview

Funding rounds

Investors

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 Kelyon