Newel Health

Name

Newel Health

Legal name

NEWEL HEALTH S.R.L.

Website

https://newel.health

Company type

Private

Founded year

2022

Operating status

Operating

Headcount range

51–100 employees

Short description

Newel Health is a Salerno-based certified legal manufacturer of AI-driven Software as Medical Devices, developing clinically validated digital therapeutics including Amicomed for hypertension, Rohkea VR for chronic pain, and Soturi for Parkinson's disease, serving pharmaceutical partners, healthcare systems, and patients across Europe.

Ownership category

akta.pro rank

Product category

Digital Therapeutics / Software as Medical Device

NAICS

Software Publishers (513210), Custom Computer Programming Services (541511), Scientific Research and Development Services (5417)

SIC

Services-Prepackaged Software (7372), Surgical & Medical Instruments & Apparatus (3841), Services-Computer Programming, Data Processing, Etc. (7370)

akta.pro primary industry

Condition-specific Digital Therapeutics (DTx) (HLACANAA)

akta.pro secondary industries

Therapeutic Companion Apps (Drug-Device-Digital Combination) (HLACANAH), SaMD – Monitoring, Triage & Risk Stratification Software (HLACANAE), SaMD – Digital Biomarkers & Algorithmic Endpoints (HLACANAF)

Keywords

• Digital therapeutics
• Software as medical device
• Chronic disease management
• Digital health platform
• Behavioral medicine solutions

Headquarters

HQ city

Salerno

HQ country

Italy

HQ region

Europe

Offices8 records

Markets served

GTM type

B2B and B2C

Offering type

Software

Cost components

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

Revenue model

1. Licensing and Royalties: Newel holds exclusive global rights to develop, manufacture and commercialize products like Rohkea (ODD-403), with Orion entitled to receive royalties from sales and sales milestone payments.
2. SaMD Co-development and Manufacturing: As a certified legal manufacturer of SaMD, Newel co-develops digital endpoints, companion therapeutics, and patient support programs, taking full regulatory accountability from design control to post-market surveillance for pharma and medtech partners.
3. Direct-to-Consumer Product Sales: Amicomed is available as a stand-alone mobile application direct to consumers in key European markets.
4. Health System and Payer Integration: Amicomed is being integrated into chronic disease programs and benefit design through collaborations with public and private insurers, with clinicians prescribing the solution.

Go-to-market motion4 records

Distribution channels4 records

Marketing channels6 records

Core offering

Newel Health develops and manufactures certified Software as Medical Devices (SaMDs) combining AI, behavioral science, and real-world clinical data for chronic disease management across cardiometabolic disease, Parkinson's, and chronic pain. The company sells its own digital therapeutics (Amicomed for hypertension, Rohkea VR for chronic musculoskeletal pain, Soturi for Parkinson's) on its proprietary H.Core AI platform, and operates as a certified legal manufacturer co-developing SaMD products, digital endpoints, and companion apps for pharmaceutical and medtech partners.

Product overview

Newel Health develops and manufactures certified AI-driven Software as Medical Devices (SaMDs) combining AI, behavioral science, and real-world data for chronic disease management. The company operates a platform-plus-products model built on its proprietary H.Core AI development platform. The product portfolio includes three named therapeutic products: Amicomed (CE MDR Class IIa certified digital therapeutic for hypertension management, serving 1.28 billion people with hypertension), Rohkea™ (CE MDR Class IIa certified VR-based cognitive behavioral therapy for chronic musculoskeletal pain), and Soturi (AI-assisted levodopa optimization platform for Parkinson's disease in active clinical study). H.Core serves as the foundational technology layer for all products, integrating regulatory compliance, behavioral science, pre-qualified clinical modules, and AI/ML capabilities. As a certified legal manufacturer, Newel Health also offers partner services including SaMD co-development, regulatory accountability, companion app development, and digital endpoint design for pharmaceutical and medtech companies. The company holds two CE MDR Class IIa certified products and has a growing pipeline across cardiometabolic disease, neuroscience (Parkinson's), and chronic pain therapeutic areas.

Differentiator

Problem solved

Functional benefit

Brands

• H-Core: Newel Health's proprietary AI development platform for building certified Software as Medical Devices, integrating regulatory compliance, behavioral science, machine learning, and real-world clinical data into a single certified foundation.
• Amicomed
• Rohkea
• Soturi
• Behavioral Intelligence Engine (BIE)

Products and services

• Amicomed CE MDR Class IIa certified digital therapeutic for hypertension management that empowers individuals to manage blood pressure through a smartphone app, providing personalized recommendations, medication reminders, and lifestyle coaching tailored to each person's health profile.
• Rohkea VR CE MDR Class IIa certified virtual reality-based digital therapeutic that delivers a 12-week program combining cognitive behavioral therapy with physical activation exercises in an immersive VR environment through a virtual mentor (SAMI), targeting chronic musculoskeletal pain and fear of movement.
• Soturi Digital therapeutic platform for Parkinson's disease management in active clinical study, using AI-assisted levodopa optimization with wearable motor symptom detection, a medication management and symptom diary, physical and speech exercises, emotional support, and physician-facing dashboards with alerts and treatment outcome predictions.
• Legal Manufacturer Services Certified legal manufacturer service (ISO 13485, MDR, FDA-aligned) under which Newel Health assumes full regulatory accountability for SaMD products from design control to post-market surveillance, including design history file management, risk management under ISO 14971, clinical evaluation, CE marking, vigilance reporting, and lifecycle updates.
• Companion App Development Co-development service for pharmaceutical and medtech partners to build companion apps, day-to-day therapy support, and adherence tools that turn connected devices into complete patient experiences.
• Digital Endpoint Development Service to develop AI-based digital endpoints powered by machine learning algorithms trained on real-world data, using connected devices and sensors to continuously and objectively track patient status during clinical trials and post-market care.

Quantifiable outcome

• 4.7 ± 1.2 mmHg systolic BP reduction (p < 0.0001) in Amicomed lifestyle-change group vs 2.5 ± 0.9 mmHg monitoring-only group
• +4 more outcomes

Named customers5 records

Segments5 records

Ideal customer profiles5 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

AI capability8 records

Feature5 records

Partnerships

Nine partnerships are on record, tiered core and minor.

• Gerresheimer AGcoreStrategic or Co-development Partner · 27 May 2026Strategic collaboration announced May 27, 2026 combining Newel Health's H-Core platform and AI-enabled analytics with Gerresheimer's drug delivery, primary packaging, and digital health solutions. Partnership aims to support pharmaceutical companies in developing integrated drug and digital therapies, enabling real-world data generation, digital endpoints, and scalable personalized medicine solutions. Four pillars: Designing Digital Endpoints, Developing Digital Medical Devices (SaMD), Unlocking AI-Driven Insights, and Creating Integrated Drug+Device+Digital Solutions.
• AOU San Giovanni di Dio e Ruggi d'AragonaminorStrategic or Co-development Partner · 14 October 2024Clinical trial site for NWL-SOT-CS-001 Parkinson's disease study. PI: Prof. Maria Teresa Pellecchia.
• IRCCS San RaffaeleminorStrategic or Co-development Partner · 14 October 2024Clinical trial site for NWL-SOT-CS-001 Parkinson's disease study. PI: Prof. Fabrizio Stocchi.
• IRCCS Fondazione Santa LuciaminorStrategic or Co-development Partner · 14 October 2024Clinical trial site for NWL-SOT-CS-001 Parkinson's disease study. PI: Dr. Clelia Pellicano.
• South Eastern Health and Social Care TrustcoreStrategic or Co-development Partner · 14 October 2024NHS Trust in Northern Ireland piloting ROHKEA VR therapy for chronic pain management. First Trust in Northern Ireland to integrate immersive VR technology into pain management services. Partnership supports clinicians with VR-augmented cognitive behavioral therapy as a tool in their pain management toolkit.
• Orion CorporationcoreOEM/ Whitelabel/ Licensing Partner · 29 January 2024License agreement for Rohkea (ODD-403), a VR-based digital therapeutic for chronic pain. Newel Health holds exclusive global rights to develop, manufacture and commercialize the product. Orion is entitled to receive royalties from sales as well as sales milestone payments. Originally developed by Orion, Rohkea provides an immersive gamified therapeutic treatment program combining cognitive behavioral therapy with physical activation exercises.
• University of Geneva (QoL Lab)minorStrategic or Co-development PartnerCollaboration on digital health technologies, data analytics, and patient monitoring systems. University of Geneva's Department of Computer Science contributes technical expertise in software development and evaluation of digital health interventions.
• University of SalernominorStrategic or Co-development PartnerNeuroscience Section partners in clinical and digital health research, contributing expertise in movement disorders, Parkinson's disease management, and clinical validation of digital therapeutics.
• Frontiers HealthcoreGTM or Marketing PartnerOfficial partner of Frontiers Health Italy 2025, premier gathering for health innovation ecosystem. Company participated as Gold Sponsor at Frontiers Health 2023 in Rome. EVERSANA-organized conference exploring digital therapeutics, hybrid care, longevity, and wellbeing.

Scale indicators10 records

Recent moves7 records

Expansion highlights6 records

Direct peers

• Kaia Health: Digital therapeutics company offering evidence-based digital therapy programs for chronic pain (including musculoskeletal pain) and COPD; directly comparable to Newel's Rohkea VR chronic pain product in terms of indication and DTx delivery model.
• Voluntis (Otsuka): Develops prescription digital therapeutics for chronic conditions including diabetes and oncology supportive care; comparable as a SaMD platform targeting pharma partnerships and chronic disease, now part of Otsuka Pharmaceutical.
• Biofourmis: AI-driven digital therapeutics and remote monitoring platform for chronic disease management, including cardiovascular conditions; closely comparable to Newel's H.Core SaMD platform approach and pharma partnership GTM.
• Welldoc: Digital health company with FDA-cleared digital therapeutics for diabetes and cardiometabolic conditions, offering enterprise B2B partnerships with health systems, payers, and pharma — directly overlapping Amicomed's hypertension focus.
• AppliedVR: Developer of FDA-authorized EaseVRx VR-based digital therapeutic for chronic pain; closest direct peer to Newel's Rohkea VR chronic musculoskeletal pain product in modality (VR) and indication.
• Akili Interactive: Pure-play digital therapeutics company with FDA-authorized EndeavorRx and other cognitive/behavioral DTx products; comparable as a publicly-recognized DTx specialist navigating reimbursement and regulatory pathways.

Emerging players

• CureApp: Japanese digital therapeutics company with a regulatory-approved hypertension DTx and nicotine addiction treatment; comparable to Newel's Amicomed hypertension product in indication and SaMD regulatory pathway.
• XRHealth: VR-based digital therapeutics platform for pain management, mental health, and rehabilitation delivered through clinician-prescribed VR; directly comparable to Rohkea VR's VR-delivered CBT approach for chronic pain.

Broad incumbents

• BrightInsight: Medical-grade IoT and digital health platform serving as regulated digital infrastructure for pharma and medtech; competes with Newel's H.Core as a SaMD development platform for life sciences partners.
• Omada Health: Larger established digital chronic disease management company addressing hypertension, diabetes, and musculoskeletal conditions through payer and employer channels; comparable in cardiometabolic/chronic pain focus and B2B distribution.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat5 records

Key risks5 records

Key highlights6 records

Customer concentration

• LinkedInlinkedin.com/company/newel-health
• Xtwitter.com/NewelHealth

Compliance9 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles6 records

Funding overview

Funding rounds2 records

Investors2 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 Newel Health