From Discovery to Market: A Pipeline Built for Partnership
Newel Health’s pipeline spans every stage of digital therapeutic development, from discovery to post-market deployment, across three key therapeutic areas: cardiometabolic, neurological, and chronic pain. Our approach mirrors the pharmaceutical product development lifecycle, enabling collaboration at every phase to integrate digital solutions that enhance therapeutic efficacy, strengthen patient engagement, and extend care beyond the clinic.
Advancing a multi-therapeutic pipeline
Evidence of strong execution across cardiometabolic, neurological, and pain-related conditions.
Therapeutic Area
Indication
Program
Preclinical
Feasibility
Clinical Trial
Certification
LCM
Therapeutic Area
Cardiometabolic
Blood pressure monitoring Hypertension
NWL-001 Amicomed
LCM
Therapeutic Area
Pain
Chronic low back pain
NWL-003 Rohkea
Certification
Therapeutic Area
Neurology
Companion App for patients with Parkison's
NWL-004 Viamova
Clinical Trial
Therapeutic Area
Neurology
Parikison's levodopa dose management
NWL-002 Soturi
Feasibility
Therapeutic Area
Cardiometabolic
Heart failure
NWL-001B
Preclinical
Therapeutic Area
Cardiometabolic
Pregnancy
NWL-001C
Feasibility
Therapeutic Area
Cardiometabolic
Obesity
NWL-005
Feasibility
Aligned with the pharmaceutical development lifecycle
Collaborate with us at every stage, from digital discovery to post-market evidence generation.
Our development process mirrors the structure of pharmaceutical R&D, enabling pharma partners to integrate software-based mechanisms of action into existing assets or explore novel digital pathways. As a certified legal manufacturer of SaMDs (ISO 13485, MDR, FDA-aligned), we ensure every product is both scientifically sound and regulatorily robust, allowing our partners to innovate safely at speed.
PHASE 01
Preclinical
Identify digital mechanisms that complement pharmacological modes of action.
We work with pharma partners to uncover where behaviorally driven or data-driven software interventions can amplify drug efficacy, adherence, or persistence. Using behavioral modeling, patient journey mapping, and real-world data analytics, we translate early scientific hypotheses into digital opportunities.
PHASE 02
Feasibility
Test and refine the digital concept before major clinical investment.
At this stage, we prototype digital mechanisms such as symptom tracking, cognitive training, or AI-guided behavioral nudges and validate feasibility with target users. This reduces uncertainty, de-risks later trials, and establishes preliminary usability and engagement data.
PHASE 03
Clinical trials
Generate clinical evidence for efficacy, safety, and engagement.
We design and legally manufacture trial-ready SaMDs that can serve as digital endpoints, adjunctive interventions, or companion therapeutics. Our quality-management and risk-control systems ensure compliance with Good Clinical Practice and regulatory documentation standards.
PHASE 04
Certification
Navigate regulatory submissions and prepare for market readiness.
Newel manages the technical documentation, clinical evaluation reports, and post-market surveillance plans required under MDR and FDA frameworks. By separating the validated medical “core” from the adaptable UX layer, we maintain compliance while enabling rapid iteration based on regulatory feedback.
PHASE 05
LCM
Sustain value through continuous optimization and real-world data.
Once approved, our H.Core platform supports lifecycle management, localization, and performance monitoring. Real-world evidence feeds back into both pharmacological and digital product strategies, strengthening market access and reimbursement dossiers.
Focused Where Digital Can Deliver Measurable Impact
Our pipeline spans cardiometabolic disease, neurological conditions, and chronic pain, three domains where behavior change, continuous monitoring, and patient engagement play a decisive role in treatment outcomes. Each therapeutic area includes assets at different stages of maturity, from CE-marked products already in market to new solutions under active development.
Transforming cardiometabolic care
Digital therapeutics that support patients with hypertension, obesity, and type II diabetes, where sustained lifestyle change and daily management are critical to success.
Advancing neurological health
Solutions for Parkinson’s disease and other neurological conditions that help patients and clinicians manage complex symptoms through continuous monitoring and personalized digital support.
Redefining chronic pain management
Evidence-based digital therapeutics that extend access to behavioral interventions, improving daily function and quality of life for those living with chronic pain.
Partner with Us to Accelerate Digital Health Innovation
Whether exploring digital endpoints in early discovery or seeking a companion therapeutic for a marketed product, Newel Health offers collaboration opportunities across the full digital medical device lifecycle.
