The collaboration combines Newel Health's H-Core platform, regulated digital medical devices, and AI capabilities with Gerresheimer's drug delivery and primary packaging expertise, extended through digital health solutions and established pharmacy touchpoints, to deploy integrated drug and digital therapies that enable real-world data generation and personalized medicine at scale.

BASEL, Switzerland, May 27, 2026 /PRNewswire/ -- Newel Health, a company that designs, develops, and operates digital medical devices (SaMD) for life sciences partners, and Gerresheimer, an innovative system and solution provider for drug delivery systems, medical devices, pharmaceutical primary packaging, and digital health solutions, today announced a partnership to support pharmaceutical and biotech companies in developing digital endpoints, digital medical devices, and integrated drug+digital solutions.

The collaboration brings together:

• Newel Health's expertise in regulated digital medical devices (SaMD), based on its H-Core platform, clinical-grade algorithms, AI-enabled analytics, and patient-centric digital experiences; and
• Gerresheimer's system-level capabilities across drug delivery, primary packaging, digital health, and established pharmacy touchpoints, enabling the integration, deployment, and activation of digital components along with drug-based therapies and patient workflows

Together, Newel Health and Gerresheimer position themselves as strategic partners for pharma companies who are seeking to embed digital endpoints, real-world data, and AI into clinical development and commercialization, without needing to build a full digital and device stack internally.

"Gerresheimer's expertise in drug delivery, manufacturing, and connected devices, together with Newel Health's science, H-Core platform, and digital medical devices, will support pharma companies to bring personalized medicine to patients safely and reliably," said Ervin Ukaj, Chief Executive Officer, Newel Health. "By combining our SaMD expertise, real-world data, and AI capabilities with Gerresheimer's global footprint, connected device, packaging and Digital Health capabilities, we help pharma design and scale digital endpoints, regulated digital medical devices, and integrated drug+digital solutions across multiple indications."

"Our collaboration with Newel Health underlines Gerresheimer's position as a system and solution provider at the interface of drug, device or packaging and digital solutions," said Mithun Ratnakumar, Director, Head of Digitalization & New Business Models at Gerresheimer. "Together, we enable pharma companies to deploy compliant, scalable solutions without having to build or operate the full digital and device infrastructure themselves."

Partnership Scope: Digital Endpoints, Real-World Data, AI, and Drug+Device+Digital

Under the partnership, Newel Health and Gerresheimer will work with pharma and biotech companies to:

• Design and validate digital endpoints using data generated by connected devices and sensors, enabling more continuous and objective measurement of patient status in clinical studies and post-market settings.
• Develop and operate digital medical devices (SaMD) built on Newel's H-Core platform, supporting monitoring, decision-making, adherence tools, and symptom tracking aligned with specific therapies and clinical pathways.
• Enable real-world data (RWD) access and AI-driven insights by combining connected devices, SaMD, and secure data infrastructure to generate high-quality, longitudinal datasets and advanced analytics for sponsors.
• Build integrated drug+device+digital solutions, where Gerresheimer's connected drug delivery and connected device platforms are engineered together with Newel's H-Core–based SaMD, AI models, and user experience into a coherent, regulatory-grade solution around the medicine.

This combined approach allows pharmaceutical companies to move beyond isolated pilots and build scalable, repeatable digital and data assets that can be deployed across therapeutic areas and markets

About Newel Health

Newel Health (part of Future Health Ventures Group) designs, develops, and operates digital medical devices (software as a medical device, SaMD) in collaboration with pharmaceutical, biotech, and medtech partners. Using its H-Core platform to build digital medical devices, Newel combines clinical research, behavioral science, and AI-enabled analytics within a regulatory-grade framework to deliver personalized digital solutions for non-communicable diseases.

Newel's portfolio includes Rohkea, an MDR Class IIa, VR-based digital therapy for chronic pain, and Amicomed, a certified digital therapeutic for hypertension designed for real-world impact and deployed through payer, corporate wellness, and direct channels. These products sit within a broader pipeline of H-Core–based solutions in cardiometabolic disease, neuroscience, and chronic pain, developed to meet concrete clinical and patient needs and to support pharma in building scalable digital endpoints, SaMD, and drug+digital programs.

About Gerresheimer

Gerresheimer is an innovative system and solution provider and global partner for the pharma, biotech and cosmetics industries. The company offers a comprehensive portfolio of pharmaceutical packaging, drug delivery systems, medical devices and digital solutions for therapy support. Gerresheimer ensures the safe delivery and reliable administration of drugs to the patient. With over 13,000 employees and 39 production sites in Europe, America and Asia, Gerresheimer has a global presence and produces locally for regional markets. 
www.gerresheimer.com

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