G&H | ITL Case Study: Enabling Next-Generation Organ Preservation with OrganOx metra®

The Challenge

Liver transplantation is a life-saving procedure - but its success is fundamentally constrained by one critical issue: organ availability.

A significant proportion of donor livers are discarded due to:

• Damage caused by traditional cold storage
• Lack of oxygen during preservation
• Limited ability to assess organ viability prior to transplant

At the same time, transplant teams face intense time pressure. Conventional preservation methods provide only a narrow window to evaluate and use donor organs, often forcing difficult decisions under suboptimal conditions.

The result is a system where viable organs may go unused - and patient outcomes are impacted.

The Solution: OrganOx metra®

OrganOx developed OrganOx metra®, a normothermic machine perfusion (NMP) platform designed to fundamentally change how donor livers are preserved and assessed.

Unlike static cold storage, OrganOx metra®:

• Maintains the liver at normal body temperature (37°C)
• Continuously perfuses the organ with oxygenated, nutrient-rich blood-based perfusate
• Enables preservation for up to 24 hours
• Provides real-time physiological monitoring (pO₂, pCO₂, pH, temperature)

This allows clinicians to:

• Conduct functional assessment of the organ prior to transplant
• Make more informed, patient-specific decisions
• Extend surgical planning windows for improved outcomes

By keeping the liver functioning outside the body, metra® transforms preservation into an active, data-driven process.

G&H | ITL’s Role: From Design Transfer to Scaled Manufacturing

To bring OrganOx metra® from innovation to global clinical use, OrganOx required a partner capable of delivering:

• Design transfer into manufacturable systems
• Regulatory-compliant production processes
• Scalable, high-quality manufacturing

G&H | ITL was selected as a strategic manufacturing partner based on its proven track record in complex medical device development and production. G&H | ITL worked closely with OrganOx to:

• Conduct a comprehensive gap analysis to transition the device into production
• Develop and compile the Device Master Record (DMR)
• Establish dedicated manufacturing work cells
• Support production engineering, quality assurance, and regulatory compliance
• Enable a seamless transfer from prototype to commercial manufacturing

This collaboration was highly integrated, with cross-functional teams from both organizations working side-by-side to ensure consistency, quality, and speed to market.

Scaling for Global Impact

The partnership enabled OrganOx to:

• Transition from single-source to dual-source manufacturing
• Expand production capacity to support international growth
• Accelerate readiness for U.S. market entry

The first G&H | ITL-manufactured OrganOx metra® systems have already been deployed in leading European transplant centers - marking a critical milestone in scaling the technology globally.

This collaboration demonstrates how advanced medical device manufacturing can directly enable clinical innovation.

By combining:

• OrganOx’s breakthrough perfusion technology
• G&H | ITL’s expertise in design transfer, regulatory rigor, and scalable production

the partnership is helping to:

• Increase the number of usable donor organs
• Improve transplant success rates
• Ultimately, extend and save more lives