United Therapeutics has announced positive Phase 1 clinical results for miroliverELAP®, marking the world’s first FDA-cleared human trial of a bioengineered liver support system. Developed by its subsidiary Miromatrix Medical, the platform represents a major milestone in regenerative medicine and organ manufacturing.
The results suggest that engineered liver constructs may soon offer lifesaving temporary support for patients suffering from acute liver failure (ALF), particularly those who are not eligible for transplantation.
Addressing a Critical Clinical Gap
Acute liver failure remains one of the most challenging emergencies in medicine. While some patients recover spontaneously and others receive transplants, roughly 30% die due to organ shortages or medical ineligibility.
miroliverELAP is designed to bridge this gap. Rather than replacing the liver permanently, it functions as an external assist system, supporting patients while their native liver recovers—or while they await further treatment.
This approach mirrors developments in cardiac and renal assist devices, but until now, no comparable technology had reached human trials for liver support.
How miroliverELAP Works
miroliverELAP combines tissue engineering with extracorporeal perfusion technology:
- A decellularized porcine liver scaffold provides native organ architecture
- The scaffold is reseeded with:
- Human endothelial cells
- Human hepatocytes from non-transplantable donor livers
- The bioengineered organ is placed in an external blood circuit
- Patient blood is circulated through the system for metabolic and detoxification support
This hybrid system integrates principles from bioprinting, organ scaffolding, and bioreactor engineering into a clinical-grade platform.
Phase 1 Trial Results
The Phase 1 study enrolled five patients with severe acute liver failure who were not transplant candidates.
Key outcomes:
- Continuous treatment for at least 44 hours
- 100% survival during treatment
- No unexpected serious adverse events
- Favorable safety profile over 32-day follow-up
The study met its primary endpoint: demonstrating feasibility and short-term safety in critically ill patients.
Full results are expected to be published in the second half of 2026.
Industry and Leadership Perspective
Dr. Jeff Ross, President of Miromatrix, emphasized the translational significance:
“This study provides early evidence that miroliverELAP… has the potential to provide liver support for patients experiencing ALF.”
Meanwhile, United Therapeutics founder and CEO Martine Rothblatt framed the work as part of a broader mission to expand organ availability:
“Yet another historic achievement… for patients for whom liver transplantation was not an option.”
These statements highlight the company’s long-term strategy of integrating regenerative platforms into mainstream clinical care.
Platform Strategy: Beyond the Liver
miroliverELAP is part of a larger organ manufacturing ecosystem at United Therapeutics, spanning:
- Xenotransplantation
- Allogeneic regenerative medicine
- Autologous regenerative medicine
Target organs include:
- Hearts
- Kidneys
- Livers
- Lungs
In parallel with its liver program, Miromatrix is developing mirokidney, a fully implantable bioengineered kidney based on the same decellularization–recellularization workflow.
This multi-organ platform approach reflects a shift from single-product biotech models toward vertically integrated “organ factories.”
Regulatory and Development Pathway
The Phase 1 trial followed FDA clearance of Miromatrix’s Investigational New Drug (IND) application in 2024.
Based on the positive results:
- A Phase 2 study is planned
- Larger patient cohorts will be evaluated
- Efficacy endpoints will be expanded
- Manufacturing scalability will be tested
At present, miroliverELAP remains investigational and is not approved for commercial use.
Implications for Biofabrication and Organ Manufacturing
From a biofabrication perspective, this trial represents a watershed moment:
1. Clinical Validation of Recellularized Organs
For years, decellularized scaffolds have shown promise in preclinical models. miroliverELAP provides one of the first human validations of this approach.
2. Hybrid Manufacturing Models
Unlike purely printed tissues, this platform combines:
- Natural organ architecture
- Cell therapy
- Perfusion engineering
suggesting that future organ manufacturing may rely on hybrid rather than fully synthetic systems.
3. New Business Models in Transplant Medicine
External organ-assist systems may emerge as:
- Interim therapies
- ICU-based products
- Subscription-style hospital platforms
This opens new commercial pathways beyond traditional transplant markets.
Bottom Line
United Therapeutics’ miroliverELAP trial marks a major milestone in translational biofabrication. It validates decades of work in organ scaffolding and recellularization, while signaling that engineered organs are moving from experimental labs into intensive care units.
For the biofabrication industry, this is more than a clinical success—it is proof that organ manufacturing is becoming a deployable healthcare infrastructure.
The Business of Biofabrication 
Leave a comment