Companies
Revivicor
its 10-gene-edited UHeart received FDA clearance to proceed with the EXPRESS clinical trial, an adaptive Phase 1/2/3 design for pig-heart xenotransplantation, following the first-ever living-patient pig-heart transplants performed under FDA expanded access.
- Country
- United States
xenotransplant
heart
us
Coverage
| CN | EU | US | |
|---|---|---|---|
| regenerative-personalized | ✓ | ✓ | ✓ |
Regulatorsfdaemanmpa
Verifiable facts
| Fact | Value | Source |
|---|---|---|
| Regulatory approval | FDA clearance to proceed with the EXPRESS clinical trial for UHeart xenotransplantation granted May 15, 2026 | investingnews.com · ir.unither.com |
| Production site | Clinical-scale, pathogen-free facility in Christiansburg, Virginia | apnews.com · vtcrc.com |
| Capacity | Approximately 125 organs per year in Christiansburg facility | apnews.com · vtcrc.com |
| Revenue | $783.3 million for the second quarter of 2026 | ir.unither.com |
| Headcount | More than 1,400 employees as of December 31, 2025 medium confidence | ir.unither.com |
Independent sources: apnews.com · investingnews.com · ir.unither.com · vtcrc.com
Technologies
| Name | Cluster | Risk | |
|---|---|---|---|
| Xenotransplantation | regenerative-personalized | High | → |
Compiled by BIOECON from primary sources.
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