UHeart by United Therapeutics: status and timeline

UHeart

UHeart is a genetically modified pig heart with 10 gene edits designed for implantation into patients with end-stage heart disease. The program builds on successful compassionate-use transplants in 2022 and 2023.

PilotStage 3 of 5

Successful transplants 2022–2023; IND clearance pending; clinical trial planned.

Updated Sep 2023Checked 10 Oct0 updates this week

Milestones

No announced next step

First pig-to-human heart xenotransplantJan 2022Complete.
Second pig-to-human heart transplant into Lawrence FaucetteSep 2023Complete.

Most important updates

Current obstacles

Mechanical demands of the heartThe heart is a constantly contracting organ; any graft dysfunction immediately compromises survival. Long-term durability is critical.

Physics limits

Cardiac xenograft vasculopathyChronic rejection in cardiac allografts leads to vasculopathy; xenotransplants face similar risk plus additional incompatibilities.

How it works

1 part

Cardiac-optimized edits

10-gene modifications for heart

Similar to UKidney but with edits optimized for cardiac function: immune regulation, anticoagulation, and prevention of cardiac-specific rejection.

Spec sheet

Spec	UHeart
Total gene edits	10 edits^R (reported)
Target patient condition	End-stage heart disease, cardiomyopathy, cardiogenic shock^R (reported)

^R reported by the company

Update log

2 updates

Sep 2023

Major: Second pig-to-human heart xenotransplant at University of Maryland Medical CenterPressTest

Jan 2022

Major: World's first successful pig-to-human heart xenotransplant at University of Maryland Medical CenterPressTest

About United Therapeutics

The team behind UHeart

United Therapeutics

Xenotransplant, gene-edited pig organs, UKidney UHeart, Revivicor

United Therapeutics develops pig-organ xenotransplants via Revivicor for end-stage renal and cardiac disease. Programs include UKidney, UHeart, and UThymoKidney.

United Therapeutics acquired xenotransplant pioneer Revivicor in 2011.
December 2024: First UKidney transplant performed under FDA compassionate-use authorization.
Three programs: UKidney and UHeart (10 edits each), UThymoKidney (single-gene); trials planned 2025–2026.

unither.com (opens unither.com)Company profile →

Founded: 199630 yrs
Headquarters: United States
Status: Public
Listed: UTHR (opens google.com)NASDAQ
Valuation: $24Best. market capOct 2026estimate
Last round: Founded1996
Works in: BiotechCell & organ therapies
Coverage: 3 programs · 5 updateslatest 1 Feb 2025checked 10 Oct
Partners: NYU Langone Health (opens nyulangone.org)FDA (opens fda.gov)Revivicor, Inc. (opens revivicor.com)
People: Martine Rothblatt (opens en.wikipedia.org)Founder, Chairperson, and Chief Executive Officer

Spec

UHeart

Total gene edits

10 edits^R (reported)

Target patient condition

End-stage heart disease, cardiomyopathy, cardiogenic shock^R (reported)