IVIVA Medical

Executive Summary

IVIVA Medical, a subsidiary of United Therapeutics, is pioneering a curative treatment for end-stage renal disease (ESRD) through its fully implantable bioartificial kidney. Leveraging proprietary 3D printing and tissue engineering, the company aims to create functional, human-scale kidney grafts that could eliminate the need for dialysis. With over 500,000 patients in the US alone dependent on dialysis, IVIVA's technology addresses a critical unmet need and a multibillion-dollar market. IVIVA is advancing through preclinical development, with recent progress in large animal models demonstrating proof-of-concept. The company expects to initiate IND-enabling studies shortly, positioning it for clinical trials within 18-24 months. Backed by United Therapeutics' resources and expertise in organ manufacturing, IVIVA has a clear path to commercialization. Successful development could revolutionize kidney replacement therapy and provide a scalable solution to the organ shortage crisis.

Upcoming Catalysts (preview)

• Q4 2026Completion of GLP large animal studies85% success
• Q2 2027Submission of IND to FDA70% success
• Q4 2027Initiation of Phase 1 clinical trial60% success