iviva medical

What iviva medical does

IVIVA Medical is a pre-clinical, pre-revenue medical device company developing fully implantable bioartificial kidneys as a potential cure for end-stage kidney disease (ESKD). Founded in 2013 as a spinout of Mass General and Harvard Medical School, the company is headquartered in Medford, Massachusetts (moved from Woburn, MA in 2024) and operates as a wholly-owned subsidiary of United Therapeutics (NASDAQ: UTHR) following its late-2023 acquisition. The company's products target patients with chronic kidney disease and ESKD who face average transplant wait times of five or more years, and healthcare providers performing transplantation procedures. Currently no paying customers are served as the bioartificial kidney has not received FDA approval and commercialization has not begun.

The company's core technology is a bioartificial kidney engineering platform centered on proprietary Thin Film Interposition (TFI) scaffolding, a 3D-printed structural technology developed in 2017 that overcomes the resolution limitations of conventional additive manufacturing. The TFI scaffolds build thinly separated hollow vascular networks layered to create human-scale matrices, which are populated with patient-derived induced pluripotent stem cells (iPSCs) and other cell types to create functional, full-scale autologous renal grafts. The autologous approach, adopted in 2023, may eliminate the need for immunosuppression and enable repeated treatments. Supporting technologies include biologic blood purification (developed 2021) and cell isolation protocols from discarded donor organs. The platform achieved proof-of-concept in first large animal survival trials in 2022.

IVIVA's revenue model will be based on hardware sales of bioartificial kidney implants distributed through healthcare providers and transplant centers upon FDA approval; no commercial revenue exists today. The company's primary inflows are capital from parent United Therapeutics and prior venture funding (a 2019 seed round, and a November 2025 initial financing round led by F-Prime with appointment of Steve Masson as President and CEO). With 11-50 employees (nearly doubled in 2024 to focus on full-scale graft creation), the company is in scale-up mode and remains multi-years from commercialization. Key validation includes the 2023 KidneyX Prize for Advanced Organ Therapeutics.

Name

iviva medical

Legal name

IVIVA Medical, Inc.

Website

https://ivivamedical.com

Company type

Private

Founded year

2013

Operating status

Acquired

Headcount range

11–50 employees

Short description

IVIVA Medical is a pre-clinical, pre-revenue medical device subsidiary of United Therapeutics developing fully implantable bioartificial kidneys for patients with end-stage kidney disease, using proprietary 3D-printed Thin Film Interposition scaffolding and patient-derived stem cells.

Ownership category

akta.pro rank

Product category

Bioartificial Kidney Implants

NAICS

Biological Product (except Diagnostic) Manufacturing (325414)

SIC

Biological Products, (No Disgnostic Substances) (2836)

akta.pro primary industry

Tissue-Engineered Constructs & Scaffolds (natural/synthetic biomaterials) (HLAAAGAB)

akta.pro secondary industries

Stem Cell Therapies (MSC/iPSC/HSC-derived) (HLAAABAE), Organoids & Organ-on-Chip (regenerative models) (HLAAAGAD), Transplantation & Advanced Therapies Pharmaceuticals (incl. Cell & Gene Therapies) (HLAIAAAO), Nephrology & Urology Specialty Pharmaceuticals (HLAIACAH)

Keywords

• Bioartificial kidney implants
• Tissue engineering scaffolds
• Renal replacement therapy
• 3D printed organ scaffolds
• Autologous cell therapy

Headquarters

HQ city

Beverly

HQ country

United States

HQ region

North America

Offices3 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Personnel, Operations, Infrastructure

Revenue model

1. Bioartificial Kidney Implants: Pre-revenue medical device company developing fully implantable bioartificial kidneys. Revenue model will be based on medical device sales through healthcare providers upon regulatory approval.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels1 record

Core offering

IVIVA Medical is developing fully implantable bioartificial kidneys as a potential cure for end-stage kidney disease. The company uses proprietary 3D-printed Thin Film Interposition (TFI) scaffolding technology to create human-scale organ scaffolds populated with patient-derived induced pluripotent stem cells, forming autologous renal grafts that may eliminate the need for immunosuppression.

Product overview

IVIVA Medical is developing fully implantable bioartificial kidneys as a cure for chronic kidney disease and end-stage renal disease. The company's product portfolio centers on bioartificial kidneys and autologous renal grafts (derived from patient-induced pluripotent stem cells), enabled by proprietary Thin Film Interposition (TFI) scaffolding technology and biologic blood purification capabilities. These components work together: TFI scaffolds provide the structural framework, which is populated with patient-derived cells to create functional human scale solute-exchange grafts that perform blood filtration and reabsorption. The autologous approach may eliminate the need for immunosuppression.

Differentiator

Problem solved

Functional benefit

Products and services

• Bioartificial Kidneys Fully implantable bioartificial kidneys designed to replace kidney function for patients with kidney dysfunction, potentially enabling patients to lead a normal life without dialysis or lengthy transplant waitlists.
• Autologous Renal Grafts

Quantifiable outcome

• Average wait time of 5+ years for kidney transplant
• +1 more outcomes

Segments2 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature5 records

Partnerships

Two partnerships are on record, tiered core.

• Mass GeneralcoreStrategic or Co-development PartnerIVIVA was founded in 2013 as a spinout of Mass General and Harvard Medical School following successful engineering of renal tissue. The academic institution provided the foundational research and technology that IVIVA continues to develop.
• Harvard Medical SchoolcoreStrategic or Co-development PartnerIVIVA was founded in 2013 as a spinout of Mass General and Harvard Medical School following successful engineering of renal tissue. The academic institution provided foundational research and technology that IVIVA continues to develop.

Scale indicators4 records

Recent moves8 records

Expansion highlights5 records

Emerging players

• Organovo: Pioneer in 3D bioprinting of human tissues, historically focused on liver tissue models and therapeutic tissue engineering. Comparable on the underlying 3D tissue/bioprinting technology stack that underpins IVIVA's TFI scaffolding approach.
• Lygenesis: Preclinical-stage company developing bioengineered organs (initially liver, expanding to other organs) by growing ectopic organ tissue in lymph nodes. Comparable because it shares IVIVA's regenerative-medicine approach to producing organ tissue to replace native organ function.
• Medeor Therapeutics: Clinical-stage cellular immunotherapy company developing personalized cell products to prevent organ rejection in kidney transplant recipients. Comparable as a cell-based therapy targeting kidney transplantation with potential to reduce or eliminate immunosuppression.
• Sana Biotechnology: Clinical-stage cell engineering platform with hypoimmune and iPSC-derived cell therapy programs aimed at organ/cell replacement. Comparable because it shares IVIVA's core scientific pillar of hypoimmune/patient-derived cells to enable transplantation without immunosuppression.

Direct peers

• eGenesis: Lead developer of genetically engineered porcine kidneys for transplantation into humans with ESRD. Comparable to IVIVA because both are pursuing a curative alternative to dialysis and donor kidney transplantation, addressing the same unmet need with a different biological approach.
• ProKidney: Clinical-stage cell therapy company focused on autologous cell therapy for chronic kidney disease to delay or prevent dialysis. Comparable because it also uses autologous cell-based technology targeting kidney function preservation/replacement in the same ESRD patient population.
• Miromatrix Medical (a United Therapeutics company): United Therapeutics subsidiary developing bioengineered livers and kidneys using perfusion decellularization/recellularization of human and porcine organs. Directly comparable to IVIVA as a sibling kidney program under the same parent pursuing a similar curative organ-engineering thesis.

Broad incumbents

• Humacyte: Public regenerative medicine company developing bioengineered human tissues (e.g., vessels, vascular trauma indications). Comparable on bioengineered, implantable tissue platform technology and on going through FDA approval for novel regenerative products.
• Talaris Therapeutics (acquired by Vertex Pharmaceuticals): Developed cell therapies to induce transplant tolerance in kidney transplant recipients (acquired by Vertex in 2023). Comparable because it addresses kidney transplantation outcomes and cell-based modulation of immune response in the same end patient population.
• United Therapeutics (organ manufacturing subsidiaries including Miromatrix): IVIVA's parent company and the most directly comparable incumbent building manufactured and ex-vivo perfused organs (lungs, kidneys, livers via Miromatrix). It is relevant because it is the strategic acquirer of IVIVA and the only public company building a diversified organ-manufacturing platform that includes kidneys.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat4 records

Key risks6 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/iviva-medical-inc

Revenue estimate

Valuation estimate

Number of profiles

Profiles1 record

Funding overview

Funding rounds2 records

Investors4 records

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about iviva medical