Miromatrix Medical

What Miromatrix Medical does

Miromatrix Medical is a clinical-stage biotechnology company developing fully bioengineered transplantable human organs and organ-derived biological products. Founded in 2009 from University of Minnesota research, the company pioneered perfusion decellularization and recellularization technology, which removes cells from harvested porcine organs via cannulation and detergent perfusion through native vasculature, leaving behind an extracellular matrix (ECM) scaffold that retains organ architecture, mechanical properties, and vascular networks. Human cells are then reintroduced through perfusion into the preserved vascular pathways, with cells migrating to appropriate microenvironments; organs are matured in bioreactors under physiological conditions. The lead product, miroliverELAP, is a bioengineered external liver assist device combining a single-use bioengineered liver with an extracorporeal blood circuit to provide temporary liver support to acute liver failure patients. The pipeline also includes mirokidney (transplantable kidney for end-stage renal disease) and miroliver (transplantable liver), with stated plans to extend to lungs, pancreases, and hearts.

All three lead products are investigational and have not received FDA clearance or approval. miroliverELAP has secured FDA IND clearance, completed a Phase 1 clinical trial (5 patients, primary safety endpoint met, 100% survival during treatment with no unexpected serious adverse events over 32-day follow-up), and received FDA Regenerative Medicine Advanced Therapy (RMAT) designation in April 2026. Miromatrix operates as a wholly-owned subsidiary of United Therapeutics Corporation (NASDAQ: UTHR) following a $91 million acquisition completed in late 2023. The company maintains its headquarters and R&D facility at 6455 Flying Cloud Drive, Eden Prairie, Minnesota, with a headcount in the 51–100 range. The business is pre-revenue, with no commercial product sales; revenue model is currently based on parent-company funding, prior minority investment from CareDx (2021), and historical federal research grants (NIDDK, NSF). Target patient populations — acute liver failure, ESRD, and ESLD — collectively address a U.S. market exceeding 600,000 patients on waitlists or chronic therapy, with roughly 17 Americans dying daily due to organ unavailability.

Name

Miromatrix Medical

Legal name

Miromatrix Medical Inc.

Website

https://miromatrix.com

Company type

Private

Founded year

2009

Operating status

Operating

Headcount range

51–100 employees

Short description

Miromatrix Medical is a clinical-stage biotechnology company developing fully bioengineered transplantable human organs, including kidneys, livers, and an external liver assist device, using proprietary perfusion decellularization and recellularization technology on porcine organ scaffolds.

Ownership category

akta.pro rank

Product category

Bioengineered Organs / Regenerative Medicine

NAICS

Biological Product (except Diagnostic) Manufacturing (325414), Research and Development in Biotechnology (except Nanobiotechnology) (541714), Surgical and Medical Instrument Manufacturing (339112), Electromedical and Electrotherapeutic Apparatus Manufacturing (334510)

SIC

Biological Products, (No Disgnostic Substances) (2836), Orthopedic, Prosthetic & Surgical Appliances & Supplies (3842), Surgical & Medical Instruments & Apparatus (3841)

akta.pro primary industry

Organoids & Organ-on-Chip (regenerative models) (HLAAAGAD)

akta.pro secondary industries

In Vitro Model Systems & Organoid Platforms (iPSC/organoids, microphysiological systems) (HLAAAIAJ), Cardiovascular & Vascular Regeneration (vascular grafts, angiogenesis) (HLAAAGAJ)

Keywords

• Bioengineered organs
• Regenerative medicine
• Organ transplantation
• Perfusion decellularization
• Liver assist device

Headquarters

HQ city

Eden Prairie

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Personnel, Operations, Infrastructure, Marketing or Sales

Marketing channels1 record

Core offering

Miromatrix Medical develops fully biological, bioengineered human organs and organ-derived biological products using proprietary perfusion decellularization and recellularization technology. The company's pipeline includes miroliverELAP, a single-use bioengineered external liver assist device paired with an extracorporeal blood circuit for acute liver failure patients, as well as transplantable mirokidney and miroliver products intended to address the shortage of donor organs. All products are investigational and have not yet received FDA clearance or approval.

Differentiator

Problem solved

Functional benefit

Brands

• miroliverELAP: Bioengineered external liver assist device for acute liver failure patients, designed to provide temporary liver support outside the body.
• mirokidney
• miroliver

Products and services

• miroliverELAP Bioengineered external liver assist device combining a single-use bioengineered liver (decellularized porcine liver scaffold repopulated with human cells) with an extracorporeal blood circuit, designed to replicate key liver functions and provide temporary external liver support to acute liver failure patients who are not transplant candidates or are awaiting transplant. Investigational product for healthcare providers and transplant centers.
• mirokidney Investigational transplantable kidney bioengineered using Miromatrix's proprietary perfusion decellularization and recellularization technology applied to porcine kidney scaffolds repopulated with human cells. Developed for end-stage renal disease patients (an estimated 100,000 new U.S. cases per year and over 100,000 on the transplant waitlist) as an alternative to long-term dialysis.
• miroliver Investigational fully bioengineered transplantable liver using decellularized porcine liver scaffolds repopulated with human cells (vascular cells and hepatocytes). Designed for patients with end-stage liver disease where liver transplantation is the best treatment option. Preclinical milestones include revascularization of a decellularized porcine liver graft with human vascular cells and demonstration of key liver function before and after transplantation in a large animal model with sustained perfusion for 15 days post-transplantation.

Quantifiable outcome

• ~30% of acute liver failure patients die without liver transplant access
• +3 more outcomes

Segments3 records

Ideal customer profiles1 record

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature6 records

Partnerships

One partnership is on record.

• CareDxminorStrategic or Co-development Partner · 28 May 2021CareDx made a minority investment in Miromatrix and entered into a research collaboration to use CareDx's technology to advance the development of bioengineered implantable organs such as kidneys and livers. This partnership provided strategic validation and technology access during Miromatrix's development phase prior to its acquisition by United Therapeutics.

Scale indicators12 records

Recent moves5 records

Expansion highlights4 records

Emerging players

• Cytori Therapeutics: Cytori Therapeutics develops cell-based regenerative therapies using adipose-derived stem cells and related cell therapy platforms. It is an adjacent regenerative medicine peer addressing organ and tissue damage through cell therapy rather than whole-organ bioengineering.
• Prellis Biologics: Prellis Biologics uses holographic 3D bioprinting to engineer vascularized human tissues and organ components. It represents an emerging approach to solving organ shortage that overlaps with Miromatrix's bioengineered organ programs.
• Humacyte: Humacyte develops bioengineered human tissues and vessels using proprietary manufacturing platforms, sharing Miromatrix's regenerative medicine and tissue engineering approach but focused on vascular access and other indications rather than whole solid organs.
• Aspect Biosystems: Aspect Biosystems is a biotechnology company developing bioprinted tissues and organ-specific therapeutic cells using a microfluidic bioprinting platform. It is an emerging peer in the bioengineered tissue and regenerative medicine space adjacent to Miromatrix's organ engineering approach.
• Revivicor (United Therapeutics): Revivicor, another United Therapeutics subsidiary, develops gene-edited pig organs for xenotransplantation. It is a sibling subsidiary pursuing an alternative whole-organ pathway that directly targets Miromatrix's end-stage patient populations.
• Makana Therapeutics: Makana Therapeutics develops gene-edited pig organs for transplantation, including kidneys and hearts, positioning it as a competing approach to Miromatrix's bioengineered decellularized organ programs for end-stage organ failure patients.

Others

• Cellink (BICO Group): Cellink/BICO provides bioprinters, bioinks, and lab automation for tissue engineering and regenerative medicine research. It is an enabling technology provider adjacent to Miromatrix's organ engineering efforts rather than a direct competitor.

Direct peers

• eGenesis: eGenesis is a biotechnology company developing gene-edited porcine organs for xenotransplantation, directly competing with Miromatrix's mirokidney and miroliver programs by targeting the same end-stage renal and liver disease patient populations with an alternative whole-organ approach.
• OrganOx: OrganOx develops the metra normothermic liver perfusion device, an external liver support system for transplant and acute liver failure patients. It is the closest functional peer to Miromatrix's miroliverELAP bioengineered external liver assist device.

Broad incumbents

• United Therapeutics Corporation: United Therapeutics is Miromatrix's parent company and a broader regenerative medicine and organ manufacturing incumbent operating in lung, kidney, and xenotransplantation programs through its Revivicor and other subsidiaries. It is the strategic acquirer of Miromatrix and a key ecosystem participant.

Market position

Weaknesses4 records

Competitive moat4 records

Key risks6 records

Key highlights6 records

Customer concentration

• Xx.com/miromatrixmed
• Facebookfacebook.com/miromatrix

Revenue estimate

Valuation estimate

Number of profiles

Profiles3 records

Funding overview

Funding rounds9 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 Miromatrix Medical