Companies
Miromatrix Medical
its miroliverELAP, a bioengineered extracorporeal liver support device built from decellularized porcine liver matrix recellularized with human cells, received FDA RMAT (Regenerative Medicine Advanced Therapy) designation.
- Country
- United States
bioengineered-organ
liver
us
Coverage
| CN | EU | US | |
|---|---|---|---|
| regenerative-personalized | ✓ | ✓ | ✓ |
Regulatorsfdaemanmpa
Verifiable facts
| Fact | Value | Source |
|---|---|---|
| Funding | Acquired by United Therapeutics for approximately $91M-$140M in December 2023 | finance.yahoo.com · ir.unither.com |
| Capacity | Over 1,000 bioengineered organs per year | sec.gov |
| Regulatory approval | FDA Regenerative Medicine Advanced Therapy (RMAT) designation; FDA Investigational New Drug (IND) clearance | ir.unither.com · businesswire.com · miromatrix.com |
| Production site | 11,000 square foot in-house manufacturing facility at corporate headquarters in Eden Prairie, Minnesota | sec.gov |
| Headcount | 76 full-time employees as of March 20, 2023 | sec.gov |
| Revenue | Recorded $953,470 in royalty revenue in 2022 | sec.gov |
Independent sources: businesswire.com · finance.yahoo.com · ir.unither.com · sec.gov
Technologies
| Name | Cluster | Risk | |
|---|---|---|---|
| Xenotransplantation | regenerative-personalized | High | → |
Compiled by BIOECON from primary sources.
Compliance
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