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Hepatic derived surgical matrix
Hepatic derived surgical matrix is a Biologic drug developed by Miromatrix Medical Inc.. It is currently in Phase 2 development. Also known as: MIROMESH Biologic Matrix.
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Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Hepatic derived surgical matrix |
|---|---|
| Also known as | MIROMESH Biologic Matrix |
| Sponsor | Miromatrix Medical Inc. |
| Modality | Biologic |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- The EVARREST® Pediatric Mild or Moderate Liver and Soft Tissue Bleeding Study (PHASE3)
- The EVARREST® Paediatric Mild/Moderate Liver and Soft Tissue Bleeding Study (PHASE3)
- Complications, Outcomes and Revisions Following Hiatal Hernia Repair With MIROMESH
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Hepatic derived surgical matrix CI brief — competitive landscape report
- Hepatic derived surgical matrix updates RSS · CI watch RSS
- Miromatrix Medical Inc. portfolio CI
Frequently asked questions about Hepatic derived surgical matrix
What is Hepatic derived surgical matrix?
Who makes Hepatic derived surgical matrix?
Is Hepatic derived surgical matrix also known as anything else?
What development phase is Hepatic derived surgical matrix in?
Related
- Manufacturer: Miromatrix Medical Inc. — full pipeline
- Also known as: MIROMESH Biologic Matrix
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing