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Biological mesh
Biological mesh is a Biological scaffold/tissue engineering product Biologic drug developed by University Hospital, Lille. It is currently in Phase 3 development for Hernia repair (ventral, incisional, or abdominal wall reconstruction), Soft tissue reinforcement and regeneration. Also known as: Biologics, Acellular dermal matrix.
Biological mesh provides structural support and promotes tissue integration through naturally-derived or bioengineered extracellular matrix material.
Biological mesh is used in the treatment of various hernia conditions, including incarcerated groin hernia, abdominal hernia, and ventral hernia, as well as ileostomy-stoma complications. It is used in conjunction with mesh repair, specifically with the Phisiomesh implant and Securestrap fixation device, for hernia repair.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +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 | Biological mesh |
|---|---|
| Also known as | Biologics, Acellular dermal matrix |
| Sponsor | University Hospital, Lille |
| Drug class | Biological scaffold/tissue engineering product |
| Modality | Biologic |
| Therapeutic area | Surgery/Tissue Repair |
| Phase | Phase 3 |
Mechanism of action
Biological meshes are scaffolds composed of decellularized or processed biological tissue (often derived from animal sources such as porcine or bovine materials, or human cadaveric tissue) that serve as a framework for tissue regeneration and repair. They are designed to be gradually resorbed and replaced by the patient's own tissue, providing mechanical support while facilitating vascularization and cellular infiltration at the surgical site.
Approved indications
- Hernia repair (ventral, incisional, or abdominal wall reconstruction)
- Soft tissue reinforcement and regeneration
Common side effects
- Seroma formation
- Infection
- Mesh rejection or inflammatory response
- Recurrent hernia
Key clinical trials
- SIS-Reinforced vs. Conventional Anastomosis for Mid-to-Low Rectal Cancer: A Multicenter RCT on Anastomotic Leak (PHASE4)
- Stoma Closure and Reinforcement Trial ll (NA)
- Regenerative Treatment of Peri-implantitis (NA)
- Study on the Cosmetic Outcome and Safety Evaluation of 3D Printed Biodegradable Biological Mesh for One-Stage Breast Reconstruction After Radical Mastectomy (NA)
- Early Clinical Outcomes of High-Purity Type I Collagen as a Biologic Reinforcement in Selected Hernia Repair Scenarios (NA)
- High-Purity Type I Collagen Augmentation in Meniscal Repair (NA)
- Biological OviTex Versus Synthetic Graft in Robotic Prolapse Surgery (NA)
- Biological Meshes in Infected Fields: a Randomized Controlled Trial (PHASE3)
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:
- Biological mesh CI brief — competitive landscape report
- Biological mesh updates RSS · CI watch RSS
- University Hospital, Lille portfolio CI
Frequently asked questions about Biological mesh
What is Biological mesh?
How does Biological mesh work?
What is Biological mesh used for?
Who makes Biological mesh?
Is Biological mesh also known as anything else?
What drug class is Biological mesh in?
What development phase is Biological mesh in?
What are the side effects of Biological mesh?
Related
- Drug class: All Biological scaffold/tissue engineering product drugs
- Manufacturer: University Hospital, Lille — full pipeline
- Therapeutic area: All drugs in Surgery/Tissue Repair
- Indication: Drugs for Hernia repair (ventral, incisional, or abdominal wall reconstruction)
- Indication: Drugs for Soft tissue reinforcement and regeneration
- Also known as: Biologics, Acellular dermal matrix
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing