Last reviewed · How we verify
Meniscal Allograft
Meniscal Allograft is a Biologic drug developed by Paul Fortin, MD. It is currently in Phase 3 development for Meniscal deficiency or irreparable meniscal tears in the knee joint. Also known as: Musculoskeletal Transplant Foundation, Meniscal transplant.
A meniscal allograft is a transplanted human meniscus tissue that replaces a damaged or missing meniscus to restore knee joint function and reduce pain.
A meniscal allograft is a transplanted human meniscus tissue that replaces a damaged or missing meniscus to restore knee joint function and reduce pain. Used for Meniscal deficiency or irreparable meniscal tears in the knee joint.
-
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 | Meniscal Allograft |
|---|---|
| Also known as | Musculoskeletal Transplant Foundation, Meniscal transplant |
| Sponsor | Paul Fortin, MD |
| Modality | Biologic |
| Therapeutic area | Orthopedics |
| Phase | Phase 3 |
Mechanism of action
Meniscal allografts are cadaveric meniscal tissues surgically implanted into the knee joint to restore the structural and biomechanical function of a damaged meniscus. The allograft acts as a biological spacer and shock absorber, distributing load across the knee joint and protecting the articular cartilage from degenerative changes. This procedure aims to delay or prevent osteoarthritis progression in patients with meniscal deficiency.
Approved indications
- Meniscal deficiency or irreparable meniscal tears in the knee joint
Common side effects
- Graft failure or resorption
- Infection
- Knee pain or swelling
- Limited range of motion
Key clinical trials
- Safety and Performance Study of the FAST-FIX FLEX System for Meniscal Repairs and Meniscal Transplantations
- Knee Osteotomy Associated With Allograft Meniscus Transplantation (NA)
- Semitendinosus Autograft vs Meniscal Allograft in Post-Meniscectomy Syndrome (NA)
- Evaluation of Clinical-functional and Radiographic Outcomes in Patients Who Underwent Meniscal Allograft Transplantation (MAT) at 10 Years.
- Sterile Allogeneic Spongioflex® Allograft as Partial Meniscal Replacement After Incomplete Meniscal Loss (NA)
- Clinical Registry Assessment of the Missouri Osteochondral Allograft Preservation System - MOPS
- PRC With Meniscal Allograft Arthroplasty for Wrist Osteoarthritis (NA)
- Partial Meniscal Replacement with Spongioflex® (PHASE4)
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:
- Meniscal Allograft CI brief — competitive landscape report
- Meniscal Allograft updates RSS · CI watch RSS
- Paul Fortin, MD portfolio CI
Frequently asked questions about Meniscal Allograft
What is Meniscal Allograft?
How does Meniscal Allograft work?
What is Meniscal Allograft used for?
Who makes Meniscal Allograft?
Is Meniscal Allograft also known as anything else?
What development phase is Meniscal Allograft in?
What are the side effects of Meniscal Allograft?
Related
- Manufacturer: Paul Fortin, MD — full pipeline
- Therapeutic area: All drugs in Orthopedics
- Indication: Drugs for Meniscal deficiency or irreparable meniscal tears in the knee joint
- Also known as: Musculoskeletal Transplant Foundation, Meniscal transplant
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing