Last reviewed · How we verify
GrafixPL PRIME
GrafixPL PRIME is a placental tissue-derived allograft that provides a biological scaffold and growth factors to promote wound healing and tissue regeneration.
GrafixPL PRIME is a placental tissue-derived allograft that provides a biological scaffold and growth factors to promote wound healing and tissue regeneration. Used for Chronic wounds (diabetic foot ulcers, venous leg ulcers, pressure ulcers), Acute wounds and surgical wounds, Burn wounds.
At a glance
| Generic name | GrafixPL PRIME |
|---|---|
| Sponsor | University of Texas Southwestern Medical Center |
| Drug class | Biological wound healing product / Placental tissue allograft |
| Modality | Biologic |
| Therapeutic area | Wound Care / Regenerative Medicine |
| Phase | FDA-approved |
Mechanism of action
This product is composed of dehydrated human amniotic membrane and umbilical cord tissue that contains native extracellular matrix components, growth factors, and anti-inflammatory cytokines. When applied to wounds, it provides a protective barrier, delivers bioactive molecules to the wound bed, and facilitates the body's natural healing processes through tissue regeneration rather than acting as a traditional pharmaceutical agent.
Approved indications
- Chronic wounds (diabetic foot ulcers, venous leg ulcers, pressure ulcers)
- Acute wounds and surgical wounds
- Burn wounds
Common side effects
- Infection at wound site
- Allergic reaction
- Delayed wound healing
Key clinical trials
- GrafixPL PRIME Evaluation Case Study (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:
- GrafixPL PRIME CI brief — competitive landscape report
- GrafixPL PRIME updates RSS · CI watch RSS
- University of Texas Southwestern Medical Center portfolio CI