Science, evidence and quality

Evidence behind the portfolio

Peer-reviewed and real-world studies on amniotic membrane allografts in hard-to-heal wounds — the research we share with providers when products are being selected.

Published studies

Full text of each study is available to providers and partners.

Efficacy of a dual-layer pre-hydrated amniotic membrane allograft in the treatment of hard-to-heal wounds

Retrospective multicentre analysis · Kapp et al., 2026

Eighty patients (83 wounds) with hard-to-heal diabetic foot ulcers, venous leg ulcers, pressure injuries and open wounds, treated after at least 30 days of optimised standard of care with less than 50% healing. Weekly applications of a dual-layer hydrated human amniotic membrane allograft (Membrane Wrap Hydro).

Findings: Complete closure occurred in 46 of 83 wounds (55.4%), with secondary endpoints of percentage area reduction, applications to closure and time-to-healing.

Read the study (PDF)

Global burden to local action: a pilot feasibility study of placental-based solutions for complex pressure ulcers using real-world evidence

Cole W, Fife C, Miao H, Medley M · International Journal of Tissue Reactions, 2026

A pilot feasibility study using real-world evidence to evaluate a placental-based amniotic tissue membrane in complex pressure ulcers, with data obtained from the U.S. Wound Registry / Intellicure database and analysed independently by the study investigators. The study was funded by the manufacturer of Membrane Wrap.

Findings: Pilot feasibility findings for placental allografts in pressure injury care, reported with the sponsor's funding role stated.

Read the study (PDF)

Comparative outcomes: amniotic tissue membrane versus standard care in diabetic foot ulcer management — a real-world retrospective cohort study

Cole W, Medley M, Encinas C · Journal of Diabetes and Treatment 10: 10149 · DOI 10.29011/2574-7568.0010149

A real-world retrospective cohort comparing an amniotic tissue membrane with standard care in the management of diabetic foot ulcers.

Findings: Comparative real-world outcomes for amniotic tissue membrane versus standard care in DFU management.

Read the study (PDF)

Quality and clinical infrastructure

Attributes the manufacturer publishes about its own wound-care platform; RevivaMed Solutions distributes the finished products.

Research & development

The manufacturer states its R&D team brings scientists, engineers and clinical experts together and integrates biomaterials science with regenerative medicine.

Clinical evidence

Published clinical data include a chronic diabetic foot-ulcer case involving Membrane Wrap and a retrospective analysis of Membrane Wrap Hydro in hard-to-heal wounds.

Clinical trials

The manufacturer's public news page lists clinical trials involving human placental membrane products and studies evaluating amnion grafts for chronic wounds.

Quality & accreditation

The manufacturer's licensing page lists 2026 FDA registration, multiple state and tissue-bank registrations, Canada registration, and AATB accreditation.

Provider & distributor support

A reimbursement and services function supports providers and distributors around reimbursement and insurance verification.

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