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Evologics America

Double-Layer Human Amnion Allograft

EvoPatch

Purpose-built amnion coverage for the surgical healing environment.

A sterile, dehydrated human amniotic membrane allograft constructed with two layers of amnion and no chorion, designed for robotic, laparoscopic and open surgical workflows.

  • Double-layer amnion
  • Chorion-free
  • Omni-directional
  • Ambient storage
  • Dry or hydrated
  • Multiple configurations
EvoPatch double-layer amnion graft with central aperture

What is EvoPatch

Human amniotic membrane, engineered as a surgical covering

EvoPatch is a sterile, dehydrated human amniotic membrane allograft intended for use as a wound covering.

Its dual-layer construction provides a broad, continuous tissue format that can be selected according to the anatomy, procedural approach and area requiring coverage.

EvoPatch can be placed dry or hydrated with sterile saline at the discretion of the healthcare provider. It is packaged for single-patient use and stored at ambient temperature.

Construction
Two layers of amnion
Composition
Chorion-free
Orientation
Either surface may face the site
Format
Broad sheet coverage

Why EvoPatch

Not just a sheet. A purpose-built amnion platform.

Surgical tissue coverings include synthetic films, absorbable barriers, hydrogels, collagen products and human tissue allografts. EvoPatch begins with human amniotic membrane.

  • Human tissue architecture

    Derived from donated human amniotic membrane rather than a synthetic polymer or animal-derived material.

  • Amnion-on-amnion construction

    Two layers of amnion form a single surgical covering.

  • No orientation decision

    The omni-directional design eliminates the need to identify a maternal or fetal side during placement.

  • Designed for surgical access

    Configurations support placement through robotic, laparoscopic and open approaches.

A surgical tissue platform, ready when needed

EvoPatch is designed for clinical handling, practical inventory management and straightforward documentation.

  • Donated human amniotic membrane

    Processed from donated human placental tissue.

  • Double-layer construction

    Two layers of amnion form the finished graft.

  • Chorion-free

    No chorion layer is incorporated into the product.

  • Sterile

    Final product sterilization is performed using gamma irradiation according to the current IFU.

  • Single-patient use

    EvoPatch must not be reused or re-sterilized.

  • Dry or hydrated handling

    Place directly from the sterile package or hydrate with sterile saline at clinician discretion.

  • Ambient storage

    Store in a clean, dry environment at 15–30°C. No refrigeration is required.

  • Tissue traceability

    Allograft identification, size, product code and expiration information support tracking.

Handling

Simple steps. Deliberate placement.

Always follow the current product Instructions for Use.

  1. 01

    Inspect

    Confirm packaging integrity and expiration date.

  2. 02

    Open

    Use sterile technique and deliver the sterile inner pouch to the sterile field.

  3. 03

    Remove

    Carefully remove EvoPatch from the inner pouch.

  4. 04

    Prepare

    Use dry or hydrate with sterile saline at clinician discretion.

  5. 05

    Place

    Position the graft where protective wound coverage is appropriate.

  6. 06

    Document

    Record allograft identification and relevant procedural information.

Coverage from focused sites to broad surgical fields

EvoPatch is available in a range of dimensions, allowing clinicians and facilities to match the graft configuration to anatomy and procedural requirements.

EvoPatch 4 by 4 centimeter square membrane
4×4 cm
EvoPatch 6 by 6 centimeter membrane with central aperture
6×6 cm End-to-End
EvoPatch 4 by 8 centimeter rectangular membrane
4×8 cm
EvoPatch Amnion Graft Double-Layer SKUs and available sizes
SKUProductSize
EAP-11EvoPatch Amnion Graft Double-Layer1×1 cm
EAP-22EvoPatch Amnion Graft Double-Layer2×2 cm
EAP-23EvoPatch Amnion Graft Double-Layer2×3 cm
EAP-24EvoPatch Amnion Graft Double-Layer2×4 cm
EAP-35EvoPatch Amnion Graft Double-Layer3×5 cm
EAP-44EvoPatch Amnion Graft Double-Layer4×4 cm
EAP-46EvoPatch Amnion Graft Double-Layer4×6 cm
EAP-46BEvoPatch Amnion Graft Double-Layer4×6 cm Butterfly
EAP-48EvoPatch Amnion Graft Double-Layer4×8 cm
EAP-66EvoPatch Amnion Graft Double-Layer6×6 cm End-to-End
EAP-67EvoPatch Amnion Graft Double-Layer6×7 cm
EAP-1010EvoPatch Amnion Graft Double-Layer10×10 cm
EAP-0612EvoPatch Amnion Graft Double-Layer6×12 cm
EAP-0212EvoPatch Amnion Graft Double-Layer2×12 cm

Broad coverage for diverse surgical environments

EvoPatch may be considered when a licensed clinician determines that additional wound covering is appropriate, consistent with the Instructions for Use, patient presentation, institutional protocol and surgical judgment.

Colorectal and Gastrointestinal

  • Lower anterior resection
  • Colectomy and bowel resection
  • Primary intestinal anastomosis
  • Rectal stump procedures
  • Adhesiolysis

Obstetrics and Gynecology

  • Endometriosis resection
  • Myomectomy
  • Hysterectomy
  • Oophorectomy
  • Pelvic adhesiolysis

Urology

  • Robotic or laparoscopic prostatectomy
  • Urethral reconstruction
  • Stricture procedures
  • Fistula-repair environments

General and Surgical Oncology

  • Breast procedures
  • Hernia procedures
  • Abdominal and pelvic oncology
  • Pancreatic procedures

Cardiothoracic, Thoracic and Vascular

  • Pericardial coverage
  • Sternal-edge coverage
  • Conduit-harvest sites
  • Esophagectomy
  • Lobectomy

Procedure examples are informational and should not imply a particular clinical outcome. Product selection remains the responsibility of the treating clinician.

Building the evidence behind the tissue

EvoPatch is part of an expanding scientific program examining how human amniotic membrane interacts with the postoperative environment.

Explore evidence and education
  • Local inflammatory signaling
  • Macrophage behavior
  • Tissue-plane preservation
  • Collagen organization
  • Material persistence and transformation
  • Clinical translation

Active foundations

Mechanistic evaluation, murine adhesion modeling and retrospective gastrointestinal review.

Translational development

Large-animal gastrointestinal research and pelvic or gynecologic adhesion development.

Prospective evaluation

Future studies may assess adhesion incidence, severity, safety, material persistence and tissue response.

Preclinical and retrospective findings are investigational and should not be interpreted as establishing comparative clinical effectiveness. Controlled human studies are required to confirm clinical outcomes.

FAQ

Common EvoPatch questions

What is EvoPatch?

EvoPatch is a sterile, dehydrated, double-layer human amniotic membrane allograft intended for use as a wound covering.

What makes EvoPatch different from an amnion-chorion graft?

EvoPatch is constructed from two layers of amnion and does not incorporate a chorion layer.

Does EvoPatch have a required orientation?

No. EvoPatch is omni-directional, so there is no required up-or-down orientation for placement.

Is EvoPatch an FDA-cleared adhesion-prevention device?

No. EvoPatch is marketed as a 361 HCT/P for homologous use as a wound covering. It has not been cleared or approved by FDA as an adhesion-prevention device.

Can EvoPatch be hydrated?

Yes. At the healthcare provider's discretion, the graft may be hydrated with sterile saline prior to placement.

Does EvoPatch require refrigeration?

No. EvoPatch is stored in a clean, dry environment at ambient temperature, 15–30°C.

Can EvoPatch be used in robotic surgery?

EvoPatch configurations are designed to support robotic, laparoscopic and open surgical workflows. Use must remain consistent with the Instructions for Use and clinician judgment.

What evidence is being developed?

Evologics is evaluating EvoPatch and human amniotic membrane through mechanistic, preclinical, retrospective, large-animal and proposed prospective clinical research.

Human tissue, responsibly presented

EvoPatch is a human cells, tissues, and cellular and tissue-based product, or HCT/P.

Evologics has determined that EvoPatch meets the criteria for regulation solely under Section 361 of the Public Health Service Act and 21 CFR Part 1271. The product is minimally manipulated and intended for homologous use.

EvoPatch has not been cleared or approved by the U.S. Food and Drug Administration. FDA establishment registration or HCT/P listing does not constitute FDA approval or a determination of regulatory compliance.

Use must be consistent with the current Instructions for Use, applicable labeling, clinician judgment and institutional protocol.

EvoPatch

Request EvoPatch information for your facility.

Connect with Evologics for product materials, available configurations, institutional-review documentation, sizing information and next steps.