XWRAP®
Amniotic Membrane-derived Allograft
XWRAP® Technology
A Proprietary Approach to Tissue Preservation
XWRAP® is manufactured using Applied Biologics’ proprietary ECM Preservation Technology™, a controlled tissue preservation methodology designed to preserve extracellular matrix architecture and provide controlled biodegradation kinetics. By preserving the structural characteristics of the extracellular matrix throughout manufacturing, XWRAP is designed to maintain its intended physical function as a wound cover for chronic wounds and a tissue plane barrier during surgical procedures before gradually resorbing.
Why Controlled Biodegradation Kinetics Matter
A temporary wound cover or tissue plane barrier is intended to remain structurally intact for a sufficient period to perform its intended physical covering or barrier function before gradually resorbing.
Applied Biologics believes that controlled biodegradation kinetics are an important material characteristic because they help maintain the structural integrity of the extracellular matrix throughout the period in which the tissue is intended to perform its physical function.
Preserving Structure While the Body Performs Its Natural Repair Processes
As with any temporary wound covering or tissue barrier, maintaining structural integrity during the period in which the body is undergoing its normal physiologic repair processes is an important material characteristic.
XWRAP is designed to preserve extracellular matrix architecture so the material maintains its structural characteristics while serving its intended physical function. The body undergoes its normal physiologic repair processes while XWRAP provides temporary physical coverage or tissue separation before gradually resorbing.
Why XWRAP® is Different
Applied Biologics believes manufacturing technology plays an important role in the performance characteristics of extracellular matrix products.
Rather than focusing solely on tissue recovery and processing, the Company has developed a proprietary ECM Preservation Process™ designed to preserve extracellular matrix architecture throughout manufacturing and produce consistent material characteristics, including controlled biodegradation kinetics.
The result is a tissue manufactured to maintain its intended physical function as a wound cover or tissue plane barrier before gradually resorbing.
Intended Use
XWRAP® is an amniotic membrane intended for homologous use as a protective barrier or cover applied to partial and full thickness acute and chronic wounds such as diabetic, venous, arterial, pressure and other ulcers, as well as traumatic and complex wounds, burns, surgical, and Mohs surgery sites.
Chronic Wounds
As a wound cover, XWRAP® is intended to provide temporary physical coverage of the wound while the body’s normal physiologic repair processes occur beneath the cover.
Applied Biologics’ proprietary ECM Preservation Process™ is designed to preserve extracellular matrix architecture and provide controlled biodegradation kinetics so the wound cover maintains its structural integrity during the period in which the wound is naturally progressing through the normal phases of healing before gradually resorbing.
Surgical Procedures
As a tissue plane barrier, XWRAP® is intended to provide temporary physical separation between adjacent tissues during the early postoperative period while normal tissue recovery occurs.
Applied Biologics’ proprietary ECM Preservation Process™ is designed to preserve extracellular matrix architecture and provide controlled biodegradation kinetics so the tissue plane barrier maintains its structural characteristics while serving its intended physical barrier function before gradually resorbing.
Features & Benefits
Simple Application
No suturing is required
Versatile
Available in multiple sizes
Easy to Use
Membrane is orientation neutral
The proprietary processing of XWRAP® has demonstrated superior handling and biodegradability characteristics.
XWRAP® exhibits a slower and more controlled breakdown, thereby offering prolonged and enhanced performance as a protective cover and wound barrier.
XWRAP® undergoes natural dehydration without heat and a gentle sterilization process, which helps preserve its durability and extracellular matrix.
XWRAP® has been selected for its exceptional performance attributes, expected to reduce product usage and enhance patient outcomes.
Ongoing clinical studies on XWRAP® are currently underway.
Sizes
XWRAP® comes in various standard sizes ranging from 1x1cm to 4x8cm to effectively accommodate various wound dimensions and clinical applications.
Additional Sizes Available:
XWRAP® can be ordered in 1 cm² increments, cut precisely to the wound. No standard-size wastage — hospitals order and pay only for the size used.
This versatile size range allows healthcare providers to select the most appropriate coverage for each patient’s specific needs, from small surgical sites to larger chronic wounds.
*Sizing images are for visual representation only and may not appear to scale on all devices.
Storage & Handling
XWRAP® offers practical storage and handling advantages for busy clinical environments. The product maintains stability at ambient room temperature and arrives sterile and ready to use, with all necessary documentation included for seamless tissue tracking and reimbursement.
Stored in ambient room temperature
Five year shelf life
Packaged sterile
Packaged for single patient / one-time use
Tissue tracking card & patient labels for billing included
Safety & Compliance
XWRAP® is recovered during delivery, from healthy, pre-screened donors and is processed following rigorous and technical quality assurance standards to preserve the structural integrity of the amniotic membrane. The donor and donor tissue have been subjected to medical and biological screening to guard against the possibility of recipient exposure to, or transmission of communicable diseases or exclusionary medical conditions. These screening procedures are performed in accordance with FDA standards, regulations and statutes and under AATB accreditation. Communicable disease testing on qualified donors is performed by an FDA registered and CLIA certified lab (Clinical Laboratory Improvement Amendments of 1988).
XWRAP® is an allograft tissue regulated under section 361 of the PHS Act and meets the criteria of Title 21 Code for Federal Regulation (CFR 1271/3 and 1271/10). From aseptic tissue recovery, processing and packaging, Applied Biologics ensures that each unit of XWRAP® meets industry standards for the use of human tissue products.
Screened in a CLIA Certified lab that meets or exceeds AATB standards
Section 361
Regulated under section 361 of the PHS Act and meets the criteria of Title 21 Code for Federal Regulation (CFR 1271/3 and 1271/10)
Research & Publications
Applied Biologics is committed to advancing the scientific understanding of amniotic membrane allografts through rigorous clinical investigation. We are currently sponsoring a multi-center randomized controlled clinical trial evaluating the efficacy of XWRAP® and standard of care versus standard of care alone in the management of nonhealing diabetic foot ulcers. This study represents our dedication to evidence-based medicine and our commitment to validating the clinical benefits of XWRAP® for patients and healthcare providers.
Official Title
Evaluating the Efficacy of XWRAP®, a Single Layer Placental-based Allograft, and Standard of Care Versus Standard of Care.
ClinicalTrials.gov ID
NCT06564831
Status
Recruiting
Study Start Date
September 2024
Trial completion
Fall 2026
Interim data
Recent Publications
“Evaluation of single layer amniotic membrane in the management of nonhealing diabetic foot ulcers: an interim analysis of CAMPX”
International Journal of Tissue Repair, vol. 1, no. 1, Oct. 2025, https://doi.org/10.63676/m04r0s60.
XWRAP® Product Family
XWRAP®
XWRAP® is a dehydrated amniotic membrane intended for use as a protective barrier and wound covering for acute and chronic wounds. Sizes below represent our standard stocked options with corresponding codes. XWRAP® can be ordered in 1 cm² increments, cut precisely to the wound.
| PRODUCT SKU | SIZE | HCPCS Code |
|---|---|---|
| XWO-60202 | 2x2cm | Q4204 |
| XWO-60204 | 2x4cm | Q4204 |
| XWO-60206 | 2x6cm | Q4204 |
| XWO-60404 | 4x4cm | Q4204 |
| XWO-60406 | 4x6cm | Q4204 |
| XWO-60408 | 4x8cm | Q4204 |
XWRAP Plus®
XWRAP Plus® is a dehydrated amniotic membrane processed using Proauctus®, an enhanced proprietary processing method which leads to improved handling properties. XWRAP Plus® is intended for use as a protective barrier and wound covering for acute and chronic wounds. Sizes below represent our standard stocked options with corresponding codes. XWRAP® can be ordered in 1 cm² increments, cut precisely to the wound.
| PRODUCT SKU | SIZE | HCPCS Code |
|---|---|---|
| XWP-70202 | 2x2cm | Q4357 |
| XWP-70204 | 2x4cm | Q4357 |
| XWP-70404 | 4x4cm | Q4357 |
| XWP-70406 | 4x6cm | Q4357 |
| XWP-70408 | 4x8cm | Q4357 |
