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World's First Advanced Gas-Flow Occlusive Wound Dressing

Healing Hard-to-Heal Wounds Through Novel Gas-Flow Dressing Technology

Game-changing technology leveraging existing global medical oxygen infrastructure to deliver continuous topical oxygen moist wound therapy. FDA-registered, clinically validated, and patent-protected. Delivering the healing power of the oxygen molecule to millions worldwide.

RashEndZ OWD Foam
Non-perineal Applications — Foam
RashEndZ OWD Diaper
Perineal/Diaper Applications — Adhesive

A Complete Wound Dressing Platform — Rolling Out 2026 and Beyond

The brainchild of a Neonatal Intensive Care Nurse — we patented and built a family of products in different configurations and sizes so that every wound on any location on any patient can be treated with the same proven protocol.

Every Wound

All types and stages — diabetic foot ulcers, venous leg ulcers, pressure ulcers, surgical wounds, incontinence-associated dermatitis, moisture-associated skin damage, dermatitis. Purpose-built configurations for perineal and non-perineal locations.

Every Setting

One clinical protocol across acute care, long-term care, home health, community, military, and VA settings. No specialized equipment or training required.

Every Patient

Pediatric through geriatric. The same therapeutic approach for a newborn with dermatitis and a 96-year-old with a Stage 4 pressure ulcer.

Advances in Wound Care · Harvard Medical School · Peer-Reviewed 2021

Gas-Flow Wound Therapy: Recognized in Peer-Reviewed Literature

"Gas flow wound therapy is another emerging moist wound dressing. It implements a wound dressing technology that applies a gentle flow of gas into the wound environment. The gas flow is capable of providing moisture to or removing moisture from the wound by adjusting the relative humidity of the gas flow. Other parameters such as oxygen, pH, temperature, and pharmaceuticals can also be provided in the gas flow. Case studies indicate significant improvements in the time to heal."

Nuutila K, Eriksson E. Moist Wound Healing with Commonly Available Dressings.
Advances in Wound Care, Vol. 10, No. 12, 2021. DOI: 10.1089/wound.2020.1232
Division of Plastic Surgery & Department of Surgery, Harvard Medical School / Brigham and Women's Hospital, Boston, MA

Global Clinical Guidelines: The Tipping Point

The clinical debate is over. Topical oxygen therapy is now recognized as an evidence-based intervention for hard-to-heal wounds by every major international wound care body. The question is no longer whether topical oxygen works — it's about which technology delivers it best.

Level 1 Evidence

Wound Healing Society (2023)

Highest evidence rating for diabetic foot ulcer treatment — Level 1, supported by well-designed RCTs.

Grade A

American Diabetes Association (2024)

TOT should be instituted when diabetic foot ulcers fail standard care — supported by multiple high-quality RCTs and five systematic reviews.

Accepted Intervention

IWGDF Guidelines (2023)

TOT is an accepted intervention for non-healing diabetic foot ulcers where standard care has failed.

Additional International Guidelines & Consensus Documents

Delphi Consensus (2021)

Guidelines for the use of topical oxygen therapy in the treatment of hard-to-heal wounds. Journal of Wound Care, North American Supplement, Vol 30, No 9, September 2021.

JWC International Consensus (2023)

Use of Topical Oxygen Therapy in Wound Healing. Journal of Wound Care, International Consensus Document, August 2023.

Latin American Expert Consensus (2023)

Expert consensus on clinical efficacy and guidelines on continuous topical oxygen therapy for the healing of complex wounds. Journal of Wound Care LATAM, October 2023.

EWMA — European Wound Management Association

Topical oxygen therapy recognized within European wound management frameworks and clinical practice guidance for chronic wound treatment.

The RashEndZ Advantage: Innovation Meets Infrastructure

We've joined the advanced wound dressing industry with a game-changing technology strategy: leveraging the existing global infrastructure of medical oxygen to heal millions everywhere—without expensive proprietary equipment.

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Universal Infrastructure

Works with existing medical oxygen in every hospital, nursing home, and portable concentrator worldwide. Zero capital equipment required.

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Superior Economics

A fraction of the cost of legacy topical oxygen systems and advanced dressings, while enabling 24-hour continuous moist wound therapy.

Simplified Workflow

No controllers, no electronics, no setup complexity. Apply like a dressing, connect standard oxygen hose. Minimal training required.

— Economic Impact —

Large and small health systems can achieve substantial cost savings by replacing topical oxygen systems and costly wound dressings with our patented RashEndZ technology.

Integrated Gas-Flow Dressing Technology

The world's first patented occlusive wound dressing engineered for continuous gas delivery — enabling existing medical oxygen infrastructure worldwide to deliver “Dynamic Oxygen Site Therapy” — DOST™

The Novel Difference: Integrated Gas-Flow Dressing Technology

RashEndZ™ uniquely combines occlusive wound protection with continuous, controlled gas delivery — a capability unavailable with advanced and conventional dressings.

The Novel Advantage: Non-occludable, non-kinkable, non-cloggable continuous flow. No proprietary equipment. Connects to existing medical oxygen infrastructure worldwide.
RashEndZ™ Fabric Side — Wound Contact RashEndZ™ Foam Side — Scaffolding
RashEndZ™ Gas-Flow Illustration RashEndZ™ OWD Physical Illustration

Multi-Layer Device Architecture

Non-woven fabric · Polyurethane layer · Hydrophilic foam perimeter.

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Elevated Chamber Design

Minimal wound-contact foam perimeter keeps the dressing off fragile tissue.

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Universal Compatibility

Connects to all medical oxygen sources — wall outlets, concentrators, or tanks.

Flexible Flow Rates

Range: 0.5–5.0 L/min. Delivers consistent low-flow moist wound oxygenation.

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Superior Adjunct Therapy

Designed to overlay other advance dressings — adds oxygen and humidity to wound therapy protocols

FDA 21 CFR 878.4020

Registered Device Classification: Occlusive Wound Dressing

"An occlusive wound dressing is a nonresorbable, sterile or non-sterile device intended to cover a wound, to provide or support a moist wound environment, and to allow the exchange of gases such as oxygen and water vapor through the device. It consists of a piece of synthetic polymeric material, such as polyurethane, with or without an adhesive backing."

— 21 CFR 878.4020(a), Class I (General Controls), Exempt from 510(k)

878.4020 Requires

"Nonresorbable, sterile"

RashEndZ™ is a nonresorbable, sterile, single-use device. It is not absorbed by the body.

878.4020 Requires

"Provide or support a moist wound environment"

RashEndZ™'s occlusive design with hydrophilic foam perimeter actively maintains a moist wound environment. Humidified gas flow adds or removes moisture as needed.

878.4020 Requires

"Allow the exchange of gases such as oxygen and water vapor"

RashEndZ™ integrated gas-flow technology delivers continuous oxygen and water vapor 24/7.

878.4020 Requires

"Synthetic polymeric material, such as polyurethane"

Multi-layer construction of polyurethane plastic layer, non-woven fabric, and hydrophilic foam—biocompatible materials verified through ISO 10993 testing.

878.4020 Requires

"Intended to cover a wound"

Elevated chamber design covers and protects the wound bed. 10mm air space with vented fabric minimizes direct wound contact while maintaining full environmental protection.

The FDA regulatory definition of an occlusive wound dressing already contemplates the exchange of oxygen and water vapor. RashEndZ™ patented the innovative technology (US 8,978,265) that transforms these regulatory requirements from passive design characteristics into active, engineered, continuous delivery—fully implementing what 878.4020 envisioned.

FDA Registered Device Listings

RashEndZ™ Advanced Occlusive Wound Dressings are registered with the FDA under 21 CFR 878.4020. The following products are currently listed:

Proprietary Name Device Identifier
Sterile Products
RashEndZWD NonWoven Poly GasPort Foam 6″ × 4″ SterileOWD-0604SF
RashEndZWD NonWoven Poly GasPort Foam 15″ × 4″ SterileOWD-1504SF
RashEndZWD NonWoven Poly GasPort Adhesive 6″ × 3″ SterileOWD-0603SA
RashEndZWD NonWoven Poly GasPort Adhesive 15″ × 4″ SterileOWD-1504SA
Non-Sterile Products
RashEndZWD NonWoven Poly GasPort Foam 6″ × 4″ Non-SterileOWD-0604NF
RashEndZWD NonWoven Poly GasPort Foam 15″ × 4″ Non-SterileOWD-1504NF
RashEndZWD NonWoven Poly GasPort Adhesive 6″ × 3″ Non-SterileOWD-0603NA
RashEndZWD NonWoven Poly GasPort Adhesive 15″ × 4″ Non-SterileOWD-1504NA

Product Code Legend

OWD — Occlusive Wound Dressing
0604 / 1504 — Dimensions (6″×4″ or 15″×4″)
S / N — Sterile / Non-Sterile
F / A — Foam border / Adhesive border

This is a partial listing. Additional device configurations may be registered. Contact RashEndZ for complete product catalog and availability.

Product Line
Device Portfolio →
Clinical Use
Wound Care Applications →
Intellectual Property
Patents →

Instructions For Use

Six-step protocol · Continuous topical oxygen moist wound therapy

1

Open Package

Do not use if damaged. Handle as Sterile. Peel open pouch at the center. Remove device. No special care required.

Note: Single use only — do not reuse.
2

Prepare Wound

Remove non-viable tissue and biofilm, cleansing the area, and controlling any signs of infection. Leave wound tissue exposed.

Caution: Do not apply topical substances to wound. It will impair oxygen absorption.
3

Position Dressing

Place dressing over wound with foam lining placed over and around the wound. Secure with bandage or tape, as preferred.

Note: Dressing may contact intact skin or the wound directly. Tape may be placed at any point on the device.
4

Secure Dressing

Secure dressing loosely, with a simple bandage, or with tape at no more than 4 locations around the dressing.

Note: The bandage or tape is only to secure the dressing in place, while allowing the oxygen to safely vent out the sides.
5

Connect Oxygen & Set Flow Rate

Attach the GasPort™ fitting to a humidified oxygen source using a standard respiratory hose. Set the oxygen flow rate to 1.0 L/min, and adjust up to 5 L/min as needed to maintain wound saturation.

Caution: Confirm gas flow at output of the hose prior to final connection with RashEndZ™.
6

Verify Functional Operation

Verify that all connection points and the humidification bottle cap are properly sealed, if using a refillable bottle.

Success: Application complete. Dressing is now delivering continuous topical oxygen therapy.
Access Full e-IFU Documentation →

Healing Millions Everywhere

Where oxygen exists, RashEndZ™ can heal. That is every hospital, nursing home, and home health setting on Earth.

Global Regulatory Strategy

CE/Global Certification

Selling to the world by end of 2026.

EU MDR 2017/745 · Rules 1
CE Class I Sterile — REZair™ Brand
Target: End 2026

EU Authorized Representative engaged.

EU MDR 2017/745 · Rules 9 & 11
CE Class IIa — oksijen™ Brand
Target: 2027

Notified Body retained — process underway.

95+
Countries accept CE or FDA mark.
One dual-regulatory strategy. Global reach.

Global Wound Burden

37M
Diabetic Foot Ulcers
18.6M new cases/yr
26M
Venous Leg Ulcers
0.32% global prevalence
11M
Arterial/CLTI Ulcers
~10% of 114M with PAD
3.2M
Pressure Injuries
1.7M+ new cases/yr

US Annual Patient Volume

2.5M
Pressure Ulcers
2.0M
Diabetic Foot Ulcers
0.5–2M
Venous Leg Ulcers
1–3M
Incontinence-Associated

Sources: IDF (2024), Global Burden of Disease Study (2021), PubMed systematic reviews

Medical Oxygen Already Exists Everywhere

No proprietary equipment to ship, install, or maintain. That's how you heal millions everywhere.

About RashEndZ, Inc.

Our Mission

Heal millions of chronic and acute wounds faster and at lower cost — using existing medical oxygen infrastructure worldwide.

Our Moonshot

Revolutionize global wound care through patented, disposable, occlusive wound aeration technology integrated with existing oxygen and air delivery systems.

Colleen John, R.N. — Co-founder of RashEndZ, caring for an infant in the NICU
Colleen John, R.N. — Co-founder of RashEndZ

Company Profile

NameRashEndZ, Inc.
HQSt. Petersburg, FL
Executive OfficeNew York City
Co-FoundersColleen John, R.N. (Clinical Advisor)
Nigel Parker (CEO & COO)
Contact Us →

One Dressing Platform. Every Wound. Every Patient. Everywhere.