Technology

Technology: Supporting Wound Care with Protevation™ Processing

At BIOHEAL THERAPEUTICS, we are supporting wound care through Protevation™ Processing—our proprietary amnion-based platform developed to support healthcare professionals in managing chronic wounds, burns, and post-surgical sites.

Our lead product, Protevion™ Hydrogel, is a porcine amnion-derived hydrogel wound dressing developed using Protevation™ Processing. It is designed to maintain a moist wound environment and offer a versatile, easy-to-apply option for clinical use.

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Who May Benefit

BIOHEAL’s product pipeline is being developed for healthcare professionals treating:

• Chronic Wounds: Including diabetic foot ulcers, venous leg ulcers, and pressure injuries.

• Diabetes-Related Ulcers: Patients with a higher risk of lower extremity wounds.

• Burns and Skin Trauma: Patients requiring wound care following burns and abrasions.

• Post-Surgical Dermatologic Procedures: Wounds from Mohs surgery, laser resurfacing, and cosmetic interventions that require moisture management during recovery.

These clinical scenarios highlight the need for versatile, easy-to-use wound covering technologies.

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The Science Behind Protevation™ Processing

Protevation™ Processing utilizes a patented process that solubilizes decellularized amnion extracellular matrix and blends it with hyaluronic acid (HA). This cell-free, shelf-stable biomaterial platform is designed to:

✅ Support moisture retention in wound management
✅ Maintain handling characteristics for clinical convenience
✅ Be stored at room temperature to facilitate use across care settings

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Product Pipeline Overview

1️⃣ Porcine Amnion Hydrogel Wound Dressing (Protevion™ Hydrogel XG-100)

• Developed as a Class II medical device for FDA 510(k) clearance.

• Designed to cover wounds and support a moist wound environment.

2️⃣ Human Amnion MicroPowder (BioHeal Micro AG-200)

• Micronized, lyophilized extracellular matrix derived from human amnion.

• Planned for submission under a Biologics License Application (BLA) for future use in wound management.

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Preclinical Insights

Foundational studies at the Wake Forest Institute for Regenerative Medicine (WFIRM) evaluated human amnion-based formulations in a porcine wound model. Observations included:

• Greater wound coverage compared to commercial comparators (Day 28)

• Organized collagen structure and mature epidermis on histology

• Reduced wound contraction in treated sites (Murphy et al., 2019)

Note: Protevion™ Hydrogel XG-100, based on porcine amnion, is a distinct product and is advancing separately through the medical device 510(k) pathway.

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Scientific and Strategic Foundation

• Regulatory Pathways:

  • Protevion™ Hydrogel → FDA 510(k)

  • BioHeal Micro AG-200 → FDA BLA (future)

• Global IP Protection: 12 issued/pending patents worldwide

• Defense-Origin Innovation: Developed with U.S. Department of Defense support for wound management applications

• Clinical Collaboration: Partnership with WFIRM to explore broader uses in wound care and dermatology

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Our Commitment

At BIOHEAL THERAPEUTICS, we are focused on developing wound care technologies designed to:

✔️ Maintain a moist wound environment
✔️ Support clinical workflows with user-friendly formulations
✔️ Offer adaptable solutions for diverse wound types and care settings

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Regulatory Disclaimer

Protevion™ Hydrogel XG-100 is an investigational product and has not yet received FDA clearance. It is not approved for sale or clinical use in the United States. All descriptions of use, features, and performance are subject to FDA review and approval.