Technology

Technology: Redefining Wound Healing with BioHeal Hydrogel XG-100

At BIOHEAL THERAPEUTICS, we are redefining regenerative wound care through BioHeal Matrix Technology (BMT)—our proprietary amnion-based platform designed to support healing in complex wounds, burns, and dermatologic surgical sites.

Our lead product, BioHeal Hydrogel XG-100, is a porcine amnion-derived hydrogel developed to address limitations in traditional wound dressings by delivering consistent moisture retention, and ease of use.

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Who Can Benefit?

BIOHEAL's  product pipeline is designed for global use across a wide range of wound types and clinical settings. Although not currently available in the United States, our technology targets patients and healthcare systems worldwide that manage:

• Chronic Wounds: Over 5.2 million U.S. adults suffer from non-healing wounds annually, including diabetic and venous ulcers.

• Diabetes-Related Ulcers: 37.3 million Americans have diabetes, placing millions at elevated risk for foot ulcers and amputation.

• Burns and Skin Trauma: More than 1 million Americans each year require treatment for burns and severe abrasions.

• Post-Surgical Dermatologic Procedures:

  • Mohs micrographic surgery is performed more than 2 million times annually in the U.S. for skin cancer removal.

  • Laser resurfacing and cosmetic procedures total over 3.5 million cases annually, often resulting in wounds that benefit from accelerated epithelialization.

These conditions are not only clinically challenging but contribute significantly to healthcare costs—emphasizing the need for easy-to-use wound solutions.

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The Science BIOHEAL MATRIX TECHNOLOGY (BMT)

BioHeal Matrix Technology (BMT) is based on advanced biomaterial science, combining decellularized amnion extracellular matrix with hyaluronic acid (HA) to support tissue healing. Both hydrogel and powder formulations are designed to be:

• Non-immunogenic

• Shelf-stable at room temperature

• Free of living cells, reducing risk of immune response 

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Technology Overview

We are advancing two product candidates under distinct regulatory pathways:

1. Porcine Amnion Hydrogel (BioHeal Hydrogel XG-100)

• Composed of solubilized, decellularized porcine amnion blended with hyaluronic acid

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

• Designed for chronic wounds, burns, and post-surgical dermatologic procedures, including Mohs surgery and laser resurfacing

2. Human Amnion Powder (Allo-XCM MicroPowder)

• A lyophilized, micronized extracellular matrix derived from human amnion

• Completed a phase III human clinical trial in patients following Mohs surgery

• In final preparation for FDA submission as a Biologics License Application (BLA)

• Targeted for topical healing in dermatologic and complex wound care applications

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Preclinical Validation Using Human Amnion

The biological foundation for BMT was validated in a pivotal preclinical study at the Wake Forest Institute for Regenerative Medicine (WFIRM) using human amnion-based formulations in a porcine full-thickness wound model.

Day 28 Outcomes (Murphy et al., 2019):

• Wound Closure

  • Human amnion hydrogel and powder achieved >99% closure

  • Outperformed AmnioGraft® (92.2%), GraftJacket® (52.1%), and untreated wounds (85.9%)

• Epithelialization

  • ~98.7% coverage with human amnion products

  • Other groups ranged from 51.5% to 92.2%

• Contraction

  • Human amnion powder: 34.5%

  • Human amnion hydrogel: 41.9%

  • Untreated wounds: 60.4%

• Histology

  • Treated wounds showed organized collagen, mature epidermis, and minimal inflammation—closely resembling healthy skin

This study used human amnion formulations in a porcine model. BioHeal Hydrogel XG-100, based on porcine amnion, is a distinct product currently advancing through the medical device 510(k) pathway.

Reference:
Murphy SV, Skardal A, Nelson RA Jr, et al. Amnion membrane hydrogel and amnion membrane powder accelerate wound healing in a full thickness porcine skin wound model. STEM CELLS Transl Med. 2019;8(6):605–619. https://doi.org/10.1002/sctm.18-0277

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Why It Matters

The WFIRM study provides one of the most compelling comparative analyses of amnion-based wound technologies. Key findings include:

• Superior performance vs. commercial comparators in closure and tissue regeneration

• Histological evidence of skin-like healing with reduced scarring

• Validation of shelf-stable, cell-free matrix designs in demanding wound environments

These results strongly support the ongoing development of BIOHEAL’s porcine medical device and human amnion biologic product lines.

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Scientific and Strategic Foundation

• Regulatory Pathways

  • Porcine hydrogel: Class II 510(k) submission planned

  • Human powder: BLA submission pending (phase III human clinical trial completed)

• Global IP Protection: 12 issued/pending patents worldwide

• Defense-Origin Innovation: U.S. Department of Defense-funded development for battlefield wound care

• Clinical Collaboration: Ongoing partnership with WFIRM to expand into surgical and regenerative applications

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Transforming Wound Care Worldwide

BIOHEAL THERAPEUTICS is committed to bringing the next generation of wound care to patients and physicians globally. Our solutions are built for clinical performance, ease of use, and scalability—from chronic wounds to surgical dermatology.

Contact us to learn more about how BioHeal Hydrogel XG-100 and Allo-XCM MicroPowder product candidates are redefining what's possible in wound healing.