Technology: Advancing Wound Care with Solamem™ Technology

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

Our lead product, Hydrivyn™ Topical Gel, is a porcine amnion-derived hydrogel developed using Solamem™ Technology. 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 Solamem™ Technology

Solamem™ Technology 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 (Hydrivyn™ Topical Gel)

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

• Designed to cover wounds and support a moist wound environment in chronic wounds, burns, and post-surgical sites.

2️⃣ Human Amnion Powder (Allo-XCM™ MicroPowder)

• 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: Hydrivyn™ Topical Gel, 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:

  • Hydrivyn™ Topical Gel → FDA 510(k)

  • Allo-XCM™ MicroPowder → 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

Hydrivyn™ Topical Gel 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.