At XenoTherapeutics, we're proud to present the clinical results of our innovative product, realSKIN®. Developed for topical use directly on severe and extensive burn wounds, realSKIN® demonstrates complete and durable wound closure, setting the potential for a new standard in burn care.
Key Features of realSKIN :
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Living Skin Transplant: realSKIN® contains live porcine epidermal and dermal cells, tissues, and intact vasculature, forming microvascular connections with host vessels for effective wound closure.
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Bioactive Compounds: Enriched with bioactive compounds analogous to those found in human skin, realSKIN® facilitates wound healing and skin regeneration.
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Optimal Wound Healing: realSKIN® promotes accelerated tissue regeneration and enhanced wound closure, offering remarkable progress in chronic wound healing and severe burn injuries.
Clinical Trial Summary:
realSKIN® underwent rigorous evaluation in Phase 1, 2, and 2b clinical trials (Study No. XENO-001, NCT03695939), as well as safety and efficacy assessments in non-human primates (GLP Study Nos. PSK17-01 and PSK18-01). Over the course of clinical trial XENO-001, realSKIN was evaluated in 25 patients with severe and extensive burn injuries.
Key Findings:
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Safety: realSKIN® has shown an impeccable safety record with no harmful effects observed so far. This includes no cases of infections, allergies, or any other complications related to its use. Our safety evaluations involved thorough physical examinations, vital signs monitoring, and comprehensive laboratory tests.
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Consistent Performance: Across all patients treated with realSKIN®, we observed consistent signs of adherence, meaning the product stayed in place as intended, supporting the healing process. This adherence, combined with its ability to sustain itself and promote blood flow (vascularity), contributed to successful wound closure in every case.
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Effective Results: In comparison to traditional treatments, realSKIN® has demonstrated equal or superior effectiveness. It consistently led to complete wound closure within 30 days after surgery, with the healing maintained for at least 90 days post-operation. This confirms its reliability and efficacy in promoting wound healing.
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Comprehensive Healing: realSKIN® has shown remarkable results in closing wounds of various depths, including those with incomplete dermal layers. This means it has the potential to effectively treat more severe or complex wounds, offering a comprehensive solution for patients with different needs.
Patient Case Examples:
Below are examples of three patients treated with realSKIN®, showcasing the time progression pictures and outcomes of their treatment:
Severe Burn Case Example 1
Example 1: Severe Burn Injury
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Description: Severe and extensive burn injury requiring surgical intervention.
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Outcome: Complete wound closure achieved by Day 31, durable wound closure confirmed at Day 85 and Month 6.
Severe Burn Case Example 2
Example 2: Severe Burn Injury
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Description: Severe and extensive burn injury requiring surgical intervention.
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Outcome: Complete wound closure achieved by Day 27.
Severe Burn Case Example 3
Example 3: Severe Burn Injury
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Description: Severe and extensive burn injury requiring surgical intervention.
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Outcome: Complete wound closure achieved by Day 24.