The New Frontier: Xenotransplantation
Unlocking Regenerative Potential
Xenotransplantation, the transplantation of animal cells, tissues, and organs to humans, holds the key to unlocking the regenerative potential of the human body.
Leveraging Genetic Similarity
By utilizing the significant genetic DNA similarity between pigs and humans, we connect the body's natural healing process with engineered pig cells. This approach aims to provide immune compatible products that offer enhanced safety, efficacy, and cost-effectiveness compared to traditional cell and tissue therapies.
Harnessing the Power to Heal
By embracing xenotransplantation, we unlock the power within us to heal and regenerate, surpassing the limitations of our biology. This innovative technique has the potential to revolutionize healthcare, providing a path to resilience, renewal, and expanded possibilities for patients in need.
Pioneering Clinical Xenotransplantation
In our research collaboration with Alexis Bio, we have made significant strides in the field of clinical xenotransplantation. Our first product, realSKIN®, stands as a pioneering achievement in this groundbreaking field.
realSKIN is living skin that intends to replace damaged or severely burned skin, allowing the patient to heal on their own; requiring fewer surgeries and faster healing.
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Treating Severe Burns
Lead Focus: Severe Burns - Patients who experience severe mixed-depth and full-thickness burn wounds require hospitalization, surgical excision, and skin grafting. During this critical period, patients with severe burns are at high risk of mortality due to the disruption in the skin barrier that contributes to organ failure and often death.
realSKIN intends to provide complete wound closure by promoting autologous skin regeneration of mixed-depth and full-thickness thermal burn wounds requiring hospitalization, surgical excision, and skin grafting for which autografting is clinically indicated.
We have completed our Phase I/II study of patients (NCT03695939) with severe burns using realSKIN , a living skin xenotransplant manufactured from genetically engineered porcine skin.
U.S. FDA Designates realSKIN as an Orphan Drug and Regenerative Medicine Advanced Therapy - realSKIN is the first live cell xenotransplant product to be designated as a Regenerative Medicine Advanced Therapy (RMAT) by the U.S. Food and Drug Administration (FDA). The investigational therapy is beginning a pivotal Phase III Clinical Trial (NCT06223269) to evaluate the safety, tolerability, and efficacy of realSKIN to provide complete wound closure of burn wounds as an alternative to autografting.
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realNERVE™ is physiologically similar to human nerves, contains neurotrophic growth factors and a matrix-rich scaffold, and intends to offer greater clinical availability.
Peripheral Nerve Injury
Lead Focus: Peripheral Nerve Trauma - Early surgical intervention is required to successfully treat severe, large-gap peripheral nerve injuries. However, all existing treatments have shortcomings, and for large-gap injuries (≥4 cm), there is no reported alternative to autologous (self) nerve.
realNERVE™ is physiologically similar to human nerves, contains neurotrophic growth factors and a matrix-rich scaffold, and intends to offer greater clinical availability.
We have completed our preclinical study of realNERVE™ for transectional radial nerve damage using a viable, whole sciatic nerve from genetically engineered, porcine donors.
realTISSUES is a collection of products that offer a new source of tissues including bone, dermis, vessels, valves, and connective tissue. These products can be produced in a safer, faster, and more efficient way that can be scaled to meet demand.
Vascularized Composite Transplants
Vascularized Composite Transplants (VCT) involve the transplantation of multiple structures that may include skin, bone, muscles, blood vessels, nerves, and connective tissue.
The most commonly known type of VCTs is for hand and face transplants. Federal regulations for these transplants became effective in July 2014.
This groundbreaking form of therapy returns vital function and identity to people who have suffered a devastating injury or illness.