What are Acute Biotherapies?
The therapeutic benefit from the transient replacement of damaged, lost or missing human cells, tissues, and proteins with interchangeable, functional animal-sourced equivalents is a reality.
Acute Biotherapies are:
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Not permanent
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Bridges the human body’s natural healing process
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Require little or no immune suppression
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Replaced by the body’s own cells of the same type in weeks to months
realSKIN is living skin that replaces damaged or severely burned skin to allow the patient to heal on their own; requiring fewer surgeries and faster healing.
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Treating Severe Burns
“What if we could replace skin that was
severely burned with new, living skin?”
Lead Focus: Severe Burns - Patients who experience severe and extensive, deep partial 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 severe and extensive deep-partial 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 live biotherapeutic skin xenotransplant manufactured from living porcine skin
U.S. FDA Designates realSKIN as 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 looking towards a pivotal Phase 3 clinical trial to evaluate the safety, tolerability, and efficacy of realSKIN to provide complete and durable wound closure from a single application, by promoting autologous skin regeneration of severe and extensive deep-partial and full-thickness thermal burn wounds requiring hospitalization, surgical excision, and skin grafting for which autografting is clinically indicated.
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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
“What if we could restore function to a
peripheral nerve that was severed due to
trauma with new, living nerve tissue?”
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.
realTISSUE™ provides a new source of vessels, valves, and connective tissue that can be produced fairer, faster, and more efficiently while also addressing safety.
Vascularized Composite Transplants
“What if we could repair or replace damaged cells, bone grafts, blood vessels, valves, and connective tissue
with new, living 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.