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 company's investigational therapy is currently under evaluation in a 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.
The hypermetabolic state in severe burns is a factor in assessing severe burn patient care needs. Severe burns are related to an increase in mortality and have long-term medical consequences related to trauma and mental illness.
XenoTherapeutics Foundation Presents Hypermetabolic State in Severe Burns
Burn Depth is an Important Factor in Assessing Patient Care Needs. At XenoTherapeutics we accelerate the development, testing, training, and commercialization of innovative, live biotherapeutic products that deliver on the promise of regenerative medicine. XenoTherapeutics Foundation is a not-for-profit, clinical-stage regenerative medicine company developing innovative cell and tissue-based research solutions.
Over 1.3 million fires occurred across the United States in 2018 resulting in more than 3,600 deaths, a 20% greater loss of life since 2009.
Deaths increase significantly with burn size, or total body surface area (TBSA). In 2015, 78% of the burn population experienced burns below 10% TBSA; 14% between 11-20% TBSA; and the remaining 8% greater than 20% TBSA. Burns over 10% TBSA are typically treated at designated burn centers such as the Sumner Redstone Burn Center of the Massachusetts General Hospital in Boston.
Mass casualty events and disasters such as New Zealand's White Island Volcano Tragedy in 2019 are marked by a period of mismatch (disproportion) between supply and demand.
Severe and extensive, deep-partial and full-thickness burns requiring hospitalization are ideally treated with Human Deceased Donor (HDD) allograft skin, which possesses many of the dieal properties of biologic dressings and plays a major role in the surgical management of extensive wounds when autologous (self) tissue may not be immediately available or is contra-indicated. Fresh allograft skin represents the gold standard for all biologic dressings emlpoyed for temporary wound closure based on a number of its distince properties compared to cryopreserved skin.
The use of fresh HDD allografts has become extremely limited in recent yeras, however, due to increased FDA regulations put in place to reduce risk of disease transmission. Disadvantages of HDD allograft include bacterial infection, viral disease transmission, and limited supply.
Source: U.S. Fire Administration (FEMA); Total Burn Care; Barone 2015