Can denovoSkin Be A Lifesaver for Burn Victims?


Burn is a global public health problem, affecting more than 180,000 deaths each year around the world. Most of these take place in low- and middle-income countries. Moreover, non-fatal burns are a significant source of morbidity, resulting in lengthy hospitalisation, disfigurement, and disability, as well as stigma and rejection. According to DelveInsight's data, there are a lot of burn victims in the seven major nations of the US, the EU-5 (Germany, France, Italy, Spain, and the UK), and Japan. In the US alone, there were around 459K burn victims who needed treatment in 2021; this number is anticipated to rise by 2032 at a significant CAGR over the projected period of 11 years (2022-2032).


Burn burns are frequently disregarded injuries that result in high morbidity and mortality. Multiple organ failures may result from the difficult-to-manage immunological and inflammatory response, metabolic alterations, and distributive shock that are all linked to severe burns. It is necessary to address the significant long-term changes they bring about to improve the quality of life. These wounds are typically categorised according to their seriousness, depth, and size.


Re-epithelialization is frequently challenging in cases with severe burns. Skin autografting is utilised to treat severe cases of burn patients who have lost their dermis and have a full-thickness defect and cannot be treated by surgeons. This is done using full-thickness skin grafts (FTSGs) or split-thickness skin grafts (STSGs). These grafts, which are taken from the patients themselves, have serious drawbacks. First, it is impossible to discover a match for allotransplantation in emergency situations since there is no location from which grafts may be taken in acute cases of burns. Second, the excised locations leave permanent scars.


The Advanced Therapy Medicinal Product (ATMP), denovoSkin, is being developed by CUTISS AG, a Swiss company specialising in regenerative skin medicine and tissue engineering. It contains cells that were isolated from a stamp-sized patient split-thickness biopsy and cultured over a collagen hydrogel. The availability of grafts in the burns market has always been plagued by significant issues with the re-harvesting and meshing of STSG. Insufficient permanent skin coverage, a significant concern in cases of severe burn injuries, is addressed with denovoSkin, a dermo-epidermal skin graft. The dermal compartment and the well-stratified epidermis were investigated over a three-month period in Phase I burns clinical trials.


Currently, biologics, standard burn care products, improved dressings, and other treatments predominate in treating burns. Alginate dressings, hydrogel dressings, foam dressings, hydrocolloid dressings, collagen dressings, and others are examples of advanced dressings. The use of biologics, such as skin grafts and other conventional burn care items, is also common. Burn rehabilitation and treatments are highly pricey, and many unmet needs remain.


The original production of CUTISS's products occurred at the Wyss Zurich Regenerative Medicine Technologies Platform's GMP facility at the University of Zurich. However, it has now moved its regenerative medicine technology from Wyss Zurich to CUTISS, making it one of the first businesses to attain complete independence in its production capabilities with an onsite facility.


DenovoSkin has been given an Orphan Drug Designation for treating burns by Swissmedic, EMA, and FDA. The Swiss engineering firms that have contributed most to the development of this medication are Zühlke Engineering and CSEM. These recognitions will assist denovoSkin in becoming the first-in-class automated tissue therapy that can effectively, safely, and conveniently treat both adults and children. This technology may also be used for other elective/reconstructive indications, such as tumour resections, plastic surgery, etc. It promises to advance skin surgery and transform the way burns are now treated.


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