Skin is the largest organ of our body . We bioengineer human skin in the laboratory starting from a post-stamp sized sample from a patient ’ s healthy skin . This personalized process assures great results in terms of regeneration but it presents challenges in terms of scalability . So , we created the world ’ s first machine that can automate the production of denovoSkin™ with the vision to optimize and de-centralize manufacturing and to make it more accessible . The machine is now in the industrialization phase .
We are soon going to commercialize the medical device VitiCell ® which treats skin pigmentation disorders , notably Vitiligo , the most common skin pigmentation disorder that affects approximately 1-2 % of the global population . VitiCell ® is a medical device that makes autologous cellular grafting possible in an outpatient setting by a medical professional , be it at a hospital , private clinic or a dermatologist ’ s cabinet .
How far is denovoSkin™ , a personalized , dermo-epidermal skin graft , away from commercialization ? Will it be available globally ? What about affordability ?
The denovoSkin™ is in late-stage clinical trials , and it is a medicinal product in the European Union and a biologic in the USA . It already
A leading European woman healthcare leader , Dr Daniela Marino is a bio scientist focused on regenerative skin medicine and tissue engineering . She holds a master in Biotechnology and a PhD in Sciences from ETHZ . During her PhD and her PostDoc , her research focussed primarily on vascular biology and skin engineering .
completed Phase 1 safety trials , and we recently announced the end of patient recruitment for Phase 2 efficacy trials in adult and adolescent burn patients . These Phase 2 results are expected in the first half of this year .
The denovoSkin ™ is already accessible for compassionate patient use .
Our plan is to make the denovoSkin™ available to patients around the world . According to the World Health Organization ( WHO ), the highest incidence of burn injuries is in low- and middleincome countries , particularly in Southeast Asia and sub-Saharan Africa . Automation is therefore key to scaling up production and reducing costs , which is why we are also working on the bioengineering machine .
Why are you keen to focus on skin pigmentation disorders and skin grafts ? What would be the market size for such products globally and in India ?
We are developing a completely novel approach
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