Swiss-made leather
Swiss startup has made a breakthrough in the treatment of burns
Marc-Andre Mizere, swissinfo.ch
Translation: Nadezhda Capone
Every year, more than 11 million people worldwide receive severe burn injuries. Thanks to the innovative developments of the Swiss company, they have hope for a cure. Recently, the startup CUTISS launched into mass production a revolutionary equipment capable of creating a biotechnological coating based on the tissue of the patients themselves in order to restore the lost skin over a large area.
The size of the denovoCast installation is slightly larger than a coffee table.
"This is not artificial skin, but it can't be called the patient's own tissue either," says Daniela Marino, co−founder and director of the medical and biological company CUTISS, established in 2017 at the University Children's Clinic Zurich (Kinderspital Zurich). "To be more precise, it is the equivalent of a skin created by bioengineering methods." At the heart of these methods is first a biopsy, that is, the in vivo taking of cells or tissues (biopsy) from the patient's body.
Then the cells of healthy skin are "grown" in the laboratory and mixed with hydrogel to create a new "skin", or rather, a biotechnological coating of denovoSkin with a thickness of one millimeter, which corresponds to the normal parameters of the epidermis and dermis. The decisive advantage of the new denovoSkin coating compared to traditional skin grafts is the ability to increase the area of the resulting sample from the size of a postage stamp to a flap almost the size of a table napkin.
The path from the laboratory to the market
The denovoSkin coating has already passed the stage of preclinical studies. Now it is in the final stage of the second phase of clinical tests. In Switzerland, the European Union and the USA, the denovoSkin coating has so far been classified as "orphan drugs" (orphan drugs, that is, intended for the treatment of very rare diseases). This means, however, that denovoSkin is already being used to treat patients, limited to two flaps of skin equivalent for each burn case.
After closing the wound with denovoSkin skin, it loses its neon pink color and quickly acquires a natural shade.
This method has also received special permissions for so-called "compassionate use". We are talking about the mechanism of using drugs whose clinical trials have not yet been completed, but for which effectiveness and an acceptable level of safety have already been proven, if there is no suitable replacement on the market to save the patient. This coating can "become a life−sustaining treatment, already surpassing in effectiveness any known method of treating extensive deep burns," CUTISS said in a press release.
A number of victims with extensive burns are already receiving assistance with the use of denovoSkin in practice. Clinical trials of the next third phase will take place with the participation of a significant number of probands. Objective: final confirmation of the effectiveness and safety of a new method of therapy for burn injuries. According to D. Marino, the denovoSkin coating will enter the mass market "if everything goes well, already in the period up to 2023."
"At the moment, we can increase the area of the initial tissue sample by 100 times, and eventually we expect to achieve a 500-fold increase," she says. The traditional method, which is based on the method of replacement removal of a skin graft from the patient's body, allows to increase the area of the sample taken only nine times, and this creates a problem of shortage of donor skin on the body of patients with burns on a scale of 50 to 70% of the body surface.
Only for the rich?
But how much will it all cost? Does all this mean that denovoSkin artificial leather with its almost fabulous characteristics will be available only to wealthy patients? "We thought about it from the very beginning," says D. Marino. "It is obvious that severe burn injuries are much more common in the countries of the global South, which, unfortunately, is partly due to military conflicts. At the moment, our specialist technicians are engaged in the manual production of wound coatings in sterile rooms, which costs a lot of money. However, the commissioning of our medical equipment will significantly reduce costs and make this method of therapy affordable even for developing countries."
What kind of equipment is this? We are talking about the denovoCast installation, which was developed jointly with the Centre Suisse d'Electronique et de Microtechnique, located in Neuchatel, the "Swiss Center for Electronics and Microtechnologies". This research and development center in the form of a public-private partnership specializes in the field of microtechnology, nanotechnology, microelectronics, system engineering, photovoltaics and communication technologies. The DenovoCast installation will be able to produce several transplants simultaneously in a fully automatic mode.
The developers assume that denovoCast will accelerate the production of biotechnological coating by more than 30% and ensure its stable quality. In general, it can be concluded that CUTISS is already well prepared to enter the world market of biocompatible materials. In Western Europe and the USA alone, the market potential of drugs and technologies for the treatment of deep burns is estimated at more than $ 2 billion, and specifically in the field of skin plastic surgery, this market is estimated at more than $ 5 billion. Will a company with a staff of less than 40 people be able to stay in such a market?
Made in Switzerland
"There are two dozen centers of excellence in the treatment of severe burn injuries in Europe. We will start by establishing contacts with these centers, and we are able to do this on our own. But later, of course, we will have to look for partners," says D. Marino.
Recently, her startup received support from the Swiss Innovation Promotion Agency Innosuisse, as well as through the EU Framework Program for Research and Innovation Horizon 2020. However, a month ago Switzerland announced the termination of negotiations with the European Union on the conclusion of a Framework agreement, which would extend to this kind of cooperation. The prospects for Switzerland's participation in the Horizon 2020 program are currently very vague.
Portal "Eternal youth" http://vechnayamolodost.ru