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Study in preparation for FDA approval successfully started

While patients with chronic wounds in Germany and other parts of Europe have been able to benefit from the effect of cold atmospheric plasma for some time now, medical cold plasma devices for wound healing have not been approved in the USA by the FDA. We want to change this by bringing the plasma care® device, which has already been used with great success here in Europe, to the USA as well. To make this possible, we are pleased to be able to cooperate with Dr. Thomas Serena, founder and medical director of the SerenaGroup®, a group of wound care and research companies, for the execution of a study. He is enthusiastic about the new treatment option: “In the beginning I was skeptical, but when we started treating patients with cold plasma the improvement in healing was convincing. We are looking forward to further research into the efficacy of cold plasma in chronic wounds.”

The study, titled “A Prospective Case Series Evaluating the Safety and Effectiveness of Cold Atmospheric Plasma (CAP) and Standard of Care in the treatment of Hard-to-Heal Wounds,” has already been initiated under the direction of Dr. Thomas Serena at the two centers, Monroeville and Austin. Several patients have already been enrolled at each center, and treatment has already been completed in four cases. The study is intended to confirm the safety and efficacy of the plasma care® device as part of the FDA approval process.