Plaz4 is said to be an advanced non-thermal plasma technology, designed to treat the fungal pathogen bioburden in a wound bed
Plasmology4 secures FDA breakthrough device designation for Plaz4 technology. (Credit: Pixabay/Arek Socha)
Plasmology4, a plasma medicine company, secured the US Food and Drug Administration’s (FDA) breakthrough devices designation for its Plaz4 platform technology.
The biomedical device company is engaged in developing plasma medicine, a new advanced field that combines plasma physics, life sciences, and clinical medicine, and facilitates the use of cold plasma technology for healthcare applications.
Plaz4 is said to be an advanced non-thermal plasma technology, designed to treat the multidrug-refractory bacterial or fungal pathogen bioburden in a wound bed.
Plasmology4 chief executive officer Robert Hummel said: “The Centers for Disease Control and Prevention (CDC) estimates that more than 2.8 million antibiotic-resistant infections occur in the United States each year, and more than 35,000 people die as a result. These illnesses lead to eight million extra days of hospitalization and over $20 billion in additional healthcare costs.
According to the CDC, antibiotic-resistant organisms are estimated to cause around 700,000 deaths per year across the world.
Plasmology4 offers plasma medicine through advanced Plaz4 technology
Plasmology4 claimed that its Plaz4 has potential to destroy microbial cells including bacteria, fungi and multidrug-resistant pathogens without harming skin and soft tissues, and has several healthcare applications, including the prevention and treatment of infections.
In addition, the results from initial pre-clinical studies of the plasma technology show considerable decease in antibiotic-resistant bacteria (MRSA) in a single topical treatment.
Under the breakthrough device program, the FDA provides priority review and supports the device development and clinical trials.
The company claimed that it has built patent portfolio comprising 38 issued patents and several patents pending, in the areas of science, research, engineering, healthcare and medical device product development.
Hummel added: “This Breakthrough Device designation is a significant advancement towards bringing forth a much needed solution to this urgent, worldwide problem of antibiotic-resistant infections and superbugs. Plaz4® is going to have a tremendous impact in healthcare.”