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FDA Grants Plasmology4® "Breakthrough Device Designation" for the Treatment of Multidrug-Refractory Bacteria
SCOTTSDALE, Ariz., Feb. 12, 2020 /PRNewswire/ -- Plasmology4®, Inc., a leader in Plasma Medicine, announced that the company's product has been granted into the U.S. Food and Drug Administration's (FDA) Breakthrough Devices Program for the treatment of "multidrug-refractory bacterial and/or fungal pathogen bioburden in a wound bed."
Plasmology4® has developed a revolutionary platform technology called Plaz4®, an advanced and specialized form of "non-thermal" plasma technology. Plasma is known as the 4th state of matter. Plaz4® has many potential healthcare applications, including the prevention and treatment of infections. This technology is capable of destroying microbial cells including bacteria, fungi and multidrug-resistant pathogens, without harming skin and other soft tissues. Results from initial pre-clinical studies demonstrate a significant reduction of antibiotic-resistant bacteria (MRSA) in a single topical treatment.
The FDA's Breakthrough Devices Program is intended to help patients receive more timely access to innovative technologies that have the potential to provide more effective treatment for life-threatening or irreversibly debilitating diseases or conditions. Under the program, the FDA will provide Plasmology4® with priority review and interactive communication regarding device development and clinical trial protocols, through to commercialization decisions.
Robert Hummel, Chief Executive Officer of Plasmology4®, 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." Globally, the CDC estimates there are 700,000 deaths per year that are caused by antibiotic-resistant organisms. By the year 2050, annual deaths are predicted to reach 10 million, adding $100 trillion to healthcare costs.
Mr. Hummel stated, "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."
Plasmology4® (www.plasmology4.com) is pioneering the emerging field of Plasma Medicine with its groundbreaking Plaz4® Technology. The Company has created a strong and valuable patent portfolio with 38 issued patents and several patents pending. Plasmology4's executive management team and Scientific Advisory Board are seasoned professionals and Key Opinion Leaders in the areas of science, research, engineering, healthcare and medical device product development.
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