Viromed Medical AG Seeks Special Approval for Cold Plasma Device for the Prevention of Ventilator-Associated Pneumonia (VAP)

• Targeted use of the antimicrobial effect of cold plasma beyond wound treatment

• Use of cold plasma could revolutionize the treatment of VAP and significantly reduce mortality

• Aiming for rapid special approval for own device in Germany and USA by 2025

Viromed Medical AG (ISIN: DE000A3MQR65; "Viromed") is launching a second pioneering study on the use of cold plasma for the prevention of ventilator-associated pneumonia (VAP). The study, under the scientific direction of Prof. Dr. Hortense Slevogt from the Hannover Medical School (MHH) and two other world-renowned institutes, aims to obtain rapid special approval for the PulmoPlas device developed by Viromed for this innovative preventive measure in Germany and the USA.

The further development and standardization of cold plasma technology for use in study-relevant cell cultures and later also in the human lung comes from relyon plasma GmbH, a wholly owned subsidiary of TDK Electronics AG. As a partner of Viromed, relyon plasma will establish the prototypes for the application and ensure the standardized generation of cold plasma as well as its characterization and consistency in the trial.

The exploitation rights are held by Viromed Medical AG.

VAP is a frequent and serious complication in mechanically ventilated patients. It occurs in patients who are invasively mechanically ventilated for at least 48 hours. Studies show that VAP occurs in 23 to 36 percent of mechanically ventilated patients and is associated with prolonged ventilation time and longer stays in the intensive care unit and hospital. The estimated mortality rate is 10 to 13 percent. In Germany alone, there were around 486,000 mechanically ventilated intensive care patients in 2023 and many thousands of deaths, with a strong upward trend. Many millions of patients worldwide are mechanically ventilated every year. The use of cold plasma against VAP would therefore have the potential to save hundreds of thousands of lives every year.

Uwe Perbandt, CEO of Viromed Medical AG: "The use of cold plasma has already proven very successful in the treatment of difficult-to-heal wounds. Our vision is to use the antimicrobial effect in other areas of application where treatment with conventional methods leads to unsatisfactory results. If several hundred thousand patients die from VAP every year, this is unacceptable. As a first mover, we are therefore systematically driving forward the relevant research and striving to obtain special approval for our PulmoPlas device as quickly as possible, as we see an urgent medical need for a better solution to the VAP problem. At the same time, we are tapping into an attractive market segment, as the global market for mechanical ventilation is predicted to see solid growth averaging 8.2% per year until 2032 due to the increase in chronic respiratory diseases."

Since October 2023, the MHH, in cooperation with Viromed Medical AG, has been investigating the safety profile of the use of cold plasma in bacterial infections of the respiratory tract using models of the respiratory mucosa. In particular, the focus is on the potential of cold plasma to kill bacteria that have infected the epithelium. In parallel, possibly associated inflammatory reactions, possible changes in cell differentiation, cell death, DNA damage as well as the therapeutic dose and the time window of application are being investigated. In order to optimize the effectiveness of different plasma compositions, their effectiveness in connection with cell damage will be investigated differentially. Due to promising preliminary results that have shown no damaging effect on the airway epithelium, a second study is now starting in parallel, which was originally planned for mid-2025. This will expand the investigation of the safety profile of cold plasma on alveolar epithelium, taking into account mechanical shear forces that act on the alveolar mucosa during breathing. In addition, the potential and safety of cold plasma to kill bacteria applied to precision-cut lung slices (PCLS) will be tested.

Prof. Dr. Hortense Slevogt, Clinic for Pneumology and Infectiology, MHH: "Ventilator-associated pneumonia not only has a high mortality rate, it is also a general burden on the healthcare system due to increased antibiotic consumption, longer patient stays and higher treatment costs. The increasing antibiotic resistance of pathogens also makes new, non-antibiotic approaches urgently necessary. If the positive preliminary results of our study continue to be confirmed and the safety of cold physical plasma in the human lung is established, cold plasma has the potential to revolutionize the treatment of ventilated patients."

About Viromed Medical AG:

Viromed Medical AG has a broad customer base in the DACH region, including various DAX companies, e.g. Volkswagen and Lufthansa, as well as federal states and various federal ministries, 1,100 hospitals, 7,000 pharmacies, and 17,000 medical practices.

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