Consortium withdraws from G-BA trial study on cold plasma therapy

Greifswald/Berlin, September 30, 2025. The consortium of the three leading cold plasma therapy companies neoplas med GmbH (Greifswald), terraplasma medical GmbH (Munich) and Cinogy GmbH (Duderstadt) will not participate in the clinical trial “Cold Plasma Treatment for Chronic Wounds” (ER-21-002), initiated by the Federal Joint Committee (G-BA).

In September 2023, neoplas med GmbH, terraplasma medical GmbH, and Cinogy GmbH formed a consortium to conduct the G-BA trial. The consortium’s goal was to carry out the study under the scientific leadership of Professor Dr. Dr. Hans-Robert Metelmann (Chairman of the Board of the National Center for Plasma Medicine) and thereby establish the scientific and statistical basis for a G-BA benefit assessment.

The decision to withdraw was not taken lightly. The determining factor was the study framework, which does not ensure implementation of the agreed study protocol in its intended form. In particular, certain providers relevant to real-world care have been excluded from participation and the remuneration for providers set under the uniform value scale is, in the consortium’s view, insufficient to cover their actual effort.

“We share the G-BA’s assessment that cold plasma therapy has strong potential and we remain committed to generating additional evidence-based data through appropriate studies,” said Ulrike Sailer, Managing Director of neoplas med GmbH.

This view was echoed by Jens Kirsch, Managing Director of terraplasma medical GmbH and Benedikt Busse, Managing Director of Cinogy GmbH: „Our goal remains to improve care for patients with chronic wounds. However, under the current conditions, this goal cannot be achieved within the framework of the G-BA trial.”

“We would like to thank all partners who have constructively contributed to the process over the past months and hope to continue the dialogue at a later stage,” added Ulrike Sailer. The consortium partners are currently planning their own studies that will reflect all relevant forms of care and create a solid data basis for future assessment procedures.

About the Consortium

For many years, neoplas med GmbH, terraplasma medical GmbH, and Cinogy GmbH have been developing innovative solutions for the treatment of chronic wounds using physical cold plasma. With their technologies, they contribute to enhanced patient safety, improved quality of life and healthcare innovation in the German healthcare system.

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