Breaking: Cold Plasma Therapy Study Suspended – Manufacturers Raise Concerns Over Study Design
Greifswald, Germany – January 10, 2025 – 16:14 In a significant development for the field of advanced wound care, a consortium of leading cold plasma therapy manufacturers has announced its withdrawal from a crucial testing study initiated by the German Federal Committee (G-BA). This unexpected halt to the “Cold Plas Care for Chronic Wounds” (ER-23-002) study raises questions about the path to wider adoption of this promising technology.
Study Suspension: A Consortium’s Concerns
Neoplas Med GmbH (Greifswald), Terraplasma Medical GmbH (Munich), and Cinogy GmbH (Duderstadt) formed a collaborative effort in September 2023 specifically to support the G-BA’s evaluation of cold plasma therapy. The study, under the scientific leadership of Prof. Dr. Dr. Hans-Robert Metelmann of the National Center for Plasma Medicine, aimed to provide the robust scientific and statistical data needed for a formal benefit assessment by the G-BA. However, the consortium has now determined that the study’s current framework prevents a meaningful and accurate evaluation.
According to a joint statement, the primary issue lies with limitations in the study’s design. Specifically, the consortium argues that the exclusion of real-world care providers and inadequate remuneration for their participation will compromise the study’s validity. “The framework conditions do not guarantee implementation of the agreed study protocol in the intended form,” the companies explained. This means the results may not accurately reflect how cold plasma therapy performs in typical clinical settings.
What is Cold Plasma Therapy and Why Does it Matter?
Cold plasma therapy, also known as plasma medicine, is an emerging field utilizing ionized gases (plasma) to promote healing. Unlike traditional thermal plasma, cold plasma operates at temperatures compatible with living tissue. It’s showing remarkable promise in treating a variety of conditions, particularly chronic wounds like diabetic ulcers, pressure sores, and surgical wounds that have resisted conventional treatments. The therapy works by stimulating cellular activity, fighting infection, and promoting tissue regeneration. It’s a non-invasive approach that could significantly improve the quality of life for millions suffering from chronic wounds globally.
Charting a New Course: Independent Studies Planned
Despite withdrawing from the G-BA study, the consortium remains committed to advancing the field. “In accordance with the classification of the G-BA, we are convinced of the potential of cold plasma therapy,” stated Ulrike Sailer, Managing Director of Neoplas Med GmbH. The companies are now focusing on independently funded studies designed to more accurately reflect real-world clinical practice.
Jens Kirsch, Managing Director of Terraplasma Medical GmbH, and Benedikt Busse, Managing Director of Cinogy GmbH, echoed this sentiment, emphasizing their dedication to improving patient care. “Our goal remains to improve the care of patients with chronic wounds. But under the current conditions we cannot achieve this goal as part of the test study.”
Implications for Patients and the Healthcare Landscape
This development could potentially delay the widespread availability of cold plasma therapy as a reimbursed treatment option in Germany. The G-BA’s assessment is crucial for securing coverage by health insurance providers. However, the consortium’s decision underscores the importance of rigorous, realistic study designs in evaluating innovative medical technologies. The planned independent studies will be closely watched by healthcare professionals and patients alike, as they could provide the definitive evidence needed to unlock the full potential of cold plasma therapy.
The consortium expressed gratitude to its partners and hopes to re-engage in dialogue with the G-BA in the future. For now, the focus shifts to building a more comprehensive and reliable data foundation through their own research initiatives. This situation highlights the ongoing challenges in bringing cutting-edge medical treatments to market and the critical need for collaboration between industry, researchers, and regulatory bodies.
Press Contact: Michael Behrens, +49 173 3473934, [email protected] (Himmelschreiber GmbH Agency)
Stay tuned to archyde.com for further updates on this developing story and the latest advancements in medical technology. Explore our health section for more in-depth coverage of innovative treatments and healthcare news.
