- neoplas med GmbH
Wound treatment with cold plasma: neoplas med achieves milestone for future reimbursement
Greifswald/Berlin, July 27, 2021. The Federal Joint Committee (G-BA) acknowledges the potential for the use of cold plasma for the treatment of chronic wounds for a medically relevant treatment innovation. The G-BA thus paves the way for an evaluation trial of cold plasma therapy for the treatment of chronic wounds and – if successful – the inclusion of cold plasma therapy in the benefits catalogue of the statutory health insurances (GKV). The evaluation procedure was initiated by neoplas med. In its decision, the G-BA refers to the promising results of clinical studies which were mainly performed with the cold plasma jet kINPen® MED from neoplas med GmbH.
In April 2021, neoplas med applied to the G-BA for the evaluation of the cold plasma treatment method for chronic wounds with the cold plasma jet kINPen® MED. The application is mainly based on the world’s first clinical trial published on cold plasma therapy for the diabetic foot syndrome and a large number of clinical results. These demonstrate a triple mechanism of action for the application of the cold plasma jet: Decontamination, enhancement of the micro-circulation and a stimulation of cell growth, which may accelerate wound healing.
With its decision of July 15, 2021, the G-BA now confirmed that the new method offers sufficient potential as a treatment innovation for a trial study. In its explanation for the decision, the Committee confirms that the method “…is based on a scientifically conclusive concept that justifies the systematic application of the method in patients with chronic wounds”.
However, before new medical treatment methods can be applied and refunded for all insured persons under statutory standard care, they first have to supply proof of their medical benefit. For this purpose, the Federal Joint Committee – the highest decision-making body of the self-administration in the German health system – reviews whether the results from clinical trials sufficiently support the additional benefit of the method, and whether the new method thus shows potential as a possible treatment innovation. If there is an indication of potential, the G-BA may initiate a trial study and decide about the inclusion in the GKV service catalogue on its basis.
About 900,000 German patients suffer from chronic wounds (i.e. wounds that heal badly or not at all) every year1, resulting in average costs of 10,000 EUR per year and patient for the German health system.2 ”We are very excited that the G-BA has recognised the potential of our cold plasma jet technology,” comments Ulrike Sailer, managing partner of neoplas med. “This result confirms us as market leaders in our pioneering work to make the benefits of our precision technology accessible to all patients in Germany.”
“Because the everyday healthcare in practices and hospitals shows that the contact-free and precise application of the cold plasma jet technology offers unique advantages that other cold plasma applications do not provide: a contact-free, pinpoint plasma application under continuous visual control which is especially suitable for uneven wound surfaces. This plasma is unlike other plasmas – the kINPen® MED generates the plasma from the gas argon. This gas has specific properties that ensure a continuous controlled plasma composition and thus a consistent treatment quality.
In the next step we will plan and implement an official trial study in coordination with the G-BA. Furthermore, we will drive the clinical development of the cold plasma jet technology in additional studies – both in wound care and other potential application areas,” explains Ulrike Sailer.
Accelerated wound healing also offers benefits for the health system
The presently available study results were decisive for the positive decision. Within this context, the
G-BA mainly based its decision on the first placebo-controlled study of cold plasma application worldwide as performed by the hospitals of Bad Oeynhausen and Karlsburg in cooperation with neoplas med. This study proved the activation and acceleration of the healing of chronic diabetic foot wounds under treatment with the cold plasma jet kINPen® MED in comparison with the standard therapy plus placebo. “The extent of wound surface closed was on average 55 per cent larger under cold plasma treatment than under the standard treatment alone. The healing process was activated in all wounds treated with cold plasma,” explains Univ. Prof. Dr. med. Dr. h.c. Diethelm Tschöpe, medical director of the diabetes centre at the Heart and Diabetes Centre of the German federal state of North Rhine-Westfalia, of the University Clinic of the Ruhr-Universität Bochum, the principal investigator of the study.
“Faster wound leading may potentially lead to an earlier discharge of patients from the hospital. Consequently, cold plasma treatments may in future not only be of benefit for the patients, they also have relevance for health economics,” Tschöpe adds. The study results were published in the summer of 2020 in the renowned Journal of the American Medical Association (JAMA).3
First cold plasma therapy guideline before the end of this year
The publication of the first treatment guideline for the “rational application of cold physical plasma” is expected before the end of this year.4 “The G-BA has defined very broad terms for the decision that include all chronic skin wounds that show no healing tendencies under standard treatment. This means the decision is in line with the world’s first treatment guideline for the therapeutic application of cold plasma which is currently under development,” states Univ. Prof. Dr. med. Dr. med. dent. Hans-Robert Metelmann (University Hospital of Greifswald, Germany, coordinator of the preparation of the cold plasma treatment guideline). And, as the founding chairman of the National Centre for Plasma Medicine adds, “many colleagues from all disciplines, who are already achieving successful medical wound treatments with their plasma jet devices on a daily basis, and whose scientific expert associations took part in the development of the guidelines with their renowned representatives are waiting for its completion.” An especially important aspect for day-to-day healthcare in medical practices and hospitals is probably going to be the already agreed-upon recommendation of the body of experts that the application on the patient may also be performed by accordingly trained medical care staff under the supervision of doctors.
Trial study to be followed by final decision about inclusion in benefits catalogue
Parallel to the recognition of the potential of the cold plasma application in wound therapy, the G-BA has initiated a procedure for the preparation of a so-called trial guideline.5 Considering the legal time limits and procedures, the decision of the G-BA on a trial guideline may be expected for 2022. This guideline will define the exact criteria, clinical endpoints and quality requirements for the trial. Based on the results of the trial study, the G-BA will make a final decision about the inclusion of the cold plasma therapy in the service catalogue of the statutory health insurance. Irrespective of this procedure, an increasing number of clinics and wound care centres is already offering a treatment with the cold plasma jet kINPen® MED to their patients with complicated chronic and germ-infested wounds today.
References
1) Final report of the PMV research group (interdisciplinary, scientific team at the medical faculty of the University of Cologne): Epidemiologie und Versorgung von Patienten mit chronischen Wunden [Epidemiology and healthcare of patients with chronic wounds], 2016. Berlin, 2016. https://www.bvmed.de/download/pmv-zusammenfassung-der-ergebnisse
2) Purwins S et al.: Cost‐of‐illness of chronic leg ulcers in Germany. Int Wound J. 2010 Apr;7(2):97-102 (DOI: https://doi.org/10.1111/j.1742-481x.2010.00660.x)
3) Stratmann B, Costea T, Nolte C, et al. Effect of Cold Atmospheric Plasma Therapy vs Standard Therapy Placebo on Wound Healing in Patients With Diabetic Foot Ulcers: A Randomized Clinical Trial. JAMA Network Open. 2020;3(7):e2010411. doi:10.1001/jamanetworkopen.2020.10411, Link: https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2768340
4) Association of the Scientific Medical Societies in Germany (Arbeitsgemeinschaft der Wissenschaftlichen Medizinischen Fachgesellschaften e.V. – AWMF): Rationaler therapeutischer Einsatz von kaltem physikalischem Plasma.[Rational therapeutic application of cold physical plasma.] Link: https://www.awmf.org/leitlinien/detail/anmeldung/1/ll/007-107.html
5) Federal Joint Committee. Beschluss über einen Antrag auf Erprobung gemäß § 137e Absatz 7 SGB V [Decision on an application for a trial in accordance with § 137e section 7 SGB V ]: Cold plasma treatment of chronic wounds. July 15, 2021. Link: https://www.g-ba.de/downloads/39-261-4939/2021-07-15_Antrag-Kaltplasma-chron-Wunden.pdf
About neoplas med GmbH
neoplas med GmbH was founded in 2009 as a spin-off of the Leibniz Institute for Plasma Science and Technology e. V. (INP) in Greifswald. Ulrike Sailer has been the company’s managing partner since the end of 2019. The aspiring company develops products for medical applications on the basis of plasma medicine research. The first milestone is the CE-marked atmospheric pressure kINPen® MED plasma jet, which is the first plasma jet worldwide that is approved for the treatment of chronic wounds and pathogen-induced skin conditions and sold internationally. It is the result of a longstanding scientific cooperation the INP institute, the medical university of Greifswald, the Charité medical university of Berlin and various industrial partners
About kINPen® MED
The plasma jet kINPen® MED is the world’s first CE-marked atmospheric pressure plasma jet with a medical device approval for the treatment of chronic wounds and pathogen-induced skin conditions. The plasma jet applies a physical cold plasma with a temperature of <40 degrees to the wound in a pinpoint and contact-free manner. Even surfaces with a more pronounced structure, recesses and cavities can be reached easily and treated evenly. The inert gas argon that is used for the generation of the plasma provides for a controlled atmosphere around generated plasma beam and thus ensures a high and consistent treatment quality.
Press contact
Claudia Kerber
Telephone: +49 (0)3834 515 201
Mobile: + 49 (0)162 23 770 70
claudia.kerber@neoplas-med.eu