kINPen® MED plasmajet, cold plasma, wound healing plasma medicine and medical device news 2020
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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
For the first time in a clinical study it was scientifically confirmed that physical cold plasma has a significantly positive effect on chronic wounds and leads to a faster healing of the diabetic foot syndrome. This was made possible by the close cooperation between physicians, scientists and entrepreneurs. Partners in the user-initiated study to improve patient wound care were the Herz- und Diabeteszentrum Nordrhein-Westphalen (HDZ NRW) in Bad Oeynhausen, the Herz- und Diabeteszentrum Karlsburg, the Leibniz Institute for Plasma Research and Technology e.V. (INP) and the Greifswald company neoplas med GmbH. The scientific results were recently published in the “Journal of the American Medical Association” (JAMA Network Open).
Picture: Participants of the press conference on September 1, 2020 in Karlsburg: Prof. Dr. Wolfgang Motz, Medical Director of the Klinikum Karlsburg; State Secretary Dr. Stephan Rudolph, Ministry of Economic Affairs M-V, PD Dr. Bernd Stratmann from HDZ NRW in Bad Oeynhausen; Prof. Dr. Kalus-Dieter Weltmann, Chairman of the Board and Scientific Director of INP, Prof. Dr. Diethelm Tschöpe, Director of the Diabetes Center at the HDZ NRW in Bad Oeynhausen; Prof. Dr. Wolgang Kerner, Director of the Karlsburg Diabetes Clinic and Ulrike Sailer, Managing Partner of neoplas med GmbH (from left to right)
Press release neoplas med GmbH
The world’s first placebo-controlled clinical trial proves the successful application of cold plasma jet kINPen® MED in diabetic foot ulcers: Reactivation and acceleration of wound healing scientifically confirmed
Greifswald/Bad Oeynhausen, July 22nd, 2020. Chronic wounds resulting from diabetic foot syndrome heal significantly faster if the standard therapy is complemented with atmospheric cold plasma treatments. This has now been successfully proved by scientists in the first placebo-controlled, randomised and patient-blinded clinical trial. The study device used was the kINPen® MED plasmajet of neoplas med, a joint development with the Leibniz Institute for Plasma Science and Technology e. V. (INP). The study results have now been published in the Journal of the American Medical Association (JAMA Network Open).[1]
Around 900,000 Germans suffer from chronic wounds, i.e. wounds that do not heal or show impaired wound healing.[2] One of the most frequent causes of chronic wounds is the diabetic foot ulcer (DFU). Diabetes or DFU account for 70 percent of all amputations performed in Germany every year.[3] Moreover, the treatment of chronic wounds results in high health care costs of around 10,000 EUR per year and patient.[4]
Case reports and laboratory tests have been suggesting for years that the application of cold atmospheric plasma (CAP) can stimulate the healing process of chronic wounds, supporting a faster wound closure. This effect has now been clinically demonstrated for the first time in a clinical trial performed by physicians and scientists at the Herz- und Diabeteszentrum NRW (HDZ NRW; University Hospital for the treatment of cardiac, vascular and diabetic diseases of the Ruhr University of Bochum, Bad Oeynhausen, Germany), and at the Klinikum Karlsburg (medical centre for cardiac and diabetic diseases, Karlsburg, Germany). This first-of-its-kind randomised, placebo-controlled and patient-blinded study investigated the treatment of 62 DFS wounds in 43 hospitalised patients with adjuvant cold plasma therapy. These DFS wounds had a severity of 1B and 2B in accordance with the Wagner Armstrong Classification, and had not shown any tendency to heal for a minimum of three weeks despite standard wound therapy in an outpatient setting.
The wounds were randomised into two groups of 31 wounds each (with patients with several wounds potentially being randomised both into the test and the control group). In the test group, the wounds were treated 8 times within the course of 14 days with cold plasma from the kINPen® MED plasmajet (30 seconds per cm² of wound surface), in addition to the standard wound therapy. The control group received a treatment with a simulated, inactive plasma (placebo). Primary study endpoints were the reduction of wound surface after 14 days of treatment and the reduction of the infection status and microbial load of the wounds. Secondary endpoints were e.g. the time to 10 % wound closure, the health-related quality of life and the safety and tolerability of the treatment.
Wound surface healing increased by 55 percent
After the 14 days of treatment the surface of the wounds treated with the cold plasma had reduced by an average of 69.5 percent. The average reduction in the placebo group was 44.8 percent. This means that the amount of wound surface closed under cold plasma treatment was 55 percent higher than the amount closed under the standard treatment alone. This is a statistically significant result (p=0.03). The plasma treatment was painless and well tolerated. None of the study patients experienced any plasma therapy related side effects throughout the course of the treatment. The patients will be kept under observation for five more years for an assessment of the long-term safety of the treatment.
[1] Stratmann B, Costea T-C, 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
[2] Abschlussbericht der Forschungsgruppe Primärmedizinische Versorgung (PMV): Epidemiologie und Versorgung von Patienten mit chronischen Wunden (Final report of the Primary Medical Care (PMV) research group: Epidemiology and Treatment of Patients with Chronic Wounds), 2016. Berlin, 2016. https://www.bvmed.de/download/pmv-zusammenfassung-der-ergebnisse
[3] Morbach S et al.: Diabetisches Fußsyndrom (Diabetic Foot Syndrome). Diabetologie 2017; 12 (Suppl 2): S181–S189 (DOI https://doi.org/10.1055/s-0043-115979)
[4] 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)
“With this study we were able for the first time to provide clinically controlled evidence that cold plasma actively promotes wound healing,” comments PD Dr. Bernd Stratmann, research director at the diabetes centre of the Herz- und Diabeteszentrum NRW and first author of the study. “This means that the results confirm previous insights from case studies. In contrast to the placebo group, the healing process was activated in all wounds treated with cold plasma (defined as a minimum reduction of the wound surface of 10 %). As a result, the cold plasma treatment led to accelerated wound healing and thus to faster wound closure compared to standard treatment alone.”
“The important study results of the kINPen® MED plasmajet represents a major milestone in the clinical development of cold plasma technology,” Ulrike Sailer, managing partner of neoplas med GmbH, is pleased to note. “Today, with its pinpoint plasma beam and controlled plasma quality, our kINPen® MED plasmajet already offers doctors and hospitals a precise and effective treatment of wounds, especially in the presence of recesses and cavities as frequently experienced in connection with the diabetic foot ulcer. We will continue our work on technological high-precision solutions – and thus on the future development of plasma medicine – together with our long-standing research partner INP, under the leadership of Prof. Dr. Klaus-Dieter Weltmann.”
Cold plasma effect activates wound healing
With regard to the end points “infection status” and “reduction of microbial load”, a bigger reduction was measured in the plasma group compared to placebo. However, the differences between the two groups were not statistically significant, as Prof. Dr. Dr. Diethelm Tschoepe, medical director of the diabetes centre of the Herz- und Diabeteszentrum NRW and principal study investigator illustrates: “All wounds were treated with the standard therapy, including wound disinfection and debridement prior to the plasma therapy, plus systemic antibiosis as required. This initial treatment regimen – applied in both groups – explains why it was not possible to demonstrate the statistically significant antimicrobial effect of cold plasma as proven in other studies.” The results support the findings of many scientific INP publications. According to PD Dr. Stratmann’s interpretation of the study results, “atmospheric cold plasma has its own individual effect that activates wound healing. This effect cannot be explained by the antimicrobial effect of the plasma alone.”
Shorter hospitalisation periods for DFS patients
The study investigated patients in an inpatient setup. Patients are usually hospitalised for the treatment of DFU if the wounds do not heal despite standard treatment under everyday life conditions. However, every hospitalisation also involves increased treatment costs and considerable limitations for the patients. According to Prof. Dr. Dr. Diethelm Tschoepe, “faster wound healing potentially leads to an earlier discharge of patients from the hospital. As a result, cold plasma treatments may not only benefit future patients, but they may also have an added economic relevance for the health system.”
Study references:
Bernd Stratmann, PhD; Tania-Cristina Costea, MD; Catharina Nolte, MD; Jonas Hiller, MD; Jörn Schmidt, MD; Jörg Reindel, MD; Kai Masur, PhD; Wolfgang Motz, MD; Jürgen Timm, MD; Wolfgang Kerner, MD, Diethelm Tschoepe, MD: Effect of Cold Atmospheric Plasma Therapy vs Standard Therapy Placebo on Wound Healing in Patients With Diabetic Foot Ulcers. JAMA Network Open; 2020;3(7):e2010411. DOI: 10.1001/jamanetworkopen.2020.10411
[1] Stratmann B, Costea T-C, 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
[2] Abschlussbericht der Forschungsgruppe Primärmedizinische Versorgung (PMV): Epidemiologie und Versorgung von Patienten mit chronischen Wunden (Final report of the Primary Medical Care (PMV) research group: Epidemiology and Treatment of Patients with Chronic Wounds), 2016. Berlin, 2016. https://www.bvmed.de/download/pmv-zusammenfassung-der-ergebnisse
[3] Morbach S et al.: Diabetisches Fußsyndrom (Diabetic Foot Syndrome). Diabetologie 2017; 12 (Suppl 2): S181–S189 (DOI https://doi.org/10.1055/s-0043-115979)
[4] 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)
With the title “Greifswald: Vorreiter in Forschung und Medizin”, the ZDF morning magazine showed how our kINPen ® MED helps to relieve patients and improve their quality of life.
