We will be holding our exclusive online event on June 28, 2022 from 6:00pm – 7:15pm and look forward to your participation.

You are welcome to register here.

As of today, we are at the Diabetes Congress in Berlin. At booth 17 we will present our cold plasma jet and its possible applications. Please feel free to visit us.

On 27.05.22, starting at 12:30 in room R3, our symposium with PD Dr. Bernd Stratmann, Diabeteszentrum NRW – Universitätsklinik der Ruhr-Universität Bochum, will take place with the title “Cold plasma jet therapy in the treatment of chronic wounds – results from the clinical study on diabetic foot syndrome and analysis of mechanistic/biochemical correlations”.

 

What an exciting first day at the German Wound Congress in Bremen: We had many interested visitors at our booth who learned about our innovative precision technology in wound healing – the Plasmajet kINPen® MED.

We would like to thank PD Dr. Bernd Stratmann from the Diabetes Center NRW, University Hospital of the Ruhr University Bochum, for his informative lecture and the many listeners for their willingness to be shown the new possibilities of effective wound management with our cold plasma jet.

We will be at booth C03 for you today from 8:30 am to 6 pm and tomorrow from 9 am to 4 pm and look forward to great discussions.

 

Every week, “WirtschaftsWoche” presents a special medium-sized company and the people behind it who have succeeded in mastering a challenge creatively, cleverly and courageously.

This time, we were featured in WiWo’s “Heroes of the  medium-sized businesses” section. We are very happy about this honor and pass on a big thank you to our customers and partners.

Comparative clinical trial shows significant improvement in wound closure and infection control based on treatment with the plasmajet kINPen® MED from neoplas med compared to best practice wound care – cost-effectiveness analysis proves high cost-savings by innovative technology

Greifswald/Feldkirch, March 10, 2022. The results of a randomized controlled trial (RTC) may offer new opportunities for the approximately two million patients with chronic wounds solely in Germany: The innovative cold atmospheric plasmajet (CAP-jet) technology showed significantly more healing progress in chronic wounds in comparison to best practice (BP) modern wound care at two study centers. Within six weeks, 59 percent of all wounds healed completely under cold plasma treatment compared to only 5.1 percent in patients under BP therapy. Time to complete healing was also considerably shorter under CAP-jet treatment, and wound infections were overcome statistically significant more rapid. With a very good tolerability profile, an economic analysis of the study data also showed a cost saving of 65 percent for the dressing material alone compared to the BP group. The study data were recently published in the journal Nature Scientific Reports.

Acceleration of wound healing and wound closure proven

In the study conducted by Prim. Univ.-Professor Robert Strohal, head of the Department of Dermatology and Venereology at the Federal Academic Teaching Hospital Feldkirch, the cold plasma procedure of the Greifswald-based company neoplas med GmbH was scientifically examined in wound care. For this purpose, he compared treatment with the CAP-jet kINPen® MED at the Austrian Federal Academic Teaching Hospitals Feldkirch and Bregenz with current best practice treatment in 78 patients with infected and non-infected wounds. ‘This study was the first to investigate the exclusive effect of tissue accessible cold plasma on wound healing and infection control without the use of an additional standard therapy,’ said Prim. Univ.-Prof. Strohal.

After treatment with the CAP-jet, the proportion of healthy tissue increased significantly faster than under the BP treatment and the wounds under CAP-jet therapy also healed significantly faster. At the end of the study, the wound area in the CAP group had reduced by 94.7 percent compared to the baseline value, in the comparison group it was only 56.3 percent. CAP also proved superior in terms of infection control. In contrast to BP therapy, all wounds infected at the start of the study showed complete resolution of infection signs. In addition, the signs of infection disappeared significantly faster under cold plasmajet therapy.

Patients’ quality of life can improve

Ulrike Sailer, CEO of the company neoplas med GmbH in Greifswald/Germany, explained: ‘The Joint Federal Committee (Gemeinsamer Bundesausschuss, G-BA) as the central decision-making body of the German health care system already recognized last year the potential of cold plasma for the innovative treatment of chronic wounds at our request. Therefore, the G-BA decided to carry out an observational trial for testing with the aim of obtaining health insurance approval. The results of the clinical trial that now have been published clearly demonstrate the superiority of the CAP-jet kINPen® MED compared to BP wound care. These results provide further evidence for the high clinical relevance of the CAP-jet precision technology. At the same time, it represents important news for millions of people who suffer from chronic wounds for years.’

Chronic wounds are often associated with high morbidity and considerable impairments in everyday life as well as the patients’ psyche. Faster wound healing and thus a shorter therapy duration by using the plasmajet kINPen® MED can therefore significantly improve the patients’ quality of life. Furthermore, a lower burden by pain during treatment can be observed, and a reduced number of dressing changes can be assumed. Patients confirmed the very good tolerability and even described the treatment as pleasant in the majority of cases.

Significant advantage in treatment costs

A cost-effectiveness analysis based on the available study data showed that 21.4 percent fewer physician visits and 34.3 percent fewer dressing changes were necessary in the CAP-jet group compared to BP. The savings alone in dressing material resulted in a cost advantage for CAP-jet therapy of 64.7 percent compared to BP. Previously, average costs of 10,000 € per patient and year were assumed. Ulrike Sailer: ‘Thus, the cold plasmajet kINPen® MED offers not only a more efficient and tolerable technology, but also opens up the opportunity for significantly higher cost-effectiveness in the treatment of chronic wounds.’

Background Information:

The study included 78 patients with wounds up to 10 x 20 cm in size and existing for at least 6 weeks. The patients were randomized in a 1:1 ratio into two groups and treated for the study duration of 6 weeks either with the CAP-jet kINPen® MED (30 seconds per cm² wound area) or suitable wound dressings according to BP wound care. Only one wound per patient was evaluated.

With regard to the treatment regime, CAP-jet therapy was administered 3 times in the 1^st week in the CAP group, 2 times in the 2^nd week and once a week in the following observation period; furthermore, the wounds were covered with gauze and a secondary dressing. In contrast, the BP group was treated with a wound phase-adapted dressing; infected wounds were additionally cleaned with an antiseptic. In both groups, patients with venous ulcers received compression therapy. The primary endpoint of the study was the amount of granulation tissue at the end of the study. In addition, cold plasma effects on wound infection, wound area, healing time, wound pH and exudate volume (wound fluid) as well as local tolerability were investigated.

Improvement in wound infection: All 13 wounds infected at baseline in the CAP-jet group showed complete resolution of infection signs without the need for additional antiseptics. In contrast, 4 of the 18 wounds infected at baseline in the BP group showed no improvement despite the use of antiseptics. Furthermore, the signs of infection decreased significantly faster under CAP-jet therapy compared to BP therapy. These data confirm the previously published evidence on the good antimicrobial efficacy of CAP.

Cold plasma is a gas containing ionized atoms, ions and electrons that has been shown to disinfect wounds and activate the wound healing process. With its fine jet, the plasmajet kINPen® MED enables highly precise treatment in anatomically and pathologically challenging areas under visual control and without touching, which is not possible with other wound therapies.

Study reference:

Robert Strohal, MD, Sandra Dietrich, DGKS, Martina Mittlböck, MD, Gilbert Hämmerle, DGKS: Chronic wounds treated with cold atmospheric plasmajet versus best practice wound dressings: a multicenter, randomized, non-inferiority trial. Scientific Reports (2022)12:3645; DOI: 10.1038/s41598-022-07333-x.

Download here

Literature:

Martinengo L et al.: Prevalence of chronic wounds in the general population: systematic review and meta-analysis of observational studies. Annals of epidemiology 2019; 29, 8-15, DOI:10.1016/j.annepidem.2018.10.005.

Agale SV: Chronic leg ulcers: epidemiology, etiopathogenesis, and management. Ulcers 2013, 413604, DOI:10.1155/2013/413604.

Vishwanath V: Quality of life: Venous leg ulcers. Indian Dermatol. Online J. 2014, 5, 397–399. Doi:10.4103/2229-5178.137828.

Green J et al.: A. Chronic venous leg ulcer care: Are we missing a vital piece of the jigsaw? Wounds UK 2017, 13, 32-40.

We are delighted to welcome you at WUWHS – World Union of Wound Healing Societies – from March 1 to 5, 2022 in Abu Dhabi at our booth no. H5-68.

You are interested in a new era of wound care?
Then join our workshops “LEAP INNOVATION COLD PLASMA JET kINPen® MED – PHYSICAL PLASMA TO ACCELERATE WOUND HEALING” in Abu Dhabi at the following slots:

March 3rd, 2022
11.00 am – 12.30 pm
03.00 pm – 04.30 pm
06.00 pm – 08.00 pm

March 4th, 2022
09.00 am – 10.30 am
11.30 am – 01.00 pm

Please register at contact@neoplas-med.eu and let us know your name, your company’s email address and your preferred date. We will check your registration and send you a confirmation of the date.
Please note: The number of places is limited.

We are delighted to welcome you at WUWHS – World Union of Wound Healing Congress from March 1 to 5, 2022 in Abu Dhabi to present our leap innovation, the cold plasma jet kINPen^® MED, to accelerate wound healing. We are looking forward to meeting you at our booth no. H5-68.

In exclusive workshops we will demonstrate our disruptive technology in action – the cold plasma jet kINPen^® MED – together with our 3 clinical experts. You will find our session dates here shortly.

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 release

Press contact
Claudia Kerber
Telephone: +49 (0)3834 515 201
Mobile: + 49 (0)162 23 770 70
claudia.kerber@neoplas-med.eu