News about the company and the plasma care®
July 5, 2019
plasma care® product video by ELLIPSA medical services GmbH
ELLIPSA medical services just released a fascinating product video of our plasma care, showing how easy it is to use the plasma care in the treatment of chronic wounds!
July 15, 2019
plasma care® – An Update
One of the burning questions in plasma medicine is “how does plasma work, is it safe and how is it produced?”. I realize that these are three questions – but they always come as a package when people speak to me.
As one of the initiators of the field of “plasma medicine” and as a former director at the Max Planck Institute for extraterrestrial Physics, who was at that time responsible for cold plasma research, I can answer these questions, but only of course for the research and development carried out by myself and my team.
But before I do this, I should like to express my gratitude to my research team, and in particular to the Max Planck Society which financed my plasma medicine research with about 6 Million Euros over a period of 8 years. Many highly cited scientific publications are our reward, as well as the knowledge that we are able to help sufferers from chronic wounds and skin diseases by means of a new benign technology that is touch-free as well as proven effective.
Our research and development strategy has always been:
- For specific applications, the plasma has to be “designed” accordingly – both for efficiency and safety.
- This can be achieved in different ways – and with differently produced plasmas – provided the basic research and know-how for plasma physics and plasma chemistry exists and is applied.
- For instance, the three goals in cold plasma wound care are:
- to design the plasma to produce, as closely as possible, the same reactive species that our own immune system produces when it is fighting infections,
- to produce reactive species that promote wound healing,
- to achieve this within a safe therapeutic window.
- In our research we found that Surface Micro-Discharge (SMD) plasmas can produce these species directly in air – and that the plasma can be “designed” and optimized for medical applications.
- Needless to say, the Micro-Discharge plasma sources are amongst the most intensively researched worldwide. For instance, in cooperation between my Max Planck Team and the University of California, Berkeley, we spent many years studying the SMD plasma physics and chemistry (including over 600 plasma-air chemical interactions) both theoretically and experimentally in order to optimize different functionalities.
All of this know-how entered into the design of the plasma care® plasma source – not only to ensure an efficient functionality in wound care, but also to ensure safety – both for the patients and nursing staff.
But Plasma Physics and Chemistry, whilst being a necessary prerequisite for the development, is not enough for a medical product.
Extensive tests are required for certification. The plasma care® has successfully passed all pre-clinical tests and has obtained CE mark approval. A prospective, randomised, placebo-controlled, multi-center medical device trial has been initiated in June, supervised by terraplasma medical (with support from a CRO).
It is a no-brainer when I say that only technologically advanced and medically tested and verified plasma devices should be employed in therapy. I hope with the extensive research and careful development, attending to many details of operation, hygiene and safety, the plasma care® will help sufferers of chronic wounds towards a better life.
Prof. Dr. Dr. h.c. Gregor Morfill
Emeritus, Max Planck Institute for Extraterrestrial Physics
Director, terraplasma GmbH
CE mark approval for the plasma care®
terraplasma medical GmbH has successfully completed the CE conformity assessment procedure for the plasma care®. In June all necessary certificates were issued to terraplasma medical GmbH from TÜV Rheinland (notified body). The plasma care® – which can now be marketed in the European Union – is a portable medical device for wound care using cold atmospheric plasma. As a professional device, the plasma care® can now be used by medical experts for the treatment of acute and chronic wounds.
The plasma care® is a handheld and portable medical device. It generates cold atmospheric plasma directly from the surrounding air by means of micro-discharges. Cold atmospheric plasma is a partially ionized gas, which causes localized and temporary formation of micropores with a diameter of few nanometers in the cell membrane. This results from physical as well as chemical processes. Reactive oxygen and nitrogen species such as nitrogen dioxide, hydrogen peroxide and ozone – produced by the plasma – enter the cell via these micropores. In prokaryotic cells (bacteria) the reactive species then react with the free DNA in these microorganisms and inactivate them by inducing DNA oxidation and double-strand breaks. Antibiotic and other resistances (as for example in the case of MRSA) do not have any influence on this mechanism of inactivation and do not impair this. Human eukaryotic cells on the other hand are not harmed by the effects of temporarily applied cold atmospheric plasma, as their DNA is additionally protected by the nuclear membrane. Moreover, cell-biological repair mechanisms provide additional protection (for example the regulation of the cellular redox-balance).
With the development of the plasma care® terraplasma medical GmbH successfully managed to integrate the complex plasma technology into a small, portable and battery-operated handheld device. The plasma care® uses an indirect plasma source based on the SMD (Surface Micro Discharge) technology (patent pending), which guarantees that no current flows through the patient. The plasma care® was developed in such a way that it significantly reduces the bacterial load in in-patient and out-patient wound care settings, especially in infected wounds which are difficult to heal, and even in the case of infections with multi-resistant pathogens. For this purpose, the plasma care® in combination with a spacer (sterile disposable) is placed onto the wound. By touching the capacitive (touch) start button the plasma production is activated and the generated reactive plasma species are transported to the wound surface without any additional flow, i.e. by pure diffusion.