Periodic Reporting for period 2 - PLASOMA (Cold plasma cures chronic wounds: a sparkling solution)
Berichtszeitraum: 2022-03-01 bis 2023-12-31
In Europe, more than 3 million people suffer from hard-to-heal wounds. These cause pain, lead to amputations and loss of independence, and are very costly. 25% of these wounds cannot be cured with any treatment and may persist for years. At Plasmacure we envision a world in which people no longer suffer from chronic wounds. Cold plasma – a gas that has been ionised - can stimulate wound healing*. Plasmacure has developed a safe way to apply cold plasma directly in a wound: PLASOMA, a medical device for wound healing stimulation with cold plasma. Groundbreaking PLASOMA is CE-certified and is available on the EU market. A series of case studies was conducted on 20 wounds with very promising results: wound closure in 60% of the chronic wounds, with a mean age of 457 days, in on average 7 weeks treatment time.**
PLASOMA consists of disposable cold plasma pads and a cold plasma pulser. The pad is put on the wound and connected to the pulser that sends energy to the pad to create cold plasma. PLASOMA treatment perfectly fits in current wound care practices because it is additional to standard treatment. Moreover, PLASOMA is made suitable for home use, where 80% of the patients are treated. PLASOMA increases quality of life, relieves the healthcare workload and reduces antibiotics use. When all hard-to-heal wounds would be treated with PLASOMA, EU healthcare costs will decrease with > € 6 billion/yr.
Application of cold plasma for medical treatments in general, and for treatment of chronic wounds specifically, is still in its infancy and clinical evidence is still limited. With the H2020 grant, a clinical study for the generation of the clinical evidence that PLASOMA can cure chronic wounds is conducted. Clinical evidence is a prerequisite to get reimbursement and for incorporation of PLASOMA cold plasma treatment in the guidelines.
The grant also provides the resources to extend the current application area of PLASOMA to home use and treatment of wider range of sizes and shapes of wounds in order to cover all chronic wounds.
To accelerate implementation of PLASOMA in clinical practice, awareness is created amongst stakeholders about the added value of PLASOMA, the p
rogress made, market launch etc. through dissemination activities targeting stakeholders and through two-way communication with the general public and health care providers.
* Source: https://www.plasmacure.nl/en/whitepaper/(öffnet in neuem Fenster)
** Source: https://www.plasmacure.nl/en/case-studies/results-20-case-studies/(öffnet in neuem Fenster)
PLASOMA consists of disposable cold plasma pads and a cold plasma pulser. The pad is put on the wound and connected to the pulser that sends energy to the pad to create cold plasma. PLASOMA treatment perfectly fits in current wound care practices because it is additional to standard treatment. Moreover, PLASOMA is made suitable for home use, where 80% of the patients are treated. PLASOMA increases quality of life, relieves the healthcare workload and reduces antibiotics use. When all hard-to-heal wounds would be treated with PLASOMA, EU healthcare costs will decrease with > € 6 billion/yr.
Application of cold plasma for medical treatments in general, and for treatment of chronic wounds specifically, is still in its infancy and clinical evidence is still limited. With the H2020 grant, a clinical study for the generation of the clinical evidence that PLASOMA can cure chronic wounds is conducted. Clinical evidence is a prerequisite to get reimbursement and for incorporation of PLASOMA cold plasma treatment in the guidelines.
The grant also provides the resources to extend the current application area of PLASOMA to home use and treatment of wider range of sizes and shapes of wounds in order to cover all chronic wounds.
To accelerate implementation of PLASOMA in clinical practice, awareness is created amongst stakeholders about the added value of PLASOMA, the p
rogress made, market launch etc. through dissemination activities targeting stakeholders and through two-way communication with the general public and health care providers.
* Source: https://www.plasmacure.nl/en/whitepaper/(öffnet in neuem Fenster)
** Source: https://www.plasmacure.nl/en/case-studies/results-20-case-studies/(öffnet in neuem Fenster)
Multi-arm, phase three clinical trial
A multi-center three-arm phase 3 clinical study is running that will include in total hundreds of patients suffering from non-healing wounds. One study arm will receive standard care with wound dressings, a second and third arm will receive standard care in combination with PLASOMA treatment once and twice per week.
All preparatory activities are completed. The clinical research associates and application specialists are recruited, the study protocol has been finalized and approved by the METC- and national authorities, and all PLASOMA systems to execute the trial are in place, including a digital app to assess the wound characteristics. The study is published at www.clinicaltrials.gov. The sites have been trained on the use of PLASOMA, on how to include patients and on how to collect the data correctly. Despite delays and set-backs due to covid-19 the study is running well and inclusion rates are ramping up. It’s too early though to tap results from this study yet.
PLASOMA suitable for treatment of large wounds and for home use
The next generation PLASOMA system is under development to make it applicable for use at home and for a wider range of wound sizes and shapes. Plasmacure solved various technical challenges along the road. Larger cold plasma pads are prepared and prototyped. The cold plasma pulser is adapted for that, as well for the use case at home.
Dissemination and communication
Multiple channels are used to disseminate and communicate our story and results. Via the website, via publications in wound care magazines and via the social media, various press releases, blogs, case studies, whitepapers and articles for non-specialists and specialists are published. Recently, a scientific publication about the first clinical results was published in the leading Journal of Wound Care.
Through online and real-life conferences Plasmacure reaches out to the leading key opinion leaders in Europe. National patient organizations and insurance companies are contacted and willing to support PLASOMA.
Various videos have been made to explain the wound healing and treatments for chronic wounds with plasma treatment to patients and professionals. Also, the impact of chronic wounds on the quality of life and promising results of PLASOMA are discussed. Plasmacure was featured prime time on Dutch national television for the general public, resulting in a high response from patients and professionals.
A multi-center three-arm phase 3 clinical study is running that will include in total hundreds of patients suffering from non-healing wounds. One study arm will receive standard care with wound dressings, a second and third arm will receive standard care in combination with PLASOMA treatment once and twice per week.
All preparatory activities are completed. The clinical research associates and application specialists are recruited, the study protocol has been finalized and approved by the METC- and national authorities, and all PLASOMA systems to execute the trial are in place, including a digital app to assess the wound characteristics. The study is published at www.clinicaltrials.gov. The sites have been trained on the use of PLASOMA, on how to include patients and on how to collect the data correctly. Despite delays and set-backs due to covid-19 the study is running well and inclusion rates are ramping up. It’s too early though to tap results from this study yet.
PLASOMA suitable for treatment of large wounds and for home use
The next generation PLASOMA system is under development to make it applicable for use at home and for a wider range of wound sizes and shapes. Plasmacure solved various technical challenges along the road. Larger cold plasma pads are prepared and prototyped. The cold plasma pulser is adapted for that, as well for the use case at home.
Dissemination and communication
Multiple channels are used to disseminate and communicate our story and results. Via the website, via publications in wound care magazines and via the social media, various press releases, blogs, case studies, whitepapers and articles for non-specialists and specialists are published. Recently, a scientific publication about the first clinical results was published in the leading Journal of Wound Care.
Through online and real-life conferences Plasmacure reaches out to the leading key opinion leaders in Europe. National patient organizations and insurance companies are contacted and willing to support PLASOMA.
Various videos have been made to explain the wound healing and treatments for chronic wounds with plasma treatment to patients and professionals. Also, the impact of chronic wounds on the quality of life and promising results of PLASOMA are discussed. Plasmacure was featured prime time on Dutch national television for the general public, resulting in a high response from patients and professionals.
The preliminary results on wound closure show a positive effect in 60% of chronic wounds after treatment with PLASOMA. These results are very good and positions PLASOMA in the premier league. Two anecdotical examples clearly show that PLASOMA is a game changer: In one casus PLASOMA showed complete wound healing in 11 weeks for a patient that was unsuccessfully treated for three years with all available advanced wound care therapies. Another patient was about to have a foot amputated due to infection of the whole foot. The infection disappeared and the wound closed after only five weeks of PLASOMA treatment. If this can be applied on a larger scale a lot of suffering and loss of productivity and quality of life will be prevented. High costs for prolonged treatment will be saved and a lot of time of scarce wound care specialists will be saved.