A small, portable cold plasma device for the treatment of chronic and acute wounds.

Información del proyecto

plasmaCare

Identificador del acuerdo de subvención: 816023

DOI

10.3030/816023

Proyecto cerrado

Fecha de la firma de la CE 20 Junio 2018

Fecha de inicio 1 Julio 2018

Fecha de finalización 31 Octubre 2018

Financiado con arreglo a

• INDUSTRIAL LEADERSHIP - Innovation In SMEs

Coste total

€ 71 429,00

Aportación de la UE

€ 50 000,00

Coordinado por

TERRAPLASMA GMBH
Germany

Periodic Reporting for period 1 - plasmaCare (A small, portable cold plasma device for the treatment of chronic and acute wounds.)

Período documentado: 2018-07-01 hasta 2018-10-31

Resumen del contexto y de los objetivos generales del proyecto

The overall objective of the feasibility study was to analyse the opportunities that lie in our cold atmospheric plasma technology for the treatment of skin wounds, as well as the commercial opportunities that follow such a development.
At Terraplasma we have developed a technology for for the treatment of wounds based on cold atmospheric plasma device and we are currently exploring further applications of the device for the home treatment of skin diseases of bacterial origin (i.e. acne) and/or minor acute wounds

Trabajo realizado desde el comienzo del proyecto hasta el final del período abarcado por el informe y los principales resultados hasta la fecha

terraplasma has completed a full analysis of the technical and business potential of the plasma care home device. Throughout this project, we have greatly expanded our knowledge regarding the clinical validation and regulatory approval required for a European market launch of the plasma care home. Furthermore, terraplasma has defined the remaining optimisation and upgrade activities required for the components of the plasma care home system and the involvement of of a contract manufacturer for the device line of production. We acknowledged that according to the current regulations, a pre-clinical validation conducted with the partnership of the Universitätsklinikum Regensburg as well as a clinical evaluation including an equivalence consideration with the professional plasma care© device would be sufficient to apply for the CE Mark.
The pre-clinical validation was defined with the key objective of demonstrating the usability of the device, to treat acne and improve acne scar healing successfully using the plasma care home device, and to demonstrate the safety of the medical device for home and self-usage. Following the obtained results, terraplasma will submit the necessary technical documentation for approval and CE Marking. In addition, we analysed the go-to-market strategy to define the approach for an effective market uptake and we started talking with 2 major medical device distributors in Europe and the US that showed interest in the forthcoming commercialization of a cold plasma device for acne treatment.

Avances que van más allá del estado de la técnica e impacto potencial esperado (incluida la repercusión socioeconómica y las implicaciones sociales más amplias del proyecto hasta la fecha)

The cold plasma technology incorporates a plasma source, which produces many millions of controlled micro-discharges, which in turn ionize the surrounding air locally and thus generate a non-equilibrium chemistry which produces a reactive mix of plasma species, which are identical to those produced by the human innate immune system in its fight against infections. We have applied the innovative cold atmospheric plasma technology to treat acute and chronic wounds in the hospital care, in an efficient and cost-effective way. The next challenge is be to apply the technology to a consumer device for the treatment of acne and minor acute wounds for use at home

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