Phytoceuticals Ltd. maakt bekend dat het de CE-markering heeft ontvangen voor â€œ1â€, de nieuwe Primary Wound Dressing (www.1wound.com), het eerste product van het wondgenezingsplatform dat het bedrijf op de markt brengt. Het is de bedoeling dat 1 de eerste keuze wordt als het gaat om verband voor acute en chronische wonden.
Volgens CEO Edi Theiler van Phytoceuticals is de Europese regelgevende goedkeuring een belangrijke mijlpaal voor het bedrijf. 1 is een innovatieve wondspray, samengesteld uit een speciale combinatie van twee plantaardige olien, Neemolie en Sint-janskruidolie.
Phytoceuticals Ltd. Receives CE Mark for 1 Primary Wound Dressing, Designed to be an â€˜All-Rounderâ€™ First Choice Product Making Successful Wound-Healing Easy
Phytoceuticals Ltd. announced today that it has received CE marking for 1, its novel Primary Wound Dressing (www.1wound.com), the first product that will be commercialized from the Companyâ€™s wound-healing platform. 1 is designed to be the first-choice dressing for acute and chronic wounds.
â€œThis European regulatory approval is a significant milestone for our Company,â€ said Edi Theiler, CEO of Phytoceuticals.
1, an innovative wound spray, is specially formulated from a proprietary combination of two plantâ€derived oils, Neem oil and St. John’s Wort oil. 1 is designed to be a powerful â€œall-rounderâ€ product for acute and chronic wounds and has the potential to become the first choice for treating skin wounds, as it is designed to be effective in a broad range of wound states. It acts as a physical barrier against desiccation and contamination of a wound and prevents adherence of the secondary dressing to the wound. In addition, 1â€™s Neem and St. John’s Wort oils have a nutritional effect, supporting healthy wound healing and protecting the periwound skin.
â€œThe use of 1 led to an impressive induction of granulate tissue, even in very deep wounds,â€ said Prof. Thomas Hunziker, M.D., University Hospital, Bern, Switzerland. â€œ1 was very well-accepted by patients since it facilitated painless removal of secondary dressings, and no adverse reactions were observed using 1.â€
â€œ1 has been approved in the EU as a medical device. Our strategy is to make 1 available in Switzerland immediately, and then eventually expand internationally, ideally together with a big industry partner,â€ said Theiler.
â€œModern biotechnology is slowly finding its way into the natural extracts industry, with companies being founded that see the development of natural extracts-based remedies on a scientific basis as a significant opportunity,â€ added Chairman Dr. Stephen Rietiker. â€œLike Phytoceuticals, these companies are developing medicines based on natural extracts that enjoy patent protection, establish reliable raw material sourcing, and therefore are able to tap into the global pharmaceutical marketâ€”thus becoming an interesting pipeline candidate for big pharmaceutical companies. This is the strategy Phytoceuticals is pursuing on a product by product basis.â€
1 is sprayed onto a cleaned wound bed and the periwound skin as the primary wound dressing. A user can easily apply it without touching the sensitive wound area to avoid trauma and pain. After application of 1, the wound and periwound skin should be covered with an appropriate secondary dressing. Application is repeated every 1-3 days, depending on the assessment of the treating wound expert. 1 can be used for approximately 30 treatments of a 10×10 centimeters area.
1 has to be administered under the supervision of a healthcare professional. Healthcare professionals can order 1 in Switzerland through Amedis AG: