Phytoceuticals Receives CE Mark for Primary Wound Dressing

In November 2010 Phytoceuticals received CE Marking for 1, its novel primary wound dressing, the first product that will be commercialised from the company’s wound-healing platform. 1 is designed to be the first-choice dressing for acute and chronic wounds.

“This European regulatory approval is a significant milestone for our company,” said Edi Theiler, CEO of Phytoceuticals.

1, an innovative wound spray, is specially formulated from a proprietary combination of two plant-derived oils, Neem oil and St. John’s Wort oil. 1 is designed to be a powerful ‘all-rounder’ 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, 1’s Neem and St. John’s Wort oils have a nutritional effect, supporting healthy wound healing and protecting the periwound skin.

“The use of 1 led to an impressive induction of granulate tissue, even in very deep wounds,” said Prof. Thomas Hunziker, M.D., University Hospital, Bern, Switzerland. “1 was very well accepted by patients since it facilitated painless removal of secondary dressings, and no adverse reactions were observed using 1.”

“1 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,” said Theiler.

“Modern 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,” added chairman Dr. Stephen Rietiker. “Like 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 market, thus becoming an interesting pipeline candidate for big pharmaceutical companies. This is the strategy Phytoceuticals is pursuing on a product by product basis.”

Application

1 is sprayed on to 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 one to three days, depending on the assessment of the treating wound expert. 1 can be used for approximately 30 treatments of a 10cm x 10cm area.

1 has to be administered under the supervision of a healthcare professional.

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