Woulgan® Biogel receives CE-marking
The novel wound healing product Woulgan® Biogel has today received CE-marking as an advanced medical device, and Biotec BetaGlucans and its international partner Smith & Nephew will immediately commence market evaluation trials. The shared long-term ambition is to establish Woulgan® Biogel as a mass-market product in the large wound healing market.
Biotec BetaGlucans AS is a wholly-owned subsidiary of Biotec Pharmacon ASA.
-This is a long-awaited major milestone for the company. Woulgan® Biogel has been shown to have positive effects on the body’s own wound healing capabilities, and we are excited about the opportunity to offer a new treatment alternative to large patient groups looking for improved solutions for healing of chronic wounds says CEO Svein Lien in Biotec Pharmacon.
Woulgan® Biogel combines hydrogel components with the company’s proprietary beta-glucan SBG, and has been CE-marked as a medical device Class III, Rule 13 under the EU Directive for Medical Devices. This is an advanced classification. DNV Nemko Presafe has acted as Notified Body responsible for the CE-marking, with the Medicines and Healthcare products Regulatory Authority (MHRA) in the UK acting as the Competent Medical Authority.
Even though hydrogel provides the primary function of Woulgan® Biogel, the advanced classification also means that Biotec BetaGlucans will be able to claim also the ancillary, medical effects of SBG in labelling and marketing. This offers a unique opportunity compared to other gels in a market perspective.
Woulgan® Biogel is a single-use primary dressing for treatment of skin wounds. Biotec BetaGlucans will initially address diabetic ulcers, leg ulcers, pressure ulcers, and burns, although the product is also approved for use on other wounds like post-surgery wounds, trauma wounds, and abrasions.
Biotec BetaGlucans and its partner Smith & Nephew share the vision of making Woulgan® Biogel a cost-effective mass product in the wound care market, and Smith & Nephew will now commence a market evaluation in a limited number of European clinics to establish end-user efficacy in a routine clinical setting.
-This evaluation will likely carry on through most of 2014, and the results should provide valuable planning tools and key parameters for the commercial strategy going forward, says Lien.
Smith & Nephew holds certain exclusive, non-transferable rights until end of the trial period.
Woulgan® Biogel will be available from Biotec BetaGlucan’s web-shop.
For further information, please contact:
CEO Svein W. F. Lien, tel +47 922 89 323
CSO Rolf E. Engstad, tel +47 959 41 542
About Biotec BetaGlucans and Woulgan® Biogel
Biotec BetaGlucans is a wholly owned subsidiary of Biotec Pharmacon ASA. Biotec BetaGlucans develop and manufactures novel immunomodulating products. Newly developed Woulgan® Biogel for use in wound healing, contains the company’s proprietary substance SBG®. Woulgan® Biogel is a sterile, thick gel containing water, glycerol, 2% SBG, and carboxymethylcellulose. The product does not contain any preservatives. The Woulgan® Biogel is a single-patient primary dressing for one-time use on skin wounds including diabetic ulcers, bedsores, leg ulcers, transplantation wounds, post-surgery wounds, trauma wounds, first- and second-degree burns, abrasions, and cuts. The company has entered into an agreement with world leaders Smith & Nephew for distribution of Woulgan® Biogel after a market evaluation period based on regular clinical use.
More information about Woulgan® Biogel is available on the company’s homepage www.biotec.no