Woulgan® Biogel closer to CE-mark
The Medicines and Healthcare products Regulatory Authority (MHRA) in the UK has informed Biotec BetaGlucans that it supports the classification of Woulgan® Biogel as a medical device class III under rule 13. Biotec BetaGlucans is a subsidiary of Biotec Pharmacon.
Biotec BetaGlucans in July 2012 submitted an application to have Woulgan® Biogel classified as a medical device in class III under rule 13 in the EU Directive for Medical Devices. This is a classification for medical devices with a secondary, ancillary medicinal effect.
Woulgan® Biogel contains Biotec BetaGlucans’ proprietary beta-glucan SBG which has such a medicinal effect. This requires the approval of an authorised medical authority, which in this case has been the MHRA in the UK.
Classification and approval of medical devices with ancillary medicinal effects are complicated processes. The MHRA has therefore consulted medical authorities in other countries with respect to the classification of Woulgan® Biogel. This has led to delays in the approval process. These consultations have now been finalised, and based on the documentation Biotec BetaGlucans has submitted- the MHRA has concluded that Woulgan® Biogel satisfies the requirements for classification as a class III medical device under rule 13.
Although certain process- and quality-related questions need answering before the MHRA can complete its final approval of the application, the company believes that this decision significantly reduces the risk related to the approval process.
Some work also remains with respect to certification from Presafe, which is the designated Notified Body responsible for the CE-marking of Woulgan® Biogel. The company does not expect this to generate any significant problems for the application.
About Biotec BetaGlucans and Woulgan® Biogel
Biotec BetaGlucans is a wholly owned subsidiary of Biotec Pharmacon ASA. Biotec BetaGlucans develops and manufactures novel immunomodulating products. The newly developed Woulgan® Biogel, for use in wound healing, contains the company’s proprietary substance SBG® (soluble beta-glucan), which supports the wound healing process. Woulgan® Biogel is a sterile 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 use on skin wounds including diabetic ulcers, bedsores, leg ulcers, transplantation wounds and post-surgery wounds amongst others. The company has entered into an agreement with the wound care world leader Smith & Nephew for distribution of Woulgan® Biogel, starting with a market evaluation in regular clinical use. The evaluation period will commence immediately upon receipt of the CE-mark.
More information about Woulgan® Biogel is available on the company’s homepage http://biotec.no/beta-glucans/woulgan-biogel/
Please also refer to a previous press release: http://biotec.no/news/woulgan-biogel-available-for-professional-wound-and-ulcer-treatment-in-2013/
Contact details:
CEO Svein W. F. Lien, tel +47 922 89 323
CSO Rolf E. Engstad, tel +47 959 41 542