Biotec Pharmacon confirms that the non medicinal part of the Dossier for Woulgan® has been filed to the Notified Body as scheduled in the Company’s announcement from July 6th. This completes the filing of the Dossier for Woulgan® to the Notified Body, DNV Nemko Presafe AS and to the UK Medicines and Healthcare products Regulatory Agency (MHRA) for their review and approval. When approved, a CE-Mark will be issued for Woulgan®, enabling it to be sold in Europe. It is expected that a CE-Mark will be issued during first half of 2013.
Biotec Pharmacon has developed a novel biogel containing the Company’s proprietary compound SBG® (Soluble Beta Glucan) for use in wound treatment. The finalized product, Woulgan® Biogel, offers the typical features of a medical device biogel formulation in addition to the biological wound healing enhancing ability of the SBG® component, considered to be an ancillary medicinal product in the formulation. Woulgan® Biogel is a sterile, homogenous, clear to hazy and viscous biogel containing Water, Glycerol, 2 % SBG®, and Carboxymethylcellulose. The product does not contain preservatives.
Mode of action:
Woulgan® Biogel provides a moist wound healing environment that promotes the natural healing process. Woulgan® Biogel contains a bioactive Beta-Glucan from S.cerevisiae.
Woulgan® Biogel is indicated for a single patient, single use as a primary dressing for dry or low exuding partial and full thickness dermal wounds including: diabetic ulcers, pressure ulcers, leg ulcers, graft and donor sites, postoperative surgical wounds (dermal lesions, trauma injuries or incisions), 1st and 2nd degree burns, abrasions and lacerations.