Biotec Pharmacon completes filing of technical dossier for Woulgan

Posted On: July 25, 2012

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.

Woulgan® Biogel

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.

Indications:
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.

More info

From Issue 15 • Categories: Tags: Aquapreneur, Beta Glucan, biogel, biomaterials, Biotec Pharmacon, cosmeceuticals, functional ingredients, marine biotechnology, marine ingredients, Woulgan • No Comments