Biotec Pharmacon ASA’s (”Biotec”, OSE: BIOTEC) subsidiary Biotec Betaglucans has received positive confirmation by the FDA that Woulgan® Gel is listed as a Class 1 exempt in the USA
Woulgan® Gel is registered as a Class 1 exempt by the FDA in the USA. This means that Woulgan® can be imported and used in the country. However, in order to receive favourable reimbursement a more advanced classification will be needed and Biotec is currently working to clarify the optimal route and strategy.
The Woulgan® Gel has passed one of the first hurdles for market access into the biggest and most important market for stalled wounds. With more than 6.5 million chronic and stalled wounds, representing one third of the global market, this is one important milestone before commercial traction can be obtained in this important market, says Svein Lien, CEO of Biotec Pharmacon.