Sangui BioTech International Inc.: FDA GRANTS FAST TRACK DESIGNATION TO GRANULOX
- FDA GRANTS FAST TRACK DESIGNATION TO GRANULOX
Witten, November, 13, 2017: Infirst Healthcare Ltd has announced that the United States (US) Food and Drug Administration (FDA) has granted Fast Track designation to Granulox 10% haemoglobin spray (porcine haemoglobin) for the treatment of diabetic foot ulcers (DFUs). It is the first and only haemoglobin spray to receive Fast Track designation - a process designed by the FDA to facilitate the development, and expedite the review of, new therapies to treat serious conditions and fill an unmet medical need.
Through a sub - license agreement with Sastomed GmbH, to which Sangui BioTech GmbH has licensed the worldwide distribution rights for Granulox, , Infirst Healthcare Ltd has exclusive US commercialisation rights for the patented haemoglobin spray, which is approved as a class III medical device in the European Union and marketed for the treatment of diabetic foot ulcers, venous leg ulcers and pressure ulcers.
Sangui BioTech International, Inc. ("SGBI") is a holding company the shares of which are being traded on the OTCQB venture stage marketplace for early stage and developing U.S. and international companies (OTCQB: SGBI). Companies are current in their reporting and undergo an annual verification and management certification process. Sangui shares also trade on the OTC markets of Berlin and Hamburg-Hannover stock exchanges (symbol: SBH). Its purpose is to provide financing and access to the capital markets for the enterprises of the Sangui group. SanguiBioTech GmbH is a ninety percent subsidiary of Sangui BioTech International, Inc.
For more information please contact: Sangui Biotech International, Inc. Thomas Striepe Fax: +49 (2302) 915191 e-mail: firstname.lastname@example.org
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