13.11.2017 09:50:56
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DGAP-News: Sangui Biotech International Inc.
DGAP-News: Sangui BioTech International Inc. / Key word(s): Miscellaneous
- 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: Some of the statements contained in this news release discuss future expectations, contain projections of results of operation or financial condition or state other "forward-looking" information. These statements are subject to known and unknown risks, uncertainties, and other factors that could cause the actual results to differ materially from those contemplated by the statements. The forward-looking information is based on various factors and is derived using numerous assumptions. Important factors that may cause actual results to differ from projections include, among many others, the ability of the Company to raise sufficient capital to meet operating requirements. Words such as "anticipates," "expects," "intends," "plans," "believes," "seeks," "estimates," and variations of such words and similar expressions are intended to identify such forward-looking statements. Unless required by law, the Company undertakes no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise.
13.11.2017 Dissemination of a Corporate News, transmitted by DGAP - a service of EQS Group AG. |
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