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Company Clinical Affairs Oceana Therapeutics Inc. / Safety Q-Med AB / Medical / Ames / / Country Columbia / Canada / / Event FDA Phase / / Facility Luke’s Roosevelt Hospital / Surgery Columbia U College of Physicians / University of Minnesota Solesta Study Design Clinical Efficacy Cindy Wong / / IndustryTerm study protocol / / MedicalCondition lymphoma assay Not / vesicoureteral reflux / fecal incontinence / / Organization FDA / MD VP / College of Physicians / Luke’s Roosevelt Hospital / Medical Devices Advisory Committee / University of Minnesota / / Person Howard Franklin / Anders Mellgren / Mitchell Bernstein / / / Position Chief Medical Officer / Head / Fisher / Professor / Assistant / Professor of Surgery Unmet Need / Vice President / / Product Solesta / CI-10 / CI-8 / / Technology 2004 2005 2006 2007 2008 2009 2010 Proof-of-concept Sweden Pivotal IDE study protocol / /
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