Oceana Therapeutics' Solesta
This article was originally published in The Gray Sheet
Executive Summary
Injectable treatment for fecal incontinence will be submitted for PMA approval in the first quarter of 2010, according to Oceana Therapeutics. The New Jersey firm acquired global marketing rights to Solesta from Swedish developer Q-Med in June. Solesta is a biocompatible substance composed of stabilized hyaluronic acid, including dextranomer. A 200-patient, randomized pivotal study of the minimally invasive device, with 12-month follow-up, "succeeded in meeting both primary endpoints," the firms announced Dec. 7
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