Q-Med AB submitted in April, 2010, together with its partner Oceana Therapeutics, a Premarket Approval (PMA) application for Solesta(TM) in the US. Solesta is a product indicated for the treatment of fecal incontinence. Representatives from Q-Med AB, Sweden, and Oceana Therapeutics met December 2(nd) with the FDA's Gastroenterology and Urology Devices Panel to discuss clinical evidence for the use of Solesta in the treatment of fecal incontinence. The FDA Advisory Panel voted 5-0, with one abstention, that the benefits of Solesta outweigh its risks. The vote by the Advisory Committee essentially endorses approval of Solesta for patients who have failed conservative therapy. The FDA is expected to take the panel's recommendation into consideration during the continued review process of the Solesta PMA. Oceana and Q-Med have an exclusive partnership for the worldwide commercialization rights to Solesta and Deflux®. Q-Med will continue to develop and manufacture all products under this agreement. Oceana will focus on continued global commercialization. Queries should be addressed to: Alexander Kotsinas, Vice President and CFO Tel: +46 73 500 1111 Per Langö, Senior Director Corporate Development Tel: +46 73 387 1521 Medical queries should be addressed to: Dr Cindy Wong, Chief Medical Officer and Head of Medical Affairs Tel: +46 73 387 1450 The information in this report is such as that which Q-Med is required to disclose in accordance with the Swedish Securities Market Act. The information was submitted for disclosure at 7.30 am CET on December 3, 2010. Q-Med AB is a medical device company that develops, manufactures, markets, and sells high quality medical implants for esthetic and medical use. The majority of the products are based on the company's patented technology, NASHA(TM), for the production of stabilized non-animal hyaluronic acid. The product portfolio today contains: Restylane® for filling lines and folds, contouring and creating volume in the face, Macrolane(TM) for body contouring, Durolane(TM) for the treatment of osteoarthritis of the hip and knee joints, Deflux® for the treatment of vesicoureteral reflux, VUR, (a malformation of the urinary bladder) in children, and Solesta® for the treatment of fecal incontinence. Sales are made through the company's own subsidiaries or distributors in over 70 countries. Q‑Med today has about 650 coworkers, with almost 400 at the company's head office and production facility in Uppsala, Sweden. Q-Med AB is listed in the Mid Cap segment of the NASDAQ OMX Nordic. Q-Med AB (publ), Seminariegatan 21, SE-752 28 Uppsala, Sweden. Corporate identity number 556258-6882. Tel: +46 18 474 90 00. Fax: +46 18 474 90 01. E-mail:info@q-med.com Web: www.q- med.com [HUG#1468522]
FDA Advisory Panel endorses approval of Solesta(TM)
| Source: Q-Med AB