Q-Med AB and Oceana Therapeutics Take Major Step Towards SOLESTA(TM) US Regulatory Filing
Published: Dec 07, 2009
UPPSALA, Sweden and EDISON, N.J., Dec. 7 /PRNewswire/ -- Q-Med AB and Oceana Therapeutics, Inc. today announced that the SOLESTA(TM) pivotal study succeeded in meeting both primary endpoints for the treatment of fecal incontinence.
"This study is the ultimate result of years of hard work as we developed a product using our minimally invasive technology," said Bengt Agerup, Q-Med's President and CEO, and inventor of the NASHA(TM) technology. "It is with great pride that together with our partner, Oceana Therapeutics, we can move forward with the FDA approval process and work towards bringing SOLESTA(TM) into clinical practice."
"We are extremely encouraged by the positive results from this pivotal trial. We believe SOLESTA has the potential to make a significant contribution in fulfilling an unmet medical need in the management of fecal incontinence and will therefore be a great addition to Oceana's product portfolio," said John Spitznagel, Chairman and CEO, Oceana Therapeutics, Inc. "These findings also mark an important milestone for the partnership between Q-Med AB and Oceana as the study outcomes will allow us to file for approval with the FDA in the first quarter of 2010."
About the Study
About Q-Med AB
About Oceana Therapeutics, Inc.
CONTACT: Serge Wurman, MS, MBA, Oceana Therapeutics, Inc., Office:
+1-732-318-3808, Cell: +1-732-208-1166
Web site: http://www.oceanathera.com/