Navigation Links
Q-Med AB and Oceana Therapeutics, Inc. Take Major Step Towards SOLESTA(TM) US Regulatory Filing
Date:12/7/2009

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.

Q-Med AB and Oceana Therapeutics, Inc. intend to submit a PMA application to the FDA during the first quarter of 2010 based on the results of this study.

"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."

Fecal incontinence is a significant problem for many adults as it relates to the loss of voluntary control of stool, or bowel movements. It affects about 2 percent of the general population. Both men and women suffer from this problem, though it is more common in women because of injury during childbirth. The condition can have devastating effects on a patient's quality of life and psychological well being as many people resort to altering their social and physical activities, even their employment, to cope with the problem.

"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."

Oceana's President and COO, David S. Tierney, M.D. added, "While SOLESTA is already available in Europe, we are confident that the publication of the study will enhance the adoption of this important treatment among the European professional community to help patients suffering from this condition."

About the Study

The Investigational Device Exemption Study was a randomized, subject and evaluator blinded, controlled, multi-center study designed to evaluate the efficacy and safety of SOLESTA for the treatment of fecal incontinence. More than 200 patients suffering from fecal incontinence were included in 13 study sites throughout the United States and Europe. Primary endpoints of the study looked at the efficacy of both groups at six months as well as evaluated the durability of response in the SOLESTA treatment group at 12 months.

About SOLESTA(TM)

SOLESTA is approved for use in Europe and Canada as an injectable treatment for fecal incontinence. SOLESTA is a biocompatible substance composed of stabilized hyaluronic acid, including dextranomer, manufactured according to Q-Med AB's patented technology, NASHA(TM). The treatment is a minimally invasive, in-office procedure. SOLESTA was developed in 2004 by Q-Med AB in Sweden. Oceana Therapeutics acquired the global rights to market and sell SOLESTA in June 2009.

About Q-Med AB

Q-Med is a medical device company that primarily develops, manufactures, markets and sells medical implants. Most of the products are based on the company's patented technology, NASHA(TM), for the production of stabilized non-animal hyaluronic acid. The company today has approximately 650 co-workers in 20 countries, with approximately 400 at the company's head office and production facility in Uppsala. Q-Med had sales of 1,272 MSEK during 2008. Q-Med AB is listed in the Mid Cap segment of the NASDAQ OMX Nordic.

About Oceana Therapeutics, Inc.

Oceana Therapeutics was founded in 2008 by a team of seasoned healthcare executives and is privately held. The Company is committed to acquiring and maximizing the potential of approved and late-stage development medical devices and specialty therapeutics, redefining the way illnesses are treated. Oceana's goal is to enable physicians to prescribe drugs and utilize devices that are tailored for the patient's disease - offering Optimal Outcomes - as well as the added economic benefit of limiting or eliminating hospitalization or reducing demand for surgery or emergency care. This approach balances both the patient's wellness needs and the physician's goal of providing outstanding patient care while efficiently balancing time and economic management constraints. For additional information about Oceana Therapeutics, visit the Company's website at www.oceanathera.com.


Media Contact
-------------

Oceana Therapeutics, Inc.
Serge Wurman, MS, MBA
Office: 732-318-3808
Cell: 732-208-1166

SOURCE Oceana Therapeutics, Inc.


'/>"/>
SOURCE Oceana Therapeutics, Inc.
Copyright©2009 PR Newswire.
All rights reserved

Related medicine technology :

1. Cell Therapeutics, Inc. (CTI) Launches Phase III Study for Pixantrone in Relapsed Indolent Non-Hodgkins Lymphoma (NHL)
2. Cell Therapeutics, Inc. (CTI) Sponsors Panel Discussion on Women and Lung Cancer on Capitol Hill
3. Cell Therapeutics, Inc. (CTI) Supports Panel Discussion on Women and Lung Cancer on Capitol Hill
4. Velcura Therapeutics, Inc. Reports Positive Pre-IND Meeting With FDA and Plans Early Clinical Trials for New Drug to Treat Multiple Myeloma Bone Disease
5. NIST Awards $2 Million to Velcura Therapeutics, Inc. for Innovative Technology R&D - Dual-Action Therapies for Bone Disease
6. Ocera Therapeutics, Inc. Completes Enrollment in FHAST1, a Pivotal Phase 3 Clinical Trial in Fistulizing Crohns Disease
7. William R. Ringo Joins Hyperion Therapeutics, Inc. Board of Directors as Chairman
8. Cell Therapeutics, Inc. (CTI) Submits European Marketing Authorization Application for XYOTAX(TM)
9. Dynamis Therapeutics, Inc. Discovers RAGE Inhibitor
10. Cell Therapeutics, Inc. (CTI) Announces Enrollment Complete in Phase III EXTEND (PIX301) Clinical Trial of Pixantrone in Patients With Second or Greater Relapse of Diffuse Large B Cell NHL
11. European Regulatory Agency Accepts Cell Therapeutics, Inc.s Marketing Authorization Application for XYOTAX(TM) for Lung Cancer for Review
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/12/2016)... Feb. 12, 2016  Aralez Pharmaceuticals Inc. (Nasdaq: ... the Company will ring the Nasdaq Closing Bell at ... York at 4:00 p.m. ET on Tuesday, ... Adrian Adams , will perform the ... to 4:00 p.m. ET.  A live webcast will be ...
(Date:2/12/2016)... Ungarn, February 12, 2016 ... sich auf den ungedeckten medizinischen Bedarf bei ... Ergebnisse seines klinischen Forschungsprogramms bekannt. Das Programm, ... ergab Verbesserungen ihrer respiratorischen Funktionen und anderer ... , ein Medizintechnikunternehmen, das sich auf den ...
(Date:2/11/2016)... 11, 2016 Stem cells are primitive cells ... self-renewal and the capacity to differentiate into mature cell ... as the first mouse embryonic stem cells were derived ... 1995 that the first culturing of embryonic stem cells ... not produced until 2006 As a result of these ...
Breaking Medicine Technology:
(Date:2/13/2016)... ... ... Many individuals looking to lead a healthy lifestyle have decreased carbohydrate consumption and ... Fitness has delved into this niche allowing those giving up their beloved pasta a ... 30 grams of protein and only 7 grams of carbohydrates per 50 gram serving--a ...
(Date:2/13/2016)... Salt Lake City, Utah (PRWEB) , ... February 13, 2016 , ... When an ... kids, Host Parents aren’t always sure what they are in for and they are often ... Pairs are more than they were hoping for. This year’s Au Pair of the Year ...
(Date:2/12/2016)... ... February 12, 2016 , ... The law firm of Morrow, ... Parishes. The purpose of these scholarships is to encourage applicants to pursue a ... seek employment within these two parishes. , “We have available jobs in St. ...
(Date:2/12/2016)... (PRWEB) , ... February 12, 2016 , ... Each year, ... will be held in Anaheim, CA at the Anaheim Convention Center. Almost 10,000 physical ... see new therapy products in action, learn more about their chosen field and network ...
(Date:2/12/2016)... FL (PRWEB) , ... February 12, 2016 , ... ... as a Service (WaaS), today announced the integration of Clarity Intelligence Platform (CIP) ... channel partners to offer real-time business intelligence (BI) to their small and medium ...
Breaking Medicine News(10 mins):