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:3/23/2017)... N.C. , March 23, 2017  Transportation Insight, ... as an end-to-end supply chain management firm with expertise ... Consumer Product Solutions Rick Zaffarano was named ... of the Supply Chain by the only publication exclusively ... global food supply chain. "Rick has brought ...
(Date:3/23/2017)... BARBARA, Calif. and INDIANAPOLIS ... (NYSE: LLY ) and the William Sansum ... the lives of Latino people affected by diabetes through ... tremendous burden of diabetes and cardiovascular disease bears a ... United States ," said David Kerr , ...
(Date:3/23/2017)...  The U.S. Food and Drug Administration today granted ... adults and pediatric patients 12 years and older with ... not received prior chemotherapy. This is the first FDA-approved ... skin cancer. "While skin cancer is one ... form called Merkel cell cancer have not had an ...
Breaking Medicine Technology:
(Date:3/24/2017)... , ... March 24, 2017 , ... The iaedp Foundation, ... other medical professionals caring for those suffering from the full spectrum of disordered eating, ... as eating disorders professionals from nearly all 50 states and several countries converged on ...
(Date:3/24/2017)... ... March 24, 2017 , ... As the ... create a communications platform that positions them as the go-to thought leader in ... their online publication as an always-on, always-fresh news, views and advocacy engine, called ...
(Date:3/24/2017)... ... ... Viewers who like to educate themselves on current issues and who enjoy ... societal issues tend to appreciate and love the "Informed" series, hosted by Rob Lowe. ... for causes around the world. , Running for charity has become a ...
(Date:3/24/2017)... ... March 24, 2017 , ... “Finding Christ ... #TruthwithGrace”: a devotional journal chronicling the writer’s path toward true communion with God. ... with God #TruthwithGrace” is the creation of published author Lea Michelle Johnson, a ...
(Date:3/24/2017)... ... , ... “The Adventures of Joey, The Dog Who Barks at Puddles”: a ... to the fullest, as God intended. “The Adventures of Joey, The Dog Who Barks ... pursuing her passion for writing, especially about truth and human behavior. , Published by ...
Breaking Medicine News(10 mins):