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,
'/>"/>

SOURCE Oceana Therapeutics, Inc.
Copyright©2009 PR Newswire.
All rights reserved

Page: 1 2 3

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:7/30/2015)... , July 30, 2015 Tianyin Pharmaceutical ... pharmaceutical company that specializes in the patented biopharmaceutical, modernized ... ingredients (API), provided updates regarding the notice it received ... (the "Exchange") indicating that the Company was below certain ... in Sections 134 and 1101 of the NYSE MKT ...
(Date:7/30/2015)... PARSIPPANY, N.J. , July 30, 2015  Growth ... Rx-to-OTC switches as they bring former prescription users to ... environment, Kline forecasts robust Rx-to-OTC switch activity ... OTC categories emerging along with many new brands entering ... switches occur over the next five years (even those ...
(Date:7/30/2015)... 30, 2015  Medimetriks Pharmaceuticals, Inc. announced today ... III clinical study for Ozenoxacin, a novel bactericidal ... the exclusive U.S. rights to Ozenoxacin 1% cream.  ... 44 centers with an emphasis on U.S. patients, ... months and older with a clinical diagnosis of ...
Breaking Medicine Technology:TPI Provides Update Regarding Non-Compliance with NYSE MKT Continued Listing Requirements 2Rx-to-OTC Switches -- Game Changers for the U.S. OTC Drugs Market through 2019, Sees Kline 2Rx-to-OTC Switches -- Game Changers for the U.S. OTC Drugs Market through 2019, Sees Kline 3Medimetriks Pharmaceuticals, Inc. Announces Completion of the Second Successful Pivotal Phase III Study for Ozenoxacin 2Medimetriks Pharmaceuticals, Inc. Announces Completion of the Second Successful Pivotal Phase III Study for Ozenoxacin 3
... 2011 Researchers presented data demonstrating increased specificity ...  MRI for the detection of breast cancer at ... National Interdisciplinary Breast Center Conference held March 12 ... poster presentation, titled Pre-Surgical Detection of Malignancies ...
... Varian Medical Systems (NYSE: VAR ) announced ... fiscal year 2011 following the close of regular trading on ... by a teleconference available to all interested parties at 2:00 ... conference call webcast will be available on the company website ...
Cached Medicine Technology:Researchers Present Key Findings Comparing PEM to MRI for Identification of Contralateral Breast Cancer at the National Consortium of Breast Centers (NCBC) Conference 2Varian Medical Systems Schedules Second Quarter FY2011 News Release and Conference Call 2
(Date:8/1/2015)... ... August 01, 2015 , ... BeverlyD, owner and founder of BeverlyD Luxe Organic ... very first small business donation to kick off the campaign for healing and Well-Being. ... legacy includes a complete line of raw, organic hair care products, as well as ...
(Date:7/31/2015)... ... July 31, 2015 , ... Ticket Down is a reputable source of authentic tickets for ... Arena. Fans of every genre of music will have an act they are excited ... of the festival, the following artists will perform: Sam Smith, Coldplay, Kenny Chesney, The ...
(Date:7/31/2015)... ... ... Ticket Down is a reliable source for authentic tickets for the 2015 ... The festival will end on Sunday, August 2nd. , Music fans have ... This unique and unbelievably popular festival attracts the best in entertainment from around the ...
(Date:7/31/2015)... ... July 31, 2015 , ... The 2nd annual Ride to Fight ... Memphis on October 3, 2015. The Ride to Fight On is a cycling fundraiser ... Methodist Healthcare, The West Clinic and The University of Tennessee Health Science Center. A ...
(Date:7/31/2015)... Rolling Meadows, IL (PRWEB) , ... July 31, ... ... great ways to communicate. Rally Insurance Group, Inc. has re-branded their social media ... provides a personal way for consumers to communicate, find information, share insights ...
Breaking Medicine News(10 mins):Health News:March4thforWellBeing Foundation Kickoff 2Health News:Cheap 2015 iHeartRadio Music Festival Tickets in Las Vegas at MGM Grand Garden Arena: Ticket Down Slashes Ticket Prices on the iHeart Radio Music Festival in Vegas 2Health News:Cheap 2015 iHeartRadio Music Festival Tickets in Las Vegas at MGM Grand Garden Arena: Ticket Down Slashes Ticket Prices on the iHeart Radio Music Festival in Vegas 3Health News:Cheap 2015 Lollapalooza Tickets: Ticket Down Slashes Ticket Prices on Lollapalooza Tickets at Grant Park in Chicago for Saturday, August 1st and Sunday, August 2nd 2Health News:West Cancer Center Announces 2nd Annual Ride to Fight On 2Health News:West Cancer Center Announces 2nd Annual Ride to Fight On 3Health News:Rally Insurance Group, Inc. Connects to Customers Through Re-branded Social Media Profiles 2
... Time for Spring Break and Summer MonthsCOLD SPRING HARBOR, N.Y., ... ear health and creator of EarPlanes(R) and ... ClearEars are revolutionary earplugs containing an FDA approved ... the ears after swimming, or even bathing, can lead to ...
... to Launch Heritage Tributes Line of Caskets in ... Heritage Casket Company, an Irish-owned memorial products company, ... memorialization and death care industries, today announced a ... for the marketing and distribution of a new ...
... dangers from inhalants at lowest point since 1991 , , ... percent of American adolescents who use drugs started by ... and air fresheners to get high, according to a ... by youths 12 to 17 years old include refrigerant ...
... Provider Teams Up with Specialty Print Packaging Materials Company to ... ... Southborough, MA (PRWEB) March 16, 2009 ... trace technology and services provider, recently entered into a collaboration ...
... LAUDERDALE, Fla. and HONG KONG, March 16 OrbusNeich ... manufacturer and marketer of innovative medical devices for the ... filed a lawsuit against Boston Scientific Corporation ("BSC"). ... for the Eastern District of Virginia, asserts claims against ...
... Saving Tips to Prevent Accidental PoisoningSAN FRANCISCO, March ... reported each year to poison control centers across ... Control System (CPCS) is dedicated to providing residents ... relating to poisoning. National Poison Prevention Week, ...
Cached Medicine News:Health News:Leader in Ear Care Health Category Expands Product Line 2Health News:Irish-Owned Heritage Casket Company Strikes Multi-Million-Dollar Partnership Deal With Pennsylvania's Matthews International 2Health News:Fewer Teens Sniffing Glue, Household Products 2Health News:Fewer Teens Sniffing Glue, Household Products 3Health News:PHARMORX Security And MSO Announce Joint Venture 2Health News:PHARMORX Security And MSO Announce Joint Venture 3Health News:OrbusNeich Files Patent Infringement Lawsuit Against Boston Scientific 2Health News:OrbusNeich Files Patent Infringement Lawsuit Against Boston Scientific 3Health News:Poison Prevention Week March 15 - 22 2Health News:Poison Prevention Week March 15 - 22 3
... AFX Lens is a direct ... in an air-filled eye. In ... a primary air-fluid exchange vitrectomy ... sutureless design make it well ...
... Prism is designed for ... are recommended for tractional ... etc.) and Rhegmatogenus retinal ... used for panretinal photocoagulation ...
... The 30° Prism ... fundus pathologies and are ... detachments (PDR, BRVO etc.) ... They can be used ...
The Chalam Mid Field lens can be used for air/gas exchange and has a bi-concave design to provide the widest field available in a direct image surgical lens. This lens was developed with K.V. Chalam,...
Medicine Products: