FRAMINGHAM, Mass., Oct. 1 /PRNewswire/ -- Solace Therapeutics, Inc., a medical device company focused on the development of non-surgical bladder control therapies announced today that it has received European CE mark approval for the Solace Intravesical System, and ISO 13485:2003 certification for the company’s Framingham facility. The company is introducing its first product, an office-based therapy for Female Stress Urinary Incontinence at the International Continence Society Meeting in San Francisco on Friday, October 2, 2009.
“This certification and CE mark approval represent a significant achievement and major milestone for Solace,” said Kevin Connors, chief executive officer of Solace Therapeutics. “Successfully completing this process allows us to move forward with the clinical development of the Solace Intravesical System in Europe.
Solace is introducing its first product, a non-surgical therapy for women with Stress Urinary Incontinence, to ICS members at their annual meeting on Friday. “Solace is targeting those patients that are dissatisfied with current therapies and choose to manage their urinary leakage with absorbent pads or diapers,” said Connors. “Solace has developed a new option for these patients.”
The Solace Balloon is a small lightweight device (about the size of a quarter) that floats within the urinary bladder. It acts as a “shock absorber” to reduce the temporary pressure changes in the bladder that cause urinary leakage. It is placed in the bladder with a soft tube-like catheter and inflated with air. The 5 minute procedure is performed in the physician’s office without anesthesia or surgery. No lifestyle change is required after the procedure, and the procedure is reversible at any time.
The Solace Balloon for women with involuntary urine leakage is currently being evaluated in several centers throughout the U.S. in an FDA IDE approved clinical trial. More information about the product is available at www.bladdercomfort.com.
About Solace Therapeutics
Solace Therapeutics is an emerging medical device company focused on the development of non-surgical office based treatments for common bladder disorders, such as stress urinary incontinence (SUI), overactive bladder (OAB), male voiding dysfunction and lower urinary tract symptoms (LUTS). Solace is dedicated to improving the patient’s quality of life by eliminating side effects typically associated with current drug and surgical therapies. Solace’s proprietary technology is designed to offer patients the following benefits:
Solace’s patented technology platform is based on the fundamental fluid mechanics principles of reducing rapid pressure changes in fluid with air-based pressure attenuation. Solace is the pioneer of applying these principles to treat bladder dysfunction. More information on Solace contact Kevin Connors at kconnors@solacetx.com or visit www.solacetx.com.
SOURCE Solace Therapeutics, Inc.
CONTACT: Kevin Connors, Solace Therapeutics, Inc., +1-508-283-1200
Web site: http://www.bladdercomfort.com/
