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Solace Therapeutics, Inc. Announces CE Mark Approval
Date:10/1/2009

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
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SOURCE Solace Therapeutics, Inc.
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