Solace Therapeutics Announces Enrollment of First Patient in the SUCCESS Pivotal Trial to Assess Safety and Effectiveness of the Solace Bladder Control Balloon System™ for the treatment of Stress Urinary Incontinence (SUI) in Women.

FRAMINGHAM, Mass.--()--Solace Therapeutics, Inc., today announced the Company has begun patient enrollment in the SUCCESS Clinical Trial (Stress Urinary InContinence Control Efficacy and Safety Study). The first patient was enrolled by Jeffrey A. Snyder M.D., with Genitourinary Surgical Consultants in Denver, Colorado. “I am excited to be part of the SUCCESS Clinical Trial and to offer women a less invasive treatment option for improving symptoms associated with Stress Urinary Incontinence,” said Dr. Snyder.

It is estimated that nearly one in three women suffer from Stress Urinary Incontinence, which can impact a women’s quality of life if untreated. Most women manage their urine leaks by wearing absorbent pads which are not considered a treatment for SUI and do not address the underlying cause. “We are delighted to begin enrolling patients into the SUCCESS trial. This trial builds on two previous randomized, controlled clinical trials and is a critical milestone towards providing a new treatment option for the millions of women with Stress Urinary Incontinence,” said Bill Gruber, President and CEO for Solace Therapeutics.

About the SUCCESS Clinical Trial

The SUCCESS Clinical Trial; a randomized, multi-centered, controlled clinical trial will assess the safety and effectiveness of the Solace Bladder Control Balloon System in women that experience urine leakage during times of physical movement such as when laughing, coughing, sneezing or during exercise. The trial is anticipated to enroll 220 women in up to 20 clinical sites across the U.S. The study endpoints evaluate women’s improvement in quality of life and reduction in urine leakage. The SUCCESS trial is the Company’s third randomized, controlled study to evaluate this treatment option. Data from the first study was published in the Journal of Urology in December 2013. To review the study, visit: http://www.jurology.com/article/S0022-5347(13)04659-4/abstract. Three month data of the Company’s second trial,the SOLECT Clinical Trial, which evaluated the safety and effectiveness of the Solace Bladder Control Balloon System in 63 patients in seven clinical sites throughout Europe, has been submitted for publication.

For more information on the SUCCESS Clinical Trial and a list of participating clinical sites please visit: www.clinicaltrial.gov/ct2/show/NCT02210273

For women interested in determining if they would be a candidate for the SUCCESS Clinical Trial, please visit: www.stopsui.com or call 1-844-Stop-SUI (1-844-786-7784)

About Stress Urinary Incontinence and the Solace Bladder Control Balloon System

Stress Urinary Incontinence, or SUI, is defined as the inability of the bladder to store urine during normal everyday physical activities that can cause sudden increases in bladder pressure. There are nearly 140 million women worldwide that deal with SUI who are seeking alternative solutions for reducing urine leaks. The Solace Bladder Control Balloon System, which received CE Mark in 2009, is a non-surgical alternative to involuntary urinary leakage caused by SUI. The Solace Bladder Control Balloon is a small, lightweight device that floats within the bladder. The balloon is designed to eliminate or reduce involuntary urinary leakage. It acts as a “shock absorber” to reduce the temporary pressure changes in the bladder that cause urinary leakage. The Solace Bladder Control Balloon procedure is performed in a trained physician’s office typically without the need for anesthesia or a long recovery period and is reversible at any time.

About Solace Therapeutics Inc.

Solace Therapeutics is dedicated to developing innovative, non-surgical and clinically effective devices that address unmet needs in lower urinary tract symptoms (LUTS). Our initial focus is on improving the quality of life for women whose daily life is disrupted by their incontinence. The Company’s venture capital investors include New Enterprise Associates and Spray Venture Partners. Please visit www.solacetx.com to learn more about Solace Therapeutics, Inc.

Contacts

Solace Therapeutics
Nicole M. Shugrue, 508-283-1200 Ext. 165
Vice President, Marketing
nshugrue@solacetx.com

Solace® Therapeutics Announces Enrollment of First Patient in the SUCCESS Pivotal Trial to Assess Safety and Effectiveness of the Solace Bladder Control Balloon System™ for the treatment of Stress Urinary Incontinence (SUI) in Women. (Photo: Business Wire)

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Contacts

Solace Therapeutics
Nicole M. Shugrue, 508-283-1200 Ext. 165
Vice President, Marketing
nshugrue@solacetx.com