Press Announcements

  A Third Randomized Controlled Trial (RCT) of the Vesair™ Bladder Control System For the Treatment of Stress Urinary Incontinence Delivers Promising Results

FRAMINGHAM, Mass.--(BUSINESS WIRE)--Solace Therapeutics, Inc., today announced that data from a multicenter 221 patient randomized controlled trial has met study endpoints with statistical significance. Dr. Eric Rovner will be presenting a poster of the results from the SUCCESS Clinical Trial at the Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction (SUFU) meeting in Scottsdale, Arizona on Thursday, March, 2nd.

  Two Clinical Abstracts on the Vesair® Bladder Control System for Treating Stress Urinary Incontinence (SUI) to be Presented at the American Urogynecology Society(AUGS) Meeting in Denver, CO

FRAMINGHAM, Mass.--(BUSINESS WIRE)--Solace Therapeutics, Inc., today announced that Stefan De Wachter, MD, PhD will be presenting long-term data from the SOLECT Trial and Denise Elser, MD will be presenting a video presentation of the removal and replacement of the Vesair® Bladder Control Balloon during the 37th Annual AUGS Meeting in Denver, Colorado September 28-30th.

  Six-month data from the SOLECT Trial awarded one of the “Best” Poster Presentations at the upcoming 31st European Association of Urology (EAU) Congress in Munich, Germany

FRAMINGHAM, Mass.--(BUSINESS WIRE)--Solace Therapeutics, Inc., today announced that Stefan De Wachter, MD, PhD, will be presenting six-month data from the SOLECT Trial during the 31st Annual EAU Congress in Munich, Germany on Saturday, March 12. The poster has been awarded “best” poster within the category of “Slings and Things in Female Incontinence.”

  Abstract Presentations Address Key Clinical Questions Regarding the Vesair® Bladder Control System for the Treatment for Stress Urinary Incontinence (SUI)

FRAMINGHAM, Mass.--(BUSINESS WIRE)--Solace Therapeutics, Inc., today announced data collected from the Company’s first two randomized controlled clinical trials will be presented at upcoming urological society meetings. Key clinical questions regarding long-term implantation and safety of the Vesair Bladder Control Balloon as well as the theory behind the use of air attenuation to reduce urine leakage during times of physical stress will be addressed.

  Solace Therapeutics Completes Enrollment of the SUCCESS Clinical Trial for the Vesair® Bladder Control System for Stress Urinary Incontinence

FRAMINGHAM, Mass.--(BUSINESS WIRE)--Solace Therapeutics, a medical technology company focused on developing breakthrough treatments for urinary incontinence, today announced that it has completed enrollment in the SUCCESS (Stress Urinary inContinence Control Efficacy and Safety Study) Clinical Trial ahead of schedule due to overwhelming patient interest.

  Presentations at the International Urogynecology Association (IUGA) Conference in Nice, France Continue to Demonstrate Safety and Efficacy of the Vesair® Bladder Control Procedure as a Treatment for Stress Urinary Incontinence(SUI).

FRAMINGHAM, Mass.--(BUSINESS WIRE)--Solace Therapeutics, Inc., today announced that two abstracts have been accepted for presentation at the International Urogynecology Association (IUGA) annual meeting being held June 9-13th, at the Acropolis Convention Center, in Nice, France.

  A Second Randomized Controlled Trial (RCT) of the Vesair® Bladder Control System Meets Study Endpoints with Statistical Significance

FRAMINGHAM, Mass.--(BUSINESS WIRE)--Solace Therapeutics, Inc., today announced that data from a multicenter 63 patient randomized controlled trial has met study endpoints with statistical significance. Data from this study will be presented by Dr. Gommert van Koeveringe at the Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction (SUFU) meeting in Scottsdale, Arizona on Saturday, February 28.

  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.--(BUSINESS WIRE)--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.

  Solace Therapeutics Receives Two FDA Clearances towards Providing Women an Office-Based Treatment for Stress Urinary Incontinence (SUI)

FRAMINGHAM, Mass.--(BUSINESS WIRE)--Solace Therapeutics, Inc., today announced the company has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the Guardian Urethral Sheath and Investigational Device Exemption (IDE) approval to begin the SUCCESS Clinical Trial. The SUCCESS Clinical Trial, the third prospective, multicenter, randomized clinical trial for the Solace Bladder Control System, will evaluate the safety and effectiveness of the system in 20 sites throughout the United States.

  Data Published in the Journal of Urology demonstrates safety and effectiveness of novel office-based, reversible treatment to reduce urine leakage in female patients with Stress Urinary Incontinence (SUI)

FRAMINGHAM, Mass.--(BUSINESS WIRE)--Solace Therapeutics, Inc., today announced that data from a multicenter 166 patient randomized controlled study has been published in the December issue of the Journal of Urology. The study demonstrates the safety and effectiveness of limiting rapid pressure changes within the bladder to reduce symptoms of Stress Urinary Incontinence (SUI).

  Solace Therapeutics Adds New Member to Board of Directors

FRAMINGHAM, Mass.--(BUSINESS WIRE)--Solace Therapeutics, a venture capital funded medical technology company focusing on treating stress urinary incontinence (SUI), announced today that Stacy Enxing Seng has joined the Board of Directors. She serves on the board alongside Ryan Drant, General Partner with New Enterprise Associates (NEA); Ali Behbahani MD, Principal at NEA; John McDonough, CEO at T2 Biosystems; and Kevin G. Connors, founding partner of Spray Venture Partners.

The Vesair Balloon Delivery System is not currently available in the U.S. It is for investigational use only.

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