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.
The Vesair Bladder Control System is a novel treatment option that is intended to treat stress urinary incontinence(SUI), is performed in a physician’s office, and is completely reversible. The Vesair Bladder Control Balloon floats at the top of the bladder and acts as a shock absorber to reduce intra bladder pressure during laughing, coughing, sneezing, and other stress related events. Data associated with the Vesair Bladder Control Balloon regarding quantitative pressure reduction, device encrustation, and patient symptom resolution are important to the medical community. These three clinical questions will be addressed in abstract and poster presentations during the upcoming ICS (International Incontinence Society) meeting in Montreal, Canada, October 6th -10th and at the AUGS (American Urogynecology Society) meeting in Seattle, Washington, October 13th-16th.
“I am very pleased to be presenting six month data from the Company’s second randomized controlled trial. Data from this study continues to demonstrate clinically meaningful safety and efficacy results. As a clinician who treats SUI mainly with surgery, the Vesair Bladder Control Balloon will be a welcomed alternative for the nearly 30 million worldwide women whose quality of life is impacted by their daily bladder leaks, many of whom do not want surgery,” said Giovanni Tommaselli, M.D, at Università Degli Studi Di Napoli “Federico II” in Naples, Italy and Co-Investigator in the SOLECT Trial. The data being presented by Dr. Tommaselli was chosen to be featured in the AUGS pre-meeting media advisory.
Other presentations include analysis of over 600 balloons removed from patients who participated in the Company’s first two randomized controlled trials and experiments on the physics of the attenuation of transient pressure spikes in a simulated bladder with underlying stress urinary incontinence. Other authors presenting data at the ICS and AUGS meetings include, Stefan De Wachter, M.D., at Universitair Ziekenhuis Antwerpen, Edegem, Belgium, Karny Jacoby, M.D., with Integrity Medical Research in Seattle, Washington, Charles Rardin, M.D., at Women and Infants Hospital in Providence Rhode Island, and Jack Zuckerman, M.D., at the Naval Medical Center in San Diego, California.
About Stress Urinary Incontinence and the Vesair Bladder Control System
Women with SUI typically experience transient increases in intravesical pressure during physical movement, for example when coughing, laughing, sneezing, or during exercise. When this increased bladder pressure exceeds the ability of the urethral sphincter to withstand it, leakage occurs. Unlike currently available SUI treatments that focus on improving the urethral closure forces, the Vesair Bladder Control Balloon is designed to reduce rapid increases in bladder pressure through the placement of a compressible air-filled balloon in the bladder. The balloon acts like a “shock absorber” to slow rapid changes in pressure and reduce leakage. The uninflated balloon is placed into the bladder through the urethra and subsequently inflated. Balloon placement is performed as an in-office procedure that does not require anesthesia, is intended to remain in the bladder for up to 12 months and replaced annually. The Vesair Bladder Control System is for investigation use only in the United States and has CE mark approval for distribution within the European Union (EU).
About Solace Therapeutics, Inc.
Solace Therapeutics is an emerging medical technology company primarily focused on a revolutionary non-surgical office-based treatment for symptoms of stress urinary incontinence. SUI affects nearly 30 million women globally and can occur in nearly 40% of all men who have prostate surgery. The cost of caring for patients with incontinence is a significant economic burden on the healthcare delivery system if left untreated. Solace is dedicated to developing value-driven innovations that can help healthcare providers improve patient outcomes, reduce procedure costs, and enhance the quality life for people whose daily life is disrupted by their incontinence. Data from the Company’s three randomized controlled trials will support the application for FDA clearance, third party reimbursement and patient adoption. Please visit www.solacetx.com to learn more about the Company.