Urovalve Granted IDE Approval for Bladder Management System

Urovalve, a medical device company focusing on developing superior products for urinary retention recently announced that the U.S. Food and Drug Administration (FDA) has granted Investigational Device Exemption (IDE) approval for the Company’s Surinate® Bladder Management System, allowing Urovalve to conduct a clinical study for the Company’s lead device in the United States.

The Surinate® Bladder Management system is comprised of a simple magnetically controlled valve that can be activated remotely by a Surinate® wearer who uses a hand held magnet to self-regulate flow.

Current technology helping men with urinary retention is both antiquated and inconvenient. Patients either have to rely on a 50-year-old product called the Foley catheter, or undergo intermittent catheterization four to six times a day. The Foley catheter is threaded through the urethra and into the bladder.  The patient empties their bladder into an external bag, which must be emptied frequently. In addition, catheterization is known to cause urinary tract infections (UTI).

Harvey D. Homan, Ph.D., President and CEO of Urovalve, who was recently appointed to the National Institutes of Health’s Center for Scientific Review special emphasis panel for Urology and Small Business was quoted in a recent press release; “…Surinate® is designed so that a patient is no longer coupled to a urine-collection bag on his leg, so no one has to know that the patient has a urinary retention condition. Equally important,” added Dr. Homan, “is the fact that Surinate® is designed with a magnetized valve inside the catheter that allows the bladder to fill and then empty only on command of the patient.  In addition, the patient uses an external magnet to open the valve in the Surinate®catheter to drain the bladder only when he needs to. Plus, the Surinate® valved catheter is designed to remain in the patient for up to 30 days. In short, with Surinate® the patient himselfhas total control over his bladder-emptying process.

Urovalve, Inc.  a privately held company located in the Enterprise Development Center at New Jersey Institute of Technology (NJIT) in Newark, New Jersey.  The company develops superior medical devices to address problems associated with urinary flow and control.

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