Urovalve Announces Start Of Patient Enrollment For Pilot Study Of Its Surinate(R) Urinary Catheter

Main Category: Urology / Nephrology
Also Included In: Medical Devices / Diagnostics
Article Date: 07 Dec 2008 - 0:00 PDT

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Urovalve, Inc., a medical device company focused on creating products for urinary flow and control, announced today the initiation of patient enrollment for a pilot study of its Surinate® Bladder Management System-designed to improve the quality of life of men who suffer from acute or chronic urinary retention, an inability to empty the bladder caused by obstruction of the urethra.

The pilot study is being conducted at four sites: VA Boston Healthcare System; VA New Jersey (East Orange) Healthcare System; Vanderbilt University Medical Center, Department of Urologic Surgery; and, The Virginia Urology Center. The pilot study is expected to conclude by the end of January 2009. The Company intends to commence a pivotal clinical study in the first half of the new year.

"Urinary retention is a common and distressing condition that can have a profound impact on a man's quality of life," said Harvey D. Homan, Ph.D., President and CEO of Urovalve. "Men with this condition currently have to rely on a half-century-old product called the Foley catheter, or intermittent catheterization four to six times a day. On the other hand, Surinate® is designed so that the patient is no longer tethered to an external urine-collection bag; thus no one has to know that the patient has a urinary retention condition.

"Equally important," added Dr. Homan, "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, so the normal filling and emptying cycle of the bladder is restored. Furthermore, the patient uses an external magnet to open the valve in the Surinate® catheter to drain the bladder only when he needs to. The patient thus has self-control over the bladder-emptying process."

"The primary feature of Surinate® is that it is valved and is intended to be actuated by the patient, who would thus be able to control the time point at which he would empty his bladder," said Eugene V. Kramolowsky, M.D., of The (Richmond) Virginia Urology Center, one of the study's principal investigators. "This represents a significant change from conventional catheters, where there is no valve and the patient voids basically into a collection bag, which is very inconvenient and somewhat unsightly. Surinate® may represent a significant advancement for men with a urinary retention condition."

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

Urovalve, Inc.

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