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Urovalve
Medical Devices & Tech
211 Warren Street, Suite 518
Newark, NJ 07103 USA
phone:(973) 596-1350
fax:(973) 643-4502
Symbol Private
Founded 1999
Employees 5
www.urovalve.com
Research Sector Medical Devices & Tech
Summary Description
Developer of patented technology to control fluid flow through small diameter flexible tubing.
Management
Harvey D. Homan, PhD., MBA, President and CEO; Thomas W. Winegar, Vice President Engineering and Development; Vincent De Caprio, Ph.D., Joseph Di Trolio, MD., Carl H. Jacobs, Ph.D., Michael Siroky, MD, David L. West, Ph.D., MPH., William Van Buskirk, Ph.D., P.E., Rafael S. Wurzel, MD.
Keywords
urology, Surinate, urinary, bladder, urinary retention, Foley catheter

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Updated: Aug. 25, 2011

Description
Urovalve, Inc. is a development-stage company seeking to commercialize medical devices regulating urinary flow and control. The company has developed a novel bladder management system intended for men suffering from urinary retention (ischuria).
Products / Services
Urovalve holds patents for its remote-operated, miniature, magnetically-controlled valves that control fluid flow through catheters or tubing in urological applications. The Surinate? bladder management system incorporates the valve into a unique (patent pending) silicone catheter designed for easy and complete insertion into the urethra. The patient can independently control bladder emptying with an external magnetic wand, as opposed to using cumbersome and conspicuous external tubes or collection bags. The Surinate? bladder management system can also prevent bacterial migration into the urinary tract, a common occurrence arising from conventional methods of bladder emptying.
Technology / Differentiation
The device consists of a short silicone catheter comprised of a malecot inlet port and miniature magnetic proximity valve. This catheter bridges the bladder neck, prostate and external sphincter to provide a valve-regulated connection between the bladder and bulbous urethra. The tiny valve is opened by a switching magnet held near the body and is closed when the magnet is moved away, restoring near-normal function. Urovalve's apparatus can be removed without surgery and replaced every thirty days.
Market / Customers
Urinary retention affects up to six million men in the United States and results from many causes, including acute urethral obstruction, hypertrophy of the prostate (BPH), detrusor muscle atrophy from aging and diabetes, and neuromuscular dysfunction due to spinal cord injury. The global market for urinary retention treatment devices was estimated at $3.2 billion in 2006, with a projected compound annual growth rate (CAGR) of 6-12% through 2012. The Surinate? bladder management system will be marketed primarily to urologists and urology outpatient centers, though caregivers have also cited the need for improved devices and may benefit from Urovalve's technology.
Competitors / Substitutes / Alternatives
No devices currently available or known to be in development combine the utility, ease of use, and cost benefits of the valved-catheter that has been developed and patented by Urovalve, Inc.
Strategy
Urovalve plans to manufacture through contract or partnerships, and will seek opportunities for collaboration for broader commercialization.
Funding
The company also has received a Phase I Small Business Innovative Research (SBIR) Grant from NIH, and is looking forward to a positive decision on a Phase II SBIR application that is pending with NIH.
Status
The National Institutes of Health (NIH) currently supports Urovalve's testing and commercialization efforts. Urovalve was awarded its Phase II Small Business Innovative Research (SBIR) grant in June 2007, worth $740,000, and received funding through its Commercialization Assistance Program (CAP) for 2007-2008. Upon successful completion of its trials, Urovalve will meet with the FDA to request a 510k pre-market notification to enable commercialization.


2012-02-21-2477