Urovalve, Inc. is a company with a mission to provide superior solutions that address problems with urinary control and flow. Within the realm of Medical Devices, this has been a drastically underserved area with little or no innovation since the early 1970’s. Even though physicians, caregivers and patients alike all recognize the need to provide a higher standard of care, there are very few options for those in need. Related issues such as infection, skin breakdown and patient dignity continue to add cost to overburdened health care systems throughout the world. As the world population continues to age, the demand in this area will continue to grow. The global market for urinary catheters (based on 2006 data) is approximately $3.2 Billion with an annual growth rate of 6-12% (BCC Research). Within that figure it is estimated that more than 90 million Foley catheters and over 100 million intermittent catheters are used each year. Urovalve is dedicated to finding innovative, clinically relevant and cost effective solutions. Currently the Company is working on two novel devices that will address important unmet medical needs for two distinctly different segments of the urinary catheter market.
Our first device, the FolEase™ Catheter with Inserter System, incorporates a unique (patent pending) pusher tube into a specially designed Foley catheter to facilitate proper placement of the catheter, especially in difficult situations such as urethral strictures. The system will be provided to the healthcare professional with the pusher tube secured within the lumen of the soft, thin-walled Foley catheter. After insertion, the pusher tube is easily disengaged and removed from the lumen of the catheter, leaving in place a soft, comfortable Foley catheter that has a large lumen relative to French size, compared to many other Foley catheters.
Urovalve projects market entry in 2011 and believes that the FolEase™ Catheter with Inserter System will be marketed under a 510(k) in the US and a CE Mark in Europe that will not require clinical studies.
Our second device, the Surinate® Bladder Management System, is aimed directly at Foley and intermittent catheters being used today for management of urinary retention in men throughout the world, and has many transformational characteristics. The Surinate® Bladder Management System is designed to free men suffering from urinary retention from reliance on Foley and intermittent catheters that severely limit activities, diminish self-image, damage skin and cause a high incidence of serious urinary tract infections. Professor Subbarao Yalla, MD, Harvard Medical School has said “...this (Surinate® Bladder Management System) could be the biggest advance for urinary catheters in more than 60 years.”
The Surinate® Bladder Management System is provided to the healthcare professional with the Surinate® Catheter pre-loaded on a unique inserter that is designed to make insertion of the Surinate® Catheter as simple to insert as a conventional indwelling catheter. However, once in place, the inserter is easily disengaged and the Surinate® Catheter is left in place passing from the bladder, through the two sphincters (i.e. “bladder neck sphincter” at the mouth of the bladder and “external sphincter” just below the prostate gland) that are normally passively closed to maintain dryness, to a point about half-way down the length of the urethra. A simple magnetic valve at the downstream end of the Surinate® Catheter is passively closed to maintain dryness and enable the bladder to fill as normal. When the patient wants to empty the bladder, he holds a small magnet actuator near to the scrotum to open the internal valve magnet and allow the bladder to drain. When the actuator magnet is moved away, the internal valve closes again to maintain dryness.
The unique elements of the Surinate® design are protected through several issued and pending patents which are owned by Urovalve.
The Surinate® Bladder Management System will require clinical studies to support a 510(k) plus de novo in the US and for issuance of the CE Mark. A clinical study of the 2nd generation Surinate® Bladder Management System that was initiated in May 2010 is near to completion and already has yielded encouraging results. Urovalve has received guidance from TUV Rhineland, a well-respected European Notified Body, that this study is adequate to support issuance of the CE Mark and plans to launch in Europe in early 2012, assuming results are positive. The US FDA has provided guidance that it will consider this a “pilot” study and will require an additional “pivotal study” to support US approval and a subsequent product launch, which is targeted for mid 2013.