Urovalve has developed two novel devices to address problems with current urinary catheters: 

• The FolEase™ Catheter with Inserter System
• The Surinate^® Bladder Management System

FOLEASE™ CATHETER WITH INSERTER SYSTEM

The FolEase™ Catheter with Inserter System is designed to be a superior method to insert a Foley catheter that can:

• Reduce the time required for healthcare professionals to complete insertion of a Foley catheter.
• Reduce the number of instances that require a urologist to be called in to complete an insertion.
• Reduce health care costs by providing an easy to use solution replacing more complex and invasive options currently employed.
• Provide options to use thin-walled catheters made of softer silicone since the inserter system confers improved column strength. An additional benefit of the thin catheter wall is an increase in flow rate and reduction in the likelihood of clogging because of the increased lumen size compared to a conventional catheter of equivalent French size (external diameter).

Combined, these benefits enhance patient comfort, reduce total healthcare costs, improve the ease of insertion and potentially improve patient outcomes.

Urovalve has developed a patent pending inserter system, preassembled with a Foley catheter.  The system is designed to facilitate insertion of a specially designed Foley catheter, in difficult situations, such as urethral strictures.  The FolEase™ Catheter with Inserter System is expected to reduce the time required for healthcare professionals to complete insertion of a Foley catheter, reduce the number of instances that require a urologist to be called in to complete an insertion, and be less expensive and simpler to use than other more invasive options, such as the Heyman Tray, that are currently employed.  These benefits will enhance patient comfort and reduce total healthcare costs.

How the FolEase™ Catheter with Inserter System Works

The system makes insertion of a Foley catheter easier via its patent pending stiffening method.  A pusher tube spans the length of the catheter.  The proximal end of the pusher reversibly locks to the proximal end of the catheter.  This ensures that the pusher remains captured throughout the insertion process to prevent trauma to the urethra.  The distal end of the pusher attaches to a handle that can disengage the proximal lock at the appropriate time, withdraw the pusher tube, and leave behind a correctly placed Foley catheter.

In current practice, a nurse often attempts the initial placement of a Foley.  If the catheter buckles during that attempt, the nurse may try a larger size catheter or a coudé-tip catheter.  If unsuccessful, the attending urologist may be called in to repeat these attempts.  The urologist is likely to perform cystoscopy on the patient and may need to dilate the urethra.  Currently, a filiform or guidewire may be placed, and then incrementally larger followers or dilators may need to be inserted until the passage is large enough to place the Foley catheter.

In contrast, the FolEase™ Catheter with Inserter System is designed to reduce catheter buckling during the first attempts.  This should increase patient comfort by reducing the extent of urethral manipulation as well as allowing placement of smaller French size Foley catheters.  Total healthcare costs will be reduced by reducing the time required for catheter placement, reducing the number of times that the urologist must be called in, and reducing reliance on more expensive dilation kits.

Urovalve plans to submit a 510(k) application for marketing authorization in the US and an application for a CE Mark for marketing authorization in Europe during Q2 2011.  The applications will be supported by in vitro laboratory tests against standard specifications and will not require clinical trials.

SURINATE^® BLADDER MANAGEMENT SYSTEM

The Surinate^® Bladder Management System is designed to be a superior, potentially transformational system for urinary drainage that:

• Provides freedom from external tubes or collection bags.
• Restores bladder function by enabling a more physiological bladder filling and emptying cycle.
• Returns control of emptying of the bladder to the patient.
• Lowers, potentially, the incidence of urinary tract infections.
• Reduces the number of catheter insertions required to once every 30 days.

Urovalve, Inc. has developed and patented a core proprietary technology for the Surinate^® design which is comprised of a simple magnetically controlled valve that can be activated remotely by a Surinate^® wearer who uses a hand–held, specially designed magnet to self-regulate flow.  Currently available devices require continuous bladder drainage or insertion of a tube into the urethra up to 5-6 times each day.  The Surinate^® Bladder Management System provides a solution to the problems of restricted life style, low self image, urinary tract infections, and related problems and expenses associated with constant day to day, hour to hour utilization.

The Company successfully completed a clinical feasibility study, which demonstrated that the alpha (α)-version of the Surinate^® Bladder Management System remained in place for 24 hours after insertion (even with vigorous exercise), the valve worked reliably and the system could be easily withdrawn without causing damage to the urethra. Based upon these results and previous laboratory studies, the Company conducted a thorough review and developed the beta (β)-version to improve the ease of insertion, make the valve easier for the patient to open without assistance, and to increase flow rate, thereby reducing the time necessary for bladder emptying. The β-version of the Surinate^® Valve was tested in a 30-day nonsignificant risk clinical feasibility study, which demonstrated that the new version of the valve operated effectively, with no reported problems of blockage or leakage.

Subsequently, Investigational Device Exemption (IDE) and Investigational Review Board (IRB) approvals were obtained to allow the Company to conduct a clinical trial of the β-version of the Surinate^® Bladder Management System for up to 30 days in up to 25 men who require catheters for management of urinary retention.  This study was initiated in May 2010, with 19 subjects enrolled to date.  Completion of enrollment and data analysis is targeted for Q2 2011 and is intended to support approval for marketing authorization in Europe (the Certificate of Europe = CE Mark).  The US FDA will require an additional comparative controlled-trial prior to approval for commercial launch.

In the urethra, the Surinate^® Bladder Management System bridges the bladder neck, prostate and external sphincter and provides a valved connection between the bladder and the bulbous urethra. 

How the Surinate^® Bladder Management System Works

 At the bladder end, the Surinate^® catheter expands into a roughly diamond-shaped cage (in medical terms a malecot) that has an opening that allows urine to enter and travel through the bladder neck (internal) sphincter and external sphincter (below the prostate) to the valve.  The valve is operated by a hand held switching magnet that is about the size of the thumb.  When the hand held magnet is brought within 3-4 centimeters of the valve check magnet, it draws the check magnet away from the valve seat, permitting urine to flow out through the urethra.  On removal of the hand held magnet, the check magnet spontaneously returns to a position occluding the valve seat.  The simplicity of operation will allow patients to function very much like normal.

Intellectual property portfolio

• The Company owns issued patents and is pursuing additional applications.
• US 5,366,506 (Nov 22, 1994), Phillip J. Davis, “Proximity intraurethral valve using permanent magnetic check”
• US 6,066,088 (May 23, 2000), Phillip J. Davis, “Intraurethral magnetic valve”
• EP 1 096 900 (Jan 20, 2000), Phillip J. Davis, “Intraurethral magnetic valve”
• WO 2008/067557 (November 30, 2007), Phillip J. Davis, Thomas W. Winegar, Harvey D. Homan and Andrew R. Leopold “System and method for implanting a catheter”
• U.S. Serial no. 11/993,356 (December 20, 2007), Phillip J. Davis, Thomas W. Winegar, Harvey D. Homan and Andrew R. Leopold “System and method for implanting a catheter”
• U.S. Serial no. 12/881,978, PCT/US10/48783 (September 14, 2010), Thomas W. Winegar “Insertion device for catheters”
• The Company was issued the trademark SURINATE^® (3,150,827) by the US Patent and Trademark Office on October 3, 2006.