OPTION-v™ PRODUCT SERIES FEATURES AND BENEFITS

The most commonly employed method of short term urinary management has been the placement of a Foley catheter into the bladder thus providing continuous drainage of urine into a collection bag. The key advantages of the Opticon devices are derived from the main concept of using the body's own bladder to store urine rather than a collection bag. When the bladder needs to be drained, the patient or caregiver merely activates a specially designed and patented valve that permits convenient draining in a manner very similar to normal voiding. Messy, cumbersome, and costly external tubing and urine collection bags are not necessary with the Opticon device as compared to the Foley catheter.

The Opticon first generation devices are designed to be very simple for physicians to employ while offering patients greater comfort and mobility. The OPTION-v™ series technology has several unique and patented design features that result in many of its clinical advantages. The features and their associated benefits are summarized below:

1. A novel drainage valve gives the patient control over the process of voiding and replaces passive, continuous drainage with normal bladder cycling.

2. A proprietary teardrop shaped balloon helps prevent leakage from around the catheter shaft by acting to block the flow of urine at the bladder neck.

3. An adjustable retainer ring allows the length and fit of the catheter to be customized to (female device) patients and, in combination with the balloon, provides both comfort and effectiveness.

4. The elimination of the urine collection bag may result in reduced urinary traumas and removal of a potential source of urinary tract infections, both associated with urine bag use.

Key benefits of the OPTION-v™ catheters were well documented in the OPTION-vf® clinical study results and include increased mobility, less pain and discomfort, less self-consciousness, less sleep disruption, and the ability to more easily shower and dress when compared to Foley catheters. The Opticon device enabled users to mimic normal voiding behavior, maintain normal bladder cycling, and enjoy substantially improved quality of life.

Introduction of this and other proprietary Opticon catheters, accessories and incontinence technology will bring rare innovation to these highly underserved multi-billion dollar markets. Innovative product features for the OPTION-v line include:

1. Patient controlled valve which is easy to manually actuate by the patient or caregiver, closes automatically when released, and includes features which maintain security from accidental leakage.
2. Does not require cumbersome and costly collection tubes and bags.
3. Teardrop shaped balloon and adjustable retainer ring (female device) provides a secure fit to minimize catheter movement and accidental leakage while maximizing comfort.
4. Microvalve balloon inflation port minimizes external protrusion from the body to maximize comfort.
5. Catheter shaft, balloon and tip are designed in a smooth continuous profile and the entire catheter is manufactured from 100% silicone (latex free) for ease of insertion, comfort, and minimal irritation.
6. A Continuous Drainage Adaptor that provides a convenient solution for situations in which a patient is expected to benefit from the use of a valved catheter after an initial continuous drainage period.

These innovative product features not only resulted in documented patient benefits (as compared to the Foley catheter) in the OPTION-vf® clinical trial but also led the FDA to suggest and approve product labeling stating: "[Clinical study results] revealed increased benefits of the OPTION-vf® catheter as compared to the Foley catheter with respect to mobility, pain/discomfort, self-consciousness, sleep disruption, and the ability to shower and get dressed." See OPTION-vf® CLINCIAL TRIAL