Product Line Overview

Practica Medical Manufacturing, Inc. currently has five FDA cleared products and other urinary management and incontinence devices under development with near term market introduction dates. Additionally, it has intellectual property and product concepts for a second generation of products more specifically focused on incontinence.

Practica's current product line is summarized below:

Practica's lead products, the OPTION-vf® and OPTION-vm™Valved Urinary Catheters, address both the short term acute care market and short term use in the chronic incontinence market for men and women. Practica has received FDA clearance for these lead products and has completed the tooling and production process to support market entry. More information about these products is included in OPTION-v PRODUCT SERIES FEATURES AND BENEFITS.

1. The OPTION-vf® is a valved urinary catheter for females that eliminates the need for a system of urine drainage bags and connecting tubes normally required with typical Foley catheters. Rather, the Practica catheter incorporates a manually activated valve at the end of the catheter that allows the patient to store urine in her bladder and to mimic normal voiding behavior. The OPTION-vf® may be used with the Continuous Drainage Adaptor when valved urinary management is desirable following an initial period of continuous drainage, as during surgery.

2. The OPTION-vm™ is a valved urinary catheter for males similar in design and function to the OPTION-vf® for females. Like the female device, the OPTION-vm™ male catheter eliminates the need for urine drainage bags and connecting tubes, and is designed for use with the Continuous Drainage Adaptor when appropriate. The male device is also manually activated through a proprietary valve at the end of the catheter that allows the patient to mimic normal urine storage and voiding behavior.

3. The OPTION-v™ CONTINUOUS DRAINAGE ADAPTOR has FDA clearance for use with the OPTION-vf® and OPTION-vm™. The Continuous Drainage Adaptor is intended for use in conjunction with an OPTION-v™ series catheter and a typical drainage bag to provide temporary continuous urine drainage in situations where the patient is temporarily unconscious or otherwise unable to operate the OPTION-v™ catheter. The Continuous Drainage Adaptor will simply be removed once the patient is capable of experiencing the full benefits of an OPTION-v™ catheter, allowing the patient to control drainage via its external valve without the associated discomfort and hazards of urine collection bags and connecting tubes.