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PRODUCT LINE OVERVIEW Opticon Medical 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. Opticon's current product line is summarized below: Opticon's lead products, the OPTION-vf® and OPTION-vmValved Urinary Catheters, address both the short term acute care market and short term use in the chronic incontinence market for men and women. Opticon 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 Opticon 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 Opticon 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 Opticon 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. 4,5. The Opticon DIRECT urinary catheters are two Foley-like continuous drainage products with several enhancements over the traditional Foley including a teardrop-shaped retention balloon (and adjustable retainer ring in the female version) designed for less leakage and greater comfort. The Opticon DIRECT products are engineered and have FDA clearance for use by males and females. (The following products are not yet available for sale in the United States.) 6. The OPTION-vs VALVED SUPRAPUBIC CATHETER will provide controlled urinary drainage with the features of the OPTION-v product line, in circumstances where a suprapubic catheter placement is preferable to urethral placement for both male and female patients. This product is positioned to complete the product line offering. 7.
Opticon plans to introduce ANTIMICROBIAL TREATED CATHETERS as soon as
practical. Clinical and laboratory data varies on the efficacy of available
antimicrobial coatings, however it is commonly accepted that effective
antimicrobial treatments can delay the microbial colonization of urinary
catheters by several days or more as compared to similar untreated devices.
Opticon has focused its efforts on the development of valved urinary catheters
that derive their principal superiority to Foley catheters from their
dramatically different function. However, as these advantages become accepted
in the marketplace, Opticon intends to partner with one of several antimicrobial
"coating" suppliers for the treatment of its catheters. This
strategy will allow Opticon to quickly offer an additional and highly
useful product benefit for its entire current line of products.
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