OPTION-vf™ CLINCIAL TRIAL

Pursuant to a series of discussions with the FDA, the Company pursued the "510(k)" Pre-market Notification process for regulatory approval to market its innovative OPTION-vf product. It was determined in the discussions between the FDA and the Company that the Company would complete a clinical study to demonstrate "substantial equivalence" to the Foley catheter and the protocol for this study was developed in close collaboration with the FDA. FDA clearance has since been gained.

Opticon's clinical study was conducted at six well-known investigation sites throughout the U.S by a highly respected group of clinical investigators. These sites included: Cleveland Clinic, Baylor University Hospital, Good Samaritan Hospital (Cincinnati), St. Luke's Episcopal Hospital (Houston) Vanderbilt University Medical Center and Williamson Medical Center (Nashville).

1. Subjects enrolled in this study were consenting adult female patients with acute conditions requiring short-term urinary intervention normally managed with a Foley catheter. Subjects were equally randomized to receive either the OPTION-vf or a standard commercially available Foley catheter with the normal urine collection bag and connection tubing. Results for 119 patients treated in this trial pointed to several significant conclusions:

• Safety and efficacy equivalence to the Foley catheter was clearly demonstrated as compared to three distinct data "end points" that were objectives of the trial.
• The population group using the Opticon device experienced slightly less incidence of bacterial infections than the group using the Foley.
• Both the Opticon and Foley population groups experienced an equivalent, very acceptable amount of "post void urine retention." Simply stated, both devices worked well in eliminating urine from the bladder.
• The number and severity of "adverse events" involving Opticon device users was similar to the number and nature of such events for the Foley device users and typical of Foley catheterization.

2. In addition, the clinical trial demonstrated that patients strongly preferred the Opticon solution over the Foley catheter based on the following key factors:

• better mobility
• less physical discomfort or pain
• less sleep disruption
• less disruption to showering and getting dressed, and
• Opticon patients felt less self-conscious with their catheter in place.

3. In their comments during and after completion of the Opticon study, the Clinical Investigators:

• acknowledged the intuitive and demonstrated benefits of the Opticon catheter
• recognized patient preference for the Opticon catheter, particularly among subjects with prior Foley experience, and
• indicated their inclination to use the product when it became commercially available.

This clinical trial met the Company's objective and its 510(k) submission package received FDA clearance.

The FDA noted the advantages of the Opticon device in recommending that the final approved labeling state that "[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."