Estimating the size of the market in urinary incontinence (UI) (at all levels of severity) is quite a challenge. Part of the problem is that most surveys that attempt to gauge the scope of the problem find over 50% of the people who suffer from UI do not even report it to their physicians under the misconceptions that UI is a natural process of growing older or just on the basis of their personal embarrassment.

Some estimates of the global scope of the problem run as high as 200 million people (at all levels of severity). However, the 200 million figure may even be quite small, as if one estimates the size of the problem just extrapolating worldwide from more credible US tabulations alone (estimates that range between 17 and 52 million people), the worldwide figure would be upwards of 340 to 500 million, or more.

Additionally, there may be specific factors that may vary the rates among different populations, such as, the differences in the many exacerbating conditions that affect a particular population group (i.e.; the lower birth rates and less obesity, perhaps offset somewhat by the higher smoking rates of the Chinese, etc.). Suffice it to say, the estimate of the numbers of sufferers worldwide, and in particular, within the targeted markets of PMD (primarily, although not exclusively, tabulated on the basis of the Company’s patent coverage) is a moving target. The chart below estimates the total population within the Company’s patent-covered markets:

Patent-covered Markets of the PMD-FCD

 US 310.2M
 Canada 33.8M
 Mexico 112.5M
 Brazil 201.1M
 England 61.3M
 Germany 82.3M
 France 64.8M
 Spain 40.5M
 Italy 58.1M
 Japan 126.8M
 Australia 21.5M

Total:  1.113-billion (out of 6.827-billion)

With regard to the specific market for the Company’s FCD product (for the treatment of severe UI), it might be reasonable to assume that those people who were categorized in the upper 35% of severity would, in some portion, be candidates for some form of severe (invasive) UI treatment, including the Company’s FCD product (e.g.; 17.5 million people).

It should be further noted that the above extrapolations only refer to the prospective patient population accumulated to date, as this population grows at the rate of almost 7% each year as newly afflicted people enter the market either as a result of the continuation of the causes of incontinence, which go untreated or under-treated, or, to a lesser extent, the re-entry into the market of patients who were previously treated with products or procedures that have since lost efficacy.

The PMD product would likely have an accumulated potential treatment market of 15 million people (within its patent-covered territories), while adding approximately 1,000,000 new afflicted patients to the prospective market every year.