About St. Michael’s Medical, Inc.
St. Michael’s Medical is a US-based medical technology company focused on the development and commercialization of products designed to meet major unmet needs for women’s reproductive health and hygiene. The company’s lead product, Guardian Gel®, has just received its Chinese FDA medical approval for broad-based STD/STI claims and antiseptic attributes.
STIs are a major global cause of acute illness, infertility, long-term disability, and death. They have severe medical and psychological consequences, affecting millions of men, women, and infants each year.
Today’s prevention options — abstinence, condoms, or mutual monogamy, are neither used by nor feasible for millions of people throughout the world.
Relying only on treatment is not practical because many infections cause no noticeable symptoms and routine screening programs are not widespread. Further, social stigma and lack of public awareness concerning STIs often inhibit a frank discussion between health care providers and patients about STIs and the need for testing.
Many women, especially those in developing countries, do not have the social or economic power required to insist on condom use and fidelity, or to abandon partners who put them at risk. Because a self-administered gel does not require a partner’s cooperation, it gives women the freedom to protect themselves at their discretion.
The total available worldwide market for such a microbicidal gel product is estimated to be over 100 billion units per year.
The Company’s product has undergone significant development, pre-clinical testing, and successful clinical studies. As further described below, the active ingredients in the product and their concentrations are below levels that require regulation as a prescription drug in most countries. Thereby, opportunities exist for both prescription drug and over the counter (OTC) commercialization strategies.
Proprietary Technology
The Company’s core technology is a topical microbicide formulation comprised of low levels of proven viral inactivating agents in a specially engineered lubricant gel designed for safety and effectiveness in vaginal applications. The formulation combines specific levels of chemicals with surfactant and detergent-like properties created to break viral cell membranes. The gel is designed to rapidly form and maintain a protective membrane over the target tissue cavity walls. Vaginal flora support and sustained lubrication are also achieved. The product is biologically inert, contains no color or perfume additives, does not stain, and is easily cleaned up.
The Company’s intellectual property is based upon trade secrets, and includes patents-pending, applied for, and trademarks that cover the current product formulation, gel composition, adaptations for new indications, applicator design, product manufacturing processes and know-how.
Branded Product Positioning
The Company plans to develop a strong brand identity for its Guardian Gel® product as well as with its foreign brand names.
Guardian Gel® comes pre-loaded in a proprietary, single-use, applicator. Commercial product packaging, promotion, pricing, and label claims will be informed by further clinical testing, geographic market requirements, and follow venue specific branding and regulatory requirements. Principal product design characteristics are listed below.
Market Driver–The Microbicide Advantage
It is currently held by many experts in the global women’s health community that an effective microbicide may offer the best promise to fight the transmission of sexually transmitted infections. As discussed above, a successful, commercially available microbicide would address several women’s health issues related to STIs. Chief among these are that cultural and economic circumstances do not afford millions of women, especially within developing nations, the power to insist on condom use or monogamy by their sexual partners. For example, research has shown that married women in developing countries are at a high risk for contracting HIV.
To emphasize by way of repeating a critical note stated above, because a microbicidal gel can be easily utilized by women without involvement of a partner, it provides women with more control and ability to prevent sexually transmitted infections. No product exists today that offers the opportunity to deliver this result.