The sexual health crisis associated with STI transmission is a $16 Billion economic burden in the American healthcare system (Center of Disease Control). There are about 1 Billion unprotected sex acts with 20 Million new STI cases each year in the US. This epidemic is also a global problem with rising rates of 498 Million new cases of STI transmission per year with 2.1 Million of these cases associated with HIV. The use of condoms is the best prevention method to minimize the spread of STI. However the lack of adequate lubrication still remains to be a major universal drawback for consistent and correct condom use. In addition to increased risks for STI transmission, inadequately lubricious condoms result in mucosal microtrauma, pain, increased chances of condom breakage, and decreased satisfaction between partners. Thus, the HydroGlyde Coating was developed in response to the clear clinical and market need to improve condoms as the last significant technological improvements was more than 50 years ago (i.e. introduction of silicone fluids as lubricants). The HydroGlyde Coating is the first of its kind and represents a significant departure from all conventional latex condoms by eliminating the need for supplemental personal lubricants and offering longer-lasting lubricity. The technological advantages include: 1) reduce mucosal microtrauma and frictional forces between the condom and tissue interface; 2) increase correct condom usage; 3) improve user satisfaction and pleasure for intercourse; and importantly, 4) an innovative solution to address health concerns of preventing the spread of STIs and unwanted pregnancies. The successful completion of our Phase I validated the coating formulation to be scalable and that HydroGlyde condoms are fabricated with consistent reproducibility under GMP-like conditions using our second-generation coating prototype (HGCoat_2).
The aims of our Phase II proposal are: 1) development and scale-up of the HydroGlyde Coating formulation and execution of trial runs in a large-scale condom manufacturing facility to produce HydroGlyde condoms under GMP standards (GPC/Karex); 2) evaluation of the mechanical properties and biocompatibility of HydroGlyde condoms in accordance to ISO 10993 and ISO 4074 for the preparation and filing of a 510(k) for FDA clearance; and, 3) perform an IRB-approved marketing study with human subjects to obtain consumer feedback on HydroGlyde condoms. Completion of these studies will position us to gain FDA approval for HydroGlyde condoms, expand our HydroGlyde team, and initiate sales. The commercialization and introduction of this innovative condom coating technology to the market will offer a viable solution to address current health challenges by offering an improved condom product with superior, durable lubrication in order to promote correct and consistent usage.
The HydroGlyde Coating is a durable hydrophilic condom coating that maintains lubricity when the surface is wetted with water or aqueous solutions. Through offering users with longer-lasting condom lubricity without the need for additional personal lubrications, this unique condom coating technology will promote consistent and proper condom usage which will reduce the spread of STIs and unwanted pregnancies. With the successful completion of our Phase I SBIR, we will now complete the next milestones to commercialize HydroGlyde condoms by conducting GMP trial runs with our partner to produce HydroGlyde condoms, performing biocompatibility and mechanical ISO testing, preparing and filing a 510(k) for FDA clearance with the assistance of a regulatory team, and initiating an IRB-approved marketing study for consumer feedback.