HYDROGLYDE COATINGS, LLC — Department of Health and Human Services SBIR Phase II: NICHD

Description

The sexual health crisis associated with STI transmission is a $Billion economic burden in the American healthcare systemCenter of Disease ControlThere are aboutBillion unprotected sex acts withMillion new STI cases each year in the USThis epidemic is also a global problem with rising rates ofMillion new cases of STI transmission per year withMillion of these cases associated with HIVThe use of condoms is the best prevention method to minimize the spread of STIHowever the lack of adequate lubrication still remains to be a major universal drawback for consistent and correct condom useIn addition to increased risks for STI transmissioninadequately lubricious condoms result in mucosal microtraumapainincreased chances of condom breakageand decreased satisfaction between partnersThusthe HydroGlyde Coating was developed in response to the clear clinical and market need to improve condoms as the last significant technological improvements was more thanyears agoi eintroduction of silicone fluids as lubricantsThe 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 lubricityThe technological advantages includereduce mucosal microtrauma and frictional forces between the condom and tissue interfaceincrease correct condom usageimprove user satisfaction and pleasure for intercourseand importantlyan innovative solution to address health concerns of preventing the spread of STIs and unwanted pregnanciesThe 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 prototypeHGCoatThe aims of our Phase II proposal aredevelopment 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 standardsGPC Karexevaluation of the mechanical properties and biocompatibility of HydroGlyde condoms in accordance to ISOand ISOfor the preparation and filing of akfor FDA clearanceandperform an IRB approved marketing study with human subjects to obtain consumer feedback on HydroGlyde condomsCompletion of these studies will position us to gain FDA approval for HydroGlyde condomsexpand our HydroGlyde teamand initiate salesThe 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 superiordurable lubrication in order to promote correct and consistent usage Project Narrative The HydroGlyde Coating is a durable hydrophilic condom coating that maintains lubricity when the surface is wetted with water or aqueous solutionsThrough offering users with longer lasting condom lubricity without the need for additional personal lubricationsthis unique condom coating technology will promote consistent and proper condom usage which will reduce the spread of STIs and unwanted pregnanciesWith the successful completion of our Phase I SBIRwe will now complete the next milestones to commercialize HydroGlyde condoms by conducting GMP trial runs with our partner to produce HydroGlyde condomsperforming biocompatibility and mechanical ISO testingpreparing and filing akfor FDA clearance with the assistance of a regulatory teamand initiating an IRB approved marketing study for consumer feedback