THE CHALLENGE
Methylene blue, a protective dye used in photodynamic therapy (PDT), has been historically used in medicines and in FDA-regulated products for its ability to destroy pathogens. Due to the shortages in personal protective equipment (PPE) during the COVID-19 pandemic, the founders of Singletto saw the potential for PDT, and more specifically antimicrobial photodynamic inactivation (aPDI), to provide added protection for healthcare professionals in a believed safe, affordable, and environmentally friendly way.
When embedded into PPE such as surgical masks, hospital gowns, privacy screens, or even used as a consumer-product spray for textiles, Singletto's Oxafence technology (which includes methylene blue) can kill a range of pathogens — with the goal of providing a safe and effective means of delivering antimicrobial protection.
EXPONENT'S MULTIDISCIPLINARY SOLUTION
How does Exponent help with a complex dual track FDA and EPA regulatory process? We ask the right questions.
In partnership with multidisciplinary experts from across Exponent, our Chemical Regulation & Food Safety and Biomedical & Engineering Sciences practices are helping guide Singletto in data and evidence gathering that demonstrates to the Food and Drug Administration (FDA) and the Environmental Protection Agency (EPA) the safety and efficacy of the Oxafence product.
Exponent's Impact
Exponent has conducted preliminary research and analysis and is helping Singletto assemble the applications for the FDA and EPA. These novel type products are not only innovative and affordable but have the potential to help slow the spread of pandemic-level viruses like SARS-CoV-2. Additionally, they carry the potential for adaptation in low- and middle-income countries to provide protection against high-threat viruses such as Norovirus and Ebola virus.
