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98 SMT007 MAGAZINE I FEBRUARY 2021 Johnson: What inspired you to create your device? Enemaerke: An early clinical study demon- strated that light therapy has the potential to be an effective treatment for people who suffer from allergic rhinitis (AR) and seasonal aller- gies. We were inspired by these findings and especially by the perspective that such ther- apy could provide non-drug relief to AR suf- ferers. We are especially motivated by the sto- ries we are hearing directly from people whose lives are not only impaired and burdened by their allergies but also learning of their con- cern about consuming the quantity of medica- tion needed to achieve some level of relief. Johnson: How long have you been working on this? Enemaerke: Ten years—from tinkering with initial prototypes, seeking patent protection, completing a pilot study, and now to undertak- ing a fastidious regulatory pathway. We had the chance to help many with their allergies during this period as we tested; we were so encouraged by their feedback and the sheer joy they experi- enced from being able to wean off medications, like corticosteroids and antihistamines. Johnson: I presume the device uses a LED light source? Enemaerke: Correct. Johnson: How did Fluo Labs achieve the board design portion of the device? E n e m a e r ke : Because we are an early-stage start-up, we chose to contract the work out to a bureau. Johnson: Over the 10 years of development, how did your circuitry develop? Were there numerous revisions/updates, or was your design pretty stable from the beginning? Enemaerke: Our design has remained rela- tively stable. However, we have dramatically improved some aspects of the product over time. Since our initial study, we have incor- porated the newest light and battery manage- ment system, while still delivering the same dosage of light (wavelengths, duration, pulse, energy). We have established the therapeutic window to alleviate the symptoms of allergic rhinitis, so the goal is to keep the light output within that window. e redesign of the unit was motivated by the need to optimize COGS. Johnson: Who are your competitors and how do you differentiate yourself from your com- petitors? Enemaerke: Our competitors are other treat- ment options. e three main forms of treat- ment are over-the-counter and prescrip- tion therapies: antihistamines, nasal steroids, and immunotherapy. Antihistamines stop the