Issue link: https://iconnect007.uberflip.com/i/1335241
FEBRUARY 2021 I SMT007 MAGAZINE 99 For many allergy sufferers, side effects can be even more problematic than the hay fever symptoms they are looking to address—side effects that are exacerbated with prolonged consumption of medication. For allergy sufferers who don't want to or cannot take medication (due to pregnancy, heart or thyroid conditions, job restrictions, etc.), unrealistic solutions are often suggested to manage their symptoms: staying indoors or minimizing outdoor activities, vacuuming car- pets and upholstered furniture twice a week, washing curtains in hot water each season, get- ting rid of stuffed animals, and keeping home and car windows closed. For consumers who are seeking non-drug solutions, there is no single natural remedy that can do the job of providing efficient symp- tom relief in a convenient treatment. With mil- lions of AR sufferers around the world, Fluo Labs sought to create a drug-free solution with no side effects. Johnson: How much will the device cost? Enemaerke: The device will sell for less than $100. Johnson: When will units be available for pur- chase? Enemaerke: Once we get approval from the FDA. We anticipate that we will be on the mar- ket in late 2021. Johnson: Has COVID changed the FDA approval process? Enemaerke: COVID has not changed the FDA approval process. On the one hand the FDA was quick to create accelerated review pro- cesses to fast track COVID-related solutions. In order, to facilitate the development of potential COVID-19 treatments, the FDA created the Coronavirus Treatment Acceleration Program (CTAP), a new program designed to expedite the development of potential COVID-19 ther- apies by using every tool at the agency's dis- posal to determine if the therapies are safe and effective for their intended uses. is entailed reallocating resources which slowed down non-essential (non-COVID) reviews. Johnson: As a medical device, what level of cer- tification is the Fluo Labs device? Enemaerke: We are satisfying the requisite ISO standards for medical devices. Johnson: Can you describe your manufacturing supply chain? Does this device require any spe- cialized printed circuit board technologies? Enemaerke: ere are multiple sources for components. e design of the PCB is unique to the device and most PCB/SMD manufac- tures are capable of producing large volume production runs. SMT007 body from making histamine, nasal corticoster- oids help control inflammation in the nose that is caused by AR, and immunotherapy shots de- crease the immune response to particular aller- gens over time. While antihistamines provide rapid relief, nas- al corticosteroids take several days before they become effective—requiring users to "prime" their body—and immunotherapy requires a three- to five-year treatment plan and frequent office visits.