IoT-Based Smart-Toilet and Mobile App for Passively Quantifying Objective Urinary Biomarkers of Dietary Intake and Personalizing Nutrition Guidance

Executive SummaryAccording to the American Heart Association (AHA), roughly 46% of the U.S. adult population suffers from high blood pressure (hypertension). Hypertension is one of the largest modifiable risk factors for heart disease, stroke, and renal failure and costs the U.S. healthcare system an estimated $131B annually. Prevalence continues to rise, and a 50% drop-off in medication adherence highlights existing shortfalls in solutions for combatting one of the nation’s largest healthcare burdens. Meanwhile, dietary modifications demonstrate the capability to meet or exceed anti-hypertensive medication endpoints for many individuals with hypertension and resistant hypertension. Although guidelines recommend lifestyle modifications as a first line treatment, little effort is often placed on this intervention. Dietary interventions incorporating self- monitoring (tracking oneandapos;s own food-related behavior) and feedback on performance significantly increase dietary self-efficacy, a factor that amplifies knowledge-based behavior-change interventions. As demonstrated by several recent controlled trials, tracking urinary sodium as a biomarker for dietary sodium intake helps individuals decrease sodium intake and reduce blood pressure. Yet getting individuals to perform consistent, routine diagnostic evaluations is exceedingly difficult. The most effective route for routine monitoring of health data is through passive testing where the individual’s burden is as nonexistent as possible. Urinalysis is a large market for an array of clinical diagnoses as well as biomarkers of lifestyle management like dietary intake and nutritional status. Meanwhile, each of us urinates daily at home, wasting good personal health data in the process. There is a clinical and commercial opportunity for ubiquitous and routine home urine testing using a smart-toilet. Bender Tech (BT) has developed multiplexed biosensors, hardware, and wireless electronics capable of integrating with a home toilet for routine urinalysis for health and wellness monitoring. SA1: Develop Electrochemical Working Electrode Specific to Sodium: We have identified and tested stable electrochemical ink formulations that have demonstrated reactivity to sodium in physiologically relevant ranges. Sensitivity testing is ongoing. SA2: Characterize and Eliminate Potential Interference and Non-Specific Interactions: Initial testing of potentially interfering ions (potassium, calcium, magnesium) shows ability to differentiate signal output. Interference testing and optimization is ongoing. SA3: Integrate Existing Biosensors and Wireless Potentiostat into Passive, Smart-Toilet Design: Various biosensors have been tested in our hardware without damage or increase in measurement CV. Full system testing will be repeated once our final electrochemical ink formulation and processing techniques have been derived.Michael Bender, CEO, is a cofounder and head of business development and software development. Brian Bender, PhD, is a cofounder and the PI on grant 1-R43-MD014073-01. Dr. Bender is leading the biosensor development work that is central to the current SBIR Phase I grant. Nick Johnson is a serial entrepreneur and BT’s industry expert. Nick has worked in new product development from ideation through to commercialization as the CTO for ShiftWear and Squats and Science within the fitness and wellness industry, serves as the Head of Samford Innovation Week’s Startup andamp; Entrepreneurship Committee, and serves as an IoT and lean startup methodology consultant for both startups and large corporations alike. Each team member has committed to the time requirements of the NIH I-Corps program.I-Corps TeamThe team consists of Brian Bender, PhD, Michael Bender, and Nick Johnson. Brian and Michael are co-founders of Bender Tech, LLC (BT) and have been developing the core technology since its founding in late 2016. Brian is the principal investigator (PI) on the NIH SBIR Phase I grant associated with this I-Corps application. Brian invented the proof-of-concept product and is leading the research and development team towards meeting its milestones. Brian has worked for UCLA’s technology transfer office and has participated in several entrepreneurial programs including the StartupUCLA accelerator, the Wasabi Ventures Academy, Cal State LA’s Biostart Boot Camp, and NC’s RIoT accelerator program. Michael is an experienced entrepreneur, having previously founded and managed a niche e-commerce company from 2008 to 2018. Michael was instrumental in developing business channels through major partnerships with ABC, NBC, and FOX, and has currently been leading business development for BT. Mr. Johnson is a serial entrepreneur with experience bringing consumer hardware and wellness products to market. Mr. Johnson has founded and led multiple companies in the IoT space, and he has served as CTO for ShiftWear and Squats and Science creating successful fitness and wellness product. Mr. Johnson is Head of Samford Innovation Week’s Startups andamp; Entrepreneurship Committee and serves as an advisor to both startups and large-scale corporate innovation arms on lean startup methodology as founder and CEO of Proto Ventures. Each member of the BT I-Corps team is committed and able to meet the travel and time requirements of the 8-week NIH I-Corps program. Benefit of NIH I-CorpsBT is also the recipient of an NSF SBIR Phase I grant (1913434) for the development of other technologies associated with our final health and wellness product. Michael and Brian recently completed the NSF’s Boot Camp program, interviewing over 30 potential customers and presenting our lessons learned at the NSF Grantee Workshop in September (‘19). In short, we found the experience incredibly insightful. We started gaining experience with better interviewing strategies as well as strategies for getting interviews with potential customers. Our interviews covered a wide range of our industry ecosystem in order to gain a better understanding of the healthcare space. Not only did we learn a great deal about this ecosystem, we also started to get a better understanding of customer needs that led us towards investigation of a consumer path. We have integrated the customer discovery process now into our routine and have continued interviews long past the Boot Camp, but we realize we have only scratched the surface with our customer discovery process and would highly value the mentorship, guidance, and oversight of the NIH I- Corps program. This experience has driven our desire to participate in a full I-Corps immersion, and we were excited to learn that the NIH’s program will specifically be geared towards healthcare.The BT team is willing to pivot its commercialization strategy based upon the learnings from the I-Corp program. BT has developed several hypotheses, but it is willing to test these hypotheses and change its business model or product design to reflect changes. Our product is still in pre-market development and is at the right time to make changes to feature-sets or go-to-market strategies.