to engage and empower millions of people to quit tobacco
Pivot (www.pivot.co, built by Carrot Inc.) is a modern, mobile, evidence-based, massively scalable, preventive service to engage and empower millions of people to quit tobacco, including combustible (i.e., cigarettes), vaporized (i.e. e-cigs), and smokeless forms of tobacco. Why is this SO important? Because more than 50m adults use tobacco in the US (over 1B globally) and every day 2,000 US kids try their first cigarette often leading to a lifetime of adult addiction. Tobacco use remains the leading cause of preventable illness, death, and health care costs in the U.S., with 480,000 annual deaths and $325 billion in annual health care expenditures and lost productivity. Globally, tobacco kills 7,100,000 people per year and costs the global economy over $1,400,000,000,000 per year (yep, that's Trillions). In the last 18 months, COVID killed 4m people while tobacco killed 11m people. Helping a person quit tobacco can reduce the lifetime risk for more than 60 deadly diseases and can add about 10 years to life expectancy. The US Preventive Services Task Force rates tobacco cessation as a "Grade A" and the ACA mandates we offer tobacco cessation broadly. There is no bigger unmet need in public health than helping people quit tobacco, and yet there has been minimal innovation and investment in this space. The last new drug was in 2006 and before Pivot, there has never been an OTC medical device to help people quit tobacco. We must do better.
Pivot (www.pivot.co) is a consumer grade, evidence-based digital health solution designed to help people quit tobacco. Pivot's key features include personalization of the user experience, proven behavioral change techniques, community support, tobacco treatment specialist coaching, FDA approved medication, the only personal carbon monoxide breath sensor on the market (cleared by FDA for OTC use) which helps a user build motivation to quit and track their progress to quitting, and a killer UX. In June 2021, Pivot received expanded indications from FDA and new labeling claims for the product, allowing claims of increased motivation, reduction in cigarette consumption, and increased quit attempts. Pivot recognizes that quitting tobacco takes time, so we offer the program as a 12 month subscription service. Pivot helps a user determine their optimal path among various personalized pathways suited to their stage of change such as "Learn" (no quitting required, no stress, just learning, building motivation, getting support, using CO sensor, joining community), "Reduce" (using practice quits and the CO sensor, users set goals for daily reduction in their tobacco consumption), "Set a Plan to Quit" (set a quit date in the next 30 days, get your nicotine replacement therapy via the app subscription, and gather your support as you prepare to quit), and "Maintain My Quit" (long term support and recidivism prevention).
Most quit programs provide five telephonic coaching sessions and nicotine replacement therapy over 8 weeks. We believe that telephonic coaching for a behavior that carries a 55% mortality rate is not sufficient to address this public health crisis. Instead, Pivot is a 12 month program with a voice that allows and welcomes any tobacco user to join. Personalization of the path is imperative to meet the needs of a diverse user population. Pivot provides all of the interventions and experiences that have been shown to be effective in the evidence base (HHS practice guideline), including behavioral change, coaching, community, and pharmacotherapy. The most differentiated component of Pivot is its FDA cleared (OTC) carbon monoxide breath sensor, which provides a real time CO value to users. The Pivot Sensor is the only CO sensor on the market with OTC clearance and outcomes claims in a cleared 510k. CO rises abruptly in the bloodstream and exhaled breath with use of combustible tobacco, then decreases with a half-life of about 4 hours during abstinence. Use of the sensor provides a personal closed feedback loop for the user (much like a digital scale for weight loss), which has been shown in several clinical trials to increase motivation to quit, prompt practice quits and 24-hour quit attempts, reduce tobacco use, and lead to successful sustained quits.
The Pivot CO breath sensor is a class II medical device (510k cleared), designed, tested and manufactured according to FDA regulations. In addition to bench testing, we conducted multiple human factors studies to enable the product to be labeled for consumer use (OTC). Subjects were evaluated for their ability to comprehend packaging, labeling, and use of the device. A clinical trial showed use of the sensor resulted in a significant increase in motivation to quit, increase in quit attempts, reduction in cigarette consumption. The sensor received clearance of a new 510k with expanded indications for use and outcomes claims related to this study. Participant quote, "The sensor motivated me to quit smoking. You can read or be told how bad smoking is for you, but seeing the results on the sensor was my wake up call. The proof is right there in front if you!" The full Pivot Program has been evaluated in a number of prospective clinical trials, including the largest study to date published in JMIR. Participants (n=319) were long-term (27 years) heavy smokers (18 cigarettes per day). 67% were not ready to quit at enrollment. During 7-mo follow-up, 72% made at least one 24-hour quit attempt. At 7-mo, 31% were quit (ITT, 30d without a single puff). Those not quit had reduced their consumption by 30%. Quit rates were the same in cohorts "ready to quit" and "not ready to quit." Three year data will be published in 2021, and show quit rates are holding at 30%.
Pivot addresses the number one cause of preventable morbidity, mortality, and health care costs on this planet, delivering proven tobacco cessation techniques in a scalable digital vector and a killer UX. Imagine eliminating 60+ preventable illnesses with a single digital solution! It can and will be done!