Company Announcements

July 16, 2021

Pivot’s Breath Sensor Receives Expanded Indications for Use from FDA


The Only Over-The-Counter Device that Increases Motivation to Quit Smoking

REDWOOD CITY, Calif., July 12, 2021 (GLOBE NEWSWIRE) — Carrot Inc., a digital health company committed to helping people quit tobacco, today announced that its Pivot Carbon Monoxide Breath Sensor has received expanded indications for use in a new 510k clearance by the Food and Drug Administration (FDA) based on published clinical trial data.

As the only over-the-counter, FDA-cleared breath sensor for smoking cessation, Pivot’s Carbon Monoxide Breath Sensor provides innovative technology that goes beyond measuring the impact of smoking cessation: The sensor has now been proven to increase a person’s motivation to quit. The new FDA clearance allows Carrot to highlight this expanded indication in its labeling and promotion of the sensor.

Carrot CEO and former Stanford head and neck cancer surgeon David S. Utley, M.D. said, “This is a significant breakthrough in smoking cessation. The emergence of an over-the-counter breath sensor that can help people quit tobacco is comparable to when consumer grade glucose meters became available, empowering people in their own diabetes care.”

He added, “Smoking is a huge health problem in the US today, more significant than people realize – 50 million people use tobacco in the US, which is a bigger problem than Type 2 Diabetes affecting about 32 million people.”

Tobacco is the leading cause of preventable death in the US, killing 480,000 US adults every year (60,000 of whom die from second-hand smoke). Quitting smoking can greatly reduce the risk of premature death and can add as many as 10 years to life expectancy (CDC).

In the clinical trial supporting the expanded indications of the Pivot Breath Sensor, Carrot tested the device with 234 heavy tobacco users. They were simply asked to use the sensor to learn how their tobacco use impacts their CO levels.

When a person inhales smoke from a cigarette, carbon monoxide in the smoke is rapidly absorbed into the bloodstream. The sensor measures and tracks CO in exhaled breath as the body eliminates CO from the bloodstream. Only 15% of the study population were thinking about quitting tobacco at the onset of the study. Over the course of 90 days, participants logged more than 48,000 breath samples, an average of over 200 per person. The use of the breath sensor resulted in more than tripling the number of participants who were ready to quit tobacco – from 15% to 48%. And perhaps even more impressive, 39% of participants cut their tobacco use by more than half in just 90 days of sensor use, and 48% of participants reported quits lasting more than 24 hours.

Dr. Utley added, “For the first time, people who smoke no longer have to look at quitting tobacco as a daunting, all or nothing event. This study showed that the sensor helped users increase their motivation to quit, decrease their cigarette consumption, and make a significant number of 24-hour quit attempts. We can now include these claims in our labeling to help more tobacco users learn about how the sensor can help them change their behavior.”

The Pivot Breath Sensor is one component of Carrot’s innovative, evidence-based Pivot tobacco cessation program, which has published clinical trial data demonstrating a 35% quit rate. The Pivot mobile app provides unprecedented behavioral change support based on cognitive behavioral therapy and self-determination theory. This isn’t a ‘one size fits all’ program: A user can choose from different paths for their journey, including learning and skills building, reduction, quit, or maintenance of quit.

Pivot users aren’t alone in their smoking cessation journey. Users are assigned a dedicated certified tobacco treatment coach for as long as they are in the program. All coaching takes place via secure in-app texting – no scheduling, no phone calls, just the support a user needs, when they want it. Nicotine replacement therapy is ordered in-app and is a proven component of evidence-based quit programs. The Pivot Community provides peer support for all users and means they are never in this alone.

Pivot is offered as a benefit through employers and health plans. Carrot has teamed up with organizations including Sportsman’s Warehouse, New York Life and BlueCross BlueShield of North Carolina to help transform the health of those struggling with both smoking cessation and ailments associated with the risks of smoking. Pivot is also available for individual purchase at pivot.co.

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Our first product, Pivot, marks a major rethinking of why and how people can quit smoking.