Rethinking
Nicotine Cessation
14 million Americans want to quit vaping.
Users know the therapies on the shelf were never built for them. So they go it alone, cold turkey. There has to be a better way.
Structured Nicotine Control
NicX replaces impulsive nicotine use with a controlled, phased system. Five devices. Decreasing nicotine levels. Timed dosage windows. Enforced lockout periods. No willpower required.
The device does the work. You just follow the system.
The Road to Approval
De Novo through FDA's device center: the slow path, chosen on purpose. The grant creates a new device classification, and every follower must clear special controls we helped define.
*FDA marketing authorization is not guaranteed. NicX is an investigational product. It has not been evaluated, cleared, or approved by the FDA and is not available for sale. Dates are targets set with our regulatory consultant, sequenced to FDA Q-Sub and combination-product guidance, and will be refined with counsel; FDA's MDUFA goal for De Novo review is 150 days and our plan assumes roughly 250 including information requests. NicX AI is in development: features and timing may change, and any adaptive behavior ships only after validation inside the regulatory program. This is the path we intend to walk, not a commitment or a schedule.
