NicX | Rethinking Nicotine Cessation
Pre-Clearance  |  Investigational Device

Rethinking
Nicotine Cessation

Five phases. 45 mg/mL down to 5.
Enforced by the firmware, not by willpower.

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The NicX device beside its white pod unit, display showing lockout timer, hits, cycles, and nicotine reduced.
The Problem

Nicotine Use Isn't Binary

Most cessation tools assume people can simply stop. They can't. Behavior exists between intention and impulse. Meaningful change requires structure, not willpower.

0%
Cold-turkey success rate
American Cancer Society
0%
Of quit attempts fail within 6 months
CDC
0%
Long-term NRT success rate
Cochrane Reviews
Introducing NicX

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.

Explore the Technology See the Science
Pipeline

The Road to Approval

Eighteen stages stand between a working prototype and a product you can actually buy. We have finished three. This is the whole road, including the parts most companies leave off the chart.

Scroll right. It keeps going. →
Foundation
Regulatory Groundwork
Clinical
Verification & Quality
Submission
Market
Program
Concept & IP
Prototype & Firmware
Formulation
Usability Pilot
Jurisdiction Determination
FDA Pre-Submission
Feasibility Study
IDE Approval
Pivotal Trial
Design Freeze
Safety & Software Validation
QMS & Manufacturing
De Novo Request
FDA Review
Marketing Authorization*
Post-Market Surveillance
Payer Coverage
Commercial Launch
NICX-01
Firmware-enforced nicotine reduction. Adults who vape.
3 of 18 complete
NICX-02
Adaptive companion system. Personalises pace inside the protocol.
1 of 18 complete
Complete In progress Not started Not applicable

*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. The usability pilot is product testing, not a clinical investigation: it has no IRB oversight, no control group, and no independent measurement, and its results will not be submitted to FDA or presented as clinical evidence. Stages are drawn in sequence but are not equal in cost, duration, or risk, and several run in parallel. Authorization is also not the finish line: coverage and reimbursement are a separate fight, and plenty of cleared devices never win it. This is the path we intend to walk, not a commitment or a schedule.

Technology

Addiction Has Evolved.
Treatment Hasn't.

Nicotine delivery has become faster, more discreet, and increasingly potent. But cessation tools remain unchanged: patches, gums, and prescriptions that address chemistry while ignoring the behavioral loop that keeps people dependent.

Most people who try to quit do so without any structured support. The result is a failure rate above 90%.

The NicX device beside its pod. The screen shows a lockout countdown of 12:45, 8 of 20 hits used, 2 of 12 cycles completed, and 1,240 mg of nicotine reduced.
NicX device, current hardware revision
The Device

The rules live in the firmware.

Not in an app you can close. Not in a plan you can talk yourself out of. Every limit is enforced on the device itself. The screen just shows you where you stand.

Lockout

Time remaining until the device unlocks again. It counts down on its own. No skip, no reset, no override.

Hits

Draws used in the current session, against the limit set by your phase.

Cycles

Sessions completed today, against the daily allowance. When the last one closes, the day is done.

Nicotine Reduced

Total milligrams avoided since day one. Progress you can read, not estimate.

The NicX System

Three Mechanisms. One System.

▽

Phased Nicotine Reduction

Five devices, each with a lower nicotine concentration. The chemical dependency decreases gradually, without withdrawal shock.

◷

Timed Dosage Control

Each session is measured in seconds, not puffs. The device tracks active inhalation time and enforces a hard stop when the session ends.

▣

Smart-Lock System

After each session, the device enters an enforced lockout period. No override. No workaround. The brain gets space to reset between exposures.

Session Active
0:20
Active draw time remaining
Smart-Lock cycle, demonstration
The Protocol

Five Phases. One Descent.

45mg
Phase 1Stabilize
Establish a baseline. Maintain familiarity while introducing structure.
35mg
Phase 2Introduce Intention
Shift use from impulse to conscious choice. Spacing increases.
25mg
Phase 3Reduce Dependency
Lower reliance through structured adjustment. Tolerance drops.
15mg
Phase 4Reinforce Control
Confidence builds. Patterns evolve. Dependence fades.
5mg
Phase 5Transition to Autonomy
Control replaces habit. The system has done its work.
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Adaptive AI In Development

The Power of a Thousand Addiction Specialists.
In Your Pocket.

The NicX companion app will use adaptive AI to personalize every aspect of the cessation journey.

A system that learns you.

Based on daily check-ins, usage patterns, and behavioral data, the system is designed to adjust in real time, modifying lockout periods, session lengths, and coaching prompts to match each user's progress. Every journey is different. The plan should be too.

Personalized Plans

AI-guided, phase-based support rooted in behavioral science. The protocol adapts to your pace, not a fixed calendar.

Real-Time Adaptation

The device responds to you, not the other way around. Struggling days get more structure. Strong days earn more autonomy.

Progress Tracking

A visual dashboard showing your journey across all five phases: sessions, lockouts, cravings, and total nicotine reduced.

Age-Gated Access

Built-in ID verification to ensure responsible use, designed in from day one.

NICXPHASE 3 · DAY 12
Good morning, Sam
You're ahead of schedule this week.
62%To Phase 4
Nicotine reduced1,240 mg
Next unlock12:45
Sessions today2 of 6
Coach

Cravings usually peak around 3pm for you. A short walk before then has helped 4 of your last 5 tough days.

Concept interface. Companion app in development.
Why Connected Matters

The device holds the line.
The app moves it.

The hardware enforces the plan. The intelligence refines it. Together, they are designed to form a closed loop: the device generates real behavioral data, the system learns from it, and the plan gets sharper with every session. That is the future NicX is building toward.

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Science

The Science Behind
Structured Cessation

NicX is designed around three clinically recognized drivers of nicotine addiction: chemical dependence, behavioral conditioning, and psychological reinforcement.

The protocol is designed to act on all three at once. Whether it does is what the study is for.

⌬

Chemical Dependence

Phased nicotine reduction gives the brain time to recalibrate receptor sensitivity without dopamine collapse.

↻

Behavioral Conditioning

Timed lockouts disrupt the compulsive use cycle, forcing intentional pauses that break habitual patterns.

▲

Psychological Reinforcement

Phase progress and cumulative reduction are shown on the device, so the work is something you can see rather than something you have to feel.

Clinical Status

NicX is an investigational product. It has not been evaluated, cleared, or approved by the FDA and it is not available for sale.

We are pursuing clinical collaborations with academic medical institutions to build our evidence base.

We have no efficacy data. When we have data worth publishing, we will publish it, whichever way it goes.

Patent protection has been filed covering our phased reduction hardware and smart-lock system.
Follow Our Progress
About

Built by the Generation
Most Affected

NicX was founded in Cleveland, Ohio by a team that grew up watching nicotine reshape a generation.

We are engineers, operators, and problem-solvers who believe cessation should be built into the technology itself, not left to willpower alone.

Our mission is to set a new standard for nicotine cessation: one built on science, driven by empathy, and designed for the modern world.

ND

Nick Dottore

Founder & CEO

Division 1 athlete turned entrepreneur. Marketing degree from Morehead State University.

WD

William Dottore

Co-Founder & Lead Engineer

Firmware and hardware lead. Architect of the smart-lock system and the device platform behind the five-phase protocol.

DG

David George

Partner & CFO

Operations and finance. Supports partnerships, planning, and the business infrastructure behind the mission.

AH

Aidan Henson

Partner & CMO

Brand and marketing lead. Drives creative direction, storytelling, and how NicX shows up in the world.

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Updates

Progress & Milestones

Short, factual, and current. This is where the work shows.

July 2026Now
Usability pilot begins. Twelve people who vape are running the full ten-week protocol on our hardware. We are testing whether the firmware holds, whether the lockout survives real life, and where the protocol breaks. This is product testing, not a clinical trial. It has no IRB and no independent measurement, and we will not present it as evidence.
June 2026
Regulatory strategy defined. De Novo through FDA's device center is our target pathway, with a formal request for jurisdiction as the first filing.
May 2026
Firmware running the protocol on real hardware. Session limits, lockout timing, and the phased step-down all enforced on the device itself. No phone required. No override path.
April 2026
Custom board fabricated. First run of our own PCBA built with our manufacturing partner and in hand for bring-up and test.
February 2026
International patent application published. WO 2026/085378, covering the phased reduction hardware and the lockout system.
2025
The foundation. Patent filed. First working prototypes built by hand. E-liquid formulated across all five concentrations, 45 mg/mL down to 5. Manufacturing partner secured.
Get Updates First
FAQ

Questions,
answered plainly.

If any answer below reads like a dodge, tell us. We would rather be clear than flattering.

The Device
What is NicX?

A nicotine reduction device. It delivers nicotine on a schedule that steps down through five phases, and that schedule is enforced by the firmware rather than by you. Each session is capped. Between sessions, the device locks.

How is this different from patches, gum, or a quit app?

Those hand you a tool and leave the decision with you. Every single time. NicX moves the decision into the hardware. The device holds the limit on the days you do not feel like holding it.

Can I override the lockout?

No. There is no code, no reset, no hidden setting. While the lockout is running, the device will not fire. That is the entire point of it.

What stops me from just buying a normal vape instead?

Nothing, and we are not going to pretend otherwise. NicX is not a cage.

What it removes is the hundred small decisions a day that willpower normally has to win. Abandoning the plan entirely is one large decision, and a much harder one to make quietly. That difference is the whole design.

Do I need the phone app?

No. The protocol runs on the device. The companion app is still in development, and it is designed to personalise the plan, not to enforce it. The device works with no phone anywhere near it.

What nicotine strengths does NicX use?

Five phases, stepping down from 45 mg/mL to 5 mg/mL.

The Protocol
How long does it take?

Roughly ten weeks across the five phases. You start at your normal strength and finish at the lowest one.

What happens when I finish?

You complete Phase 5 at the lowest strength, and you stop. There is no Phase 6. The device is built to make itself unnecessary.

What if I fall behind or slip?

The current protocol is fixed, deliberately. The adaptive companion system in development is intended to let the plan bend to the person instead of the other way around. We will have far more to say about that once we have study data.

Evidence & Status
Is NicX approved by the regulator?

No. NicX is an investigational product. It has not been evaluated, cleared, or approved by the FDA, and it is not available for sale. We are pursuing a De Novo pathway through FDA's device center. Authorization is not guaranteed.

Is there evidence that NicX works?

No. And we are not going to dress up what we have.

We are running a usability pilot with twelve people who vape. It has no IRB, no control group, and no independent measurement, so it cannot tell us whether NicX works. It can tell us whether the device survives ten weeks in someone's pocket, whether the firmware holds, and where the protocol breaks. That is what it is for.

Real evidence needs a real trial, with oversight and a control arm. That is ahead of us, not behind us. Everything on this site describes what the device does. None of it is a claim about what the device achieves.

Is nicotine itself harmful?

Nicotine is the compound that creates and sustains dependence. It is addictive, it acts on the cardiovascular system, and it is not safe for adolescents or during pregnancy.

NicX is not a health product and makes no safety claims. It exists to reduce dependence on nicotine, not to defend it.

When will NicX be available, and what will it cost?

We have not set a launch date or a price. Both depend on a regulatory path we are still walking. The waitlist is the fastest way to hear it first.

Practical
Who can use NicX?

Adults who already vape and want to stop. You must be 21 or older. NicX is not for people who do not currently use nicotine.

What happens to my data?

The device keeps its own usage record. The companion app has not shipped, and we will publish a full privacy policy before it does. We will not sell your data.

Can I invest, partner, or collaborate on research?

Yes, and we want to hear from you. Write to [email protected] and say which one.

Still have a question?

Join the Waitlist
Waitlist

Be the first to know
when NicX moves.

One field. No spam. Real milestones only, and the data when we have it.

Prefer email? Reach us directly at [email protected]

Future Users

Where the study lands, and what it means for people who want to stop.

Clinicians & Researchers

Updates on our trial, protocol, and collaboration opportunities.

Investors & Partners

Milestone announcements as we move through development and regulatory strategy.

NicX
NicX Labs  |  Cleveland, Ohio  |  [email protected] |  (216) 906-0481
© 2026 NicX. All Rights Reserved. NicX is a pre-clinical product in development. It has not been evaluated, cleared, or approved by the FDA.