# Hale: A Mobile-Connected Medical Vaporizer that Alleviates Nicotine Dependence

> **NIH NIH R41** · HAVA HEALTH INC · 2022 · $278,283

## Abstract

PROJECT SUMMARY
Cigarette smoking is a significant public health concern impacting 34 million adults in the USA by increasing their
risk for cancer and cardiovascular disease, including 16 million living with chronic smoking-related diseases.
National campaigns for smoking cessation have been promoted by public authorities, and other groups. In
addition, pharmaceutical-grade nicotine replacement therapy (NRT) products have been developed to assist with
cessation (gums, lozenges, patches, etc.). Sadly, current standard NRT dosing is not effective for many smokers
since nicotine is provided at much lower doses than cigarettes. Many smokers switched to using e-cigarettes
(ECs) with cartridges (electronic nicotine delivery systems or ENDS). ENDS closely mimic the act of smoking
and provide rapid nicotine dosing that can be scaled back manually. Recent studies have shown limited
effectiveness data in support of the continued use of EC in smoking cessation plans, but more data are needed.
Hence, effectiveness must still be improved for NRTs since addiction is complex, and current NRTs lack similar
nicotine dosing and sensorimotor mimicking compared to smoking cigarettes. This highlights a significant,
unmet clinical need for an NRT combining the behavioral aspects of smoking with automated nicotine
dosing. Hava Health Inc. leverages these behavioral aspects with flavorless formulations and automated,
gradual nicotine reduction controlled by an app to improve smoking cessation. Therefore, the goal of this
Phase I project is the development of Have Health’s Hale Vaporizer System, a proprietary NRT using an
automated ENDS including the Hale vapor device, flavorless nicotine formulations, and a phone app that
automatically lowers nicotine intake gradually over time. For Specific Aim 1, testing will be conducted of the
Hale vaporizer’s performance and aerosol safety profile with a finished version of the device. This will include
device safety testing in aerosolizing custom nicotine and non-nicotine formulations. In Specific Aim 2, a limited
in vivo dose-range finding study to translate former findings to a more clinically relevant model. Studies will be
initiated in rats introduced to aerosol via smoke machines, in a repeat dose nose-only inhalation toxicology study.
At specified time points post exposure to vapor, we propose collecting and testing: a) blood for nicotine
concentration b) lung tissue for toxic or tissue specific effects. To our knowledge, no commercially available NRT
is available using flavorless nicotine formulations and an automated electronic delivery system that is not
manually adjusted by the patient. The proposed studies are necessary for further development of the Hale
Vaporizer System into a best-in-class NRT to help improve compliance by aiding smokers along the path to
smoking cessation in a timely manner.

## Key facts

- **NIH application ID:** 10601467
- **Project number:** 1R41DA057798-01
- **Recipient organization:** HAVA HEALTH INC
- **Principal Investigator:** Joshua Israel
- **Activity code:** R41 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $278,283
- **Award type:** 1
- **Project period:** 2022-09-30 → 2024-09-29

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10601467

## Citation

> US National Institutes of Health, RePORTER application 10601467, Hale: A Mobile-Connected Medical Vaporizer that Alleviates Nicotine Dependence (1R41DA057798-01). Retrieved via AI Analytics 2026-05-27 from https://api.ai-analytics.org/grant/nih/10601467. Licensed CC0.

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