//Pre-clinical testing further substantiates Pulze’s harm reduction potential

TWO NEW PIECES OF IN-VITRO TESTING CONDUCTED BY IMPERIAL BRANDS SCIENCE PRESENT FURTHER EVIDENCE OF HEATED TOBACCO’S HARM REDUCTION POTENTIAL COMPARED TO COMBUSTIBLE CIGARETTE SMOKING. MATTHEW STEVENSON, INVESTIGATIVE AND MECHANISTIC TOXICOLOGY SENIOR MANAGER, EXPLAINS.

Pulze is our innovative heated tobacco (HT) device which heats – but doesn’t burn – a portion of reconstituted tobacco contained in its iD stick consumable. The resulting aerosol contains the nicotine and tobacco aromas adult smokers desire, but alongside fewer and lower levels of harmful chemicals (up to 96%) compared to combustible cigarette smoke.

To understand the impact exposure to this chemically less complex aerosol has on human cells, our scientists tested Pulze and its iD tobacco consumables in two pre-clinical assays: scratch wound and 3D lung model.

The tests assess cardiovascular disease and lung toxicity endpoints respectively, and feature as part of our broader alternatives to animal testing framework, which – as endorsed by PETA − prioritises human-relevant in-vitro assays over in-vivo studies using laboratory animals.

1. Scratch wound assay

This test uses endothelial cells (the single cell-thick layer that lines all human blood vessels) which help maintain healthy cardiovascular function. In the body, these cells help prevent blood coagulation, as well as helping control blood clotting and flow via vascular contraction and relaxation.

In this assay, researchers make a scratch in a layer of endothelial cells. The time taken for the cells to fill (‘heal’) the ensuing gap (‘wound’) is then measured.

As the above microscopy footage shows, combustible cigarette smoke exposure causes the gap in the cell to close at a dramatically slower rate compared to the air control. While the aerosol produced by the Pulze device and iD consumable does demonstrate some inhibition of endothelial cell movement, the wound closes at a significantly more rapid rate than with the cells exposed to cigarette smoke.

1. 3D lung model (cilia beat frequency)

The second test mimics human lung (bronchial) tissue. Although a number of different respiratory-related tests can be conducted using this model, this specific experiment focused solely on the cilia  − mobile hair-like structures that line human airways.

As part of their normal behaviour, cilia ‘beat’ – gently clearing the human airway of mucus and trapped dirt particles to assist lung function. In this assay, researchers looked for changes to the normal cilia beat activity.

As the above microscopy footage demonstrates, combustible cigarette smoke significantly inhibits the cilia beat frequency, which is visible in the air control. The aerosol produced by the Pulze device and iD consumable, however, has less of an impact on the cilia, with the cells continuing to beat for the duration of the experiment.

Overall, these preclinical laboratory studies show the aerosol produced by the Pulze and iD had appreciably less biological impact on both endothelial and bronchial cells compared to combustible cigarette smoke.

These findings add to the broader body of scientific literature evidencing heated tobacco’s harm reduction potential; in this case specifically, how HT aerosols demonstrate a reduced biological impact on several endpoints of smoking-related disease compared to combustible cigarette smoke.

The studies also provide us with the confidence to proceed with Pulze and iD’s scientific substantiation, including further pre-clinical studies on other smoking-related disease endpoints and research in clinical settings, as we look to make a meaningful contribution to tobacco harm reduction through our portfolio of Next Generation Products.

For more information on Pulze, or the wider category, take a look at our range of infographics and blogs on the science of heating without burning, our recent pre-market perceptions and behavioural study and the device’s further preliminary pre-clinical testing.

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