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"Does Revelar really work?"

The Revelar device has been developed using exacting testing to insure its precision and consistency. The Coefficient of Variation (CV) is a calculation of the precision of a testing device. This is expressed in a +/- percentage format. An acceptable CV range for physiological devices is +/- 10%. The Revelar device is currently testing below that. The Pulse Science Advisory Board has consulted with statisticians and scientists and is satisfied that Revelar accurately measures free radical damage.

"What does Revelar measure?"

Revelar measures a patient's baseline aldehyde level and provides a numerical score. Aldehydes are known by-products of free radical damage, and have historically been measured in more expensive blood tests.

"What else do we know about Aldehydes?"

Aldehydes are the end product of a process that breaks down phospholipids via a chemical chain reaction that starts with the formation of unstable compounds known as lipid hydroperoxides and ends with aldehyde release. Numerous studies over the past three decades using tissue or plasma samples have shown that certain low molecular weight compounds aldehydes are very effective biomarkers of oxidative stress.

"What is Oxidative Stress?"

Each cell in our bodies is surrounded by a membrane made up of high molecular weight unsaturated fatty acid molecules called phospholipids. When the body does not have enough natural antioxidants to protect it from the reactive oxygen based free radicals that we produce as a byproduct of breathing (collectively known as reactive oxygen species, or ROS), these phospholipids (as well as proteins and DNA) can be attacked by the excess free radicals present, resulting in a condition we call oxidative stress. Many diseases, as well as exposure to toxins are known to cause oxidative stress; these can include heart disease, cancer, autoimmune and neurodegenerative diseases, rapid aging and others (M. Trevisan, American Journal of Epidemiology 2001).

"Why not measure aldehydes with one of the blood tests?"

Several reasons. The blood tests are not as accurate. The previous gold standard, TBARs, has been widely criticized in large part because it measures a single aldehyde, MDA. Revelar measures multiple aldehydes, including important saturated aldehydes found in the gas phase of breath. This provides a more representative biological picture. In addition, Pulse created a breath test so that patients can easily and non-invasively take the test. This is key to making Revelar useful to your patients and you.

"How specifically does Revelar measure only Aldehydes?"

The Revelar reagent is extremely specific. Other reagents are known to react with aldehydes, but they also react with structurally related molecules like ketones (normally generated in the body by the breakdown of carbohydrates and amino acids) and thus would not provide results that are highly specific. In contrast, the Revelar reagent shows very low reactivity with such non-relevant compounds, especially those known to be present in exhaled breath. For example, it shows almost no reactivity with the ketones 2-butanone or acetone (the latter is a natural metabolite that is normally present at low levels in breath, elevated in the breath of diabetics), or with aldehydes such as acetaldehyde, a natural metabolite that is elevated in the breath after drinking alcohol, and salicylaldehyde, an aldehyde that is not produced by oxidative stress.

"How do I describe the score to my patients?"

A good way to describe the score to patients is:

"The test we are about to perform measures the level of aldehydes in your breath. Studies show that aldehydes are direct byproducts of oxidative stress. The higher the score shown by the test, the more aldehydes found in your breath, which may indicate higher oxidative stress. On a scale of 1 -1000, our range in "normal" subjects is between 300 and 900. The higher the score, the higher the aldehyde level."

"Studies show that the lower the level of aldehydes, the better. But here's what's most important: if you can establish a baseline, then you have a starting point to understand your aldehyde levels and can take the steps to reduce those levels. Some of it might be lifestyle; some of it might be genetic. But, by knowing the score, you will have a better idea of how to lower your aldehyde levels and potentially slow down the rate of oxidative stress."

"The device is not a diagnostic instrument nor can it be used to treat, cure or prevent disease. Instead, just like a thermometer, it is a tool to measure the aldehydes in your system and take the steps to lower them, helping to improve your score from the 'base-line' to your 'best-line."

"I don't know how to market."

We understand that doctors learn to help people, and are not necessarily trained to do marketing and business building. The Revelar device tells its own story. It gives the doctor information that allows him or her to make recommendations that can lead to lower aldehyde scores.

"What kind of help will I get from Pulse?"

As a user of the Revelar device, doctors will have access to a system that provides a brief description of the test and which allows doctors to make recommendations to patients, track their behavior, and track their scores. Pulse is completing a web platform that will also allow doctors to track scores.

Pulse also provides account Services for technical support, business issues and marketing support. During business hours a doctor or his or her staff can call or e-mail their questions and get prompt answers.

"Is the device patented?"

The Revelar test is patented — the breath tube technology is subject to a patent approved in October 2007. There are several additional patents pending. The reagent technology is subject to both trade secret protection and patents. The unique reagent is able to detect extremely low concentrations of aldehydes — in the low parts per million — in breath.

"How often should I test?"

In general the patient should be tested first to establish a baseline score and then every 2-3 weeks until you are confident that progress has been made. Test as needed to ensure the patient continues to maintain improved scores.

"Will results vary by patient?"

Yes. The higher the Revelar score, the higher the number of aldehydes. Because of differences in physiology from one person to the next, it is important that the user measure their Revelar score against their own Revelar scores and not the Revelar scores of others. Once a baseline score is established, the goal is to lower that score. A user should always take note of any rise in their Revelar score — regardless of how high or low the baseline score is at the beginning — and understand what may be leading to those higher results.