How is the Emitbio™ RD19 used?

The Emitbio™ RD19 is recommended for use twice daily, for complete 5-minute sessions. It is used in-home for less than one week as a treatment for mild-to-moderate COVID-19.

Who should use the EmitBio RD19 and when?

The Emitbio™ RD19 is intended for use as a treatment for mild-to-moderate COVID-19 in adult patients with positive results of direct SARS-CoV-2 viral testing who are 18 years of age and older.

What does the RD19 do?

The EmitBio™ RD19 directs precise selected wavelengths of visible light through the mouth and on to the pharynx, bathing these areas with a predetermined treatment dose.

How does this help?

People who used the EmitBio RD19 as directed experienced a 99.9% mean reduction of SARS-CoV-2 viral load. Most notably viral load continued to drop even after light treatments had ceased. Recently published evidence shows a clear-cut relationship between SARS-CoV-2 viral load and COVID-19 symptom severity. Furthermore, this light-based therapy was demonstrated to accelerate symptom resolution for patients by more than 48 hours. When the amount of virus in the body was reduced, people got better.

Has the EmitBio RD19 been clinically tested?

Yes. A randomized, placebo-controlled, double-blind Phase I/II clinical trial was conducted.

Where were the clinical studies conducted?

All the EmitBio studies were conducted in the United States and were supervised by experienced and highly qualified 3rd party contract research organizations.

What were the clinical trial results?

In the clinical trial, 4 days of treatment with the EmitBio device achieved a 99.9% reduction in average viral load of SARS-CoV-2 (the virus that causes COVID-19) and accelerated time to symptom resolution in patients by more than 48 hours compared to the control group.

What is viral load and how does it affect a person with COVID-19?

Viral load is simply how much virus you have in your body – in medical terms it refers to how much virus is measured in a standard volume of fluid, like saliva. In our trial, and in other studies, the quantity of virus and total bioburden on the body were strongly correlated with disease outcomes. When you reduce the amount of virus in the body, people get better faster.

So, people who treat with the EmitBio RD19 get better faster?

In our study, coronavirus was eliminated faster with treatment. An analysis of trend over time definitively showed that the people treated with the EmitBio RD19 had a significantly faster decline of SARS-CoV-2 viral load than those who received a placebo.

I thought the problem with this virus was the lungs. How does this help?

The SARS-CoV-2 virus primarily infects cells in the upper respiratory tract (nose and throat) that are rich in the receptors the virus uses to initiate infection. Once infection occurs, SARS-CoV-2 spreads to lower levels of the respiratory tree, including lung tissues that, at times, result in severe pneumonia and death. While severe disease is almost always manifest in the lungs, primary infection generally occurs in the upper airway. Preventing infection or inhibiting replication of the virus in the upper respiratory tract can prevent or minimize spread to the lungs thus mitigating severe COVID-19 pneumonia.

Why are we bathing the pharynx with light?

The surface cells of the pharynx are part of the body's frontline of defense from respiratory pathogens like viruses.

I have heard there are different mutations of the COVID-19 virus. Does it work equally on all mutations?

The EmitBio treatment is mutation resilient. Unlike vaccines and monoclonal antibody treatments, the way the EmitBio treatment works is not dependent on SARS-CoV-2 genetics or configuration of viral spike proteins. This leads to utility as a treatment for currently circulating mutations of the SARS-CoV-2 virus and/or possible future genetic drift.

Are people still infectious while using the device?

Safety was investigated in two separate human studies. In a clinical trial of patients with mild-to-moderate symptoms of COVID-19, with twice daily dosing there were no local reactions or treatment related adverse events attributed to the use of the EmitBio RD19. In a separate study with healthy volunteers, with daily dosing for up to two weeks the treatment was also shown to be well tolerated.

Is this an alternative to a vaccine?

No. This is not a vaccine. It is complementary.

Where does this therapy fit with the COVID-19 vaccines?

This therapy is a complement to vaccines. The fastest way to eliminate COVID-19 in society is by quickly reducing viral load in people with active infections and mitigating transmission to others. The advent of vaccines is a welcome relief, but administering vaccines takes time. Elimination is best achieved through both vaccines and treatments for those who are not yet or choose not to be vaccinated – or for whom the vaccine was not effective.

What does the light treatment do?

Safe doses of visible light effectively create an antiviral environment by inactivating viral particles before they infect the cell and inhibiting viral growth after the virus had infected the cell.

How does the EmitBio RD19 light affect the body?

This unique visible light has also been demonstrated to signal activation of the innate immune response, for example by stimulating the release of the body’s reserves of nitric oxide and increasing endogenous production of nitric oxide in barrier epithelial cells among other things. Numerous scientific studies have shown that Nitric Oxide (NO) is vital to our innate immune response by helping to disrupt infection, inhibit viral reproduction and summon the body’s immune cells to contain, attack, and destroy viral invaders.

What is nitric oxide?

Nitric oxide is a naturally occurring molecule, only two atoms large, that the body produces to regulate blood flow, control inflammation, and defend against invading microorganisms.

Can you have too much nitric oxide?

The body is very adept at controlling nitric oxide production and has several feedback mechanisms in place to regulate too much or too little. Nitric oxide rapidly breaks down into nitrates and nitrites that are easily eliminated from the body.

How long does it take to use the EmitBio RD19?

We recommend using the EmitBio twice daily for five minutes.

How long should I wait between the twice daily uses?

For best results we recommended using the EmitBio RD19 twice a day with sessions about 8 to 12 hours apart. We do not recommend using the EmitBio RD19 with less than 4 hours between sessions.

How long do I have to use the EmitBio RD19?

Using the EmitBio RD19 is recommended for twice daily dosing for up to a week. Each treatment should be for the complete, pre-set five minutes.

What if I miss a treatment at the time I usually treat?

If you are able, treat yourself twice in the same day with the treatments separated by at least 4 hours and preferably 8 to 12 hours apart. If you cannot do this, then restart treatment at the next scheduled treatment time.

If I use it more often than recommended, can it hurt me?

We do not recommend using the EmitBio RD19 more than twice daily for five minutes per session. There may be the possibly of burn injury to the oral mucosa if the device is used excessively and not as specifically directed.

Can I share the EmitBio RD19 with other people?

No, the device is a non-sterile, single user, multiple use device.

Is the EmitBio RD19 FDA approved?

The EmitBio RD19 has received Emergency Use Authorization (EUA) from the United States Food and Drug Administration. EUA is a mechanism to facilitate the availability and use of medical countermeasures during public health emergencies, such as the current COVID-19 pandemic. For more info on FDA EUA see https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization

Are there any contraindications for adults?

Do not use the EmitBio RD19 if: • You have any anatomical pathology or other physical limitation which would prevent you from using the device correctly. • You have any non-removable metal piercings inside of the mouth, including the tongue and cheeks, or orthodontia that would interfere with using the EmitBio RD-X19 device correctly. • You are allergic to the surface materials of the EmitBio RD19.

Can children use this device?

This device was engineered specifically for use in adults and is not recommended for pediatric use.

What powers the EmitBio RD19?

The EmitBio RD19 is powered by a rechargeable lithium battery.

How do I clean and care for the EmitBio RD19?

Follow directions in the instructions for use provided. The EmitBio RD19 should be cleaned frequently enough to maintain good hygiene. The body should not be immersed in water. These parts may be wiped with a damp cloth or paper towel or pre moistened wipes. The light guide and positioner are washable with warm water and soap.

Does it shut off automatically?

Yes. The EmitBio RD19 will shut off at the end of the 5-minute period.

How often do I need to recharge?

The EmitBio RD19 should be fully charged after every treatment and will not function after four treatments without charging.

Can I charge the EmitBio RD19 device in my vehicle?

No. The device must be charged using the supplied AC adapter

Does it come with a 220V adapter?

The charger is a universal power supply and is operational with inputs of 100-240V AC, 50-60 Hz. It is supplied with the US NEMA 2 blade electrical connection. Operation outside of areas that use this standard would require an adaptor kit.

Is there a warranty?

The EmitBio RD19 is covered by a 24 Month Limited Warranty.

Is it safe?

Safety was investigated in two separate human studies. In a clinical trial of patients with mild-to-moderate symptoms of COVID-19, with twice daily dosing there were no local reactions or treatment related adverse events attributed to the use of the EmitBio RD19. In a separate study with healthy volunteers, with daily dosing for up to two weeks the treatment was also shown to be well tolerated.

Why is it safe?

The EmitBio RD19 uses blue light in the visible part of the spectrum to stimulate and boost the body’s natural defenses. There is also a low total light energy. Evidence from photobiological safety studies indicates that, at the light frequency used by the EmitBio RD19, a dose that could result in simple reddening of the tissue (erythema) would need to be over 10 times the dose delivered by the EmitBio RD19. Dental Light Devices have been used safely and routinely for years in the oral cavity – without harm.

Does it use UV rays to kill germs?

The EmitBio RD19 uses Visible Light not UV. The emission spectrum of the light used by the EmitBio RD19 is in the blue range of visible light. Less than 0.009 of the total spectral power is in the UVA range. There are NO MEASURABLE EMISSIONS in either of the dangerous UVB or UVC regions of the spectrum.

What kind of light does it use?

The EmitBio RD19 uses visible blue light.

Can I use my EmitBio RD19 to disinfect surfaces?

No. Both the type of light and the power levels will not kill or inactivate pathogens on surfaces.

What kind of plastic is used for the mouthpiece? Is it BPA-free?

The plastic that come in contact with the mouth is a medical grade TPE (Thermoplastic Elastomer). It is BPA-Free, Halogen Fee and safe for long term use.

How does it feel? Does it get Hot?

The device can be slightly warm to the touch when illuminated but will not exceed safe and comfortable temperatures.

I have heard that blue light can disrupt my sleep. Should I not use at night?

There is no known issue with using the EmitBio RD19 at any time of day. Studies of circadian rhythms have shown that disruption occurs in the brain through the eyes. When used as directed, the blue light on the EmitBio RD19 does not interact with the eyes.