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Detoxifying is the most essential action anyone can take to start the process towards vibrant, energetic and youthful health. It is staggering to learn how widespread toxi

According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product

ns are part of our daily lives. Toxins are unavoidable and hard to eliminate and accumulate over years. The average weakened and toxic body has no way to metabolize this b

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

uild up of stored chemicals; heavy metals, acids and disease causing toxins….Until Now!

Using a LuxSauna infrared sauna will start you on the road to detoxification. Infr

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

ared heat saunas are an amazing improvement over traditional steam rooms and (very) hot rock saunas which produce maximum heat with minimal penetration; millimeters deep.

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

LuxSauna uses far infrared heat waves that uniquely penetrate deep enough into the human body to expedite the elimination of dangerous disease-causing toxins and acids. “I

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

frared heat is the only heat that penetrates deep enough and hot enough to melt subcutaneous fat, (at 40C or 104F), which is where the body stores dangerous toxins and aci

ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc

ds, and literally shakes them lose so they can be directly expelled safely out of the body through our sweat.” Says David Floyd, CEO of LuxSauna Inc.

An added health bene

easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi

fit of using an infrared sauna is weight loss. In addition to expending nearly 600 calories in a half hour session, you will eliminate stored up acids in the body. The ave

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

rage American consumes a predominantly acid diet that overwhelms our bodies. Ironically, the (smart) human mechanism for avoiding damage caused by acids is that the body s

and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ

tores acids away in fat to protect vital organs. No matter how much you diet, the body does not allow the total release of excess fat deposits in most people. Only when th

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

acid is excreted can the body allow the release of stored up fat. Toxins are acid as well, so the alkaline balance can be restored quickly by the use of a sauna as well a

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

s the elimination of acids, which will lead to predictable weight loss for those who have excess fat.

Studies have shown that over 95 % of disease is caused by the lack o

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

f oxygen. Where there is no oxygen, cancer thrives. Where there is an oxygen or alkaline environment, no disease can survive! The German Biochemist, Dr. Otto Warburg disco

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

vered this in 1923 and received the Nobel Prize in 1931 for doing so. Why do most doctors continue to ignore this and prescribe disease-causing drugs that merely hide the

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

symptoms and avoid the cause? Finally, people are starting to become more educated! They are doing their own research and learning that toxins are ubiquitous and unavoidab

t?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel

e and are in fact the main cause of disease.

The success of LuxSaunas far infrared saunas is based on our company’s focus on the whole health package, the whole body. All

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

the personnel at Luxsauna spend months in training to fully understand the health benefits and specific detoxification strategies and techniques using a sauna. Our staff

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

motivates people to eliminate their toxic load and modify their diet to consume more alkaline foods and liquids. For example: It takes 10 glasses of 10.4 PH alkaline water

.

As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de

to neutralize one can of Coke! So you can see how beneficial an infrared sauna could be. The ability to sweat 3 to 4 pounds of sweat in one half hour session which includ

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

es 15%-20% toxins and acids will greatly enhance the speed at which you can alter your ability to create an alkaline and disease free and healthy bodily environment.

# #

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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