Date: 22 April 2016
From: Ted Cole, DO, OIRF Medical Advisor
RE: UVLRX mentioned in Vol. 12, Issue #4
Through the years I have been a strong proponent of Ultraviolet Blood Irradiation, and have used several machines with excellent results. The new unit by UVLrx Therapeutics is quite intriguing, but also has some areas of concern.
The machine is currently being used under an IRB. I have been part of a few IRB studies, and I can attest that good results in an IRB does not automatically result in FDA approval. The latest example of this was the study on chelation therapy, which showed very positive results (even after the data was manipulated), but has resulted in no FDA action.
If this machine does not get FDA approval, it will be illegal to use once the IRB is completed. The company has said that they expect approval in June of 2016, but they have not yet submitted their 510k clearance forms. This amounts to wishful thinking, as no one can predict what the FDA will do.
If the machine isn’t approved by the FDA, they can shut the entire process down. This happened to a sublingual UVB machine that I used. We had great results with it, and it offered the best balance of ease of use and results of any of the machines I used. But, all of the units were confiscated and the company was shut down by the FDA because it didn’t get approval.
The second issue is cost. The current quoted price is $25,000, but the actual cost to obtain it is $45,800 once all of the other items are added. This includes $18,000 for supplies. In contrast, the sublingual machine only required a piece of plastic over the oral prongs. The company also states that the price of the machine will double to $50,000 once (if!) they obtain FDA approval. At their suggested price of $160 per treatment, it would take well over 300 treatments to break even at the current cost of the equipment. They suggest adding a “consult fee” for each treatment to increase the charges. No matter how you cut it, this is expensive. The sublingual unit I used cost around $12,000, and the price for the disposable plastic was negligible. The disposables for this unit are currently $60 per treatment, and will increase to $75 if they get FDA approval.
If this unit does not get FDA approval, one will be left with an expensive door stop, assuming the FDA doesn’t confiscate them! I do hope that this or some other endeavor to bring UVB to the market is successful, but the buyer must be aware of all aspects of the situation when purchasing any equipment.
S/Dr. Ted Cole
Ohio, USA
Please follow this link to see the introductory article: UVLrx, by Dr. Michael Galitzer
Please follow this link to see linked article: Comments & a Dilemma, by Carolyn Winsor
From THE BRIDGE Newletter of OIRF
Published May 2016
© Copyright 2016, Dr. Ted Cole, OH USA
Date: 22 April 2016
From: Ted Cole, DO, OIRF Medical Advisor
RE: UVLRX mentioned in Vol. 12, Issue #4
Through the years I have been a strong proponent of Ultraviolet Blood Irradiation, and have used several machines with excellent results. The new unit by UVLrx Therapeutics is quite intriguing, but also has some areas of concern.
The machine is currently being used under an IRB. I have been part of a few IRB studies, and I can attest that good results in an IRB does not automatically result in FDA approval. The latest example of this was the study on chelation therapy, which showed very positive results (even after the data was manipulated), but has resulted in no FDA action.
If this machine does not get FDA approval, it will be illegal to use once the IRB is completed. The company has said that they expect approval in June of 2016, but they have not yet submitted their 510k clearance forms. This amounts to wishful thinking, as no one can predict what the FDA will do.
If the machine isn’t approved by the FDA, they can shut the entire process down. This happened to a sublingual UVB machine that I used. We had great results with it, and it offered the best balance of ease of use and results of any of the machines I used. But, all of the units were confiscated and the company was shut down by the FDA because it didn’t get approval.
The second issue is cost. The current quoted price is $25,000, but the actual cost to obtain it is $45,800 once all of the other items are added. This includes $18,000 for supplies. In contrast, the sublingual machine only required a piece of plastic over the oral prongs. The company also states that the price of the machine will double to $50,000 once (if!) they obtain FDA approval. At their suggested price of $160 per treatment, it would take well over 300 treatments to break even at the current cost of the equipment. They suggest adding a “consult fee” for each treatment to increase the charges. No matter how you cut it, this is expensive. The sublingual unit I used cost around $12,000, and the price for the disposable plastic was negligible. The disposables for this unit are currently $60 per treatment, and will increase to $75 if they get FDA approval.
If this unit does not get FDA approval, one will be left with an expensive door stop, assuming the FDA doesn’t confiscate them! I do hope that this or some other endeavor to bring UVB to the market is successful, but the buyer must be aware of all aspects of the situation when purchasing any equipment.
S/Dr. Ted Cole
Ohio, USA
Please follow this link to see the introductory article: UVLrx, by Dr. Michael Galitzer
Please follow this link to see linked article: Comments & a Dilemma, by Carolyn Winsor
From THE BRIDGE Newletter of OIRF
Published May 2016
© Copyright 2016, Dr. Ted Cole, OH USA
About the author
Theodore (Ted) J. Cole, NMD, DO, MA
OIRF: Member Board of Medical Advisors, Lecturer
OIRF Modalities: Electro-Acupuncture According to Voll (EAV), BioResonance, MORA Therapy, Inhaled Ionized Oxygen (IIO2)
Studies in psychobiology, biochemistry and molecular biology, with double major in clinical psychology and experimental psychology. Graduated from Ohio University College of Osteopathic Medicine in 1986. Board certification in family practice with additional Doctor of Naturopathic Medicine and is Board Certified in Integrative Medicine. Is in private practice in Cincinnati, Ohio.
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