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Ecomike

07/04/24 1:33 PM

#1257 RE: RMacchio #1256

The device is already FDA Approved:

"The book is directly tied to the Hypoxia platform technology which uses the MDX Viewer as an analytical method, which is an FDA approved device to measure tissue oxygenation. "

You said:

He is head of MDX Life Sciences which has developed the MDX Viewer and is seeking FDA approval for the device. You shouldn't spread misinformation.

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Ecomike

07/04/24 1:35 PM

#1258 RE: RMacchio #1256

"MDX Viewer as an analytical method, which is an FDA approved device to measure tissue oxygenation. The device measures the consumption of oxygen molecules in tissues on a cellular level.

The output of the MDX Viewer is the Brain Metabolic Score BMS, which is a vital part of the approval process for Bioxytran’s acellular oxygen carrier (AOC) molecule called BXT-25. Bioxytran plans on using the BXT-25 in its clinical trials for ischemic stroke and Alzheimer’s disease patients as a way to replace hyperbaric oxygen treatment (HBOT).



https://www.globenewswire.com/news-release/2024/06/27/2905450/0/en/Bioxytran-s-Advisor-Releases-Book-on-Hyperbaric-Oxygenation-Related-to-Stroke-Alzheimer-s-Patients.html
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theswordman

07/10/24 12:52 PM

#1263 RE: RMacchio #1256

Macchio is correct. From MDX website (notice the vague answers--tricky wording on several items on website??)

Q. WHAT IS THE REGULATORY STATUS OF THE DEVELOPED MEDICAL DEVICE?

A. MDX Life Sciences is capable to provide a FDA approved device that will monitor 4 physiological
parameters from tissues of patients in real time. The TMS will need a special approval by the FDA.