Moving on to Version 2.0
For those unfamiliar, NASA and the Department of Defense use a scale to rank the readiness of new technology. The scale, called the Technology Readiness Level (TRL), starts with an idea (TRL 1) and progresses to actual performance in the target market (TRL 9). TRL 6 is the level where a prototype has been created and shown to function in a controlled environment. This scale works well for software, hardware and military devices. The TRL 6 prototype is essentially Version 1.0 of any technology. Once you get to TRL 6, it’s time to start working on Version 2.0
After the completion of our successful animal safety trial, we are moving forward with upgraded versions of our prototypes in anticipation of our planned human volunteer trial. Our engineers are upgrading components to the hardware used in our sensor controller device. The hardware upgrades will allow for increasing the amount of data we can collect during each testing session. Our software engineers are also working on upgrades to the electromagnetic control systems, and the interfaces between our hardware and the User interface which technicians will operate during human studies. This will be Version 2.0 of our EMF disturbance technology.
We have a new and fascinating affiliation with the Wilson College of Textiles at North Carolina State University (https://textiles.ncsu.edu). They have a group called SHIFT designing “Smart Textiles” which integrate sensors into fabric. The cloth vests used for our animal safety trial were pretty basic and had pockets into which we inserted the EMF sensors. We are applying for grant funding to integrate our EMF sensors and wiring into a “Smart Textile” fabric. We would be able to position sensors in the fabric over target areas and “wire” the sensors through the fabric to a dataport. There are many potential commercial applications for this form of “Smart Textile” that extend beyond our company’s needs. This is our plan for Version 2.0 of our wearable, 3-dimensional sensor array.
One of the issues about crossing over TRL 6 is the possibility of technology acquisition. Now that we have demonstrated the potential for our patented EMF disturbance technology to magnify the EM energy emissions, other larger companies in the medical device space may determine that our technology would be an attractive addition to their portfolio. If the goal is to speed up the path to FDA approval and commercial sales, this would help accelerate that process. Right now, we are focused on remaining independent and are on track to meet our goal of FDA approval by 2026.
This month, we are in negotiations for two future clinical trials. This primary trial is the human volunteer trail for a cardiac application of EMF disturbance. We are also negotiating to use our technology for a potential neurosciences application. Stay tuned and follow us on the Web site for more information.
