2024- The year in review
I wanted to share the many accomplishment of our start-up that occurred last year for our followers and investors. We began 2024 with a working prototype of our medical device that was manufactured in 2023 by Wayfarer Engineering and CITSCORP. Both engineering firms did extensive pre-clinical testing in anticipation of our animal safety trial. The performance of our electromagnets was outstanding, creating accurate and reproducible electromagnetic fields (EMF) for our research.
Les and I completed a second start-up incubator program with First Fight Venture Center in Research Triangle Park, NC that focused on potential collaborations with the Department of Defense. Although at first glance this might seem like an unlikely partnership, the military and the Department of Veteran’s Affairs care for millions of active duty and retired warfighter patients. Les has developed a close relationship with the Fort Liberty Research Institute and North Carolina DevTech. This led to interest in using our technology to assess traumatic brain injury (TBI) which is a common injury in warfighters. In association with the UNC Chapel Hill Department of Radiology, we are awaiting news on a grant application for a second animal safety trial for the diagnosis of TBI.
We won several awards and grants in 2024. This included a grant from NC Idea for the cardiac application of EMF disturbance technology. NC Idea is a private foundation started in 2005 that awards grants for promising start-ups in North Carolina. We were awarded a grant by the North Carolina Defense Manufacturing Community Support Program (DMCSP) to participate in the Propellor incubator program. Lastly, we received the Gold Award from First Flight Venture Center acknowledging the potential commercial success of our medical device technology.
The animal safety trial required for FDA approval of our medical device had to be postponed twice in early 2024 due to conflicts with our university collaborator. We were finally able to start our clinical trials in March, 2024. The animal safety trial was completed in April. The results of the trials were outstanding! Eighty-six percent (86%) of our sensor tests were able to detect the electromagnetic field created by the hearts of Rhesus monkeys. More than seventy percent (70%) of our imaging tests met the industry standard Signal-to-Noise ratio of greater than 3. Most importantly, none of the animal patients experienced any adverse effects from the study. We are now in the process of publishing the results from the animal safety trial in a peer-review journal.
Following the animal safety trial, we invested in improvements in our technology that will create more data points during each patient study. We continue in negotiations with potential university collaborators for the human indications trial of EMF disturbance technology. Lastly, Les and I went on the “Road Show” in the fall of 2024 to seek additional investment capital. We were fortunate to be chosen to pitch to several Angel Investment firms in the Research Triangle area of North Carolina. The feedback we received was encouraging. The investors are impressed with out technology and the potential for our platform. The consensus is that we are still too early in commercialization and need to get FDA approval first for more investor interest.
Over the last year, EMF Disturbance Monitors, Inc. has extended our list of collaborators. Notable additions include joining the ASSIST program sponsored by the National Science Foundation, a collaboration with the Wilson College of Textiles at NC State University for the development of “Smart Textiles”, assisting NASA and Langley Air Force base in testing conductive yarn circuits, collaborating with the Fort Liberty Research Institute and the UNC THRIVE program to submit a grant for an animal safety trial of TBI and working with the North Carolina Small Business and Technology Development Center (SBTDC) and Eva Garland Consulting for 4 grant applications.
All in all, 2024 was a breakthrough year for EMF Disturbance Monitors, Inc. With the successful completion of the animal safety trial, we are now focused on completing the human indications trial for the cardiac application of our technology and investigating a second FDA indication for our technology in the diagnosis of traumatic brain injury (TBI). Follow Les Hamashima on Linkedin as he explains how we will avoid the “Valley of Death” and succeed in getting to the FDA for approval of EMF disturbance technology.
