Local couple works on a device that could alter the quality of life of millions of seniors for the better – Valley Roadrunner

Rob and Anita Baranowski of Left Coast Engineering.

Its not often that you can work on a project that could revolutionize the quality of life of millions and perhaps billions of people.

Valley Center couple of Rob & Anita Baranowski, founders and owners of Left Coast Engineering in Escondido, are in that estimable position. Working with a research company NeuroEM Therapeutics of Phoenix, Arizona, they have created a working prototype of a wearable device that appears to reverse Alzheimers disease memory loss. The device provides electromagnetic wave treatment to the entire forebrain.

When I was interviewing the Baranowskis, I suggested it might take the FDA a dozen years to approve of the breakthrough for common use, and Left Coast President Rob Baranowski said, Its a longer path than it should be but its an attainable accomplishment.

Left Coasts projects are all referrals. One of the engineers they were working with on another project made the introduction in 2014 by saying, There guys need a new product in radio design.

The first prototype produced was for a primate trial, after there had been a rodent trial. However, they ended up skipping the primate trial and went directly from mice to humans. You might ask, how can you tell if a mouses Alzheimers improves? The answer is that mouse brainpower is measured by how well they learn from performing mazes.

People, of course, are exponentially more complicated than mere mice. For instance, you need approval from the Western Institutional Review Board (WIRB) for such trials, when you dont need it for experimentation on animals.

The studies are being conducted at the NeuroEM labs in Florida. NeuroEM Therapeutics is a clinical stage medical device company focused on development of Transcranial Electromagnetic Treatment (TEMT) to treat neurodegenerative disorders such as Alzheimers Disease, Traumatic Brain Injury, and Parkinsons Disease. The company is headquartered in Phoenix, Arizona and has obtained research support from the NIH (National Institute of Health) and angel investors. NeuroEMs head device (the MemorEM) is a first-in-class medical device that provides full brain electromagnetic treatment in-home and with near complete mobility. For more information about NeuroEM Therapeutics, go to http://www.neuroem.com.

Left Coast Engineerings Heather Nelson and Amy Archipov put the finishing touches on the control boxes for the NeuroEM MemorEM 1000 units used in the recent study that reversed Alzheimers symptoms.

Two months of daily treatment reversed cognitive impairment of Alzheimers disease by apparently affecting the disease process itself by eliminating its root cause.

A study co-authored by Left Coast Engineerings President Rob Baranowski was published recently in the Journal of Alzheimer s Disease following a recent Western IRB clinical trial of the treatment protocol.

The clinical trial concluded last December and focused on the safety and initial efficacy of what NeuroEM calls Transcranial Electromagnetic Treatment (TEMT), using the LCE-designed noninvasive, easy- to-wear device: the MemorEMTM.

In a study performed at the University of South Florida/Byrd Alzheimer s Institute, after just two months of in-home use, one hour/twice a day, the average memory decline in 88% of patients with mild to moderate AD was reversed back to their better cognitive levels of a year earlier. The study also indicates that, at least for the study s 2-month treatment period, TEMT was safe in all eight participating patients.

Seven of the eight AD patients responded with statistically significant improvements.

There is no way to know if the memory loss will return later on, Rob Baranowski said. At this point it is unknown whether they regenerate. Although we do know that two weeks later they still had positive results.

NeuroEM labs is now preparing to do an extended double-blind trial with 150 subjects in a double-blind.

I contacted Dr. Gary Arendash, the inventor of this potentially game changing technology, who received his training at the University of California San Francisco Medical Center and his Ph.D and post-doctoral training at the UCLA Brain Research Institute. He said he was inspired by the fact that the brain is the last frontier of medicine!

One of the patients of the Transcranial Electromagnetic Treatment (TEMT) which helps Alzheimers patients recover memorywith her husband. She is wearing the device.

The genesis for the study occurred, as it often does in scientific research, with a happy accident.

We actually thought that providing electromagnetic waves to the brain would bring about Alzheimers sooner and were very surprised that our Alzheimers mice showed higher cognitive abilities following this treatment, Dr. Arendash said. We repeated the experiment several times before we believed the results. The initial study was published in 2010.

While Dr. Arendash was at the University of South Florida/Byrd Alzheimers Center seven independent laboratories worked with them as collaborators on this project. The clinical work that we just completed in Alzheimers patients involved around six laboratories, he said.

They have no evidence as yet that the recovered memory is permanent. The next step, said Dr. Arendash, Is to perform a large Pivotal clinical trial that, if successful, could form the basis for an application to the FDA for our MemorEM head device to be the first effective therapeutic against Alzheimers Disease.

Blood and cerebrospinal fluid (CSF) analyzed for AD markers revealed changes consistent with TEMT breaking up small aggregates (oligomers) of two toxic proteins in the brain called A-beta and tau. Both of these are currently thought to be the root causes of AD. In addition, MRI brain scans following the 2-month treatment period revealed evidence of increased communication between neurons in the brain area critical for cognitive integration. One of the study participants proudly told researchers, Ive come back!

At the end of the two-month study, none of the patients wanted to give their MemorEM devices back, resulting in a 4-month extension study with the University of South Florida/Byrd Alzheimer s Institute. happening now with plans forthcoming for a larger study of 150 patients in 2020.

The cap developed by Left Coast for treating Alzheimers patients.

This pioneering study suggests that TEMT may be an entirely new therapeutic intervention against Alzheimer s disease. Declared, Arendash, Our bioengineering technology may be succeeding where drug therapy against this devastating disease has thus far failed. TEMT appears to be affecting the Alzheimers disease process through several actions directly inside neurons (brain cells), which is where we believe the disease process needs to be stopped and hopefully reversed.

The electromagnetic (radio frequency) wave treatment used by Dr. Arendash in his previous Alzheimers mice research are generated in the portable MemorEM device that LCE designed for the human study, explained Baranowski. The fields generated by the device penetrate into the brain cells to depths that pharmaceuticals cant get to. Once inside the brain cells, the radiofrequency waves breaks up toxic protein aggregates, which seems to effectively reverses the disease s cognitive decline.

Left Coasts expertise in wireless and custom radio transmitters made them a natural to work on a commercially viable implementation of an RF treatment device. Several versions later, LCE developed the wearable MemorEM for NeuroEM, including the head cap, cabling, electronics, and packaging. Left Coast delivered the final units to NeuroEM for the clinical trial.

Rob Baranowski was affected by the patient testimonials. Hearing the interviews of the trial participants really made me step back, he said. Across the hundreds of products weve developed, this is the first time Ive heard from a user that our product has altered the course of their life. The enthusiasm in their voicesit certainly gives the work that we do here a different perspective.

Left Coast Engineering is in its 20th year as a full-service, electronic product design resource. The company supports both new and next-gen product designs from concept to production, including product definition, certification testing, production test, validation/verification and intellectual property protection. The company has steered more than 150 designs from start to finish. More information can be found at http://www.LeftCoastEngineering.com

Rob Baranowski, LCE president, and Amy Archipov, LCE engineering coordinator, run the Transcranial Electromagnetic Treatment (TEMT) units through a test sequence during the R&D phase of the product development.

About NeuroEM Therapeutics, Inc.

NeuroEM Therapeutics is a clinical stage medical device company focused on development of Transcranial Electromagnetic Treatment (TEMT) to treat neurodegenerative disorders such as Alzheimer s Disease, Traumatic Brain Injury, and Parkinson s Disease. The company is headquartered in Phoenix, AZ and has obtained research support from the NIH, the Glass Charitable Foundation, and angel investors. NeuroEM s head device (the MemorEM) is a first-in-class medical device that provides full brain electromagnetic treatment in-home and with near complete mobility.

For more information about NeuroEM Therapeutics, go to http://www.neuroem.com.

Left Coast Engineering prepares to ship the NeuroEM units out for the human trial, which was aimed at testing the units for both safety and efficacy in mild to moderate Alzheimers Disease patients.

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Local couple works on a device that could alter the quality of life of millions of seniors for the better - Valley Roadrunner