Are there other companies developing our technology?
There are no other companies that utilize our electromagnetic/radiofrequency technology against the cognitive impairment of Alzheimer’s Disease. There are several academic institutions in Europe utilizing very different electromagnetic approaches against AD that have not, however, been shown to affect the AD process. Indirect competitive technologies include Transcranial Magnetic Stimulation (tMS), Transcranial Ultrasound (tUS), and Deep Brain Stimulation (DBS). These treatment modalities are very expensive and/or invasive and have thus far not been shown to be effective against AD. Other indirect competitors include several companies (Cognito Therapeutics, Vielight) who are clinically testing photomodulation (LED or infrared light) approaches against AD. Drugs are also indirect competitors; but to date, over 150 drugs have failed to even slow down AD cognitive decline, much less stop or reverse it.
Have your pre-clinical results been independently confirmed by other laboratories?
Yes. Following our initial 2010 publication, three independent laboratories published results in 2013, 2015, and 2018 showing that similar electromagnetic treatment to Alzheimer’s mice can provide cognitive benefit and/or substantially decrease Alzheimer’s neuropathology. In addition, our own pre-clinical studies were performed in collaboration with seven independent laboratories, all of which were blind to which mice received treatment and which ones did not. NeuroEM Therapeutics has recently partnered with MegaNano BioTech, Inc. to form a joint NeuroEM/MegaNano Research Laboratory (Research Park, Tampa) for continued basic science research into Transcranial Electromagnetic Treatment against neurologic disorders.
Is this technology safe for human therapeutic use?
Our recently-completed Pilot clinical trial in AD subjects was the first to administer TEMT to the entire human brain over an extended period of time. As such, a primary goal of that clinical trial was to determine the safety of daily, long-term, and global TEMT – specifically in AD subjects. No recurring adverse side effects were reported over the 2-month treatment period involving a total of 120 one-hour treatments administered twice daily. Daily diaries kept by the subjects’ caregivers indicated no consistent changes in blood pressure or body temperature associated with TEMT, as well as no recurring changes in daily activities or anxiety level/mood. Moreover, no adverse effects were ascertained at every clinical visit and no visible induction of tumors/micro-hemorrhages was evident when comparing pre- vs. post-treatment anatomic MRI scans. Most of the AD subjects in our original 2-month Pilot trial continued treatment and it is now almost 2 years since they first began treatment. No deleterious behavioral or physiologic effects have been observed or reported during this extended period of treatment.
Therefore, TEMT appears to be a safe therapeutic intervention for chronic treatment of AD, at least for the parameters being utilized with the Gen1 device. This is consistent with a large body of epidemiologic literature, including extensive analysis by the National Institute of Environmental Health Sciences (NIEHS), indicating that humans exposed to similar electromagnetic field (EMF) frequencies/power levels via mobile phones have no health or safety risks, no deleterious behavioral/physiologic effects, and no induction of brain cancer, even after many years of EMF exposure.
It is important to recognize that NeuroEM’s bioengineering technology is being utilized in specialized devices that have many unique electromagnetic emitters. The result is full brain treatment that, although complying with FDA/FCC regulations, delivers global electromagnetic treatment to the human brain. Although NeuroEM’s Generation 1 (Gen1) MemorEM devices were utilized in its Pilot clinical trial in AD subjects, the company’s new Gen2 MemorEM devices are being utilized in ensuing AD clinical trials.
When will NeuroEM’s head device be commercially available to treat AD?
It is anticipated that, with adequate funding and adherence to our clinical timeline, our Gen2 MemorEM™ device for treating AD could be available for commercialization in early 2023.
How can I or my loved one with AD participate in a clinical trial involving treatment with Transcranial Electromagnetic Treatment (TEMT)?
The clinical locations for NeuroEM’s Pivotal clinical trial in AD patients will be announced on this website and social media prior to the beginning of patient recruitment for that trial. To be contacted for advance information on when our Pivotal clinical trial will occur and at what clinical locations, please be sure to register on the “Contact Us” page of this website.