NIA Small Business Showcase: NeuroEM Therapeutics
There is currently no way to prevent, stop, or reverse Alzheimer’s disease (AD), despite the investment of billions of research dollars and two decades of trying to do so. NeuroEM is a clinical-stage medical device company committed to developing and commercializing Transcranial Electromagnetic Treatment (TEMT) as an effective treatment and possible preventative for AD and other neurodegenerative diseases. The company pioneered this noninvasive bioengineering technology by showing that TEMT protects against and reverses memory loss in mice with AD, and through several disease-modifying mechanisms. These mechanisms include disaggregation of both A-beta and tau oligomers (the consensus root causes of AD) and intraneuronal mitochondrial enhancement. Discovery of these TEMT mechanisms of action would not have been possible without funding provided by three NIH/NIA grants. Unlike drugs that cannot get into the brain or neurons well, TEMT easily penetrates all neurons of the brain to target intraneuronal disease processes that drugs are not capable of reaching.
As translational follow-up to its extensive foundation of six published preclinical studies, NeuroEM recently published a small clinical trial demonstrating that two months of daily in-home TEMT via its eight-emitter MemorEMTM device reversed memory impairment in AD patients while providing beneficial changes to blood/cerebrospinal fluid (CSF) AD markers and to both fMRI and PET brain imaging. This study was extended to two and a half years, during which time there was continued safety during use of the device and a stoppage of cognitive decline was observed in multiple tasks evaluated, as verified by the AD patients’ own caregivers. No other AD therapeutic in clinical development can claim this level of safety or broadly based and long-term cognitive benefit. In view of NeuroEM’s promising preclinical and clinical results, the U.S. Food and Drug Administration (FDA) awarded NeuroEM’s MemorEMTM device in 2020 the first Breakthrough Designation for any drug or device against AD cognitive decline. We at NeuroEM believe that our bioengineering technology could provide the first therapeutic intervention to stop and reverse the memory impairment of AD — not just slow it down. Through its extensive intellectual property (IP) portfolio and platform technology, NeuroEM is positioning itself as the only provider of TEMT for treatment of a variety of neurodegenerative diseases and conditions.
Company Milestones
Scientific
- 2016: NeuroEM designs, develops, and fabricates the first device to provide full brain TEMT to humans (MemorEMTM).
- 2017: The initial clinical trial of TEMT in AD patients is initiated.
- 2018: The initial clinical trial in AD subjects is successfully completed, demonstrating safety and efficacy.
- 2019: Initial clinical trial results are published in the Journal of Alzheimer’s Disease and are the most read paper in the journal for 2019.
- 2020: FDA awards NeuroEM Breakthrough Designation in treatment of AD for the company’s MemorEMTM head device, which is the first device or drug given that designation by FDA.
- 2021: NeuroEM completes a two-and-a-half-year extension of its initial clinical trial, continuing to show safety as well as stoppage of cognitive impairment over a period of two-plus years.
- 2022: Two additional major scientific papers are submitted and published, demonstrating TEMT’s ability to stop Alzheimer’s cognitive decline over a two-and-a-half-year period and also its ability to rebalance the body and brain’s immune system in AD.
- 2022: NeuroEM will complete the design and begin production of its GEN2 (second-generation) MemorEMTM devices.
- 2022: A pivotal (Phase IIb/III) clinical trial using the GEN2 MemorEMTM devices is expected to begin.
- 2023: Interim results are expected from the pivotal clinical trial.
- 2025: The pivotal clinical trial will be completed.
- 2025: The MemorEMTM device for safely stopping and/or reversing AD cognitive decline will be submitted to FDA.
Business
- 2016: NIH awards NeuroEM $255,000 in funding through a Small Business Innovation Research program (SBIR) Phase I grant for basic research.
- 2016: A private foundation provides $515,000 in funding for a pilot clinical trial with TEMT.
- 2016-2020: NeuroEM raises $1.5 million in series seed funding.
- 2021: NIH awards NeuroEM $2.2 million in funding through an SBIR Phase II grant.
- 2022: A Series A preferred raise for $5 million is initiated and expected to be completed.
- 2023: A Series B preferred raise for $15 million to $20 million is initiated and expected to be completed.
Financial Overview
NeuroEM Therapeutics’ research and operational activities have been funded by a variety of investment mechanisms, including approximately $4.2 million in NIH/NIA grant support from TEMT’s inception, $515,000 through a private foundation, $1.5 million in notes from angel investors, and more than $325,000 from NeuroEM’s co-founders.
NeuroEM is currently seeking funds to carry out a two-part Phase IIb/III (pivotal) clinical trial in subjects with mild or moderate AD to assess the long-term safety of TEMT and its long-term ability to 1) stop and reverse cognitive and functional decline, 2) beneficially affect AD markers in CSF and plasma, 3) modulate both brain and plasma immune markers, 4) induce favorable brain activity changes, and 5) inhibit cerebral atrophy. This will be a randomized double-blind placebo-controlled trial consisting of two components: Component A of this pivotal trial will be funded through NeuroEM’s current Series A raise of $5 million, and Component B will be funded by a $15 million to $20 million Series B raise to be initiated approximately one year after starting Component A. The design of both Component A and Component B have been reviewed by FDA, and their suggestions have been incorporated into both trial designs.
As indicated above, a Series B raise of $15 million to $20 million will be initiated approximately one year in the future. Nondilutive funding for additional/complementary clinical trials will also be pursued through NIH/NIA grant submission during the next three years. The bottom line is that NeuroEM Therapeutics has an expedited low-cost path to FDA approval of three to four years and ensuing commercialization for a much-needed intervention against AD.
Intellectual Property
NeuroEM has a robust patent portfolio that currently consists of three issued patents and 12 patent applications (six continuation-in-part applications and six Patent Cooperation Treaty applications). The issued patents provide coverage for TEMT technology against multiple neurologic diseases and disorders and protection for the company’s MemorEMTM devices, particularly regarding the range of various treatment parameters. The company’s current patent applications further cover the functionality and capacities of the MemorEMTM device, as well as extending the disorders treatable by TEMT. Collectively, these patents/applications provide NeuroEM with substantial and expanding IP coverage for TEMT technology and should make NeuroEM the only company legally able to market TEMT against a variety of neurologic disorders in the United States and internationally.
Product Development and Regulatory Strategy
NeuroEM is currently finalizing development and fabrication of its GEN2 MemorEM device, which will be used in all future clinical trials, including the upcoming pivotal clinical trial. NeuroEM intends to pursue regulatory clearance of MemorEMTM from FDA through the De Novo 510(k) pathway. Previous engagements with FDA have already confirmed that there is no suitable predicate device for MemorEMTM, that the product is of low to moderate risk, and that the De Novo pathway is appropriate for NeuroEM. FDA has also supported the non-significant risk designation by the Western Institutional Review Board issued before initiation of our initial clinical trial. NeuroEM believes it is only three to four years away from a possible FDA application for its MemorEMTM device to safely treat AD. Following FDA approval, expedited availability of the device to the public via payers (i.e., Medicare, insurance plans) should occur in view of the MemorEMTM’s Breakthrough Device Designation by FDA. NeuroEM intends to also put into place a self-pay option in both the U.S. and Europe, expecting to apply for a Conformitè Europëenne (CE) mark in Europe soon.
Commercialization Strategy
While NeuroEM is fully committed to direct commercialization of the MemorEMTM product, we also recognize that the most expedient way to get the product to market may be to enter into a strategic partnership and/or position NeuroEM as an eventual acquisition target. With further successful clinical data, NeuroEM will be in a strong position to attract a strategic partner from the pharmaceutical and/or medical device sectors. These companies look for innovative new technologies and growth opportunities. Another option is to partner with a Contract Commercial Organization to deploy and scale commercialization on behalf of NeuroEM on a profit-sharing basis.
Company Details
Phoenix, AZ
Industry: Therapeutics
Management Team:
- CEO and Co-Founder: Gary Arendash, Ph.D.
- Chief Business Officer and Co-Founder: Jon McGarity
- Chief Financial Officer and Co-Founder: Lyle Scritsmier
Point of Contact:
Gary Arendash, Ph.D.
Email Dr. Gary Arendash
(480) 395-1481