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Worldwide over 55 million people suffer from dementia with over 10 million new cases each year creating an unsustainable burden for caregivers and healthcare providers. Unfortunately, early detection is challenging. Currently used clinical tests such as the MMSE are not sensitive for early detection and can lead to misdiagnosis. Imaging with PET or MRI is expensive, cumbersome and difficult to scale for routine testing.
BEAM™ is a proven EEG platform built on an extensive normative database with over 10,000 sessions and a library of biomarkers developed using machine learning AI algorithms to map the progression of cognitive decline across the dementias. BEAM is objective, highly accurate for early detection, non-invasive, easy to use, cost effective, safe for routine testing and can monitor treatment efficacy with reimbursement using existing CPT codes. They envision BEAM empowering physicians to use individual patient’s biosignatures to assist in diagnosing the type of dementia or psychiatric disorder and ensure an optimal treatment plan.
The global cognitive diagnostic market is estimated at $102B with a CAGR of 8% bringing the market to $238B by 2030. The US market accounts for approximately 30% of the total. BEAM biomarker analytics have the capability to quantify disease severity & assess treatment efficacy using extracted endpoints in combination with AI-machine learning algorithms. Advanced Brain Monitoring has validated the biomarkers in multi-modality comparisons and demonstrated high test-retest reliability for these metrics. BEAM is sensitive enough to discriminate Mild Cognitive Impairment from Depression and can distinguish Alzheimer’s, Lewy Body, Parkinsons Dementia as well as PTSD and GAD, giving physician’s the tools they lack to provide the best patient care.
Company Milestones
Scientific and Clinical
- ABM has eight clinically validated biomarkers for neurodegenerative diseases and psychiatric disorders.
- Their science team has written over 100 peer-reviewed original research papers and publications and created proprietary algorithms that drive advanced statistical analysis.
- ABM has received over $40M in research funding primarily from NIH and DARPA
Business
- Advanced Brain Monitoring is a leader in AI / machine learning field of science for nearly 25 years
- ABM is a pioneer the development of mobile, scalable, easy to use EEG technology and has commercialized 7 FDA Cleared, CE marked products
- ABM technology has been successfully deployed in over 50 clinical trials worldwide for sponsors such as J&J, Biogen, Roche and Atai.
- ABM has an extensive patent portfolio.
Financial Overview
ABM has been self-funded for 25 years with $40M in Non-dilutive funding for research. They are currently seeking $15M in the next 15 months to spin off neurotech division, finalize upscaled and outsourced manufacturing, develop branding strategies, build the distribution network and support expansion into psychiatry and general medicine. They will seek an additional $5M in the following year if needed.
Intellectual Property
Advanced Brain Monitoring has a library of Intellectual Property with over 20 international patents. ABM has filed a provisional for the BEAM platform. It is anticipated that several PCT’s will be filed within the year related to BEAM.
Product Development and Regulatory Strategy
The X-Series device and software that provide the foundation for BEAM™ are FDA cleared and CE marked. They have been fully operational for over 5 years, deployed over 50 clinical trials worldwide and used in several major research projects for NIH and DARPA. The library of biomarkers and AI/ML algorithms has been in development for over 10 years. Combined, this new and innovative platform provides physicians with the tools they need to accurately diagnose early-stage dementia, track the disease progression and determine if treatment protocols are effective. BEAM is ready for commercialization.
Commercialization Strategy
The US cognitive diagnostic market is estimated at $30B. Advanced Brain Monitoring will focus initial commercialization effort on the 16,500 Neurologists in the US. ABM is currently establishing strategic partnerships with key services providers to neurology clinics, thereby expanding their product offerings. Neurologists pay a nominal monthly service fee that includes the device, software and unlimited reports. The service provider will receive a percentage of the monthly fees providing them with recurring revenue. The Neurologist will bill insurance for each diagnostic session using existing CPT codes. The patient will have an accurate diagnosis with a clear path to optimize treatment.
Company Details
Advanced Brain Monitoring, Inc.
Carlsbad, CA
Industry: Devices
Management Team:
- Chris Berka, CEO
- Gina McNamara, VP Finance
- Amir Meghdadi, Director of Research
Point of Contact:
Gina McNamara
gmcnamara@b-alert.com
(858) 243-3775
SBIR