elminda BNA technology unlocking secrets of brain disorders

Closely-held elminda’s Brain Networks Analytics (BNA) technology is going beyond genetics, imaging and behavioral tests to unlock brain functioning and how the brain changes over time, combining Big Data and AI-driven analytics in a single technology platform.

“BNA is a validated, reproducible and efficient way to measure brain function. As it grows, it will become the go-to analysis tool to diagnose and predict brain function and a way to measure the impact of therapeutic intervention on the brain,” CEO, Ronen Gadot, says in an interview with BioTuesdays.

“We believe that if you wish to effectively treat something, you first must be able to measure it,” he adds.

However, there are currently no good ways to accurately measure brain functions, such as sensory processing, attention, memory and response precision, he points out. “That was the problem we set out to solve in order to provide early detection of brain disorders and eliminate trial and error from therapeutic interventions of those disorders.”

In addition, he suggests that BNA can help pharmaceutical companies develop new therapies for the brain.

Mr. Gadot, who was selected by the World Economic Forum to serve on a council about the future of neurotechnologies and brain sciences, explains that the input to BNA is a 12-to-50 minute non-invasive standard EEG recording of specific brain functions.

Data are uploaded to the cloud and automatically validated, cleaned and analyzed. The technology interprets brain functions, disorders and the effect of therapeutics, creating customized actionable reports for a physician.

“We have collected a very large amount of demographic and clinical data coupled with electrical brain recordings over the past decade in order to determine what is normal brain functioning and abnormal brain functioning,” he adds.

According to Mr. Gadot, elminda’s big database, which is already the world’s largest and continues to grow rapidly, provides “core knowledge-based interpretation of brain activity patterns.” In addition, the company’s AI-driven analytics platform removes “noise” from the EEG signal, extracts clinically relevant information from Big Data through secondary analysis and simplifies an individual’s complex brain activities into actionable clinical insights.

elminda currently has datasets of healthy and unhealthy brain functions from more than 400,000 specific brain recordings, which Mr. Gadot predicts will grow to more than one million by mid-2020.

“As this database grows, we can extract more insights for early detection of brain problems, better diagnosis, and ultimately better treatment and management of brain disorders,” he contends.

BNA has CE Mark approval in Europe, including Israel, with wide coverage for clinical use. In the U.S., BNA has FDA clearance to be used for six brain functions in individuals aged 14-to-25. There are more than 25 clinical sites around the world using BNA.

That early international success hasn’t gone unnoticed. Last year, well-known North American medical technology industry veteran, Arun Menawat, was appointed elminda’s chairman. Dr. Menawat is currently CEO of Profound Medical (TSX:PRN; OTCQX:PRFMF) and, before joining Profound, he led fluorescence imaging pioneer and leader, Novadaq Technologies (acquired by Stryker).

Mr. Gadot says that in the first half of 2019, elminda plans to seek FDA approval to expand the use of BNA for patients up to the age of 85 along with a greater range of brain functions.

The company’s business model is based primarily on charging per test, he says, adding that elminda expects to generate $1-million of revenue in 2018, its first year commercializing BNA.

The BNA technology is covered by 60 issued and pending patents that allow the company to take any electrical physiological data and analyze it to extract diagnostic information.

After considering many applications to use BNA, Mr. Gadot says elminda decided to initially focus on brain wellness and brain disorders, two very large markets with high unmet medical need.

Brain wellness involves “red flagging” people with potential problems so that intervention can take place at an earlier stage. For example, he contends that a lot can be done to delay the onset of dementia. For example, a leading accelerator of dementia is hearing loss, which is easy to treat even though many people delay the use of hearing aids by 10 years, Mr. Gadot notes.

“Including BNA testing as part of an annual physical checkup also can monitor the progress of brain wellness and determine the impact of therapeutic interventions,” he adds. Some 95% of people having annual checkups are healthy, or “at least think they are healthy” and may only need annual follow-ups to monitor their brain functions, he points out.

Regarding brain disorders, the company is initially focused on depression because of its prevalence and the current, ineffective trial and error approach to treatment. Approximately 52% of first prescriptions for depression are ineffective. Mr. Gadot says elminda is developing biomarkers with a predictive value of up to 90% to help determine which drugs and other therapies will work and which will not, and then optimize a treatment by measuring a drug’s effect on the brain after a week or two, way before a clinical effect can be observed. This approach is now being actively utilized in several psychiatric practices.

“BNA also can capture a treatable and reversible cause for cognitive dysfunction consistent with mood disorder, modification and monitoring.” And when BNA red flags someone possibly at risk for significant brain disease, the company can recommend referral to a neurologist for further evaluation. “In all these cases, we are providing valuable information while adding to our database and generating revenue.”

In addition to brain wellness solutions, and medical diagnostic and treatment solutions, elminda has partnered with Novartis to use BNA for the development of new brain therapeutics.

Early in its development, elminda partnered with The Villages Health in Florida, which is the world’s largest older-adult community with a population of more than 120,000 people. The partnership has allowed elminda to build a large database of normal and aging brains at five BNA testing locations, and develop a lifetime brain health management service.

“At The Villages community, there is a strong interest to have their insured population tested annually to detect disease early and prevent degeneration because it will lower costs,” Mr. Gadot points out.

elminda also has produced a research study from its modeling of memory functions at The Villages, which has been nominated as a finalist for the Positive Aging Award for Excellence in Research by the American Public Health Association.

Mr. Gadot says the company’s initial commercial target for its Brain Wellness solution is China, which has a mature market for annual check ups and an established payment model for private and corporate insurers. “The Asian market is largely geared to healthy people who would like early detection of problems.”

elminda recently completed a pilot-testing program with iKang Guobin Medical Center in Shanghai and is now discussing collection of the first large China database and a commercial launch that would add BNA testing to annual checkups. elminda also has another client in China and one in Hong Kong.

There are more than 400 million annual health checkups conducted in China, growing at more than 10% a year, he points out. Globally, some 2.5 billion people undergo annual health checks, with brain-related disorders affecting more than one billion people.

That success hasn’t gone unnoticed either. Mr. Gadot notes that elminda recently received a proposal for an investment from a strategic Chinese player. “We are also exploring financing options to potentially combine that with a Series D round in the U.S. before ultimately going public on a U.S exchange.”*

In the U.S., Mr. Gadot says elminda intends to market BNA to psychiatric clinics and hospitals, with a traditional health insurance reimbursement-based business model. “People diagnosed with depression would trigger a BNA test to develop a baseline score and determine optimum medications and closely follow-up treatment efficacy.”

According to Mr. Gadot, “the annual health check up market in the U.S. is not a mature market that we can tap into as we are in Asia, but we are exploring how we might establish this.”

The company is conducting pilot programs with several U.S. psychiatric clinics to establish proof of commercial viability of BNA. Within a year of beginning a pilot program at a large Mid-Western psychiatric clinic, the company added a second BNA lab, with a third lab ordered in the third quarter of 2018 in order to increase capacity to 600 tests a month, he adds.

There are two Current Procedural Terminology (CPT) codes set by the American Medical Association for reimbursement of brain activation during an EEG recording and a digital analysis of an EEG, with an average national coverage of $780.

elminda has four U.S. sites that have billed for more than 5,000 cases with a high acceptance rate, he adds. “We are operating within these two CPT codes and have not yet developed our own potential codes that would cover BNA testing. But, we are certainly working on it.”

Mr. Gadot says BNA provides information “unattainable by clinical assessment alone and objectively detects early brain function abnormalities. After all, what is more important than your brain.”

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*This article does not constitute an offer to sell or the solicitation of an offer to buy any securities of elminda, and shall not constitute an offer, solicitation or sale of any security in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

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