We’re going on the Road Show…

Funding your start-up is a tricky issue. On the one hand, you’re focused on your next-best-thing concept and the work you are doing to move your idea forward. On the other hand, every business has bills, even if you opt out of a salary as a matter of financial necessity. Funding usually starts with family and friends. If you’re lucky, you get small grant funding based on the recognition that your business can create jobs, income and taxes. At some point, you need to involve professionals in venture capital. EMF Disturbance Monitors, Inc. has made it to that point.

Professional investors come in a variety of flavors like Investor Network Funding, Crowd Funding, Angels, Seed Funding and traditional Venture Capital. Network Funding is represented as a large group of small dollar capital investors who are advised by salaried staff about investment options. Typically, they request an upfront fee to present start-up investment opportunities to their network of investors. You choose a funding goal. Their network of investors can opt in/op out of your company. The Network Investor company then takes a percentage of the network funds directed to you (typically 4-6%) in addition to their upfront fee. Network investors like smaller projects, since the capital base they tap is smaller. Medical devices are expensive, slow investments that are not well aligned to Network Funding.

Crowd Funding is often used for B to C (Business to Consumer) companies. Crowd Funding companies charge an upfront fee to access a platform pitching to online consumers who donate money to help create a new product they might want to use. Crowd Funding companies also usually request a percentage of the funds raised online. This is called a Finder’s Fee (typically 10-15%). Some Crowd Funding companies use established platforms (Kickstarter, Indiegogo) and others have their own platform. EMF is not a B to C company so Crowd Funding is not our thing.

Angels and Seed Funding are professional investment companies that specialize in early investment for promising start-ups. They typically do not charge any upfront fees or take a percentage of the funds raised. Angels and Seed funds are extremely risky investments for their members, since more than half of start-ups fail. However, if one of their investments becomes a Unicorn (the eventual, ridiculously successful company), they can more than make up for the losses on their start-up investment failures. Several of the Angel investment firms we have contacted are offshoots of more traditional Venture Capital firms, allowing the firm to direct some funds to high-risk/high reward start-up investments. Angel and Seed funding is our sweet spot for funding this year.

Traditional Venture Capital funds have evolved recently to fund more mature, less risky start-ups. Often, the start-ups they fund are companies who are seeking expansion, rather than early, existential funding. Venture Capital firms are usually started by successful business executives as a vehicle for investment in the high-risk/high-reward start-up sector. Traditional Venture Capital firms usually do not charge a start-up fee or a Finder’s Fee. Many Venture Capital firms employ full-time staff to search for investment opportunities. These staff are often incentivized financially for discovering successful investment opportunities. EMF has contacted several traditional Venture Capital firms who accept medical device start-ups as investments.

Les Hamashima, our CEO, and I will be on the road in October to Pitch EMF Disturbance Monitors, Inc. as a good investment opportunity to Angel Funds, Seed Funds and Venture capital firms. The funding we are seeking will be used to complete our FDA clinical indications trial at UNC Chapel Hill and our application for FDA approval. We’ll keep you posted on our web site as we try to partner with additional investors and move our company forward.

Working with the Department of Defense

EMF Disturbance Monitors, Inc. is an American company based in North Carolina. In the southern United States, the Department of Defense is among the largest employers in each state. North Carolina has major military facilities for all branches of the Department of Defense with the exception of the Space Force. As with any employer, soldiers, sailors, marines and astronauts require food, clothing and equipment for their jobs. This provides an economic opportunity for many industries, including start-ups. I think you would agree that our men and women in the military deserve the best products available, given the sacrifices they make on our behalf every day.

North Carolina has recognized the economic impact of the Department of Defense and has supported many resources to match North Carolina companies with business opportunities. One resource is First Flight Venture Center, a non-profit located in the Research Triangle Park. First Flight Ventures acts to coordinate opportunities with providers in the military industry space. EMF Disturbance Monitors, Inc was recently chosen to participate in the Propeller incubator program with a focus on business opportunities with the Department of Defense.

Our company is developing a medical device platform to measure electromagnetic energy emitted by muscles and nerves. The Department of Defense has more than 2 million employees. Each one is also a patient who requires medical assessment, diagnosis of medical problems and treatment of potential employment-related injuries. We view this population as potential customers who may benefit from our new technology. Our technology has the potential to identify differences in electromagnetic energy production by muscles and nerves in patients with a disease as compared to normal patients.

The greatest potential use of our technology is in studying patients where the electromagnetic energy emission is significantly higher or lower than norms. One such potential application is traumatic brain injury (TBI). Warfighters suffer from TBI as an employment-related injury. This includes open head injuries and closed head injuries. Some of the most difficult challenges in treating TBI are patients with closed head injuries. One example would be a soldier who sustains a TBI when an IED flips a motor vehicle in a war zone. Although warfighters with TBI may not have abnormalities seen with a CT scan or MRI, their symptoms are consistent with a brain injury. PET scans (a medical device that measures metabolic activity by using radioactive glucose) can sometimes detect a decrease in cellular activity in a particular area of the brain. However, there are currently no non-invasive, outpatient tests which can assist medical providers in identifying specific areas of the brain which are underperforming after TBI.

EMF Disturbance Monitors, Inc. is working with First Flight Venture Center to study the possibility that EMF disturbance technology can identify abnormalities in electromagnetic energy emission by nerve centers after TBI. This would involve a clinical study, similar to our recent successful cardiac study, where we test EMF disturbance technology in patients with TBI and normal control patients. Stay tuned as we investigate this opportunity for another potential application of our technology.

Moving on to Version 2.0

For those unfamiliar, NASA and the Department of Defense use a scale to rank the readiness of new technology. The scale, called the Technology Readiness Level (TRL), starts with an idea (TRL 1) and progresses to actual performance in the target market (TRL 9). TRL 6 is the level where a prototype has been created and shown to function in a controlled environment. This scale works well for software, hardware and military devices. The TRL 6 prototype is essentially Version 1.0 of any technology. Once you get to TRL 6, it’s time to start working on Version 2.0

After the completion of our successful animal safety trial, we are moving forward with upgraded versions of our prototypes in anticipation of our planned human volunteer trial. Our engineers are upgrading components to the hardware used in our sensor controller device. The hardware upgrades will allow for increasing the amount of data we can collect during each testing session. Our software engineers are also working on upgrades to the electromagnetic control systems, and the interfaces between our hardware and the User interface which technicians will operate during human studies. This will be Version 2.0 of our EMF disturbance technology.

We have a new and fascinating affiliation with the Wilson College of Textiles at North Carolina State University (https://textiles.ncsu.edu). They have a group called SHIFT designing “Smart Textiles” which integrate sensors into fabric. The cloth vests used for our animal safety trial were pretty basic and had pockets into which we inserted the EMF sensors. We are applying for grant funding to integrate our EMF sensors and wiring into a “Smart Textile” fabric. We would be able to position sensors in the fabric over target areas and “wire” the sensors through the fabric to a dataport. There are many potential commercial applications for this form of “Smart Textile” that extend beyond our company’s needs. This is our plan for Version 2.0 of our wearable, 3-dimensional sensor array.

One of the issues about crossing over TRL 6 is the possibility of technology acquisition. Now that we have demonstrated the potential for our patented EMF disturbance technology to magnify the EM energy emissions, other larger companies in the medical device space may determine that our technology would be an attractive addition to their portfolio. If the goal is to speed up the path to FDA approval and commercial sales, this would help accelerate that process. Right now, we are focused on remaining independent and are on track to meet our goal of FDA approval by 2026.

This month, we are in negotiations for two future clinical trials. This primary trial is the human volunteer trail for a cardiac application of EMF disturbance. We are also negotiating to use our technology for a potential neurosciences application. Stay tuned and follow us on the Web site for more information.

The Results of the Animal Safety Trial Explained

I have been waiting to write this post until the animal safety trial was finished and all the results had been reviewed. As a scientist, I was very impatient to share this information. As an officer of EMF Disturbance Monitors, Inc., I also have an obligation to only share information with the public that is valid and reproducible. I can now say that our animal safety trial was an unqualified success! Not only are we moving forward with our planned human volunteer trial, we have attracted additional capital investment in the company.

The most important outcome of an FDA animal safety trial is to document whether the tests we performed caused any injury (Adverse Events) to the animals tested. They did not. The Rhesus macaque monkeys wore our sensor vest for 30-45 minutes and returned to their enclosures with the other monkeys. The staff at the Biomedical Imaging Research Center at the University of North Carolina at Chapel Hill observed animal behavior before and after the tests. They reported no Adverse Events, confirming that the test is safe. Our thanks go out to the UNC staff who were incredibly professional.

The secondary outcome of an animal safety trial is to determine whether the technology was able to estimate the electromagnetic field produced by the monkey hearts. This was also successful. In each test, the animal was compared both to its own baseline (the EMF generator turned OFF) and to our control animal (Reese, the stuffed animal resembling a Rhesus monkey). The EMF disturbance data obtained from the tests animals was significantly different than the controls and estimated the electromagnetic field created by the heart of the animals. The tests were performed on different days with different sensor vests, and the results were reproducible.

The innovation that EMF Disturbance Monitors, Inc. has patented is the ability to indirectly estimate the electromagnetic field created by the muscles (such as the heart) and nerves. Based on published estimates of the heart’s electromagnetic field (EMF) strength, our technology appears to have magnified the weak EMF of the heart by a billion times (10 to the 9th power)! This allowed us not only to create “normal” cardiac EMF disturbance values for Rhesus monkeys, but also to show that the individual monkeys had subtle differences in their cardiac EMF studies.

In 2009, EMF Disturbance Monitors, Inc. completed our first “Proof-of-Concept” at GA Tech for a sports medicine application. Now, in 2024, our UNC animal safety trial has again confirmed this “Proof-of-Concept” for a cardiac application. Our plan as a company is to continue to move forward with FDA approval by testing human volunteers, hopefully this fall at UNC. You can follow our progress on our Web site or on our Linkedin page.

What We Have Learned From The First-Stage Animal Safety Trial

EMF Disturbance Monitors, Inc. collaborated with the Biomedical Imaging Research Imaging Center at the University of North Carolina at Chapel Hill on March 20, 2024 for the first stage of our animal safety trial. A second stage of the animal safety trial is planned in April, 2024. We collected data for three days which our team has already begun to analyze. I want to assure all of our readers that the Rhesus macaque monkeys who were our study patients in the trial were treated well and in accordance with national standards. Both rejoined their colony later in the day.

Much of the data we collected involved verifying that our prototypes performed correctly. We tested the magnetic fields created by our electromagnets to assure the fields were stable and uniform. We tested our specialized electromagnetic sensors in various orientations and in the wearable, 3-dimensional vest. Reese, our stuffed Rhesus monkey, was tested in a variety of electromagnetic fields while wearing the vest. Reese was an outstanding patient and provided us with loads of data.

After verifying that our equipment was performing correctly, we tested our technology on two Rhesus macaque monkeys. Each monkey wore the sensor vest for 30 minutes while we obtained readings in a series of electromagnetic fields. This is the most important data we obtained during this stage of the trial.

Our company will not be reporting the results of the EMF disturbance technology data until we complete the second stage of the animal safety trial. What I can confirm is that the prototype equipment performed well. The electromagnetic fields created by the EMF generator were stable and uniform. The data from the pre-clinical portion of the trial confirmed Maxwell’s law, a law in physics that describes how the energy of an electromagnetic field diminishes with increasing frequency. The specialized sensors (MC95rW, Magnetic Sciences, Acton, MA, USA) were extremely sensitive and consistent. We confirmed that our data files from each test were logged correctly.

We are excited about the second stage of the animal safety trial. We have asked our engineers to make some minor upgrades to our software and hardware based on the initial results to improve our data capture and to narrow down the optimum frequency of the electromagnetic field for the detection of electromagnetic energy emissions of the heart. In May, I hope to share some of the exciting scientific data we obtained from our animal patients. Follow our journey on our Website, emfdisturbancemonitors.com and on Linkedin.com

It’s Happening! The Clinical Trial is in March!

I have spoken in previous blogs about why EMF Disturbance Monitors, Inc. needs FDA approval to begin sales in the U.S. I’ve also gone over the rationale for needing clinical trials for new forms of medical devices. (You can read those blogs in the list below). After discussions with the FDA staff, EMF Disturbance Monitors, Inc. will be applying for approval as a Class II medical device in the De Novo medical device category. This means there are no similar medical devices which the FDA has reviewed and approved. Our medical device will be a “first of its kind”. As such, we will need to provide the FDA with information about how our technology works and the safety of our technology.

In March, 2024, EMF Disturbance Monitors, Inc. will collaborate with The University of North Carolina at Chapel Hill for both a pre-clinical trial and an animal safety trial of our new technology. The pre-clinical trial will focus on calibrating our equipment prototypes and establishing the optimal conditions for our animal trial. This means the equipment will be shipped to UNC, assembled and tested without animal patients. To complete our pre-clinical trial, we will run tests on “Reece”, our stuffed animal which resembles a Rhesus monkey. This pre-clinical data will be important to create a safe environment for our animal trial.

Our animal safety trial is designed to demonstrate that we can detect electromagnetic energy emissions from the heart of a Rhesus monkey. Rhesus monkeys are much smaller than humans. They are about the size of a large house cat. Although their hearts are small (about the size of a ping pong ball), Rhesus monkeys share 98% of our human DNA. Their hearts are built like ours, and function in the same way. During the trial, the Rhesus monkeys will wear a little cloth vest with sensors while we determine the best testing environment for detecting electromagnetic energy emissions from their hearts. After the test, they will return to their enclosures with their group.

The information we will collect from the pre-clinical trial and the animal safety trial will be extremely important and valuable. Because we are a “De Novo” medical device, any information from these tests will be important to share with the medical community and the FDA. We are in the process of creating our cloud data storage environment, where all our our trial data will be available for analysis and reporting. Cloud data storage and information sharing will be critical to our role as a medical device for diagnosis of congestive heart failure. It will also permit machine learning and artificial intelligence to constantly update the algorithms needed for an accurate diagnosis of heart disease. I will be sharing photos of our trials on our Web page over the next 2 months. I have to admit that I’m a little nervous but also really excited! Follow along with our journey at emfdisturbancemonitors.com

“Microwave syndrome”: hypersensitivity to electromagnetic radiation

Patient safety is one of our core principals at EMF Disturbance Monitors, Inc. We are a Class II medical device according to current FDA guidelines. Because our technology involves exposing patients to low-frequency electromagnetic radiation for a short time period, we need to follow standards published by organizations such as the U.S. Food and Drug Administration (FDA), the U.S Occupational Safety and Health Organization (OSHA) and the Federal Communications Commission (FCC). For the geeks among you, the safe exposure to electromagnetic energy is 10 mW/cubic cm based on current standards. Our exposure times must meet these limits to assure safe exposure during the test.

So, is there any evidence that electromagnetic energy exposure can harm humans? The answer is yes. Reports from Russia, Scandinavia and Taiwan suggest that some individuals have “hypersensitivity” to electromagnetic radiation exposure. This has been dubbed “Microwave syndrome”. The reports concern soldiers who had prolonged exposure to cathode ray tubes (EMF doesn’t use cathode ray tubes). These soldiers reported fatigue, dizziness, problems with concentration, sleep disturbances and skin rashes. Cathode ray tubes can produce electromagnetic radiation at high frequencies (EMF uses low-frequency electromagnetic energy). Cathode ray tube electromagnetic energy emission is often referred to as an “electron gun”. The soldiers were using military equipment with cathode ray tubes during the Cold War (1950-1980). More recently, “hypersensitivity” to electromagnetic radiation has also been reported from people who live near high-power lines and transformers. Studies from Poland and Finland suggested that the risk of depression and anxiety might be higher in residents who live within 50 m of a high-voltage power line or transformer (EMF does not use high-voltage equipment). The transformers operate at 400,000 volts (EMF operates at less than 50 volts).

Interestingly, there are also potential risks from electromagnetic energy exposure at the other end of the spectrum. Studies in rabbits have suggested mild hearing loss after exposure to ultra low frequency electromagnetic energy exposure in the range of 50 Hz. There are also concerns that ultra-low frequency electromagnetic energy used by military submarines for communication might interfere with body functions of mammals like whales who communicate with ultra-low frequency sound. rTMS is an FDA-approved treatment for depression that uses ultra-low-frequency electromagnetic energy pulses. The FDA has limited the time exposure of rTMS (Repetitive Transcranial Magnetic Stimulation) due to possible side effects with prolonged exposure (EMF does not use ultra-low frequency energy exposure).

If you’re still following the science of this, it would appear that the potential risk of human complications from electromagnetic energy exposure has a “sweet spot”. The sweet spot lies somewhere between ultra-low frequency electromagnetic energy exposure and high-voltage/high-frequency electromagnetic energy exposure. The other important point is that “hypersensitivity” to electromagnetic energy exposure is rare in humans. Most individuals who live near high power lines do not report symptoms of “Microwave syndrome”. EMF disturbance technology uses electromagnetic energy exposure that falls in the “sweet spot”. Our first clinical study used energy at 2000 Hz. Our student volunteers did not report any side effects from exposure.

Our core principle of patient safety requires that we complete safety tests for electromagnetic energy exposure in humans before requesting FDA approval. Even though our technology uses energy exposure in ranges that are considered “low risk” for human complications, it is important to confirm safety by asking all of our human test subjects if they experience any side effects as a result of our test. Our Human Volunteer study is planned for the fall of 2024. Each volunteer will complete multiple questionnaires over a 30-60 day time period to validate the safety of our technology. Follow along with our journey to FDA approval by checking our website.

How We Handle Patient Data

Data analytics is booming in the United Sates. My daughter works as a senior director in a large, global professional services firm. She is definitely my “40 under 40” star in this emerging data and technology. Nearly everyone agrees that “data is king”. But, “garbage in, garbage out” is a real thing in medicine. So how will we handle our data responsibilities?

We’ll start with an example. Usually, when you see a primary care provider for a visit, a trained staff member takes your vital signs (heart rate, temperature, blood pressure, etc). Sometimes the staff take your blood pressure the old fashioned way by listening with a stethoscope. More recently, the staff may apply an automated blood pressure cuff. Taking your blood pressure manually means the staff must enter your blood pressure in the electronic medical record manually (first point for possible data error). If the staff member uses an automated blood pressure device linked to your electronic medical record (EMR), there is a second possible point of data error. Automated blood pressure cuff readings can vary with the position of the patient. application technique by the staff, or even anxiety. If the cuff reads your blood pressure incorrectly, and is attached to your EMR, the abnormal blood pressure reading is forever in your EMR, even if the staff believes it is incorrect. It can’t be erased based on a “Data Policy” (another potential point for data error). Each EMR and practice staff handle this situation differently, but that reading is not deleted. You’ll be explaining that one to your provider for the next several years. And don’t get me started on errors in coding your medical conditions…

So, what we want is data that is valid and enough data to determine that our medical device really does what we tell you it does. So, we are working with engineering partners on our hardware to make sure the measurements we are going to analyze are valid and reliable. We have run computer simulations. Our engineering partners have double-tested every sensor. We have planned on redundant data capture and redundant data storage. We have followed FDA recommendations for data integrity, HIPAA compliance and secure data storage for our upcoming clinical trials.

Electromagnetic field disturbance technology requires that we take millions of readings from an array of sensors during your study. There are lots of potential problems with recording that data correctly. Electric power in the study area can fluctuate. Sensors can malfunction, Electronic connections can come loose. The internet connection can go down. The list is long. The strength of our technology is in taking enough readings from your sensors that outliers can be identified and statistically removed during your data analysis. There is a principal in scientific research called “statistical significance”. Statistical significance means that there is less than a 5% chance that the outcome is random (device doesn’t work). It also means we have tested enough patients to be 90% sure that our data analysis is valid. Our clinical study designs are built around the principal of statistical significance so you can be confident that our cardiac testing is accurate.

The most exciting thing about our upcoming trials is that we will get to work with consultants who are at the forefront of machine learning and artificial intelligence (AI). Our data analysis will require 5 dimensions. Our measurements with be 3-dimensional over time and will have a 5th dimension of strength. This kind of reporting was unthinkable when I started my medical education in the 70’s. I admit I’ve had to brush up on data analytics to envision this. Thankfully, I have a really good consultant who is also the mother of 3 of my granddaughters.

Our Data Plan is to deliver information to the provider in multiple ways: facts, a 3-dimensional interactive CAD model and a movie of the heart beating while it is emitting energy. I hope that this multifunctional display will help providers identify deviations from normal that are statistically significant. That information should allow an earlier diagnosis of heart failure and an earlier opportunity for intervention. Follow our journey on our Web site as our clinical trials begin in 2 weeks.

Dissecting Services Offered to Your Startup

One of the reasons I asked my friend, Les Hamashima, to join me in this startup was my acknowledgement that I need help with business operations. Practicing medicine was so much easier that running a startup. I understood the relationships with patients, hospitals and vendors. The startup world is less transparent, especially when you begin to get solicitations from service providers.

After working on EMF Disturbance Monitors for more than a decade, I have begun to understand the different categories of startup services. I am trying to raise up my business and make it commercially successful. Startup companies represent new business opportunities for established companies like venture capital, business service providers and business consulting firms.

If you are a new startup, maybe my analysis will help.

Every startup needs 3 business services: legal, accounting and insurance. Lawyers help you incorporate, help protect your intellectual property and help you write documents that define your relationships with investors and other businesses. Accountants help you categorize your expenses and prepare your taxes so if you are acquired, your finances are in a format that other businesses can understand. Lastly, insurance brokers provide protection from liability in the event your product is accused of poor performance or injury.

Venture capital companies are the unicorn of startups. Venture capital has become part of the portfolio of wealthy individuals, family businesses and universities. Most are done professionally by companies that review pitches from promising startups and choose the few that are most likely to succeed based on criteria developed by each venture capital company. My advice is to shotgun venture capital companies with your “leave pitch” and hope that one sticks. They are unlikely to seek you out, so make it a habit to reload your shotgun regularly and seek out new sources of funding by pitching at events or through the online portals of the venture capital solicitations.

Business service companies offer services like marketing, management and finance. Many offer “fractional” services like a part-time CEO, part-time CFO, etc. This concept is similar to staffing firms. These services are critical to the success of your startup. Often, you need these services before you can afford to hire your own full-time employee in this role. Hence, the part-time or “fractional” employee concept. Many startups use these services in their early stages, until they can afford a full-time employee of their own. The only down-side of the “fractional” services concept may be some awkwardness (real or perceived) if the business services company that sells this service has it’s own venture capital arm. Essentially, the insider they provide your company gives their company an advantage in negotiations about investment or acquisition. This conflict can be mitigated by careful wording of your contract.

Lastly, there are business consultants. These are companies that offer advice about business operations or “warm” introductions to venture capital. These solicitations are the least transparent. Some have internal venture capital operations and others tout connections with external venture capital companies. Many of the solicitations we have received are seeking a salary and a productivity bonus (“finder’s fee”) for any venture capital obtained through their connections. Professional venture capital companies employ individuals who seek out promising startup investments for their company to review. I understand this process and see the value because the employee gets a bonus from their employer (not me) for finding a good investment opportunity. I see more risk in paying a consultant a salary and a finder’s fee if the consultant underperforms and does not close any venture capital deals while under contract with me.

I have noticed a trend that companies are combining these services into a “one-stop shop” where you can buy business services, business consulting and potential venture capital from the same provider. This makes your decision as a founder much more complex. I think the best idea is to prioritize what services your startup needs and deal with the industry leaders in those services. We all need venture capital but we are more likely to get noticed if we have a strong and profitable business. I hope this review is helpful to young startups and can help you clarify why these kind of companies are seeking you out as a client.

The Potential for Electromagnetic Energy as both Diagnosis and Treatment

Our company, EMF Disturbance Monitors, Inc. is developing a new medical device for the diagnosis of congestive heart failure. But did you know that electromagnetic energy (EM) can be used both for diagnosis and treatment of disease?

The U.S. Food and Drug Administration (FDA) has approved the use of low-frequency electromagnetic energy as treatment for pain, depression and bone healing. The treatment for pain is called PEMF (Pulsed ElectroMagnetic Field). PEMF has also been used to help bone fractures heal. The treatment for depression is called rTMS (Repetitive Transcranial Magnetic Stimulation). There is also an off-label use of electromagnetic energy for treatment called RIFE (named after the inventor Royal Rife). RIFE was originally used to kill bacteria. Over the past century, patients have used RIFE machines for broader indications such as general well-being.

Our company’s device uses low-frequency electromagnetic energy for diagnosis. There are many uses for EM in the diagnosis of disease including EKG (electrocardiogram), EEG (electroencepholgram, EMG (electromyelogram), MRI (magnetic resonance imaging), magnetocardiogram and electromagnetic field disturbance. An EKG detects EM energy from the heart using pads on your skin. An EEG detects EM emeissions from the brain using pads on your scalp. An EMG detects EM emissions from muscles using pads on the skin near those muscles. An MRI machine uses high-frequency EM to create images of the body. A magnetocardiogram detects low-frequency EM emissions of the heart using specialized, super-cooled sensors. Our technology, EMF disturbance, creates a safe, external electromagnetic field (EMF) which is “disturbed” by the EM emissions of muscles and nerves.

As I discussed in a previous blog, advances in computer analytics and the development of smaller, highly-sensitive EM sensors has accelerated the study of biomagnetism. Scientists have been aware for more than a century that organs of the body emit electromagnetic energy, In the last 50 years, there has been a rapid increase in the number of medical devices which have received FDA approval for the use of EM in the diagnosis and treatment of disease. In February, 2024, we will begin our first clinical trial using EMF disturbance technology.

You can follow our journey toward FDA approval through Linkedin and on our web site, www.emfdisturbancemonitors.com.

Why Companies Have to File Reports

EMF Disturbance Monitors, Inc. is a Delaware S corporation. As an S corporation, we have officers, a Board of Directors and stockholders. Every employee and investor has a stake in the success of our company. Employees want to be proud of their company’s performance. Officers and the Board of Directors want to make decisions about the future of the company that will make it financially successful. And investors want to get dividends on the money they gave the company to fund operations. One way to satisfy all their needs is to file reports.

We are currently in a Series A fund raising round to obtain $ 2 million USD. The purpose of those funds is to complete the clinical trials necessary to obtain FDA approval and to begin manufacturing devices for sale. As investors consider whether to help fund EMF, we provide them with reports about how we have used Founder Funding. As of today, 100% of our Founder Funding has gone to Research and Development (R&D) and maintaining our Intellectual Property (IP) protection. Investors should be impressed that we have been very frugal with our capital to help accelerate EMF Disturbance Monitors, Inc. toward commercial success.

As our engineers complete the prototypes for the first electromagnetic field (EMF) generator and the first, wearable, 3-dimensional sensor array vest, we are moving away from the design phase to the clinical phase. Our first clinical trial, an animal safety trial, is set to begin in the next 2 months at the University of North Carolina at Chapel Hill, my alma mater. Based on the Series A funding pledged to date, we should quickly move to a human volunteer trial later in 2024.

Our investors will receive quarterly and annual reports on our budgets and expenses as we move forward. I am proud to share both the progress of the company and the lean financial approach that EMF has taken in 2023. 2024 will be the largest budget in the company’s history. You can follow our progress either on our web site or on Linkedin.

How We Protect Intellectual Property

I just applied for my 6th patent, so I guess that qualifies me as a serial inventor. I’ve learned a lot about protecting intellectual property over the past 15 years. Intellectual property, or IP, covers a broad range of information that a company would like to keep proprietary. In our case, the IP is patents on ideas about the use of electromagnetic field disturbance technology. Patents are public information, although the U.S. patent office has recently changed it’s software to make it harder to search for patents. If you’re a company, Intellectual Property also includes things like your client list, your supplier list, your manufacturers and even your employee training.

In the case of EMF Disturbance Monitors, our IP protection gives us an advantage over potential competitors by assuring that our technology cannot be copied by another company without licensing. That protection is not indefinite and usually lasts 20 years. That means we have to design, test, manufacture and sell our systems within 20 years to take advantage of IP protection. In 20 years, our technology is likely to have changed significantly and additional IP protection may be needed. For now, our employees and investors can be confident that we are the only company licensed to manufacture and sell electromagnetic field disturbance systems in the U.S and abroad.

As our company matures, we anticipate that we will develop different kinds of Intellectual Property like software algorithms, new electromagnetic field generators, new sensor arrays and applications for other medical conditions like sports medicine. It’s exciting to think that this novel and potentially disruptive technology will expand the production of intellectual property and the need to protect it. We’re grateful that our consulting engineers have nearly completed the first prototype of EMF disturbance technology for a cardiac application. In the spring of 2024, our animal trials should be completed and we will begin scheduling human volunteer trials. Keep up with our quest for producing new IP by following us on our web site.

How the Government Funds Startups

One thing I have learned from being involved in a start-up is that getting investors is the chokepoint for innovation. My CEO and I have met scores of founders with interesting and disruptive ideas who cannot move forward due to lack of outside investment. These founders have a strong work ethic, a good plan, and enough passion about their start-up to work without compensation. Essentially, it means that nearly all start-ups are second jobs. Founders usually have a day job which pays their bills. They use sweat equity and personal savings to get their company up and running.

In our GRO incubator, we spoke to a start-up founder who lives in Northern Europe. This founder spent time in the U.S. because our country is considered to be the Holy Grail for innovation and start-ups. He confirmed that the “start-up culture” (yes, that is a phrase) in Europe is decades behind the U.S. and trying to catch up. One of the problems with U.S. venture capital is that we are a “mature” start-up culture which focuses on identifying start-ups who have the best chance to become a “unicorn” and reward the venture capital company with profits that exceed the Standard and Poor index. If I become an investor in a venture capital company, I would want the same. Sadly, for start-ups that are not unicorns, the journey ends sooner with no benefit to the founder or the investors.

What the U.S. is missing is the incentive to fund start-ups with better tax incentives. Start-ups who can pay their employees wages in the Angel Investor stage would be a source of tax revenue for the U.S. and a source of tax deductions for the investors, even if the companies fail (which they do 80-90% of the time). The failure rate for family-owned businesses (usually service businesses) in the U.S. is estimated to be 50%. Yet, the government allows these small businesses robust tax deductions and capital write-offs. Banks who work with the U.S. Small Business Authority (SBA) receive loan guarantees to offset loan losses from small businesses that fail. Most start-ups are software or non-service businesses (like manufacturing). The tax code has largely ignored this area and left it to private equity. There are limited options for investors to recover their losses in Angel Investment stages through tax write-offs or capital losses.

One bright spot in the U.S. is the availability of SBIR and STTR grants. These are competitive grants designed to incentivize start-ups or small businesses with government grants. The competitive process assures that the best business ideas receive funding. The government agencies who sponsor these programs like the National Institutes of Health (NIH) and National Science Foundation (NSF) do not receive equity or stock in exchange for their grant investment. Most of the successful founders in biotech that I have interviewed cite SBIR or STTR grant money as a crucial funding mechanism that helped them through their Angel Investor stage. The only problem with SBIR and STTR grants is the long upramp to funding (12-18 months from application).

In January, EMF Disturbance Monitors will apply for our first SBIR grant. If successful, this funding will accelerate our trajectory to FDA approval and device manufacturing. Follow along on our Web page as we continue the journey from an idea to a successful medical device manufacturer.

What is a Clinical Trial?

When an inventor comes up with a new idea for a medical device or treatment, the medical community and the U.S. Food and Drug Administration (FDA) are initially skeptical about recommending the innovation for medical practice. Oversight is critical to making sure that an innovation about diagnosis or treatment is safe and effective. To convince the medical community (and the FDA) that your new idea has merit requires that you do clinical trials.

Clinical trials are usually performed in association with medical schools and are considered research. Clinical trials involve recruiting volunteer patients to use the new medical device or treatment. The volunteers must be told that the medical device or treatment is unproven or “experimental”. The volunteers must agree to participate knowing that the medical device or treatment may not be effective. All volunteers must be given the opportunity to stop participating in a clinical trial if they become uncomfortable with the clinical trial process for any reason. Lastly, the volunteers are told that the information from their trial participation may not be made public until the trial is completed. Clinical trials always use a concept called the “Null Hypothesis”. The “Null Hypothesis” means that the researchers must assume the device or treatment does not work. The trial is only considered successful if the data from the trial disproves the “Null Hypothesis” and shows that the device or treatment actually worked as intended.

There is a concept called the “Standard of Care” which providers use to diagnose and treat diseases. The “Standard of Care” is loosely defined as what a trained and licensed practitioner would order (to diagnose) or prescribe (as treatment) for the same or a similar illness. The “Standard of Care” evolves over time, as new and better options become available to providers. The “Standard of Care” permeates all of medicine, as it is taught in medical schools, practiced by providers, and reviewed by peers if the diagnosis or treatment is ineffective. In order for a new device or treatment to become part of the “Standard of Care”, the researchers must convince medical providers and the FDA that the new invention has merit based on successful clinical trials.

If you have ever volunteered for a clinical trial, you helped advance medicine whether the device or treatment actually worked. Many past volunteers become aware of the trial’s success or failure by watching the media years after they participated. If the device you tested becomes available to other patients, your participation in the trial made that possible. If you were in a treatment trial and the treatment is now available to other patients, your involvement helped medical providers accept that treatment as part of the “Standard of Care”. EMF Disturbance Monitors will begin our first clinical trials next year to determine if our patented technology can diagnose heart disease. Follow us along on that journey as we try to advance medicine.

Why is Early Diagnosis of Heart Disease Important ?

Once a provider has diagnosed a disease like congestive heart failure or cancer, we review options for treatment with the patient. Both in heart disease and in cancer, there are “stages” of disease which indicate the severity. Stage 1 is the earliest and mildest stage. Stage 4 is the most advanced stage. The treatments we offer to patients are, in part, determined by the stage of the disease. Treatments may include lifestyle changes, medication or even surgery. The types of treatments, and the effectiveness of those treatments, become more limited as the stage of the disease advances.

Congestive heart failure is typically a chronic disease. Chronic implies that the root causes of heart failure started long before the disease is diagnosed. It is rare for congestive heart failure to start suddenly, unless it occurs after a significant heart atack (myocardial infarction) or a severe viral infection (myocarditis). Whether congestive heart failure is sudden (acute) or chronic, the universal cause of congestive heart failure is that the heart cells produce less energy. This results in a progressive decrease in the heart’s main function which is to pump blood.

As we discussed in a previous blog, injured heart cells can recover with treatment. Some cells in the body, like skin, can make new skin cells when old cells die. When you “peel” after a sunburn, the old, dead skin cells peel off and the body makes new skin cells to replace the old ones. However, your body is unable to make new heart cells to replace heart cells that die. If we could diagnose congestive heart failure at an early stage, your provider would have more and better options for your treatment. If congestive heart failure is diagnosed at a later stage, your provider has fewer and less effective options.

All of the current tests that are used to diagnose congestive heart failure are based on detecting damage to the heart. This means that the congestive heart failure is almost always at a later stage when it is diagnosed. This limits the options for treatment that your provider can offer. It also means the treatment may not be as effective as if the treatment was started at an earlier stage. One of the incentives for creating EMF Disturbance Technology was the possibility of creating an innovative, non-invasive test that could diagnose congestive heart failure at an earlier stage. This would potentially provide both patients and providers the widest range of effective treatment options. You can follow our journey on our web site as we begin clinical trials for the early diagnosis of congestive heart failure.

A Shout-out for Incubators

My youngest grandchild was born 4 weeks early and narrowly avoided admission to the NICU. As an obstetrician, I always associated the word “incubator” with a small plastic box where a premature baby lives from birth until independence. I didn’t know much about the start-up industry who borrowed the word “incubator” to describe an organization who helped promising young businesses. Now that I am about to graduate from a start-up incubator, I have found a lot of commonalities.

A premature infant is a person with unlimited potential. Because that baby arrived too soon, it requires the help of technology and professionals to gain independence. Premature babies born in hospitals without the appropriate intensive care have a lower chance of survival. The course of each individual baby’s NICU stay is rocky, with unforeseen bad days and good days. With the right assistance and advice, a preemie graduates the NICU and goes home to a celebration. As infants, a child who started in the NICU will always face challenges. With attentive parents and continued pediatric support, most grow up to be healthy, thriving children.

Start-up businesses are a lot like preemies. Most have a great idea with significant potential. If they are brought to market too early, they are unlikely to survive. If they are lucky enough to gain entrance to a start-up incubator, the chance of survival as a business increases dramatically. There is extensive technology available to help start-up businesses. The key is you need a professional to guide your business toward the right resources and away from the wrong resources. Even in an incubator, there are bad days and good days as your advisors point out the very glaring shortcomings of your idea and business plan. At the end of the incubator, there is a celebration as you pitch your business idea to a group of investors and prominent start-up celebrities. After the incubator is over, you still face challenges. If you have the right support from your team and your investors, you can grow to be a successful and thriving business.

My co-founder, Les Hamashima, and I were accepted into the GRO incubator program at the Council for Entrepreneurial Development (CED) in the Research Triangle Park of North Carolina in the USA in August, 2023. We felt we had a solid idea with great potential for a business. But, I admit now, we weren’t ready to be an independent business yet. CED offered technology assistance and advice from professionals in our incubator, just like an NICU. We had a rocky course trying to address weaknesses in our business plan. I feel we met our milestones, just a preemie who is trying so hard to get off assistance and be independent. This week, we get discharged from our intensive care incubator in a celebration called DEMO DAY. CED has already offered continued support after graduation to make sure our business can be successful and thrive. So, hat’s off to incubator programs like GRO. If your business is a start-up preemie, you should seriously consider asking for intensive care in an incubator like we did.

What is a Non-Invasive Medical Device?

Healthcare providers use many different technologies to search for the cause of your medical illness. It starts with old school techniques like asking you questions about your problem and performing a physical examination. Often, we need more information to help use find the most likely cause of your issue, especially if there are several possibilities (“a differential diagnosis”). For example, feeling exhausted and dizzy can be symptoms of common mild diseases such as stress, poor diet or viruses. The same symptoms can also be signs of more serious issues like heart disease, stroke or cancer. So, your provider orders more tests to figure out the most likely cause for your medical symptoms.

Additional information can be obtained by examining you from the outside (X-ray, ultrasound, MRI) or from the inside (blood drawing, injection of contrast agents, placements of catheters). Studies that require needles or catheters are called invasive studies because we “invade” your body with medical equipment or chemicals. Studies done from the outside without needles or catheters are classified as “non-invasive”. Patients prefer non-invasive studies since no one likes needles or catheters. EMF disturbance technology is an example of a “non-invasive” device since we don’t use needles or catheters.

The term “non-invasive” device is not really accurate, however. X-ray machines expose your body to X-ray radiation. Too much X-ray exposure increases your risk of cancer. Ultrasound sends sound waves into your body. High-energy ultrasound waves can destroy kidney stones but can also injure normal tissue. MRI sends high-frequency magnetic energy into your body. If you have metal objects inside your body (pacemaker, bullet), the MRI energy can move or damage the object. So, “non-invasive” studies use various kinds of energy that invisibly “invade” your body during the study. The FDA has written strict guidelines for “non-invasive” devices using X-ray, sound waves or magnetic energy to insure your safety during a “non-invasive” study.

EMF disturbance technology is a “non-invasive” medical device. EMF does not use needles or catheters. The device exposes the patient to low-frequency electromagnetic energy. The exposure is similar to wireless cellphone chargers, only at a lower energy frequency. The FDA and other government agencies have studied this kind of electromagnetic energy exposure and have come to the conclusion that devices that emit this kind of electromagnetic energy are safe enough to be used in the home of consumers. Because EMF disturbance is an innovative or “disruptive” technology, we have committed to a series of safety trials for both veterinary and human patients. The non-invasive nature of our technology should be a plus for patient satisfaction. But, safety of our patients is the most important principle in the development of EMF disturbance technologies. You can follow us on this journey as we begin our clinical trials in 2024.

Biomagnetism- The Good and the Bad

In a previous blog, we talked about the principle of biomagnetism. Biomagnetism is the ability of the body to create electromagnetic energy when your use your nerves and muscles. Biomagnetism is a relatively new term that encompasses this concept.

Over the years, I have watched my granddaughters learn how to walk. The learning process is initially slow and then accelerates. It starts with standing, then scooting along the furniture and ends up with them running away from me. As a physician, I understand that they are constantly using nerves and muscles to perfect the process of walking. Nerves in their brain and spine communicate with muscles in their body. The nerves and muscles are using electromagnetic energy to power those little legs. When they fall, they learn which muscles to use and which muscles not to use. It is fascinating. Every parent knows the joy of watching those first few steps.

When I watch a gymnast perform a floor routine or a pitcher throw a fastball, I am witnessing the pinnacle of biomagnetism. The balance, force and coordination are humbling. These are examples of the best of biomagnetism. Unfortunately, as a doctor, I also have seen the worst of biomagnetism. I have cared for patients with seizure disorders where the brain’s biomagnetism was uncontrolled. I have cared for paraplegics where a spinal cord injury terminated the biomagnetism from the brain, leaving the patient unable to walk. In the realm of cardiac disease, I have helped friends, family and patients who have had irregular heart beats caused by abnormal biomagnetic energy emitted by the heart. Research into biomagnetism has allowed scientists to stop seizures with biomagnetic implants. Engineers are learning how to detect biomagnetism in the extremities of amputees to create smart prosthetic devices that return function that was lost. We are all familiar with pacemakers, which detect abnormal biomagnetic energy produced by the heart and intervene to prevent fatal heart rhythms.

Until recently, research in magnetic energy has focused almost exclusively on industrial applications. Our company is on the forefront of medical research into the biomagnetism of animals and humans. EMF plans to collaborate with a leading Southeastern university to study the biomagnetism changes in patients with heart failure. Measuring biomagnetic energy directly is challenging, but our new platform promises to measure biomagnetism indirectly and use this information to aid in the diagnosis of health and disease. Follow along with us as we explore how to use electromagnetic field disturbance technology to use biomagnetism for good.

Why Do We Need FDA Approval?

Patient and friends often ask me why medical care is so expensive. Healthcare costs in the United States are more expensive than in any other country in the world. Why? The answer is complicated. On the one hand, healthcare innovation is alive and well in our country, with new devices and medicines becoming available every year. On the other hand, an often overlooked reason is that the US has an enviable safety record for these innovations because of the Food and Drug Administration.

The FDA is responsible for reviewing and approving new medical devices and prescription medications. This is a long and expensive process which involves proving that the device or medicine is safe for users and effective at the purpose for which it is intended. When a manufacturer creates a new device or medicine, the company works with the FDA to achieve approval for the sale of the device or medicine in the US. This may involve safety testing in animals or cell cultures before testing on humans. Patients must then volunteer to be in a medical study to test the intended use of the device or medicine. The manufacturer must warn volunteers about potential adverse events associated with the device or medicine. Many study volunteers decline to participate or withdraw from studies due to safety concerns. If the device or medicine is not found to be effective, then the company’s investment in research is lost.

By the time a company is successful in getting FDA approval for a new medical device or prescription medication, the company has already invested millions of dollars in research and development. When the company begins to manufacture and sell the product, the pricing must include the cost of manufacturing, marketing and research. The company must also make a profit on the device or medication, so that investors in the research are repaid. Lastly, patent protection for medical devices and medications in the US has a time limit, so the manufacturer must make back all their costs before generic drugs or similar devices can be manufactured by other companies.

By now, you can appreciate how hard it is to go from a great idea to the sale of a new medical device. It is a long and expensive process. It is important to remember that the FDA approval process was designed to protect consumers from fraud. When your provider orders a test or gives you a prescription, you can be confident that the device or medicine has been proven to be safe and effective. Our company has begun the process of seeking FDA approval for EMF disturbance technology. We will keep you informed as our journey progresses.

What is Biomagnetism?

I bought an emergency flashlight that doesn’t require batteries. You shake the flashlight back and forth for a while and the light comes on. My wife and I use this flashlight when the power goes out. How does it work? (spoiler alert- brief science lesson coming up…).

Well, inside the flashlight cylinder there is a magnet that looks like a ring. I use my energy to shake the flashlight. When I shake the flashlight, the magnet slides back and forth over coils of copper wire. My energy moves the magnet over the coils. The motion of the magnet over the copper wire transfers my energy into direct current electricity. Direct current electricity in the wires charges the reusable battery and the light comes on. So, in essence, I am the battery since my energy created the electric charge. Enough of the science lesson.

Our bodies are just like batteries and charge when we eat. Muscles and nerves in our bodies create small electromagnetic fields when we use them. When you lift a free weight with your arm, the muscles in your arm move just like the magnet in the flashlight. Not only does it create force to lift the weight, the muscles also create electromagnetic energy. The electromagnetic energy you create is called biomagnetism. Human brain cells use biomagnetism to communicate with each other. Certain forms of algae use biomagnetism to create light in the ocean when disturbed. Electric eels use biomagnetism to create energy shocks so they can stun their prey Even though you might not have heard of biomagnetism, there are examples everywhere is nature.

As physicians, we can identify biomagnetism using technologies like the EKG (heart biomagnetism), EEG (brain biomagnetism) and EMG (muscle biomagnetism). The problem is that the amount of electromagnetic energy created by biomagnetism is usually so small that current technologies have trouble directly measuring it. EMF Disturbance Monitors has patented a method to indirectly measure biomagnetism. Stay tuned as we explore the opportunities to use this platform to study biomagnetism in both animals and humans.