Revolutionizing Mental Healthcare: A Journey with Fred Walke, CEO of Wave Neuro

Fred Walke (FW): Throughout my career, I've consistently sought out pattern recognition to bring ideas and proven strategies from various industries into adjacent companies that have been centered around improving health and quality of life. Early in my career, I was the CEO of a PE (Riverside Partners) backed company, Microdental in which we achieved explosive growth by rethinking positioning and shifting focus from low differentiation, pain-oriented, restorative dentistry to one focused on aesthetics and total health which catalyzed 30x value creation and growth compared to the industry.

After a rewarding period of turning around companies focused on various aspects of healthcare from 2013 to 2017, a personal experience with my daughter's head injury she received while playing soccer led me to groundbreaking technology. I discovered this technology through my work for a family investment office in 2016. Later, in 2018, I began consulting for the company which led me to the opportunity to utilize the technology to help my daughter. Through a brain scan of just ten minutes, we surpassed all of the information we had gathered in the previous 2 years from top medical facilities. She went on a 3-week journey of this non-invasive treatment where she saw massive improvements in her mood, academics, and sports performance.

Overcoming the constraints of past traumas that seemed like a depression, she successfully navigated her junior and senior high school years, excelling academically. She even became the captain of the soccer team and eventually pursued higher education in college. It's remarkable to think that without this treatment, she might have faced prolonged challenges and remained at home, but instead, she's now flourishing in life.

Motivated by my daughter's positive transformation through a personalized biomarker-guided protocol, I committed to making this technology widely known. I embarked on a mission to commercialize the technology, recapitalize it, and acquire additional assets to build a robust intellectual property portfolio and new, significantly improved, mental healthcare standards. In mental health, unfortunately, you become the identity of your illness. If you're a runner and you have a pulled hamstring, you're a great runner with a pulled hamstring. If you have a brain injury or some form of mental illness, you become a labeled person. You are seen as the angry, quiet, sad person versus a person with a brain not functioning properly. The scan and the report by itself are so empowering to people because, for the first time, it allows them to separate themselves from the identity of illness. Being able to see the brain function, and see its deterioration or changes, allows you to say, okay, I'm a good person. It is my brain that is not functioning properly. If I can get my brain to function properly, I can be the person I used to be or am capable of being.

So, that's how I got into it. In 2019, I founded Wave. A few years later, we are at 200 licenses globally, 15 countries in five continents. More than 15,000 patients have been treated using our technology with zero adverse events. Most importantly, every patient and licensee is a referral from another, further underscoring how transformative this intervention is – we routinely perform 3 times better than the most advanced care.

(FW): The current state of neuroscience presents a wealth of information and innovation, but fragmented communication among different camps hinders progress. By bridging these gaps, we have the potential to reshape the mental health care system, challenging the conventional approaches and shattering the traditional model of waiting for symptoms to manifest to eventually address illness.

This technology empowers individuals by providing insights into brain function, separating them from the stigma of mental illness. Witnessing the positive impact, and realizing there is too much pain, shame, and suffering in mental healthcare, I decided to make it my mission to advance this technology and bring it to the masses. With a background in raising capital and commercializing healthcare technology and products, I aim to navigate the innovative landscape of neuroscience and connect various camps to revolutionize the mental healthcare system.

(FW): Our intellectual property (IP) stems from 25 years of research across institutions like Brown, Harvard, USC, Stanford, Duke, and Texas A&M University. The core is biomarker-guided protocols for TMS or neuronal changes, utilizing EEG for personalized brain function alterations. We've acquired patents spanning nearly two decades, focusing on enhancing efficacy and application.

Our software suite, MeRT, bridges FDA-approved devices like EEG, fMRI, CT, and blood biomarkers with TMS and other forms of stimulations. We aim to increase efficacy, access, and throughput, making TMS more versatile and efficacious, moving far beyond severe depression. By understanding the correlation between neural network function and coherence, we understand the foundational role neuron performance plays in mental health. We're pioneering an FDA pathway for personalized TMS treatments across multiple indications such as anxiety, PTSD, and more.

We aspire to catalyze innovation on both sides of the platform, optimizing EEG and refining stimulation methods. We also see promise in utilizing our insights to guide pharmaceutical, nutraceutical, and psychedelic treatments when desired. Our approach is to maximize your potential by monitoring the brain's performance while new interventions are delivered. For example, we have IP that guides the dosing of psychedelics by monitoring neuron activity to ensure optimal benefits without overstimulation.

With a comprehensive approach, we're building the largest pre- and post-EEG database to tailor efficient treatments. I wouldn't call what we are doing futuristic or a moonshot because it's real. We're doing it today, utilizing already FDA-approved equipment. We are just doing it in a safer, more personalized manner. We are focused on satisfying the FDA’s needs to allow for use across multiple indications and as a pathway to provide insurance reimbursement. Our model can reduce costs, expand treatment accessibility, and enhance efficacy, making a significant impact on mental healthcare.

(FW): In the realm of military health, we're particularly focused on addressing PTSD, a condition closely linked to anxiety. Both conditions manifest as an acceleration of neurons, creating heightened anxiousness. Our ongoing FDA-grade trial focuses on PTSD, and our technology, already in commercial use, showcases promising outcomes in this area. We also extend our efforts to autism, where a lack of frontal lobe development results in slowed or incoherent neurons and manifests in shut-down communication.

We aim to provide relief in areas where traditional medicine falls short, focusing on significant unmet needs. In the case of PTSD, particularly sexual trauma, we seek to help individuals return to their highest potential while reducing the need for excessive medication and dilution of their personal best. So, we envision our technology working alongside existing modalities while solving problems where pharmaceutical interventions and therapeutic interventions haven't been as successful. Traumatic brain injury, another substantial unmet need, is also within our purview.

In discussing war-related trauma, such as that experienced by Ukrainian fighters, we recognize the long-lasting impact on generations. Our technology, capable of scanning the brain and identifying neuronal issues, offers a potential solution to symptoms like anxiety and overstimulation caused by artillery-based conflicts.

By understanding the impact of poor sleep, environmental factors, and trauma on neuron function, we strive to make a substantial difference in the lives of those affected. We can scale quickly, anywhere, without the bottlenecks of traditional services which is a major advantage to the technology, adjacent to its increased effectiveness and outcomes.

(FW): We prioritize personalized treatment by scanning each individual's brain for unique patterns and using AI to create tailored protocols. After processing the collected data through AI, we identify commonalities in treatment where specific aspects may not have been as effective. This enables us to create personalized protocols by combining nutrients, stimulation, and interventions like ABA therapy, especially for patients with autism. Whether it's a deficiency or excess production of hormones or proteins, we help individuals understand the potential effects. For instance, in autism cases, we've observed significant improvements by assisting individuals in managing their diet and incorporating specific supplements that positively impact their performance.

With a vast database of over 60,000 pre- and post-EEGs, the largest in the world, we analyze outcomes and progression through treatment. Through correlation analysis, AI enables us to identify commonalities and develop protocols that combine nutrients, stimulation, and therapies.

Our goal is to transition from acute care to proactive hygiene care, leveraging wearable sensing devices to predict and address brain function changes before symptoms arise. We're working towards eliminating illness, with AI guiding the most effective interventions for each person. That's my goal. That's what we're trying to do.

Collaborations with partners like OpenAI and insights from industry leaders, including Sam Altman, have enriched our approach. We've recently closed our Series B funding round, signaling our commitment to advancing technology that enhances health outcomes, reduces reliance on the healthcare system, and maximizes individual performance. These exciting developments mark a shift towards a future where technology plays a pivotal role in personalized healthcare, not just a role in how we interact with healthcare.

(FW): Currently, we have two key initiatives in motion to accelerate our mission. We've successfully onboarded top talent from biotech and pharma to bolster our commercial team. Simultaneously, we're gearing up for our Series C funding round, kicking off at JP Morgan’s annual healthcare conference. This will further drive our commercial efforts and expedite FDA trials for our De Novo device designed to treat PTSD. While the algorithm evolves based on symptoms and indications, the device remains relatively static, allowing for swift expansion into other indications.

Our primary focus is on improving safety and access while scaling rapidly to address the severe lack of diagnostic and curative resources in the market today. We believe that addressing neuron dysfunction is pivotal in promoting mental health. Whether it's upregulating or downregulating, our protocols target different mental illnesses, guided by the personal brain data of each patient. With virtually no marketing or sales efforts, we continue to showcase significant growth. The funding, in short, is for further growth acceleration and market penetration of the business: we are at 200 licenses and expect to be close to 500 licenses by the end of 2024.

(FW): The main technological challenge we currently face involves navigating through antiquated EEG products that make bold claims but fail to deliver actionable data. We seek technologies with the right inputs, combining frequency detection with spatial resolution for medical-grade applications. Additionally, we aim to enhance TMS devices, such as our mobile device called Sonal, by focusing on a more user-friendly and sophisticated design.

That said, we are not interested in being in the hardware business and our involvement in Sonal originated from acquiring NeoSync through an IP purchase. While we revamped the product by adding Bluetooth and modern features, the method of creating the electrical or magnetic field remains unchanged, yielding profound benefits. This device, treated as a wellness tool, is not actively marketed, but users, including high-performing athletes, warfighters, executives, and families, express strong positive feedback. It's a 30-minute daily routine, easily done at home. While the device shows promise in addressing mild cognitive impairment related to aging, it's currently a back-burner project due to resource constraints. Proceeds from future endeavors, like Series C funding, may support further investigation into this area.

In terms of prevention, our approach involves analyzing EEG data and leveraging AI to predict and address brain function changes before symptoms manifest. We envision a shift from acute care to proactive hygiene care, using wearable sensing devices to optimize individual performance and minimize reliance on the traditional healthcare system.

(FW): Understanding the role of technology in medicine is crucial, as it serves as a powerful force multiplier. The limitations in rapidly producing more doctors and infrastructure, along with cost and wait time issues, highlight the need for a paradigm shift. While there's an upward trend in accepting the impact of technology on healthcare, it's not yet widely recognized as the standard.

We can't produce more doctors rapidly enough. We can't produce more infrastructure rapidly enough. The cost becomes prohibitive at times, and the wait times become prohibitive. The mental shift that needs to happen is the understanding of technology and how it works.

Electrophysiology and brain performance are pivotal determinants of mental and cognitive health. Convincing both consumers and doctors of the efficacy of technologies like EEG and TMS is crucial. The challenge lies in educating practicing physicians, many of whom trained a decade ago when these advancements were not as widely studied. Well, EEG was known for seizure detection and TMS was somewhat antiquated and not necessarily something that was studied broadly. So you have physicians that are in the market that aren't necessarily in tune with the advancements that are happening because they happen so quickly in technology. This lag in medical education hinders the rapid adoption of innovative technologies. This does not even address the role reimbursement plays in the adoption of new technologies and processes.

The future of medicine could be vastly different, but change in such a large industry is gradual. Starting with addressing acute and the most challenging medical issues, especially those less affected by traditional methods, allows us to enter the larger populations of sufferers that may not be as severe. The slow adoption is attributed to the evolving nature of medical education and the challenge of keeping up with rapidly changing state-of-the-art technologies. Technology advances are outpacing the University physicians’ education system’s ability to teach them.

Being non-invasive, and non-pharmacological gives us the ability to layer into pretty much anywhere, and in combination with, all of medicine. As long as we can demonstrate efficacy, which we do very, very well, I believe there'll be adoption. Change is going to be slower than any of us want but we are dedicated to causing this change and to improving the system as we move through it.