Many would argue that society is facing a mental health crisis. The toll of mental illness has increased in recent years, with suicide rates at a 30-year high as of 2017. Depression, anxiety, insomnia: all are serious medical conditions that affect tens of millions across the country and globe. 

It’s unsurprising, then, that mental health now makes up the number one category of healthcare costs in the United States, ahead of cancer, diabetes, or heart disease; spending on mental health treatment in the United States is expected to reach $239 billion by 2020. Recent insurance policy changes, namely the Affordable Care Act, increased the number of insured Americans by 14 million; an additional 2.5 million are expected to seek mental health treatment by 2020. 

While scores of individuals suffer from mental illness, and a good proportion seek mental health treatment, current treatment options are often ineffective and cause dramatic side effects. The effectiveness of drug treatments like antidepressants is hotly debated, and many studies contradict in their estimate of ultimate efficacy in treating depression. One study found that only about 60% of drug users experienced a change in their symptoms, and that symptom reduction was only 50%. In addition, many of those who routinely use antidepressants struggle to quit, creating a dangerous cycle of substance addiction and worsened side effects. 

Mental health struggles have increasingly been drawn out of the shadows and into the spotlight of popular media and culture. As society is more and more receptive to the conversation of mental health, the call for more effective mental health treatment grows louder and louder. 

The Fisher Wallace Stimulator, manufactured by Fisher Wallace Laboratories, is an FDA-approved medical device proven to reduce symptoms of depression, anxiety, and insomnia. The device consists of a simple hand monitor that attaches to two sponge-covered electrodes placed on the temples; the wearer turns on the device for 20 minutes per day, allowing neurostimulation to produce serotonin and reduce cortisol. 

The Fisher Wallace Stimulator is backed by a number of published studies that demonstrate the device’s effectiveness in mental health treatment. Given regular use for 20 minutes per day, many patients experience symptom reduction within the first week of use; a clinical trial from 2015 demonstrated a large difference in symptom reduction between the Fisher Wallace Simulator and a placebo device. 

Fisher Wallace focuses on marketing its device to both healthcare providers, who prescribe it to their patients as part of a mental health treatment plan, and consumers themselves via Google advertisements and e-commerce. The consumer pitch is clear: Fisher Wallace argues that its solution is clinically proven to be more effective than drug treatments with fewer side effects (1% side effect rate versus the 38% side effect rate of medications), and is actually affordable for the everyday consumer. The device retails for $699, much less expensive than a long-term course of prescription medications for most patients. 

Fisher Wallace has been named an INC 5000 fastest growing company, and generated $4.7 million in revenue in 2018. 50,000 Fisher Wallace Simulators have been sold, and over 10,000 healthcare providers prescribe the device to their patients. Fisher Wallace has been EBITDA-positive for the last three years. 

Fisher Wallace is led by co-founders Kelly Roman and Charles Fisher. Fisher is the son of Avery Fisher, founder of Fisher Radio/Fisher Electronics and leading patent holder in electronics manufacturing. Fisher grew up in the electronics business, and served as a sales executive at IBM before acquiring the intellectual property behind the Fisher Wallace Stimulator. CEO Kelly Roman joined the company as a leader in neuromodulation product development, regulatory affairs, healthcare marketing, and clinical trial strategy. He previously served as an executive in digital advertising and SaaS, and contributes consumer business sense to the company. 

Fisher Wallace envisions itself as a global, full-stack mental health and wellness company. While its immediate plans for growth rely on the launch of Version 2 of the Fisher Wallace Stimulator, which will include a mobile app for more sophisticated digital health services, the long-term vision is much more ambitious. Fisher Wallace plans to evolve from a hardware-based medical device company into a software provider and data aggregator. They also intend to offer digital health services, potentially meaning telemedicine, and offer corporate wellness and mental health solutions for employers. 

• Opportunity for digital health expansion: Fisher Wallace clearly recognizes the opportunity to pivot from a medical device/hardware company toward a modern digital healthcare provider that integrates its wearable device with consumers’ online life. While the Fisher Wallace app and future digital health services have not yet been released, and therefore cannot be fully evaluated, digital health (and its neighbor, telemedicine) is a rapidly expanding space, and could prove particularly lucrative for a company with a strong record of treatment effectiveness.

• Diversified business model: While most medical device companies cater purely to healthcare providers, Fisher Wallace takes an innovative approach in appealing directly to the patient. This approach is not possible for many device companies, which manufacture products far too complex for the consumer to appreciate, but the simplicity of the Fisher Wallace Stimulator’s core selling points makes for a straightforward sales and marketing pitch. Generating revenue from both DTC e-commerce and traditional healthcare provider routes lends an interesting diversity to Fisher Wallace’s P&L, and could be a robust signal of future growth.
• Proprietary assets: Like many medical device companies, Fisher Wallace carries unique value in its intellectual property: patents for the Fisher Wallace Stimulator. The Stimulator also bears FDA clearance, an asset in itself. These key resources heighten barriers to entry for any potential competitors, and guarantee a minimum value threshold for a future exit opportunity. 
  

Fisher Wallace is not a young, unproven startup; it is an established medical device company with a host of validated clinical trials and academic studies demonstrating the Simulator’s efficacy, and almost $5M of annual revenue and positive EBITDA to show for that success. The device’s consumer appeal is obvious, and Fisher Wallace distinguishes itself as a medical company focused on both healthcare providers and patients themselves. 

However, for a company that touts its ability to market and appeal to consumers rather than purely healthcare professionals, the product itself lacks a modern, appealing look and feel. Visiting Fisher Wallace’s website and viewing the product calls up a classic medical device aesthetic, far out of line with the carefully-designed consumer brands that today’s consumer has come to expect, particularly in digital health. Fisher Wallace indicates that the latest version of their device will feature improved design, but that device has not been released yet. 

Nonetheless, Fisher Wallace is a successful and growing company that is well-positioned for acquisition or public offering within the next several years. Large corporate medical companies like Medtronic, Boston Scientific, and Teleflex have proven their interest in device acquisitions in recent years; Fisher Wallace holds patents and proprietary FDA clearance, which is a worthy asset for a strategic buyer. 

Given Fisher Wallace’s diversified, consumer-friendly business model, its opportunity to expand into digital health and other healthcare and wellness verticals, and its patent and FDA clearance assets, Fisher Wallace sends strong growth signals beyond its topline revenue figures. While potential investors should recognize the importance of Fisher Wallace’s upcoming device version two launch in assessing the company’s future opportunities, Fisher Wallace is a Deal to Watch.