Over the next two weeks, Fisher Wallace will be launching three clinical trials, one for the treatment of major depressive disorder, one for the treatment of generalized anxiety disorder, and one for the treatment of insomnia. These trials are intended to satisfy the FDA's clinical data requirements for full FDA-Approval for each indication. The current due dates for data submission to FDA are October 19th for depression (which may be extended by the agency due to the pandemic), and December 19th for anxiety and insomnia. Once we submit the data to FDA, it should take approximately a year for the agency to render an approval decision for each indication.
There are no other medical devices that are currently FDA-Approved to treat depression, anxiety and insomnia (though a few for depression alone, and at least one for insomnia alone). Fisher Wallace will be in a great position to rapidly expand market access with only one of the three approvals; with all three, we will be in an unprecedented position to drive massive adoption by patients, providers, insurance companies and employers. One can never have 100% confidence in the success of any clinical trial, as there are many variables, however I have high confidence that each will succeed, given the clinical feedback we have received to date from our 60,000+ patients and 10,000+ providers, as well as the smaller studies we've already conducted to date, such as our 2015 depression study at Mount Sinai Beth Israel hospital.
I also spoke today with Ximedica, a premier engineering, industrial design and software firm, and am strongly leaning towards them as the partner we will choose to fully develop our Version 2 device, which I expect will be released in Q1 or Q2 next year. We want to do more than make the device look better and give it a standard app. We want to leverage this unprecedented clinical hardware platform as a big piece in a larger puzzle that brings together evolving forms of telemedicine and digital health. More on this later - right now, we are laser focused on completing our clinical trials on deadline.
Our first shipment of devices from our new contract manufacturer arrived at Fisher Wallace's fulfillment center today. The massive cost savings resulting from new production will start to be realized in September (when we will be finished paying the invoices of our previous supplier). I expect to ramp up our sales via increased advertising in September.
Despite the damaged US economy, our sales have remained strong. We lost money in January - March and then returned to profitably in April. Our investments in clinical trials over the next few months will be significant, but we have the cash on hand, thanks to your investment in our Reg-CF round on StartEngine, to cover them.
I'd like to conclude today's update with a few recent testimonials from our customers who emailed us about their experience using our device during the pandemic. These underscore the true value we are providing to patients during these challenging times:
“I use my Fisher-Wallace device for treatment of depression and anxiety. During the Coronavirus quarantine, I am finding it especially helpful in dealing with anxiety. I am a healthcare worker currently working in a COVID-19 triage center. There is a great deal of risk associated with my work and this can increase my anxiety level. My Fisher-Wallace device has helped me keep my anxiety about work and being cooped up on my days off under control. I highly recommend the Fisher-Wallace device for anyone with depression and/or anxiety.”
- Julia, Indiana
“I am currently using the Fisher Wallace Stimulator daily during the lockdown for anxiety and depression. I find that it is helping me stay calm during these long days of having to stay indoors and having no human contact, as I live alone. It has kept this time bearable and I am immensely glad to have it.”
- Anonymous, New Hampshire
“I originally bought the stimulator this winter because my Seasonal Affective Disorder was particularly bad this year. and work particularly stressful. It helped immediately with my depressed mood and it also increased my energy level and anxiety. I began feeling better fairly quickly and stopped using it at the end of February because I was doing so well. Now, life has really taken quite a stressful turn. I am an ER nurse, and although my hospital has only had a handful of coronavirus cases at a time, I know that it is coming. I think it must be like waiting for a hurricane to hit your house-it's pretty terrifying! We don't feel safe in the ER, because we are told we cannot have N95s even while we are treating presumed positive cases. We only get to have that type of mask once the patient is admitted and the next MD in the chain orders the test. That's too late for us in the ER. Needless to say, I've been feeling more stressed than usual, anxiety is back and energy is dropping like a stone. I started using the device again, and it again has caused a quick improvement in all of my symptoms. I pondered a long time before buying it, but I figured if I tried an antidepressant, which may or may not work, I would be spending significantly more over a few months in co-pays than in just buying the stimulator. And if I stop using the device because I'm feeling better, there's no withdrawal unlike antidepressants-which can be AWFUL. I really recommend giving this product a try. I think you will be very pleasantly surprised. Thanks,”
- Barb, Pennsylvania
“My name is David and I've been using the stimulator for anxiety as well as insomnia. I use it twice a day. It has helped me during the lockdown to keep my anxiety in check as well as to help me sleep at night. I find it most useful when I wake up in the middle of the night and can't get back to sleep. The Fisher Wallace stimulator helps keep me centered. It also helps keep my days structured which I think is key to dealing with the uncertainty that has been going on since the Covid-19 pandemic started.”
- David, New York
“I use my Fisher Wallace stimulator twice a day to help me combat depression and insomnia. It is one of the most effective tools I have found for this purpose, and I have not had any sleepless nights since the quarantine started.”
- Michael, Washington
“My doctor suggest I try the Fisher Wallace for insomnia and anxiety. I was very reluctant to try it out and it was in my home for 2 weeks before I tried it out. The worry of the virus was making it so I could not sleep more than 3 hours at night and my anxiety was increasing by the day. I finally tried it and two weeks later I am back to a normal sleep pattern and my anxiety level is decreasing with each day of use. I am so glad that I have the fisher wallace as it has provided great relief from anxiety and insomnia for me.”
- Carol, Kansas
“I received my FW last August. I’d suffered from insomnia for years before this. I’ve used it routinely for months but am particularly glad I have it now. I find that the nights I don’t use it, I have interrupted sleep. In this situation that we find ourselves in, I have realized I need to use it every night to manage the anxiety and sadness. I’m so glad I have a reliable approach to manage all of this. It has made all the difference!”
- Patricia, Michigan
Thanks for your consideration, stay safe and be well.
Kelly Roman, CEO