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Kelly Roman
Co-Founder and CEO of Fisher Wallace Laboratories
Kelly Roman is the Co-Founder and CEO of Fisher Wallace Laboratories, a company known for its innovative wearable neurostimulation technology aimed at treating depression, anxiety, and insomnia. He has held this position since June 2009, contributing significantly to the development of devices that assist in mental health management through neurostimulation.1
Background and Education
Kelly Roman graduated from Harvard University with a Bachelor of Arts in English, where he studied creative writing. He also attended Deerfield Academy, a prestigious preparatory school.12
Professional Experience
Before founding Fisher Wallace Laboratories, Roman had a diverse career that included roles such as:
- Board Trustee at AIM I and AIM II Charter High Schools, where he served from May 2017 to May 2020.
- Author of "The Art of War: A Graphic Novel," published by HarperCollins in 2012, which received critical acclaim.
- Director of Business Development at Oddcast and Director of Sales at Nielsen, where he was recognized with the 2005 President's Award for Innovation.13
Roman's leadership at Fisher Wallace Laboratories reflects his commitment to improving mental health solutions, and he has openly shared his personal experiences with depression, highlighting the impact of the company's products on his life and the lives of others.3
Highlights
Following is my deep dive re: where our newly published depression data is taking us (and our wearable brain stimulation technology). If you’ve not seen the article, here are the results of our trial, published in The Journal of Clinical Psychiatry:
https://lnkd.in/eD87raDZ
Notably, active treatment was significantly superior to sham in Week 1, with a robust effect size and nearly 40% of the 185 female subjects responding (≥50% improvement) in the first 7 days. In short, this study positions our Version 2.0 wearable technology (called OAK) as the most rapid self-administered treatment for depression.
By Week 4, 73.9% of female subjects responded to treatment - a level of response typically only seen with ECT. There were no reports of any serious adverse events.
We believe this data will support approval in Europe for the acute treatment of depression and allow us to bring OAK to market there next year. OAK was designed by the teams behind Beats, Nest, and the HoloLens, and looks more like a sleek consumer wearable than a medical device - patients will literally be able to choose the color of their depression treatment. All of this serves our overarching mission: to vastly improve access to mental healthcare, particularly for women, Gen Z and Gen Alpha who have the highest prevalence of depression.
In the US, the FDA regulates wearable neuromodulation for depression as a Class III medical device - the same as a pacemaker. We therefore must successfully conduct one more depression study, and to achieve this, we are fortunate to be working with Maurizio Fava, Psychiatrist-in-Chief of Massachusetts General Hospital.
Dr. Fava’s innovations have transformed how depression research is conducted, and our new study will leverage two of his key innovations: the SAFER Interview and the Sequential Parallel Comparison Design (SPCD). Dr. Fava intends MGH clinicians to conduct the SAFER Interviews to help ensure each subject meets the study’s inclusion / exclusion criteria, which we expect to lower the previously observed sham/placebo response rate. The SPCD will divide our study into two 6-week stages (12 weeks total), with the primary endpoint pooling the results of all subjects in the first stage with the stage 2 results of stage 1 sham non-responders who are re-randomized for stage 2. In short, I expect the results to far exceed those in our recent, outstanding 4-week study. This may end up setting a new bar for wearable neuromodulation research for depression.
In the meantime, the phenomenal results of an anxiety study we recently conducted with the Seattle Police Department are being drafted for publication - stay tuned.
If you are a researcher interested in using our technology for clinical research, please reach out - I look forward to supporting your efforts. Feel free to message me on LinkedIn or email [email protected].
Visit Fisher Wallace at the APA Annual Meeting 👉 Booth #749 (across from the J&J pavilion)
Enjoy free access to the results of Fisher Wallace's recent depression trial, published in The Journal of Clinical Psychiatry. The results validate Fisher Wallace's Version 2.0 wearable neuromodulation technology (OAK) as the most rapid patient-administered treatment for depression:
https://lnkd.in/eD87raDZ
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