Photo by OCBJ
Santa Ana-based FluxWear, a wearable tech company, said that it will partner with Hoag and Children’s Hospital of Orange County (CHOC) to conduct clinical trials of its neuromodulation hat device, dubbed Shift.
The company anticipates enrolling 150 participants starting mid-October.
FluxWear launched the latest version of Shift commercially on its website in August and says it is on track to make $300,000 in revenue.
Eighteen-year-old CEO Kamran Ansari co-founded FluxWear alongside Nadia Ansari, his 20-year-old sister and chief operating officer of the company in 2020.
“We hope to achieve FDA breakthrough status by the end of this year through both of these studies,” Kamran told the Business Journal.
Clinical Trials
Both clinical trials will examine patient-use of Shift and its effect on disease states where there’s no existing pharmaceutical alternative.
The clinical trial with Hoag will study chemo-induced peripheral neuropathy and the CHOC trial will look at post-concussive disorder where symptoms of pain don’t resolve for three to four months.
“We found some fantastic principal investigators and physicians who are really excited about this,” Kamran said.
In 2021, Shift received approval from the Food and Drug Administration as a low-risk Class I wellness device.
PEMF Therapy
The device, installed on a hat, works by sending low-level electromagnetic currents to different areas in the brain and reenergizes damaged cells, speeding up the natural healing process.
This process, called pulsed electromagnetic field therapy (PEMF), is designed to stimulate the brain to enter a meditative state of mind, which not only helps with chronic pain, but also stress and anxiety.
“It’s only recently been highlighted that chronic pain and anxiety feed into each other,” Kamran said.
Based on previous clinical trials, Shift was found to be 62% effective in reducing pain and 66% effective in reducing anxiety.
One of the largest issues with chronic pain is that there is no central way to treat it, Nadia said.
Conventional medicines often lead to side effects and take a couple of months to take effect while alternative therapies are costly and limited to the clinic’s operational hours.
Shift, on the other hand, can lower a pain level of 10 or nine down to two in just 25 minutes, according to Kamran.
Trial and Error
Kamran first came up with Shift while searching for ways to reduce his sister’s severe chronic pain.
In 2017, Nadia was diagnosed with a rare autoimmune disease called Guillain-Barre Syndrome, leading her to seek out several unsuccessful therapy options.
Kamran became fascinated by one of these therapies, a device that worked best out of everything Nadia had tried.
“That was like magic—this invisible magnetic force that was actually able to touch what seems to be this impenetrable pain that she had,” Kamran said.
He studied PEMF therapy every day for more than three years in search of a way to make a portable and effective device for Nadia.
Affordable Care
Kamran and Nadia bootstrapped FluxWear with a combination of their own funds and angel investors.
Rather than look for investors, the siblings are focused on collecting hard data and getting that published before raising more funds.
“We’re not in this to trap someone into buying a cheap wellness product,” Kamran said. “We want the science to shine through.”
The company’s advisory board includes Shaista Malik, executive director of the UCI Susan Samueli Integrative Health Institute.
FluxWear currently sells Shift for $595. In comparison, PEMF mats sell on average for around $2,000.
Moving forward, Kamran and Nadia hope to make their product more accessible by getting part of the costs covered by insurance.
