Light therapy could soon become a treatment option for depression, anxiety and other mental health conditions, according to the execs running San Clemente medtech startup Medify Inc.
Founded in 2020 by medical device veteran Ray Harrington, Medify is developing at-home, wearable products powered by photobiomodulation (PBM), or infrared therapy that stimulates cells in the brain, which in turn increases mental acuity and lowers stress levels, according to the company.
“Studies have shown increased blood flow to the brain can elevate mood and cognition,” Harrington said.
“We’re extremely excited about our technology’s potential to help many.”
In January, Medify’s pilot product, the Titan-IR headset, became the first FDA class II device that uses PBM for the “maintenance and management” of brain health, representing a “huge milestone” for the company, officials said.
Medify reported selling out of units during a preorder sale last November; its clients comprised behavioral and mental health clinics across six states.
Portland, Ore.-based Kaiser Northwest Permanente recently became Medify’s first major partner; the organization is putting a “substantial amount” towards a clinical study examining the device’s potential to treat depression and anxiety, Harrington said.
“Kaiser Northwest Permanente is at the forefront, if not the leader, for this technology,” he added. “To have a multibillion-dollar entity that understands what we’re doing, and be willing to partner with us, shows a huge commitment on their part.”
Expected to have some 150 participants, the Kaiser-backed study will be among the largest for wearable medical devices, and the largest-ever study for PBM.
In addition, Medify’s goal is to create a combination product with a diagnostic and treatment aspect, with the help of a seed investor.
“We’ve self-funded through the entire process, so we’re looking for a seed partner to understand our vision,” Harrington said.
The company is planning to move its headquarters to Irvine due to its proximity to the medical device space and access to capital, he said.
Harrington entered the medical device industry in the early 2000s. Working for a number of small and large companies. He oversaw the development of several new technologies, including Johnson & Johnson’s Ethicon endosurgery, Acclarent’s balloon sinuplasty, and Xoft’s electronic brachytherapy.
“Looking back, you realize how instrumental every step was,” he said. “I always knew the startup world was for me.”
Most recently, Harrington served as director of business development for Neuronetics Inc. (Nasdaq: STIM), the first medical device company to treat mental health. Neuronetics, valued around $85 million, pioneered a noninvasive treatment known as transcranial magnetic stimulation (TMS) to treat major depressive disorder.
It had a “very unique basis” on his current work at Medify, he said.
Neuronetics developed the first FDA-approved transcranial magnetic therapies to treat major depressive disorder.
Medify’s technology “takes what Neuronetics did and makes it wearable, so people can treat their symptoms on their own time and not in several sessions at a medical practice,” Harrington told the Business Journal late last year.
By the second quarter of 2022, Medify aims to officially launch the Titan-IR to consumers, clinicians and physicians.
In conjunction, Medify will release the first fully customizable, multi-wavelength PBM mobile app. Connecting to the Titan via Bluetooth, the app will deliver six settings that promote brain wave activity, from low-frequency Delta waves, to high-frequency Gamma waves, Harrington said.
The company recommends several 15-minute sessions per week for the first few weeks of treatment.
“That will help increase your brain’s bloodflow over a period of time,” and eventually improve mood and cognition, Harrington said.
Further down the line, once the Kaiser clinical study for depression and anxiety is complete, Medify hopes to examine the Titan-IR in treatment settings for post-traumatic stress disorder.
“Once we get tangible information, that will furthermore increase our addressable market by tenfold overnight,” Harrington said, adding that the technology’s global addressable market could range between $74 billion and $75 billion.
“Perhaps it’s even more.”