by some of the new data indicating that these types of devices could be as efficacious or more so than drug treatment,” Zohar says. Paul, who is currently a professor of neurology, neuroscience, and psychiatry at Weill Cornell Medical College in New York, agreed to join Tal’s board and serve as it interim chief scientific officer.
Zohar and Bermingham believe that the macro-environment around depression will generate interest among investors and physicians alike in the technology that Tal is developing. The World Health Organization ranks major depressive disorder fourth among all diseases in “disability adjusted life years”—or the number of healthy years lost to disability or early death. The organization projects the disease will jump in the rankings to second by 2020. And drug treatments are problematic, Bermingham says. They can lose their effectiveness over time, and they sometimes cause side effects like erectile dysfunction, which themselves can aggravate the depression. “It really disincentivizes people from taking the drugs,” he says. As a result, “There’s a lot of interest in devices that will modulate mood.”
Most of the devices that have been tried in depression have been too extreme to gain much traction in the market. Electroconvulsive therapy, for example, uses such an enormous electric shock that it has to be performed under anesthesia. Deep brain stimulation, which has been studied but not yet approved for treating depression, requires a pacemaker-like device to be implanted into the brain. Tal’s LFMS device is small enough to fit on a table and is no more involved than a standard imaging test.
There is some evidence to support the notion that less invasive devices to treat depression are in demand. In 2008, Malvern, PA-based Neuronetics began marketing a device that uses repetitive transcranial magnetic stimulation (rTMS) to treat depression. “The takeup has been good, even though the labeling is pretty narrow,” Bermingham notes. (The device is approved only for treating patients with major depressive disorder who failed to respond to drug treatment.)
The rTMS treatment is given for about 37 minutes, five days a week for two to six weeks. It uses a strong magnetic field that causes neurons to fire in specific regions of the brain. LFMS, by contrast, uses a tiny current—with a voltage that’s one one-thousandth the size of that used in rTMS—to “tickle” the center of the neuron rather than forcing it to fire, Bermingham says. Tal hasn’t developed the treatment protocol for its technology yet, but Bermingham suspects it will require a shorter regimen than rTMS, because patients in early trials of LFMS showed significant improvements after a single treatment lasting less than a half an hour.
Tal is planning to conduct a large clinical study of its device and is currently exploring additional funding sources. Ultimately the technology may be studied for treating other psychiatric conditions, such as post-traumatic stress disorder. Says Bermingham, “We think this could be a paradigm change for the treatment of these patients.”
