If you’re suffering from depression, then going to a doctor’s office, sticking your head into a magnetic coil and getting your brain electronically stimulated might not seem all that appetizing. But what if the antidepressants you’ve been prescribed haven’t helped—and that new procedure, in a half hour or less, just might?
That’s the kind of thing Tal Medical, a company being incubated by PureTech Ventures, is trying to prove. Today, Boston-based Tal is announcing that the National Institute of Mental Health will fund a 90-patient proof-of-concept trial for its anti-depression device, which uses a low-strength magnetic field to try to essentially reset the circuitry of the brain and quickly alleviate the symptoms of depression.
Tal’s device, which is unnamed as of yet, was the first technology or experimental drug selected over an unspecified group of competitors under the NIMH’s Rapid-Acting Treatments for Treatment Resistant Depression (or RAPID) program—an initiative set up by the agency to bankroll initial trials for depression treatments that act quickly, within 72 hours.
That means Tal—a small company housed within the Boston offices of PureTech and still without a full-time CEO—now has the juice to run a sizeable study without bringing in an institutional investor and diluting ownership stakes. Between seed funding Tal has raised from PureTech and unnamed private angel investors, and the outside dollars going towards the NIMH trial—as well as a small, separate biomarker study—the company has gotten access to about $6 million in funding, according to chief operating officer and PureTech principal Andrew Miller.
“It’s allowed us to push the technology towards what could be a very key value inflection point for the company,” he says.
Miller points out, however, that while the NIMH will fund the study, it’s not a direct grant to Tal—it’s essentially a contract between the agency and Massachusetts General Hospital, one of the six sites the proof-of-concept trial is taking place in. Maurizio Fava, the director of the depression clinical and research program at MGH, is the study’s principal investigator.
Miller wouldn’t say how many others were vying for the NIMH’s support, only saying a “number” of other competitors were considered and it “wasn’t one or two.” And other similar studies will likely follow under the RAPID program. But Tal’s device was the first to win such backing, and because of it, the startup has already begun enrolling patients in its study.
Tal is recruiting patients with major depressive disorder who haven’t responded to one to three antidepressant courses. They’ll be broken into two groups and treated either with Tal’s device, or a sham therapy, in a 20-minute session up to four times over the course of four days. Investigators will follow up with these patients for 28 days, and judge the device’s effectiveness and durability based on how these patients score—both before and after treatment—on the Hamilton Depression Rating Scale, a standard diagnostic test administered by mental health specialists. Tal wants to see a clinically meaningful separation between the two groups, according to Miller. The company said it expects to wrap up the trial later this year.
For those unfamiliar with the Tal story, PureTech formed the company in 2011 based on work at McLean Hospital in Belmont, MA. Researchers at McLean had seen in a prior study that the moods of patients with bipolar disorder improved after their brains were imaged in an MRI machine. So a team of McLean researchers tried to figure out what caused that effect, and determined it was the brain’s short-term exposure to low-field magnetic stimulation (LFMS). They went on to publish a few studies on animals and some patients with bipolar and major depressive disorder, and the results were encouraging enough to catch PureTech’s attention.
PureTech consulted with former Eli Lilly executive and Weill Cornell Medical College professor Steven Paul, and then decided to license the technology and turn it into a depression treatment. Paul became chairman and co-founder of Tal, and over the past two years, the company has been working behind the scenes completing a prototype of the product and pushing its clinical development.
What they’ve come up with is
