The first antidepressant drugs were discovered by happenstance in the 1950s when experimental tuberculosis treatments unexpectedly brightened patients’ moods. Happy accidents have happened in the medical device field, too, and Tal Medical of Boston has reeled in $14 million in Series B funding to push one forward.
Tal is developing a treatment for severe depression that is derived from a type of magnetic resonance imaging, or MRI, the now common technology that looks for damage in the body’s soft tissues. During a study at McLean Hospital in Belmont, MA, more than ten years ago, researchers were routinely scanning people with bipolar disorder to observe the effects of an experimental drug on their brain chemistry. They found, however, that the scans themselves seemed to have an immediate positive effect on the patients’ depression.
Founded in 2011, Tal is building upon those results with a version of MRI called low field magnetic stimulation. (The device pictured above with co-inventor Michael Rohan, a physicist at McLean, is a prototype, and the commercial version will likely look different, said Tal CEO and president Jan Skvarka.)
Existing investor PureTech, which formed the company, and undisclosed institutional and angel investors participated in the financing. The Series B money should help the company answer clinical questions in the next year or so that could lead in 2016 to a so-called “pivotal” trial: the final step before FDA considers its worthiness for commercial use. In that setting, which would require more funding, Tal would try to confirm in a much larger population that low field magnetic stimulation brings rapid relief of depression symptoms. So far, the results Tal has to show are only from small studies run at McLean.
Tal also needs to run a trial to find the right dose of low field magnetic stimulation: Is it 20 minutes at a time? Forty minutes? An hour? And how many sessions are optimal? The company also doesn’t yet know how long the positive effects recorded at McLean actually last. An ongoing trial funded by the National Institute of Mental Health, which Xconomy wrote about in early 2014, aims to measure the treatment’s durability. It was the first project to receive funding from the NIMH’s Rapid-Acting Treatments for Treatment Resistant Depression (or RAPID) program, which it launched to initiate trials for depression treatments that act quickly, within 72 hours.
The RAPID trial should divulge its data in mid-2016. A duration of a few days means low field magnetic stimulation will probably be “a niche product” to get suicidal patients past the darkest days, said Skvarka. Even with a longer duration, the device is meant to treat people in psychiatric facilities with severe depression who need rapid relief of symptoms. It’s not meant to compete with drug regimens. “We can’t compete with the convenience of popping a pill and the cost of generic Prozac,” said Skvarka. “It’s for the patient who needs immediate help.”
It might not compete with drugs, but Tal has attracted the talents of several drug veterans with neuroscience experience, a testament to slow or no progress in treating mood disorders pharmaceutically, despite the stunning rise of antidepressant prescriptions in this century.
Former Eli Lilly head of research and Voyager Therapeutics CEO Steve Paul is Tal’s cofounder and a board member. The company recently hired as chief medical officer Atul Pande, who was GlaxoSmithKline’s head of neuroscience for five years. And former Merck research and licensing executive Ben Shapiro sits on Tal’s board of directors.
There are other devices that use electricity to alter brain chemistry and alleviate depression. Patients who don’t respond to drugs can try a brain stimulation technique called repetitive transcranial magnetic stimulation (rTMS), which is delivered via devices from Neuronetics, approved in 2008, and Brainsway, approved in 2013.
There is also electroconvulsive therapy, which essentially induces a seizure in a patient under anesthesia. Tal aims to show its MRI-based method is both safe and works much faster than other electro-options.