CEO: Jan Skvarka
The scoop: Tal Medical hopes to achieve the equivalent of the Holy Grail for neurology treatment: a fast-acting, widely effective, noninvasive antidepressant. Neither drugs nor devices have been able to deliver that. Antidepressant drugs take at least four to 6 weeks to kick in and are effective only about one-third of the time. Tal's device is based on low field magnetic stimulation (LFMS).
What makes Tal Medical Fierce: The mood-elevating aspect of LFMS was first noticed as an artifact in an MRI study being conducted on bipolar patients at McLean Hospital in Belmont, MA, about a decade ago. In 2010, early stage investor PureTech founded Tal and licensed a series of issued and pending patents from the hospital.
A proof-of-concept, sham-controlled trial in patients with major depressive and bipolar disorders demonstrated that within minutes of receiving a single, 20-minute LFMS treatment, patients have an antidepressant response greater than drugs achieve in four to 10 weeks or transcranial magnetic stimulation reachees in 6 weeks.
The National Institute of Mental Health (NIMH) is sponsoring another trial under its RAPID treatment program to evaluate novel, rapid-acting antidepressant treatments. It was chosen for the funding in January from a field of 20 applicants.
The company is currently working on refining the dose--20 minutes may not be the most effective amount of time--and the durability of treatment. "We are trying to improve dose and durability. If this works, it will be a potentially game-changing treatment in the field of psychiatry," said Tal Executive Chairman Dr. Steve Paul.
He has had ample experience by which to measure the field; Paul is a psychiatrist who recently retired as president of Lilly Research Laboratories, part of Eli Lilly ($LLY). While there, he helped develop Cymbalta, a major antidepressant. Prior to that, he was the scientific director of NIMH.
What to look for: Tal expects to have pivotal U.S. data by mid-2015; a launch could follow between 2016 and 2018. The focus is on U.S. approval rather than the typical Europe-first path that many medical device start-ups follow. Reimbursement could prove the biggest hurdle, though.
"If it works rapidly and gives an effect that is somewhat greater than drugs, I think reimbursement will no problem," Paul said. He added that the criteria that will drive reimbursement are "rapid effects, robust effects and virtually no side effects." To date, the device has been used on about 150 patients with no side effects, he added.
PureTech's Daphne Zohar, who is on Tal's board, likened the device's capacity to "almost rebooting the neurocircuitry of the brain without having to do it with complex chemistry." -- Stacy Lawrence (email | Twitter)
PureTech's Tal Medical faces a clinical test of its rapid depression treatment