|Tal President and CEO Jan Skvarka|
Tal Medical has its roots in the serendipitous discovery that MRI imaging has a fast, mood-elevating effect. So far, it's managed to establish in the clinic that its low-field magnetic stimulation device built to recreate those conditions is rapid-acting. But now it's raised a $14 million Series B round to help establish the durability of that effect and the best dosage for depression treatment.
The durability trial is ongoing, dubbed RAPID, and is slated to read out during the first half of 2016. That trial is almost entirely funded by the National Institute of Mental Health, Tal President and CEO Jan Skvarka told FierceMedicalDevices. The 120-patient trial is double-blind and sham-controlled. It has three arms: four treatment days, two treatment days and sham treatment.
"In previous trials, we've confirmed the rapid onset of action for a single, 20-minute session; we confirmed an antidepressant effect," Skvarka said. "But the durability question was never asked before. How long does the treatment last?"
Much of this financing will go to support a dose optimization trial, which Tal will start later this year to determine if the 20-minute treatment length is optimal for results. The current amount of time comes from attempting to replicate the original conditions in an MRI. In addition, later this year the startup will also begin a study of the device in bipolar depression--the RAPID study is in unipolar depression patients.
The existing clinical data from two trials in unipolar and bipolar depression have found that a single 20-minute treatment session with the Tal device has a greater effect than antidepressant drugs after 4 to 10 weeks or repetitive transcranial magnetic stimulation after 6 weeks.
As much as 10% of the U.S. population has a major depressive disorder, including bipolar depression, and drugs can take several weeks, or even months, to start to be effective.
The financing will also support the refinement of the actual device for commercialization, which Skvarka said is currently in the form of a small open-sided box into which the patient partially places the head. The form factor for the marketed device, though, will largely depend on what the company discovers in its dose optimization study.
To that end, Tal has hired Mike Madden as EVP of product development; he previously had senior R&D roles at Boston Scientific, Medtronic and Bard. Raju Kucherlapati, who is the Paul C. Cabot Professor of Genetics and a Professor of Medicine at Harvard Medical School, also joined the Tal board.
Tal Medical hopes to have a device on the market in 2018. Given the technology's history coming out of MRI, Skvarka doesn't expect the device would have to go through a PMA process. But the startup does expect to target a U.S. clearance first, before Europe, given its more attractive reimbursement environment, he added.
Existing investor and founder PureTech is participating in the recent financing, along with a new, undisclosed institutional investor and some undisclosed, prominent individual investors.
- here is the release
Special Report: FierceMedicalDevices' 2014 Fierce 15 - Tal Medical