Depression Market Poised for New Commercial Activity

by James Cavuoto, editor

October 2017 issue

The market for treating major depression and related psychiatric disorders with neuromodulation therapies, which had stalled in recent years after two failed clinical trials, seems ready to rebound. Several new vendors have announced new noninvasive brain stimulation devices and at least one established vendor of implanted devices released clinical data that holds out promise for new commercial activity.

A Swedish firm called Flow Neuroscience recently announced a new neuromodulation therapy for depression based on transcranial direct current stimulation. The system consists of a medical grade tDCS headset and a smartphone app that helps users change their daily routines and break the negative behavioral patterns that come with depression. tDCS is approved for treating depression in most of Europe.

At the recent Neurotech Leaders Forum, Fisher Wallace Labs described their new Kortex system, which includes both a tDCS headset and virtual reality goggles. The device also can use functional near infrared spectography and EEG data to help predict treatment outcome and to customize the stimulation paradigm in real time. Fisher Wallace intends to market Kortex initially as a wellness device, but the company is planning a 150-patient randomized control trial for depression and other psychiatric disorders.

Meanwhile, Neuronetics Inc., the first firm to market a magnetic stimulation system for treatment of depression, recently signed a distribution deal with Japanese pharma company Teijin. Teijin will distribute the product in Japan.

In the implanted device segment, Abbott, which earlier this year acquired St. Jude Medical, released long-term data from the company’s BROADEN study of DBS of area Cg25, which failed a futility analysis in 2013. Newly published data in The Lancet: Psychiatry reported that DBS may offer some patients an option for managing their chronic, treatment-resistant depression. The authors concluded that after 24 months of stimulation, nearly half of all DBS patients responded to the therapy. Of these patients, 26 percent of patients experienced remission of their depression; a remission rate that steadily grew over time.

While the BROADEN study initially found no statistically significant difference in efficacy between the stimulation group and the control group after six and 12 months, after the initial 12-month study, 77 of 90 participants entered into a four-year follow-up study. Within that follow-up study, the authors found that patients receiving DBS therapy saw response and remission rates of 29 percent and 14 percent at 12 months, 53 percent and 18 percent at 18 months, and 49 percent and 26 percent at 24 months, respectively.

“Innovation within the field of neuroscience takes time and is filled with opportunities to learn, adapt and learn again. This study is a strong example of how our therapies can contribute to the innovation taking place within the broad field of neuroscience,” said Allen Burton, medical director within Abbott’s neuromodulation division. “We applaud the researchers who led this study and look forward to future advancements to support the care of people suffering from chronic, treatment-resistant depression.”

“While I am disappointed by the initial results, I’m encouraged by the long-term outcomes seen in this trial, which are consistent with previous and ongoing experience with DBS outside of this clinical trial,” said Helen Mayberg, professor of psychiatry, neurology, and radiology at Emory University in Atlanta, GA. “There are refinements to optimize DBS delivery that may prove useful to understand these findings and move the therapy forward. For example, we now know that implantation method and directionality matter for optimal patient outcomes. We look forward to seeing what new innovations, such as use of advanced imaging to guide the implantation and use of directional leads, can do in the future.”

Other DBS manufacturers are looking at the depression indication with interest. At a recent investor’s day presentations, executives at Boston Scientific pointed to OCD, depression, and Alzheimer’s disease as potential new directions for DBS.

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