Nexstim NBT system’s shorter protocol receives FDA clearance

26 March 2019 (Last Updated March 26th, 2019 11:02)

Nextism has received approval by the US Food and Drug Administration (FDA) for a new protocol that reduces the session time of navigated brain therapy (NBT) by 34 minutes when treating major depression disorder (MDD).

Nexstim NBT system’s shorter protocol receives FDA clearance
MDD is a recurrent chronic disorder with significant unmet clinical need. Credit: Małgorzata Tomczak from Pixabay.

Nextism has received approval by the US Food and Drug Administration (FDA) for a new protocol that reduces the session time of navigated brain therapy (NBT) by 34 minutes when treating major depression disorder (MDD).

The NBT system is a transcranial magnetic stimulation (TMS) therapy that first secured FDA clearance in 2017. The device leverages navigated TMS (nTMS) to enable accurate, reproducible stimulation of the specific brain area related to the treatment of depression.

Called Theta Burst Stimulation (TBS), the new treatment protocol requires only three minutes per session.

“The new protocol will deliver multiple benefits for both our customers and the patients they treat.”

TMS treatment centres are expected to benefit from increased efficiency and improved ease-of-use when treating MDD patients with the NBT system.

Nexstim chairman and CEO Martin Jamieson said: “The FDA clearance of the much shorter TBS protocol for our NBT system is important as we continue to commercialise the device in the US. The new protocol will deliver multiple benefits for both our customers and the patients they treat.”

MDD is a recurrent chronic disorder that is known to affect 2%-5% of people in developed countries. Around 20%-40% of patients are known to receive inadequate benefit from existing treatment options such as pharmacologic agents and psychotherapy.

Brain stimulation via repetitive TMS has demonstrated effectiveness in the treatment of the disorder in patients that did not recover after pharmacologic therapies.

The NBT system received a CE mark in Europe for treating MDD and chronic neuropathic pain. The device is also available for diagnostic applications.