Nexstim said today that it won FDA 510(k) clearance for a new, shorter treatment protocol for its Navigated Brain Therapy transcranial magnetic stimulation system intended to treat major depressive disorder.
The Helsinki-based company said that the FDA cleared the system for a Theta Burst Stimulation treatment protocol, which is much shorter than its previously cleared treatment protocol.
The newly cleared protocol for the NBT system takes only 3 minutes per session, significantly shorter than the 37-minute standard treatment protocol the company won FDA clearance for in November 2017.
Nexstim said that a large multi-center clinical trial of the new protocol showed it to be non-inferior to the standard protocol, and said that the new, shorter treatment will improve both patient access and treatment experiences for patients. The company added that the shorter protocol will also improve efficiency and ease of use for TMS treatment centers.
“The FDA clearance of the much shorter Theta Burst Stimulation protocol for our NBT system is important as we continue to commercialize the device in the United States. The new protocol will deliver multiple benefits for both our customers and the patients they treat. This approval reflects Nexstim’s continuing investment in our navigated TMS technology to ensure that more and more patients in the U.S. can gain access to this unique, personalized and reproducible approach to treating MDD,” chair & CEO Martin Jamieson said in a press release.
Last November, Nexstim said that it pulled the trigger on a 30-to-1 reverse split of its stock as the company looks to reduce its share capital.