Company announcement, Helsinki, 25 March 2019 at 9.00 am (EET)
Nexstim Plc (NXTMH:HEX, NXTMS:STO) ("Nexstim" or "Company"), the targeted neuromodulation company developing and marketing pioneering navigated personalised, non-invasive brain stimulation systems for the treatment of Major Depression Disorder (MDD), today announces that its NBT® system has received FDA clearance for a new much shorter treatment protocol, Theta Burst Stimulation (TBS), for the treatment of MDD.
The new TBS protocol for the NBT® system takes just 3 minutes per session to deliver. This is significantly shorter than the 37-minute standard treatment protocol, for which Nexstim’s NBT® system is currently FDA-cleared. The clinical efficacy and safety of the TBS protocol has been established to be non-inferior to the standard protocol in a large multi-center clinical trial*.
The new TBS protocol improves both patients’ access to Transcranial Magnetic Stimulation (TMS) therapy and their treatment experience: shorter therapy sessions will make TMS available to many who do not have the time or capacity to sit for extended periods of time.
The shorter TBS protocol will also be beneficial for TMS treatment centres by increasing efficiency and improving the ease of use for Nexstim’s NBT® system when treating patients with MDD.
MDD is a recurrent and frequently occurring chronic disorder with significant unmet clinical need; it affects 2-5% of the population in developed countries, 20-40% of patients gain insufficient benefit from current treatment options such as pharmacologic agents and psychotherapy. Stimulation of the brain through repetitive TMS has been demonstrated to be effective in the treatment of MDD in patients who have failed pharmacologic treatment.
The NBT® system uses a unique method of TMS known as navigated Transcranial Magnetic Stimulation (nTMS) which allows for personalised, accurate, reproducible stimulation of the specific area of the brain associated with the treatment of depression.
Martin Jamieson, Chairman and CEO, Nexstim Plc commented: “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.”
* Blumberger D, et al., Effectiveness of theta burst versus high-frequency repetitive transcranial magnetic stimulation in patients with depression (THREE-D): a randomised non-inferiority trial. Lancet 2018; 391: 1683–92
Further information is available on the website www.nexstim.com or by contacting:
Martin Jamieson, Chairman and CEO
+44 771 516 3942
Sisu Partners Oy (Certified Adviser)
+ 358 40 842 4479
Citigate Dewe Rogerson
David Dible/Shabnam Bashir/ Sylvie Berrebi
+44 (0)207 2822949
About Nexstim Plc
Nexstim is a medical technology company focused on the development and commercialization of its world-leading SmartFocusTM TMS technology, a non-invasive brain stimulation system for the treatment of Major Depressive Disorder (MDD). The Company’s proprietary Navigated Brain Therapy (NBT®) system, a highly sophisticated 3D navigation, is the only personalised, navigated transcranial magnetic stimulation (TMS) approach providing accurate targeting of the TMS to the specific area of the brain associated with MDD.
Nexstim’s NBT® system has been launched in the US for the treatment of MDD following clearance from the FDA for marketing and commercial distribution for this indication. The NBT® system is CE marked in Europe for the treatment of major depression and chronic neuropathic pain.
In addition, Nexstim is commercialising its Navigated Brain Stimulation (NBS) system for diagnostic applications, based on the same technology. The NBS system is the only FDA cleared and CE marked navigated TMS system for pre-surgical mapping of the speech and motor cortices of the brain. Nexstim shares are listed on the Nasdaq First North Finland and Nasdaq First North Sweden.