Company Announcement, Helsinki, 15 January 2025 at 9 AM (EET)
Nexstim Plc (NXTMH:HEX) ("Nexstim" or "Company") and Sinaptica Therapeutics, Inc. (“Sinaptica”), a clinical-stage company leading the development of a new class of personalized neuromodulation therapeutics to treat Alzheimer’s and other primary neurodegenerative diseases, today announce that co-development of the SinaptiStim® Neuromodulation System is underway, with planned March delivery of the first investigational unit for validation testing and use in forthcoming clinical trials. Nexstim is customizing the system to Sinaptica’s specifications, incorporating high resolution 64-channel electroencephalography (EEG) from Bittium to enable precision calibration of the therapy for each Alzheimer’s patient. The new research system will be used in Sinaptica’s upcoming clinical trials in Alzheimer’s patients and beyond, with multiple trials scheduled to begin in 2025.
On June 7, 2024, Nexstim announced that it had signed a non-binding Letter of Intent (LOI) for a long-term 10-year agreement to collaborate with Sinaptica to develop, manufacture and supply SinaptiStimTM-AD Systems. The SinaptiStimTM-AD Systems are based upon Nexstim NBS System 6 TMS, with neuronavigation medical device hardware and related software, including integrated EEG software. The parties continue negotiating the definitive agreements for the long-term 10-year collaboration.
“Delivery of our first investigational system is a significant tangible step forward in our mission to change the treatment landscape for Alzheimer’s,” said Ken Mariash, Sinaptica CEO. “The patented SinaptiStim® system takes neuromodulation to the next level, leveraging Nexstim’s elegant workflow-driven neuronavigation, integrating high-resolution EEG from Bittium, and enabling Sinaptica to confirm propagation of evoked potentials within the brain network that drives human memory—thus inducing network-wide neuroplasticity to slow disease progression. This is Personalized Medicine at the Connectome level.”
“We greatly value our collaboration with Sinaptica and unique customization of the SinaptiStim® system for Alzheimer’s, which has achieved the rare feat of a highly successful Alzheimer’s Phase 2 study” said Mikko Karvinen, CEO of Nexstim. “We look forward to advancing our partnership on this promising novel approach, which if successful could have a major impact on one of the largest areas of unmet need in medicine."
Further information is available on the website www.nexstim.com, or by contacting:
Mikko Karvinen, CEO
+358 50 326 4101
The Company’s Certified Advisor is Carnegie Investment Bank AB (publ).
About Sinaptica Therapeutics, Inc.
Sinaptica Therapeutics is a clinical-stage neuromodulation therapeutics company leading the development of a new class of novel personalized therapeutics to revolutionize the treatment of Alzheimer’s and other primary neurodegenerative diseases. The company utilizes a patented non-invasive approach to treating Alzheimer’s via precision neurostimulation of a key brain network involved in memory, the Default Mode Network. Sinaptica’s scientific co-founders pioneered research on this novel approach which a growing body of evidence indicates can slow disease progression. Sinaptica’s mission is to bring a safe, effective, and non-invasive neuromodulation therapy to Alzheimer’s patients that can help to significantly slow the progression of cognitive, functional, and behavioral decline. Learn more at sinapticatx.com and follow us on LinkedIn and X @SinapticaTX.
The SinaptiStim® System is for investigational use only. It has not been approved by the U.S. Food and Drug Administration and is not available for commercial sale in any geography.
About the SinaptiStim® System.
The SinaptiStim® System is an investigational new approach to treating Alzheimer’s disease using non-invasive personalized precision neuromodulation. Calibrated to each individual’s brain, the therapy is delivered weekly in 20-minute sessions in a recliner, with safe, painless, customized neurostimulation technology targeting prescribed areas of the precuneus section of the brain. The precuneus is the central hub of the Default Mode Network (DMN), an important brain network associated with episodic memory and introspection. There has been a tremendous amount of recent research identifying the DMN as playing a central role in AD pathology and progression. It is thought that stimulating the DMN induces neuroplasticity and stabilizes the brain’s electrical network, helping to preserve existing connectivity and build new memory pathways and connections.
The technology was granted Breakthrough Device Designation by the FDA in 2022 and the company is preparing for a pivotal randomized controlled clinical trial in 2025. In the upcoming trial the treatment will be calibrated quarterly using TMS and EEG concurrently in combination with MRI-guided neuronavigation, which enables the SinaptiStim® System to achieve customized precise repeatable targeting and dosage for each patient, tracking progress and adjusting over time to achieve the best possible individualized outcomes with its nDMN therapy. The pivotal trial will also be designed to determine the effects of SinaptiStim® System on several biomarkers measuring beta amyloid, phosphorylated tau, neural inflammation, and synaptic transmission.
About Nexstim Plc
Nexstim is a Finnish, globally operating growth-oriented medical technology company. Our mission is to enable personalized and effective diagnostics and therapies for challenging brain diseases and disorders.
Nexstim has developed a world-leading non-invasive brain stimulation technology for navigated transcranial magnetic stimulation (nTMS) with highly sophisticated 3D navigation providing accurate and personalized targeting of the TMS to the specific area of the brain.
Nexstim’s Diagnostics Business focuses on commercialization of the Navigated Brain Stimulation (NBS) system. The NBS System 5 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’s Therapy Business markets and sells the NBS System 6 which is FDA cleared for marketing and commercial distribution for the treatment of major depressive disorder (MDD) in the United States. In Europe, the NBS 6 system is CE marked for the treatment of major depression and chronic neuropathic pain.
Nexstim shares are listed on Nasdaq First North Growth Market Finland.
For more information, please visit www.nexstim.com