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Sinaptica Announces Initiation of Co-Development of the SinaptiStim® Precision Neuromodulation System to treat Alzheimer’s Disease; On Track for Pivotal Clinical Trial Initiation in 2025
Development is underway for March delivery of the first non-invasive investigational neuromodulation system in coordination with partners Nexstim and Bittium
Building on the recently released positive one-year Phase 2 clinical data in Alzheimer’s patients, the FDA-designated Breakthrough Device integrates TMS with EEG, adding a customized workflow and Sinaptica’s patented MAINTAIN™ cloud-based Personalization Software, which determines optimal stimulation parameters specific to each patient
CAMBRIDGE, Mass., January 15, 2025--(BUSINESS WIRE)--Sinaptica Therapeutics, Inc., 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 announced that co-development of the SinaptiStim® Neuromodulation System is underway, with planned March delivery of the first clinical system for validation testing and use in forthcoming clinical trials. Partner Nexstim (NXTMH:HEX) is customizing the system to Sinaptica’s specifications, incorporating high resolution 64-channel electroencephalography (EEG) from industry leader Bittium (BITTI:HEX) to enable precision calibration of the therapy for each Alzheimer’s patient. The new system will be used in Sinaptica’s upcoming clinical trials in Alzheimer’s patients and beyond, with multiple trials scheduled to begin in 2025.
Sinaptica has developed a new non-invasive neuromodulation therapy ("nDMN") to treat Alzheimer’s disease using personalized precision repetitive transcranial magnetic stimulation targeting the Default Mode Network (DMN), the primary functional brain network most impacted by Alzheimer’s disease. Sinaptica’s advanced new approach for the first time incorporates the patient’s MRI and concurrent EEG information in order to determine personalized treatment parameters. The result is identification and confirmation of the correct target network engagement of the DMN at a safe-but-effective dose, which is specific to each patient.
The company recently presented positive Phase 2 data at the Clinical Trials on Alzheimer’s Disease (CTAD) conference in October 2024, showing strong statistically significant slowing of Alzheimer’s disease progression in mild-to-moderate patients on all key gold-standard measures in all three domains: cognition, function, and behavioral disturbances (CDR-SB, ADAS-COG11, MMSE, ADCS-ADL, and NPI). These successful results were accomplished with no serious side-effects. No patients dropped out of the study due to inability to tolerate the weekly painless noninvasive therapy. In the United States, approximately 6.6 million individuals aged 65 and older are living with Alzheimer's disease, with limited treatment options.
"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 SinaptiStim system takes neuromodulation to the next level, leveraging Nexstim’s elegant workflow-driven neuronavigation, integrating high-resolution EEG from Bittium, and our patented MAINTAIN™ cloud-based personalization software, 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."
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.
With over 30 years of experience in biosignal processing, Bittium provides innovative, high-quality solutions for ECG and EEG monitoring, EMG measurement, and at-home sleep apnea testing to health care professionals and service providers. Bittium's customizable offering consists of devices, accessories, analysis software, and a service platform tailored to meet customer needs. Bittium also specializes in the development of reliable, secure communications and connectivity solutions leveraging its over 35-year legacy of expertise in advanced radio communication technologies. Bittium is listed on Nasdaq Helsinki. www.bittium.com
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 Sinaptica Therapeutics
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.
