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Sinaptica Therapeutics, Inc

Sinaptica Therapeutics公司

., 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.

，一家临床阶段公司，领导开发一类新的个性化神经调节疗法，以治疗阿尔茨海默氏病和其他原发性神经退行性疾病，今天宣布，正在共同开发sinaptim®神经调节系统，计划于3月交付首个临床系统，用于验证测试并用于即将进行的临床试验。

Partner .

合作伙伴。

Nexstim

下一个

(NXTMH:HEX) is customizing the system to Sinaptica’s specifications, incorporating high resolution 64-channel electroencephalography (EEG) from industry leader

（NXTMH:HEX）正在根据Sinaptica的规格定制该系统，并结合了业界领先的高分辨率64通道脑电图（EEG）

Bittium

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.

（BITTI:HEX）可以对每位阿尔茨海默病患者的治疗进行精确校准。新系统将用于Sinaptica即将进行的阿尔茨海默氏病患者及其他患者的临床试验，多项试验计划于2025年开始。

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.

Sinaptica开发了一种新的非侵入性神经调节疗法（“nDMN”），使用针对默认模式网络（DMN）的个性化精确重复经颅磁刺激治疗阿尔茨海默氏病，默认模式网络是受阿尔茨海默氏病影响最大的主要功能脑网络。Sinaptica的先进新方法首次结合了患者的MRI和并发脑电图信息，以确定个性化治疗参数。

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..

结果是以安全但有效的剂量识别和确认DMN的正确目标网络参与，这是针对每位患者的。。

The company recently presented

该公司最近介绍

positive Phase 2 data

第二阶段数据为正值

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-COG.

在2024年10月举行的阿尔茨海默氏病临床试验（CTAD）会议上，在认知，功能和行为障碍（CDR-SB，ADAS-COG）这三个领域的所有关键金标准测量中，显示轻度至中度患者阿尔茨海默氏病进展的统计学显着减慢。

11

11

, 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..

，MMSE，ADCS-ADL和NPI）。这些成功的结果是在没有严重副作用的情况下完成的。没有患者因无法耐受每周无痛无创治疗而退出研究。在美国，大约660万65岁及以上的人患有阿尔茨海默病，治疗选择有限。。

“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.

Sinaptica首席执行官肯·马里亚什（KenMariash）表示：“我们的第一个研究系统的交付是我们改变阿尔茨海默病治疗格局的使命中迈出的一大步。”。“SinaptiStim系统将神经调节提升到了一个新的水平，利用Nexstim优雅的工作流程驱动的神经导航，整合了Bittium的高分辨率脑电图，以及我们获得专利的MAINTAIN™基于云的个性化软件，使Sinaptica能够确认诱发电位在大脑网络中的传播，从而驱动人类记忆，从而诱导网络范围内的神经可塑性以减缓疾病进展。

This is personalized medicine at the connectome level.”.

这是连接体层面的个性化医学。”。

“We greatly value our

“我们非常重视

collaboration with Sinaptica

与Sinaptica的合作

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.'.

Nexstim首席执行官米科·卡维宁（MikkoKarvinen）说：“这是一项非常成功的阿尔茨海默氏病2期研究中罕见的壮举。”。。

About Nexstim Plc

关于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是一家芬兰的全球运营增长型医疗技术公司。我们的使命是为挑战性的脑部疾病和紊乱提供个性化和有效的诊断和治疗。

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开发了一种世界领先的非侵入性脑刺激技术，用于导航经颅磁刺激（nTMS），具有高度复杂的3D导航，可将TMS准确且个性化地定位到大脑的特定区域。

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的诊断业务专注于导航大脑刺激（NBS）系统的商业化。NBS System 5是唯一一个FDA批准且CE标记的导航TMS系统，用于术前大脑语音和运动皮层的映射。

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的治疗业务营销和销售NBS System 6，该系统已获得FDA批准，可在美国用于治疗重度抑郁症（MDD）的营销和商业分销。在欧洲，NBS 6系统被CE标记用于治疗重度抑郁症和慢性神经性疼痛。。

Nexstim shares are listed on Nasdaq First North Growth Market Finland.

Nexstim股票在芬兰纳斯达克第一北方增长市场上市。

For more information, please visit

有关更多信息，请访问

www.nexstim.com

网站：www.nexstim.com

About Bittium

关于Bittium

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的可定制产品包括设备、配件、分析软件和为满足客户需求而定制的服务平台。

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. .

Bittium还专门开发可靠、安全的通信和连接解决方案，利用其在先进无线电通信技术方面超过35年的专业知识。Bittium在纳斯达克赫尔辛基上市。

www.bittium.com

www.bittium.com

About the SinaptiStim

®

®

System

系统

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.

SinaptiStim®系统是一种使用非侵入性个性化精确神经调节治疗阿尔茨海默病的研究性新方法。该疗法针对每个人的大脑进行校准，每周在躺椅上进行20分钟的治疗，安全，无痛，定制的神经刺激技术针对大脑楔前叶的指定区域。

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..

楔前叶是默认模式网络（DMN）的中心枢纽，DMN是与情景记忆和内省相关的重要大脑网络。最近有大量研究确定DMN在AD病理学和进展中起着核心作用。据认为，刺激DMN可诱导神经可塑性并稳定大脑的电网络，有助于保持现有的连通性并建立新的记忆通路和连接。。

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.

该技术于2022年获得FDA的突破性设备指定，该公司正在为2025年的关键随机对照临床试验做准备。在即将到来的试验中，治疗将每季度使用TMS和EEG同时结合MRI引导的神经导航进行校准，这使得SinaptiStim系统能够为每位患者实现定制的精确可重复靶向和剂量，跟踪进展并随着时间的推移进行调整，以实现其nDMN治疗的最佳个性化结果。

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..

该关键试验还将被设计用于确定SinaptiStim®系统对几种测量β淀粉样蛋白，磷酸化tau，神经炎症和突触传递的生物标志物的影响。。

About Sinaptica Therapeutics

关于Sinaptica Therapeutics

Sinaptica Therapeutics

Sinaptica治疗学

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.

是一家临床阶段神经调节治疗公司，领导开发一类新型个性化治疗药物，彻底改变阿尔茨海默病和其他原发性神经退行性疾病的治疗方法。该公司利用一种获得专利的非侵入性方法，通过对涉及记忆的关键大脑网络（默认模式网络）的精确神经刺激来治疗阿尔茨海默氏病。

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.

Sinaptica的科学联合创始人开创了这种新方法的研究，越来越多的证据表明这种方法可以减缓疾病的进展。Sinaptica的使命是为阿尔茨海默氏病患者带来一种安全、有效、无创的神经调节疗法，这有助于显着减缓认知、功能和行为衰退的进展。

Learn more at .

更多信息，请访问。

sinapticatx.com

sinapticatx.com

and follow us on

继续关注我们

LinkedIn

LinkedIn

and X

和X

@SinapticaTX

@SinapticaTX

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The SinaptiStim

该 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.

该系统仅供研究使用。它尚未获得美国食品和药物管理局的批准，也不可在任何地区进行商业销售。