The Study Results, Published in Psychiatry Research, Demonstrated a 67% Overall Response Rate and 32% Remission Rate

这项发表在《精神病学研究》上的研究结果显示，总有效率为67%，缓解率为32%

High Safety Profile Achieved with Mild and Temporary Side Effects

安全性高，副作用轻微且暂时

HAIFA, Israel and NEW YORK, Feb. 6, 2024 /PRNewswire/ -- GrayMatters Health (GMH), developer of digital self-neuromodulation therapies for mental health care, announces the publication of a peer-reviewed article in the Journal of Psychiatry Research demonstrating the safety and efficacy of its FDA-cleared Prism for PTSD device.

海法，以色列和纽约，2024年2月6日/PRNewswire/--GrayMatters Health（GMH），用于精神卫生保健的数字自我神经调节疗法的开发人员，宣布在《精神病学研究杂志》上发表一篇同行评议的文章，证明其FDA批准的Prism用于PTSD装置的安全性和有效性。

The prospective, single arm, multi-site, open label trial evaluated men, women, and treatment-resistant combat veterans with chronic post-traumatic stress disorder (PTSD)..

这项前瞻性、单臂、多部位、开放标签试验评估了患有慢性创伤后应激障碍（PTSD）的男性、女性和抗治疗退伍军人。。

Prism for PTSD is the first self-neuromodulation device to receive FDA clearance as a prescribed adjunct to standard-of-care for PTSD. The treatment, now available in select clinics in the United States, digitizes brain activity associated with PTSD to scientifically help patients gain control of their PTSD symptoms..

Prism for PTSD是第一个获得FDA批准的自我神经调节装置，作为PTSD护理标准的规定辅助手段。该疗法现已在美国部分诊所上市，它将与创伤后应激障碍相关的大脑活动数字化，以科学地帮助患者控制创伤后应激障碍症状。。

'The results demonstrated a high rate of symptom improvement, a low rate of adverse events and a low attrition rate,' said Professor Charlie Marmar, Principal Investigator of the study at NYU Langone. 'I am encouraged that Prism, as an adjunctive therapy, will significantly benefit patients with PTSD and allow clinics to offer more options and better outcomes.'.

纽约大学朗贡分校（NYU Langone）这项研究的首席研究员查理·马尔玛（CharlieMarmar）教授说：“研究结果表明，症状改善率高，不良事件发生率低，损耗率低。”我感到鼓舞的是，Prism作为一种辅助疗法，将使创伤后应激障碍患者受益匪浅，并使诊所能够提供更多选择和更好的结果。”。

The study enrolled 79 patients. The primary endpoint was met with a response rate of 67% for Clinician Administered PTSD Scale (CAPS-5) at three-month follow-up. The average reduction in CAPS-5 total scores was 13.5 points, demonstrating clinically meaningful improvement. Secondary outcomes including PTSD Checklist for DSM-5 (PCL-5) and Patient Health Questionnaire (PHQ-9) also demonstrated statistically and clinically significant improvement from baseline to eight weeks and three months.

该研究招募了79名患者。在三个月的随访中，临床医生管理的创伤后应激障碍量表（CAPS-5）的主要终点反应率为67%。CAPS-5总分平均降低13.5分，表明临床上有意义的改善。次要结果包括创伤后应激障碍DSM-5检查表（PCL-5）和患者健康问卷（PHQ-9），也显示从基线到八周零三个月的统计学和临床显着改善。

Moreover, 32% of patients achieved remission three months following completion of Prism treatment. The safety profile was high with only mild and temporary adverse events reported..

此外，32%的患者在完成Prism治疗后三个月达到缓解。安全性很高，仅报告了轻微和暂时的不良事件。。

'Millions of Americans struggling with PTSD must navigate medication side effects, revisit traumatic experiences with psychotherapy or choose not to seek treatment due to societal stigma,' said Oded Kraft, CEO and Co-Founder of GMH. 'These clinical results build on prior research and demonstrate that Prism offers patients living with PTSD an effective and safe pathway toward improved mental health.'.

GMH首席执行官兼联合创始人奥德·卡夫特（OdedKraft）说，数百万患有创伤后应激障碍的美国人必须应对药物的副作用，通过心理治疗重温创伤经历，或者由于社会耻辱而选择不寻求治疗这些临床结果建立在先前的研究基础上，并证明Prism为患有PTSD的患者提供了改善心理健康的有效且安全的途径。”。

Prism's core technology is the world's first digital biomarker of brain activity associated with mental health disorders. The EEG-fMRI-Pattern (EFP) biomarker was developed by applying advanced statistical models to register fMRI amygdala data with EEG. This puts a neuroscience-based tool into the hands of clinicians to improve patient care.

Prism的核心技术是世界上第一个与心理健康障碍相关的大脑活动数字生物标志物。EEG-fMRI模式（EFP）生物标志物是通过应用先进的统计模型将fMRI杏仁核数据与EEG注册而开发的。这使临床医生掌握了一种基于神经科学的工具，以改善患者护理。

Prism for PTSD uses a computer simulation and EEG headset to create a novel, immersive environment for training individuals to self-modulate an amygdala-based biomarker associated with PTSD..

Prism for PTSD使用计算机模拟和脑电图耳机来创建一个新颖的沉浸式环境，用于训练个体自我调节与PTSD相关的基于杏仁核的生物标志物。。

About GrayMatters Health

关于灰质健康

GrayMatters Health (GMH), develops self-neuromodulation therapies to enhance mental health care outcomes. GMH is the first company to develop a treatment based on digital biomarkers of brain-mechanism-specific activity associated with mental disorders. GMH's flagship FDA-cleared product, Prism for PTSD, is an award-winning digital therapy offering providers a neuroscience-based technology that augments standard-of-care therapies while improving patient outcomes.

灰质健康（GMH）开发自我神经调节疗法，以提高心理健康护理效果。GMH是第一家开发基于与精神障碍相关的大脑机制特异性活动数字生物标志物的治疗方法的公司。GMH的旗舰FDA认证产品Prism for PTSD是一种屡获殊荣的数字疗法，为提供者提供了一种基于神经科学的技术，可以增强护理治疗的标准，同时改善患者的预后。

The company is collaborating with leading mental health institutions to evaluate Prism for additional mental disorders..

该公司正在与领先的心理健康机构合作，评估Prism是否存在其他精神障碍。。

GMH's core patented technology has been extensively researched and featured in a variety of peer-reviewed publications, led by Professor Talma Hendler, MD, PhD and her team at Tel Aviv University. Learn more by visiting our website https://graymatters-health.com and following us on LinkedIn and X.

GMH的核心专利技术已被广泛研究，并在特拉维夫大学医学博士TalmaHendler教授及其团队领导的各种同行评审出版物中发表。通过访问我们的网站了解更多信息https://graymatters-health.com并在LinkedIn和X上关注我们。

Logo - https://mma.prnewswire.com/media/2335280/GrayMatters_Health_Logo.jpg

标志https://mma.prnewswire.com/media/2335280/GrayMatters_Health_Logo.jpg

SOURCE GrayMatters Health Ltd.

SOURCE GrayMatters Health有限公司。