BURLINGAME, Calif.--(BUSINESS WIRE)--Magnus Medical, Inc., a pioneering therapeutic neuromodulation company transforming the treatment of neuropsychiatric disorders, today announced the commercial launch of the SAINT® neuromodulation system, a groundbreaking, rapid-acting therapy for treatment-resistant major depressive disorder (MDD)..

加利福尼亚州伯灵格姆市——（商业新闻短讯）——马格纳斯医疗公司（Magnus Medical，Inc.），一家开创性的治疗性神经调节公司，正在改变神经精神疾病的治疗方法，今天宣布商业推出SAINT®神经调节系统，这是一种开创性的快速治疗难治性重度抑郁症（MDD）的方法。。

Treatment with SAINT changes a person’s brain circuitry to treat MDD more effectively by modifying activity in brain networks that are related to depression. Granted Breakthrough Device Designation and 510(k) clearance by the U.S. Food & Drug Administration (FDA), SAINT therapy has led to dramatic improvements in people’s symptoms of severe depression in a clinical setting..

SAINT治疗通过改变与抑郁症相关的大脑网络的活动，改变了一个人的大脑回路，从而更有效地治疗MDD。SAINT therapy获得了美国食品和药物管理局（FDA）的突破性设备指定和510（k）许可，在临床环境中，人们的严重抑郁症症状得到了显着改善。。

“We are thrilled to be the first site in the nation to offer the breakthrough, FDA-cleared SAINT neuromodulation system for individuals suffering from depression, and I am very optimistic that this new approach will change people’s lives,” said Laura B. Dunn, M.D., chair, Department of Psychiatry and director of the Psychiatric Research Institute at the University of Arkansas for Medical Sciences.

阿肯色大学医学博士、精神病学系主任、精神病学研究所主任劳拉·邓恩（LauraB.Dunn）说：“我们很高兴成为美国第一个为抑郁症患者提供突破性的、FDA批准的圣神经调节系统的网站，我对这种新方法将改变人们的生活非常乐观。”。

“The innovative SAINT protocol provides neuroscience-based, targeted, personalized, non-invasive rapid treatment for patients with one of the most disabling psychiatric conditions - major depression. As a practicing psychiatrist, I know firsthand how important it is for patients to have new options to help them get their lives back.

“创新的SAINT协议为患有最致命的精神疾病之一-重度抑郁症的患者提供了基于神经科学的，有针对性的，个性化的，非侵入性的快速治疗。作为一名执业精神病医生，我直接知道患者有多重要，有新的选择来帮助他们恢复生活。

At the UAMS Psychiatric Research Institute, our mission is to provide outstanding, expert-driven psychiatric care for our patients..

在UAMS精神病学研究所，我们的使命是为我们的患者提供杰出的，专家驱动的精神病护理。。

“With our interventional psychiatry program, Helen L. Porter and James T. Dyke Brain Imaging Research Center, and our inpatient and outpatient treatment programs all housed under one roof, our teams of mental health experts will work seamlessly together to implement the SAINT protocol, tailored to each patient’s individual needs,” continued Dr.

“我们的介入精神病学项目海伦·L·波特（HelenL.Porter）和詹姆斯·T·戴克（JamesT.Dyke）大脑成像研究中心（Brain Imaging Research Center），以及我们的住院和门诊治疗项目都在一个屋檐下，我们的心理健康专家团队将无缝合作，实施SAINT协议，根据每位患者的个人需求量身定制，”博士继续说道。

Dunn. “We are excited to bring the future of brain science directly to the people of Arkansas and the entire region.”.

邓恩。“我们很高兴能将脑科学的未来直接带给阿肯色州和整个地区的人民。”。

SAINT therapy works by leveraging structural and functional magnetic resonance imaging (MRI) scans to inform a proprietary algorithm that pinpoints the optimal anatomical target for precise neurostimulation in individuals with major depression. The innovative treatment is performed on an accelerated, five-day timeline, ensuring that stimulation targeting is meticulously customized to each person’s unique brain connectivity..

SAINT therapy的工作原理是利用结构和功能磁共振成像（MRI）扫描来通知专有算法，该算法可以精确定位抑郁症患者精确神经刺激的最佳解剖目标。这种创新治疗是在一个加速的五天时间表上进行的，确保刺激目标是根据每个人独特的大脑连接精心定制的。。

“We’re more than thrilled by the successful launch of the SAINT neuromodulation system, which represents an enormous shift in the treatment landscape for clinical depression,” said Brandon Bentzley, M.D., Ph.D., co-founder and CSO of Magnus Medical, who was also trained by Dr. George at MUSC, the birthplace of clinical TMS for the treatment of neuropsychiatric disorders.

Magnus Medical的联合创始人兼CSO Brandon Bentzley博士说：“我们对SAINT神经调节系统的成功推出感到非常兴奋，它代表了临床抑郁症治疗领域的巨大转变。”Magnus Medical的联合创始人兼CSO也是由MUSC的George博士培训的，MUSC是临床TMS治疗神经精神疾病的发源地。

“This is the first step in making SAINT therapy accessible to everyone, making it possible for people who have suffered too long to reclaim their lives and find dramatic relief much more quickly. By offering a rapid-acting, clinically proven, highly effective treatment, SAINT has the potential to completely transform the way major depression is treated, particularly for individuals who have been ineffectively treated by prior antidepressant medications.”.

“这是让每个人都能接受SAINT治疗的第一步，这使得那些遭受了太长时间痛苦的人能够更快地恢复生活并找到戏剧性的缓解。通过提供一种快速有效的、临床证明有效的治疗方法，SAINT有可能彻底改变重性抑郁症的治疗方式，特别是对于那些以前抗抑郁药物治疗无效的人。”。

The company also announced that it received approval for a New Technology Add-on Payment (NTAP) from the Centers for Medicare & Medicaid Services (CMS) for its SAINT neuromodulation system. This is the first time CMS has approved an NTAP for Interventional Psychiatry. The NTAP is available for the commercial launch of the SAINT therapy and is eligible for additional reimbursement of up to $12,675 per hospital inpatient treatment..

该公司还宣布，已获得医疗保险和医疗补助服务中心（CMS）对其SAINT神经调节系统的新技术附加支付（NTAP）的批准。这是CMS首次批准NTAP用于介入精神病学。NTAP可用于SAINT therapy的商业启动，并且有资格获得每家医院住院治疗高达12675美元的额外报销。。

The American Medical Association (AMA) issued new Category III Current Procedural Terminology (CPT) codes for targeted, accelerated iTBS for depression, encompassing the SAINT neuromodulation system, effective July 1, 2024. The company is actively pursuing robust payment for SAINT therapy through Medicare in the hospital outpatient setting and working directly with private insurance companies.

美国医学协会（AMA）发布了新的III类现行程序术语（CPT）代码，用于针对抑郁症的有针对性的加速ITB，包括SAINT神经调节系统，自2024年7月1日起生效。该公司正积极寻求通过医疗保险在医院门诊环境中为SAINT疗法支付高额费用，并直接与私人保险公司合作。

Magnus Medical expects to have selective insurance coverage in both the hospital inpatient and outpatient setting and the physician’s office. The company anticipates that coverage will grow over the next several years..

Magnus Medical希望在医院住院和门诊以及医生办公室都有选择性的保险。该公司预计未来几年覆盖率将有所增长。。

About Treatment-Resistant Major Depressive Disorder (TR-MDD)

关于难治性重度抑郁症（TR-MDD）

Major Depressive Disorder, or MDD, is an episodic disorder that can last months or years.1 Treatment-resistant MDD is a condition that impacts over 50% of people with depression who don’t respond to medications and psychotherapy.2 In the U.S., 20% of adults experience depression at some point in their lives,3 which amounts to approximately 52 million people out of 260 million adults.4 Research shows that 10.4% of adults experience MDD within a 12-month period and 20.6% over their lifetime.5 Considering the total adult population, this means an estimated 26 million Americans struggle with depression each year..

重度抑郁症（MDD）是一种持续数月或数年的发作性疾病。1难治性MDD是一种影响超过50%对药物和心理治疗无反应的抑郁症患者的疾病。2在美国，20%的成年人在生活中的某个时候会患抑郁症，3这相当于2.6亿成年人中约有5200万人。4研究表明，10.4%的成年人在12个月内会患上MDD，而在他们的一生中则有20.6%。5考虑到成年总人口，这意味着估计每年有2600万美国人与抑郁症作斗争。。

About Magnus

关于马格纳斯

Magnus Medical, Inc., is a privately held therapeutic neuromodulation company driven to transform lives by restoring mental health. Co-founded in 2020, the company’s first product is the SAINT neuromodulation system, which provides a new form of individualized neurostimulation for treatment-resistant depression indicated for adults who have failed to achieve satisfactory improvement from prior antidepressant medications.

Magnus Medical，Inc.是一家私营的神经调节治疗公司，旨在通过恢复心理健康来改变生活。该公司于2020年共同成立，其首款产品是SAINT神经调节系统，该系统为治疗难治性抑郁症提供了一种新形式的个性化神经刺激，适用于那些未能从先前的抗抑郁药物中获得令人满意改善的成年人。

The SAINT treatment protocol has shown high remission and response rates in both prior open-label studies, with approximately 80-90% of people achieving remission of depression symptoms following the five-day treatment protocol.6 A double-blinded randomized controlled trial (RCT) produced results that indicated a 79% remission of depression symptoms in people in the active treatment arm following the protocol.7 For more information, visit https://www.magnusmed.com..

SAINT治疗方案在之前的两项开放标签研究中均显示出较高的缓解率和缓解率，大约80-90%的人在五天治疗方案后缓解了抑郁症状。6一项双盲随机对照试验（RCT）产生的结果表明，按照该方案，积极治疗组的抑郁症症状缓解率为79%。7有关更多信息，请访问https://www.magnusmed.com..

1. https://apps.who.int/iris/bitstream/handle/10665/254610/WHO-MSD-MER-2017.2-eng.pdf

1https://apps.who.int/iris/bitstream/handle/10665/254610/WHO-MSD-MER-2017.2-eng.pdf

2. Pigott, H. E., Kim, T., Xu, C., Kirsch, I. & Amsterdam, J. What are the treatment remission, response and extent of improvement rates after up to four trials of antidepressant therapies in real-world depressed patients? A reanalysis of the STAR*D study’s patient-level data with fidelity to the original research protocol.

2.Pigott，H.E.，Kim，T.，Xu，C.，Kirsch，I。＆Amsterdam，J。在现实世界抑郁症患者中进行了四次抗抑郁治疗试验后，治疗缓解率，反应率和改善程度如何？对STAR*D研究的患者水平数据进行重新分析，忠实于原始研究方案。

BMJ Open 13, e063095 (2023)..

BMJ Open 13，e063095（2023）。。

3. https://jamanetwork.com/journals/jamapsychiatry/fullarticle/2671413#:~:text=Findings%20In%20this%20national%20survey,associated%20with%20comorbidity%20and%20impairment

3https://jamanetwork.com/journals/jamapsychiatry/fullarticle/2671413#:~：文本=调查结果%20在%20这%20国家%20调查中，与%20合并症%20和%20损伤相关

4. https://www.census.gov/library/stories/2021/08/united-states-adult-population-grew-faster-than-nations-total-population-from-2010-to-2020.html#:~:text=In%202020%2C%20the%20U.S.%20Census,from%20234.6%20million%20in%202010

4https://www.census.gov/library/stories/2021/08/united-states-adult-population-grew-faster-than-nations-total-population-from-2010-to-2020.html#:~：text=In%202020%2C%20U%20U。S、 %20人口普查，从20234.6%2000万%20到202010%

5. https://jamanetwork.com/journals/jamapsychiatry/fullarticle/2671413#:~:text=Findings%20In%20this%20national%20survey,associated%20with%20comorbidity%20and%20impairment

5https://jamanetwork.com/journals/jamapsychiatry/fullarticle/2671413#:~：文本=调查结果%20在%20这%20国家%20调查中，与%20合并症%20和%20损伤相关

6. Cole EJ, Phillips AL, Bentzley BS, et al. “Stanford Accelerated Intelligent Neuromodulation Therapy for Treatment-Resistant Depression.” The American Journal of Psychiatry. 2020;177(8):716–726.

Cole EJ，Phillips AL，Bentzley BS等人，“斯坦福加速智能神经调节疗法治疗难治性抑郁症”，《美国精神病学杂志》。2020年；177（8）：716-726。

7. Cole EJ, Phillips AL, Bentzley BS, et al. “Stanford Neuromodulation Therapy (SNT): A Double-Blind Randomized Controlled Trial.” The American Journal of Psychiatry. Oct 29, 2021.

Cole EJ，Phillips AL，Bentzley BS等人，《斯坦福神经调节疗法（SNT）：一项双盲随机对照试验》，《美国精神病学杂志》。2021年10月29日。