[Image from the SetPoint Medical website]SetPoint Medical today announced FDA Investigational Device Exemption approval to study its proprietary neuroimmune modulation platform for people with relapsing-remitting multiple sclerosis.

[来自SetPoint Medical网站的图片]SetPoint Medical今天宣布FDA研究设备豁免批准，为复发缓解型多发性硬化症患者研究其专有的神经免疫调节平台。

Valencia, California–based SetPoint plans to initiate a multicenter, randomized, double-blind, sham-controlled pilot study in 2025. The plan is to enroll 60 people across the United States.

位于加利福尼亚州瓦伦西亚的SetPoint计划在2025年启动一项多中心、随机、双盲、假对照的试点研究。该计划将在美国各地招收60名学生。

“We look forward to initiating this pilot study to advance SetPoint’s platform in another therapeutic area,” Dr. David Chernoff, SetPoint Medical’s chief medical officer, said in a news release. “The results from our studies in validated preclinical models of MS suggest that the SetPoint System has the potential to address the urgent unmet medical need for novel therapies that reduce demyelination and promote remyelination — providing new hope for people living with MS.”.

SetPoint Medical首席医疗官David Chernoff博士在新闻稿中表示：“我们期待启动这项试点研究，以推动SetPoint平台在另一个治疗领域的发展。”。“我们在经过验证的MS临床前模型中的研究结果表明，SetPoint系统有可能解决对减少脱髓鞘和促进髓鞘再生的新型疗法的迫切未满足的医疗需求，为MS患者提供新的希望。”。

The SetPoint system includes an implantable, rechargeable neurostimulation device. The miniaturized stimulation device goes on the vagus nerve and is placed through a small incision on the left side of the neck in an outpatient procedure. Once a day, the device’s programming electrically stimulates the vagus nerve to activate innate anti-inflammatory and immune-restorative pathways..

设定值系统包括一个可植入式充电神经刺激装置。微型刺激装置位于迷走神经上，在门诊手术中通过颈部左侧的小切口放置。每天一次，该设备的编程电刺激迷走神经，激活先天性抗炎和免疫恢复途径。

In March, the FDA granted SetPoint Medical’s system a Breakthrough Device Designation and accepted the company into its Total Product Life Cycle Advisory Program (TAP) pilot.

3月，FDA授予SetPoint Medical系统突破性的设备名称，并接受该公司进入其总产品生命周期咨询计划（TAP）试点。

The device was also granted Breakthrough Device Designation and accepted into the Total Product Life Cycle (TPLC) Advisory Program (TAP) Pilot in March 2024 for the treatment of relapsing-remitting multiple sclerosis (RRMS).

该设备还被授予突破性设备名称，并于2024年3月被纳入总产品生命周期（TPLC）咨询计划（TAP）试点，用于治疗复发缓解型多发性硬化症（RRMS）。

In addition, the SetPoint Medical system has breakthrough designation for treating rheumatoid arthritis (RA). The company says recent topline results from its RESET-RA clinical study demonstrated the system’s potential. According to SetPoint, the study showed the system could provide a safe and effective treatment alternative for people with moderate-to-severe RA who are incomplete responders or are intolerant to biologic or targeted synthetic disease-modifying anti-rheumatic drugs..

此外，SetPoint医疗系统在治疗类风湿性关节炎（RA）方面取得了突破性进展。该公司表示，其RESET-RA临床研究的最新结果证明了该系统的潜力。根据SetPoint，研究表明，该系统可以为中度至重度RA患者提供安全有效的治疗替代方案，这些患者对生物或靶向合成疾病缓解抗风湿药物反应不完全或不耐受。