Medtronic Acquires Stimgenics, Pioneer of DTM™, a Novel Spinal Cord Stimulation Therapy

美敦力收购新型脊髓刺激疗法DTM™的先驱者Stimgenics

2020-01-09 06:19:28 GlobeNewswire

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Randomized Control Trial Results to be Presented at NANS Jan. 23-26 in Las Vegas; New, Proprietary Differential Target Multiplexed Therapy Available on Medtronic Intellis Spinal Cord Stimulation Platform Medtronic plc (MDT) announced it has acquired Stimgenics, LLC, a privately-held company based in Bloomington, Illinois, that has pioneered a novel spinal cord stimulation (SCS) waveform known as Differential Target Multiplexed (DTM™) Spinal Cord Stimulation. The therapy, which is delivered via the Medtronic Intellis™ platform, is a new and unique programming option to treat patients with chronic pain. Three month results from a randomized control trial (RCT) evaluating DTM versus conventional SCS will be presented at the upcoming North American Neuromodulation Society (NANS) 23rd Annual Meeting on January 23-26 in Las Vegas. The RCT will continue to evaluate outcomes through 12 months follow-up. The DTM waveform may engage a novel mechanism that modulates both neurons and glial cells, expanding the understanding of SCS mechanisms of action. The DTM waveform has been studied in animal models, showing statistically significant reversal of pain behaviors compared to either low frequency or high frequency alone.1,2 In addition, preclinical studies investigating the genome of nerve-injured animals suggests that the DTM waveform has a greater impact in the neural-glial interaction than other frequencies alone. Decades of basic science research have expanded the understanding of the role of glial cells in the nervous system, which outnumber neurons 12:1 in the spinal cord.3-6 Glial cells are no longer thought to be only “glue” in the brain and spinal cord, but active contributors to neural processing and various disease states including chronic pain.7 “Stimgenics’ research is deeply rooted in clinical science that began with animal work more than a decade ago. Our preclinical data demonstrated that the modulation of both neurons and glial cells may return glial cells to their normal state and modify how they interact with neurons, which could normalize biological processes and break the pain cascade,” said Dr. Ricardo Vallejo, co-founder and director of research at Millennium Pain Center in Bloomington, Illinois, and founder and lead investigator of Stimgenics, LLC. “I’m thrilled that Medtronic has acquired a therapy that has the potential to significantly improve outcomes for chronic pain patients.” Stimgenics’ preclinical research on the neuronal-glial mechanism of action has been recognized at various medical society meetings. Over the course of the past two years, the team has received six “best of” awards for their research, three of which were specific to research investigating the DTM mechanism of action. NANS awarded the “Best Basic Science Research Award” to Stimgenics at their annual meeting in both 2018 and 2019. “Medtronic is committed to providing clinically-proven therapeutic options for millions of patients suffering from chronic pain around the world,” said Marshall Stanton, M.D., president of the Pain Therapies business, which is part of the Restorative Therapies Group at Medtronic. “We believe that DTM therapy will advance the treatment of chronic pain, supported by clinical evidence and preclinical research on a neuronal-glial mechanism of action. It’s an exciting, new proprietary SCS waveform that will be available on the Intellis platform, and we are looking forward to seeing the results of the randomized control trial data later this month at NANS.” This transaction is expected to be neutral to fiscal year 2020 earnings per share and meet Medtronic’s long-term financial metrics for acquisitions. Additional terms of the transaction were not disclosed. About Stimgenics, LLCStimgenics, LLC is a private company based in Bloomington, Illinois, that pioneered a novel spinal cord stimulation waveform known as Differential Target Multiplexed (DTM) Spinal Cord Stimulation. About Medtronic Pain TherapiesMedtronic has more than a 40-year history of developing innovative medical devices that have been shown to alleviate pain in different disease states and has a broad portfolio of device-delivered therapies that are alternatives or adjuncts to oral opioids.8 Medtronic strives to be at the forefront of medical device innovation and to develop high-quality pain therapies that reduce pain and improve quality of life. While Medtronic pain therapies do not treat opioid addiction, the company is committed to leveraging its capabilities and product portfolio in partnership with stakeholders — patients, providers, payers, regulators, elected officials, patient advocacy groups and employers — to address the unmet needs of pain patients and to support efforts to prevent opioid misuse due to chronic intractable pain. About the IntellisTM PlatformThe Intellis platform offers the world’s smallest implantable neurostimulator. It is powered by proprietary OverdriveTM battery technology and was designed to overcome limitations with other SCS systems, optimized for a wide range of energy demands and provides effective long-term pain relief for patients. The neurostimulator also features SureScanTM MRI, allowing access to MRI anywhere in the body under certain conditions, and AdaptiveStimTM technology, which automatically adjusts stimulation based on the patient’s needs and preferences in different body positions to ensure the patient receives the right dose of stimulation at the right location. About MedtronicMedtronic plc (www.medtronic.com), headquartered in Dublin, Ireland, is among the world's largest medical technology, services, and solutions companies – alleviating pain, restoring health, and extending life for millions of people around the world. Medtronic employs more than 90,000 people worldwide, serving physicians, hospitals, and patients in more than 150 countries. The company is focused on collaborating with stakeholders around the world to take healthcare Further, Together. Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results. -end- References Michelle ClaypoolPublic Relations+1-763-526-9452 Ryan WeispfenningInvestor Relations+1-763-505-4626
将于1月23日至26日在拉斯维加斯举行的 NANS 随机对照试验结果;美敦力(Medtronic) Intellis 脊髓刺激平台上提供的新的、专有的微分目标多路疗法 美美敦力(Medtronic)公司( MDT )宣布已经收购了 Stimgenics , LLC ,一家位于伊利诺伊州布卢明顿的私人控股公司,它开创了一种新的脊髓刺激( SCS )波形,称为微分目标多路复用( DTM ™)脊髓刺激。该疗法通过美敦力(Medtronic) Intelllis ™平台提供,是治疗慢性疼痛患者的一种新的、独特的编程选择。三个月的随机对照试验( RCT )评估 DTM 与常规 SCS 的结果将在即将于1月23日至26日在拉斯维加斯举行的北美神经调节协会第23届年会上公布。RCT 将在12个月的后续行动中继续评估结果。 DTM 波形可能参与一种新的调节神经元和胶质细胞的机制,扩大对 SCS 作用机制的理解。在动物模型中对 DTM 波形进行了研究,发现疼痛行为与低频或高频相比有统计学意义的逆转。1,2此外,研究神经损伤动物基因组的临床前研究表明, DTM 波形对神经-胶质相互作用的影响比单独使用其他频率更大。几十年的基础科学研究扩大了对神经系统中神经胶质细胞的作用的理解,神经系统中神经细胞的数量超过脊髓中神经元的12:1。3-6胶质细胞不再被认为是大脑和脊髓中的“胶水”,而是神经加工和包括慢性疼痛在内的各种疾病状态的积极贡献者。7 “ Stimgenics 的研究深深植根于10多年前动物研究开始的临床科学。我们的临床前数据表明,神经元和胶质细胞的调节可能会使胶质细胞恢复正常状态,并改变它们与神经元的相互作用方式,从而使生物过程正常化,并打破疼痛级联,”布鲁明顿千禧疼痛中心联合创始人兼研究主任 Ricardo Vallejo 博士说。伊利诺伊州, Stimgenics , LLC 的创始人和首席调查员。“令我兴奋的是,美美敦力(Medtronic)已经获得了一种治疗方法,有可能显著改善慢性疼痛患者的预后。” Stimgenic 对神经元-神经胶质作用机制的临床前研究已在各种医学学会会议上得到认可。在过去两年中,该小组因其研究获得了六项“最佳”奖,其中三项特别针对调查 DTM 行动机制的研究。NANS 在2018年和2019年的年度会议上向 Stimgenics 颁发了“最佳基础科学研究奖”。 “美敦力致力于为全球数百万慢性疼痛患者提供临床证明有效的治疗方案,”美敦力(Medtronic)修复治疗集团旗下疼痛治疗业务总裁 Marshall Stanton 说。“我们相信 DTM 治疗将促进慢性疼痛的治疗,临床证据和对神经元-神经胶质作用机制的临床前研究将提供支持。这是一个令人兴奋的,新的专有 SCS 波形将在 Intellis 平台上提供,我们期待看到的结果,随机控制试验数据本月晚些时候在 NANS 。” 本次交易预计在2020财年每股收益为中性,符合美美敦力(Medtronic)收购的长期财务指标。本次交易的其他条款未披露。 关于 Stimgenic , LLCStimgenics , LLC 是一家位于伊利诺伊州布卢明顿的私人公司,开创了一种新型脊髓刺激波形,称为微分目标多路复用( DTM )脊髓刺激。 关于美敦力(Medtronic)疼痛治疗美敦力有40多年的发展创新医疗设备的历史,这些设备已被证明可以减轻不同疾病状态的疼痛,并有广泛的设备交付的治疗,是替代或辅助口服阿片类药物。8美美敦力(Medtronic)力争走在医疗器械创新的最前沿,开发高质量的止痛疗法,减少疼痛,提高生活质量。虽然美敦力(Medtronic)疼痛疗法不能治疗阿片类药物成瘾,但该公司致力于利用其能力和产品组合,与利益相关者合作——患者、提供者、支付者、监管者、民选官员、患者倡导小组和雇主----解决疼痛患者未得到满足的需求,并支持防止因慢性顽固性疼痛而滥用阿片类药物的努力。 关于 IntellisTM 平台 Intellis 平台提供了世界上最小的植入性神经刺激器。它由专利的 OverdriveTM 电池技术提供动力,旨在克服其他 SCS 系统的局限性,针对广泛的能源需求进行优化,并为患者提供有效的长期疼痛缓解。神经刺激器还具有 SurScanTM MRI ,允许在特定条件下在身体任何地方使用 MRI ,以及 AdaptiveStimTM 技术,该技术根据患者在不同身体位置的需求和偏好自动调整刺激,以确保患者在正确的位置接受正确的刺激剂量。 关于 MedtronicMedtronic plc ( www.medtronic.com ),总部位于爱尔兰都柏林,是世界上最大的医疗技术、服务和解决方案公司之一,为世界各地数百万人减轻痛苦、恢复健康和延长生命。美敦力(Medtronic)在全球拥有90,000多名员工,为150多个国家的医生、医院和患者提供服务。该公司的重点是与世界各地的利益相关者合作,使医疗保健进一步发展。 任何前瞻性声明都会面临风险和不确定性,例如美敦力(Medtronic)公司提交给美国证券交易委员会的定期报告中描述的风险和不确定性。实际业绩可能与预期业绩存在重大差异。 -结束- 参考文献 Michelle Claypool 公共关系+1-763-526-9452 Ryan WeispfenningInvestor Relations +1-763-505-4626

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