Mayo Foundation for Medical Education & Research

Data selected for oral presentation reinforce previous findings on safety and efficacyMALVERN, Pa., Oct. 14, 2024 (GLOBE NEWSWIRE) -- Neuronetics, Inc. (NASDAQ: STIM), a medical technology company focused on designing, developing, and marketing products that improve the quality of life for patients who suffer from neurohealth disorders, announced today their participation at the American Academy of Child and Adolescent Psychiatry (AACAP) in Seattle, WA, from October 14th-19th, including an oral presentation at the “Research Pipeline: New Findings on Therapeutics” session featuring data generated utilizing the NeuroStar TMS (transcranial magnetic stimulation) System. In addition, NeuroStar will exhibit at booth #416, where demonstrations of the device will be given. “We are proud to present the largest sample to date of adolescents and young adults with major depressive disorder, highlighting the truly unmatched benefit NeuroStar TMS can provide to this population with limited approved treatment options,” said Cory Anderson, Senior Vice President of Research & Development and Clinical. “As the leading TMS device and the only one FDA-cleared to treat adolescents aged 15 and older as a first-line adjunct treatment, NeuroStar is uniquely positioned to support patients and providers by treating young people with depression.” The following data were selected for a prestigious oral presentation. A Naturalistic Study of Transcranial Magnetic Stimulation Treatment in Adolescents and Young Adults with Depression and Anxiety Presenter: Dr. Paul E. Croarkin, Professor of Psychiatry, Pediatrics, and Pharmacology, Ervin A. and Margaret C. Mueller Director, Mayo Clinic Children's Research Center, Mayo Clinic College of Medicine and Science.Overview: In the oral presentation, Dr. Croarkin will present the largest sample to date of adolescents and young adults treated with TMS for MDD, highlighting the benefits of treatment in both depressive symptoms and anxiety for this population.Presentation Date: October 16th at 1:30 PM PT “These data are robust and reinforce the positive trend adolescent psychiatrists have seen since the FDA-clearance of NeuroStar for adolescents aged 15 and up earlier this year, which is the overwhelmingly positive clinical outcomes for young patients with major depressive disorder,” said Dr. Melissa Fickey of Embracing Life Wellness Center, AACAP member, and board-certified child, adolescent, and adult psychiatrist. “With an impressive 78% response rate and 48% remission rate for this population1, NeuroStar is truly making a difference in the lives of adolescents across the country struggling with depression.” For more information about NeuroStar TMS Therapy, please visit www.neurostar.com. About NeuroneticsNeuronetics, Inc. believes that mental health is as important as physical health. As a global leader in neuroscience, Neuronetics is redefining patient and physician expectations with its NeuroStar Advanced Therapy for Mental Health. NeuroStar is a non-drug, noninvasive treatment that can improve the quality of life for people suffering from neurohealth conditions when traditional medication hasn’t helped. NeuroStar is indicated for the treatment of depressive episodes and for decreasing anxiety symptoms for those who may exhibit comorbid anxiety symptoms in adult patients suffering from MDD and who failed to achieve satisfactory improvement from previous antidepressant medication treatment in the current episode. It is also FDA-cleared as an adjunct for adults with obsessive-compulsive disorder and for adolescent patients aged 15-21 with MDD. NeuroStar Advanced Therapy is the leading TMS treatment for MDD in adults with over 6.6 million treatments delivered. Neuronetics is committed to transforming lives by offering an exceptional treatment that produces extraordinary results. For safety and prescribing information, visit www.neurostar.com. Media Contact:EvolveMKD646.517.4220NeuroStar@evolvemkd.com _______________1 NeuroStar TMS results analyzed from 1,169 adolescent patients and a subset with available CGI-S data demonstrated a 78% response rate and 48% remission rate; PHQ-9 demonstrated 59.4% response and 30% remission, respectively. Patients had an average 10+ point improvement in their depression symptoms when using the PHQ-9.

Early prediction of nonresponse abstract selected for oral presentation as a prestigious Top 4 Abstract at CTMSS 2024MALVERN, Pa., June 13, 2024 (GLOBE NEWSWIRE) -- Neuronetics, Inc. (NASDAQ: STIM), a medical technology company focused on designing, developing, and marketing products that improve the quality of life for patients who suffer from neurohealth disorders, announced today their participation at the 12th Annual Meeting of the Clinical TMS Society (CTMSS) in London, England from June 13th-15th. Six posters and one oral presentation will feature data generated utilizing the NeuroStar TMS (transcranial magnetic stimulation) System. In addition, NeuroStar will exhibit at booth #303. “We are thrilled to present this meaningful evidence at the Clinical TMS Society Annual Meeting and engage with TMS providers and researchers about recent advancements in our field,” said Cory Anderson, Senior Vice President of Research & Development and Clinical Affairs. “Our extensive data and strong clinical presence establish NeuroStar as the leading TMS device, treating the highest number of patients and supporting providers in delivering exceptional patient care in clinical settings.” The following data will be presented: When to Hold and When to Fold: Early Prediction of Nonresponse to Transcranial Magnetic Stimulation in Major Depressive Disorder Presenter: Dr. Harold Sackeim, Professor in Psychiatry and Radiology at Columbia UniversityOverview: In the poster and oral presentation, Dr. Sackeim will explain how early improvement reliably predicts potential responders to treatment; however, the absence of such improvement does not reliably forecast non-response.Presentation Date: June 14th at 2:45 PM BST The Impact of Treatment Gaps on Effectiveness of Transcranial Magnetic Stimulation in MDD Presenter: Dr. Linda Carpenter, Professor of Psychiatry and Human Behavior at Brown UniversityOverview: Dr. Carpenter will present data regarding the impact of deviations to the established TMS treatment timing on treatment effectiveness.Presentation Date: June 14th at 4:00 PM BST Accelerated Transcranial Magnetic Stimulation: Preliminary Efficacy Findings Using a Pragmatic Tool Presented by: Sonder Behavioral Health & Wellness, Minnetonka, MinnesotaOverview: This study will showcase feasibility, safety, and efficacy results using NeuroStar with a pragmatic accelerated TMS protocol without the need for neuroimaging.Presentation Date: June 14th at 4:00 PM BST Effectiveness of TMS for Adolescents and Young Adult Real World Outcomes in Patients with Major Depressive Disorder Presenter: Dr. Paul E. Croarkin, Associate Professor of Psychiatry and Psychology, Division Chair, Child and Adolescent Psychiatry, Mayo Clinic College of Medicine and ScienceOverview: Dr. Croarkin will discuss data that led to NeuroStar's latest FDA clearance to treat adolescents as a first-line, adjunct treatment for major depressive disorder (MDD).Presentation Date: June 14th at 4:00 PM BST Sensitivity of the PHQ-9 and QIDS-SR16 to the Therapeutic Effects of TMS in Major Depressive Disorder Presenter: Dr. Kenneth Pages, Medical Director of TMS of South TampaOverview: Dr. Pages will contrast the Patient Health Questionnaire-9 (PHQ-9) and the Quick Inventory of Depressive Symptomatology (QIDS-SR16) regarding each scale’s sensitivity to detection of symptom changes in patients with MDD.Presentation Date: June 14th at 4:00 PM BST Symptom Profiles Before and After TMS in Major Depressive Disorder Presenter: Dr. Todd Hutton, Chief Medical Director at Southern California TMS CenterOverview: Dr. Hutton will identify the impact of TMS on individual symptom domains of MDD utilizing both the PHQ-9 and QIDS-SR16.Presentation Date: June 14th at 4:00 PM BST For more information about NeuroStar TMS Therapy, please visit www.neurostar.com. About NeuroneticsNeuronetics, Inc. believes that mental health is as important as physical health. As a global leader in neuroscience, Neuronetics is redefining patient and physician expectations with its NeuroStar Advanced Therapy for Mental Health. NeuroStar is a non-drug, noninvasive treatment that can improve the quality of life for people suffering from neurohealth conditions when traditional medication hasn’t helped. NeuroStar is indicated for the treatment of depressive episodes and for decreasing anxiety symptoms for those who may exhibit comorbid anxiety symptoms in adult patients suffering from MDD and who failed to achieve satisfactory improvement from previous antidepressant medication treatment in the current episode. It is also FDA-cleared as an adjunct for adults with obsessive-compulsive disorder and for adolescent patients aged 15-21 with MDD. NeuroStar Advanced Therapy is the leading TMS treatment for MDD in adults with over 6.4 million treatments delivered. Neuronetics is committed to transforming lives by offering an exceptional treatment that produces extraordinary results. For safety and prescribing information, visit www.neurostar.com. Media Contact:EvolveMKD646.517.4220NeuroStar@evolvemkd.com

Pictured: Novo Nordisk's corporate headquarters in Denmark/iStock, Ole Schwander The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee on Friday voted against the approval of Novo Nordisk’s once-weekly insulin icodec injection for type 1 diabetes. In a 7-4 vote, the panel of external experts found that insulin icodec’s benefits do not outweigh its risks. The FDA’s advisers flagged the elevated risk of hypoglycemia associated with the investigational once-weekly insulin, compared to Novo’s daily injection Tresiba (insulin degludec). “When compared to the current standard degludec, which has a good safety profile … this was an incremental increase,” Matthew Drake, associate professor of medicine at Mayo Clinic College of Medicine, said during the meeting. Drake, who voted against icodec, added that he was concerned that the once-weekly injection would need to be approved “with contingencies,” such as the specific need for continuous glucose monitoring (CGM). “The patients who may be most likely to benefit from this … are unfortunately the ones tend to be the least likely to actually monitor their blood sugar with some regularity.” Paul Tibbits Jr., a patient representative who voted in favor of insulin icodec, said that he agreed that the investigational injection was “approvable” but only with “significant caveats,” such as the inclusion of a CGM requirement on its label, excluding patients “who have hypoglycemic unawareness” and potentially disallowing the use of the drug in patients who are in their first year of diabetes. These limitations would be “some of the more draconian limitations the FDA could put” on a product, Tibbits Jr. said. “As a patient representative, I certainly want to help people with diabetes, but I also don’t want to hurt them, and I think this product has the potential to do both.” Novo Nordisk is seeking approval for insulin icodec, a long-acting analog of insulin, to help boost glycemic control in patients with diabetes. Unlike once-daily insulin products, icodec differentiates itself by offering a once-weekly injection option, making it more convenient for patients. To support its type 1 diabetes approval bid, the pharma provided data from the ONWARDS 6 trial, which showed that insulin icodec could elicit glycemic control that was non-inferior to daily basal insulin. However, the investigational once-weekly regimen led to a higher risk of “clinically significant” or “severe” hypoglycemic episodes, according to its briefing document. The FDA’s internal reviewers flagged this risk, noting in its briefing document that while hypoglycemia is an expected side effect of insulin products, icodec did not yield “additional glycemic control or other benefit” in type 1 diabetes patients. The FDA is not required to follow the advisory committee’s recommendation, though it often does. Its target action date for insulin icodec is in the third quarter of 2024. Tristan Manalac is an independent science writer based in Metro Manila, Philippines. Reach out to him on LinkedIn or email him at tristan@tristanmanalac.com or tristan.manalac@biospace.com.