NeuroStar Announces New Publication in JAACAP Open Highlighting Treatment Efficacy in Depressed Adolescents

Rhea-AI Summary

Neuronetics (NASDAQ: STIM) announced significant findings published in JAACAP Open regarding the effectiveness of NeuroStar TMS therapy in treating adolescent and young adult depression. The study, based on the world's largest TMS outcomes dataset, analyzed 1,283 patients aged 12-21 and found that approximately 70% of patients showed clinically meaningful improvement.

Since receiving FDA clearance in March 2024 for treating adolescents aged 15-21, NeuroStar has seen a one-third increase in adolescent treatments. The research demonstrated similar efficacy to adult populations, with less than 1% reporting worsening symptoms. The study is particularly significant as only two FDA-approved medications exist for adolescent depression, both carrying major safety warnings.

Positive

• 70% of adolescent and young adult patients showed clinically meaningful improvement
• One-third increase in adolescent treatments since FDA clearance in March 2024
• Less than 1% of patients reported worsening symptoms
• Results consistent with adult population efficacy
• Expanding treatment options in an underserved market with limited FDA-approved alternatives

Negative

• None.

News Market Reaction – STIM

-0.67%

13 alerts

-0.67% News Effect

+3.0% Peak in 21 min

-$2M Valuation Impact

$319M Market Cap

0.3x Rel. Volume

On the day this news was published, STIM declined 0.67%, reflecting a mild negative market reaction. Argus tracked a peak move of +3.0% during that session. Our momentum scanner triggered 13 alerts that day, indicating notable trading interest and price volatility. This price movement removed approximately $2M from the company's valuation, bringing the market cap to $319M at that time.

Data tracked by StockTitan Argus on the day of publication.

Real-world data showing NeuroStar is effective in adolescents and young adults with depression from the world’s largest TMS outcomes dataset

MALVERN, Pa., July 30, 2025 (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 the publication of significant real-world findings in the Journal of the American Academy of Child & Adolescent Psychiatry Open (JAACAP Open), a leading peer-reviewed medical journal covering pediatric psychiatry. The study found strong antidepressant treatment effects in adolescent and young adult patients treated with NeuroStar TMS (transcranial magnetic stimulation). The results in these adolescent and young adult patients were consistent with those previously reported in adults.¹

“Since NeuroStar was the first TMS manufacturer to receive FDA clearance as an add-on therapy to treat adolescents, ages 15-21, with major depressive disorder in March 2024, we have seen over a one-third increase in adolescents being treated with NeuroStar, highlighting the importance and rapid uptake in the younger patient population,²” said Keith J. Sullivan, President and CEO of Neuronetics. “These findings reinforce the unique leadership role Neuronetics plays both as an innovator and a resource for clinical research with our proprietary TrakStar^® dataset. We will continue to work with providers and payers to expand access to NeuroStar TMS for appropriate young patients.”

The findings are based on research from the NeuroStar TrakStar Clinical Database, the world's largest database of depression outcomes. In a sample of 1,283 patients comprised of 682 patients aged 12-19 and 601 patients aged 20-21, approximately 70% of patients reported positive clinically meaningful improvement, and less than one percent reported clinically meaningful worsening, as measured by the Patient Health Questionnaire-9 (PHQ-9). The trajectory of improvement was similar to results from the adult populations, which showed a robust correlation between the sessions completed and the clinical improvement in depression symptoms, reaffirming the importance of completing a full treatment course to maximize treatment benefits.¹

“These data, derived from the largest sample of adolescent and young adult patients who have received NeuroStar TMS, demonstrate the undeniable results NeuroStar TMS provides, which is consistent with the efficacy and meaningful benefit we see with adult populations,” said Todd M. Hutton, MD, Chief Medical Officer of Southern California TMS Center and former President of the Clinical TMS Society. “One in five adolescents experience an episode of major depressive disorder, and the majority go untreated as there are only two FDA-approved medications for this population and both come with major safety warnings.^3,4,5 There is a huge opportunity for NeuroStar TMS to provide a safe and effective option to these patients at a critical time in their lives and development.”

For more information about NeuroStar TMS Therapy, please visit NeuroStar.com.

About Neuronetics
Neuronetics, Inc. believes that mental health is as important as physical health. As a global leader in neuroscience, Neuronetics is delivering more treatment options to patients and physicians by offering exceptional in-office treatments that produce extraordinary results. NeuroStar Advanced Therapy is a non-drug, noninvasive treatment that can improve the quality of life for people suffering from neurohealth conditions when traditional medication has not helped. In addition to selling the NeuroStar Advanced Therapy System and associated treatment sessions to customers, Neuronetics operates Greenbrook TMS Inc. (Greenbrook) treatment centers across the United States, offering NeuroStar Advanced Therapy for the treatment of MDD and other mental health disorders. NeuroStar Advanced Therapy is the leading TMS treatment for MDD in adults, with more than 7.4 million treatments delivered, and is backed by the largest clinical data set of any TMS treatment system for depression, including the world’s largest depression outcomes registry. Greenbrook treatment centers also offer SPRAVATO^® (esketamine) Nasal Spray, a prescription medicine indicated for the treatment of treatment-resistant depression (TRD) in adults as monotherapy or in conjunction with an oral antidepressant. It is also indicated for depressive symptoms in adults with major depressive disorder (MDD) with acute suicidal ideation or behavior in conjunction with an oral antidepressant.¹ Greenbrook has provided more than 1.8 million treatments to over 55,000 patients struggling with depression.

The NeuroStar Advanced Therapy System is cleared by the U.S. Food and Drug Administration for adults with MDD, as an adjunct for adults with obsessive-compulsive disorder, to decrease anxiety symptoms in adult patients with MDD that may exhibit comorbid anxiety symptoms (anxious depression), and as a first line adjunct for the treatment of MDD in adolescent patients aged 15-21. For safety information and indications for use, visit NeuroStar.com.

Neuronetics Contact:
Investors:
Mike Vallie or Mark Klausner
ICR Healthcare
443-213-0499
ir@neuronetics.com

Media:
EvolveMKD
646.517.4220
NeuroStar@evolvemkd.com

References:

1. Croarkin PE, Aaronson ST, Carpenter LL, Hutton TM, Pages K, Chen B, Sackeim HA. The Effectiveness of Transcranial Magnetic Stimulation in Adolescents and Young Adults With Major Depressive Disorder. JAACAP Open (2025), doi: 10.1016/j.jaacop.2025.06.006.
2. FDA 510(k) Clearance K231926. Data on File. Neuronetics. 2025.
3. National Institute of Mental Health. https://www.nimh.nih.gov/health/statistics/major-depression#part_2565.
4. Wilson, S. Dumornay, N.M. Rising Rates of Adolescent Depression in the United States: Challenges and Opportunities in the 2020s. J Adolesc Health. Mar 2022; 70:354-355.
5. Flores, M.W., Sharp, A., Carson, N.J. et al. Estimates of Major Depressive Disorder and Treatment Among Adolescents by Race and Ethnicity. JAMA Pediatrics. 2023; 177:1215-1223.

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¹ The effectiveness of SPRAVATO^® in preventing suicide or in reducing suicidal ideation or behavior has not been demonstrated. Use of SPRAVATO^® does not preclude the need for hospitalization if clinically warranted, even if patients experience improvement after an initial dose of SPRAVATO^®. For more important safety information about SPRAVATO^®, please visit spravatohcp.com.

FAQ

What were the results of NeuroStar's (STIM) adolescent depression treatment study?

The study of 1,283 patients showed approximately 70% of adolescent and young adult patients achieved clinically meaningful improvement in depression symptoms, with less than 1% reporting worsening symptoms.

How many adolescent patients were included in the NeuroStar (STIM) JAACAP Open study?

The study included 1,283 patients, comprising 682 patients aged 12-19 and 601 patients aged 20-21.

When did NeuroStar (STIM) receive FDA clearance for adolescent depression treatment?

NeuroStar received FDA clearance in March 2024 as an add-on therapy to treat adolescents ages 15-21 with major depressive disorder.

How has NeuroStar's (STIM) adolescent treatment adoption changed since FDA approval?

NeuroStar has seen a one-third increase in adolescent treatments since receiving FDA clearance in March 2024.

What is the significance of NeuroStar's (STIM) treatment for adolescent depression?

NeuroStar provides a safe and effective alternative treatment option in a market where only two FDA-approved medications exist, both carrying major safety warnings, addressing the needs of the one in five adolescents who experience major depressive disorder.