NeuroStar® Advanced Therapy Receives FDA Clearance as a First-Line Add-On Treatment for Adolescents with Depression
Neuronetics, Inc. (NASDAQ: STIM) receives FDA clearance for NeuroStar Advanced Therapy as an adjunct treatment for major depressive disorder in adolescents aged 15-21. The therapy, the first and only of its kind for this age group, shows promising response rates and safety profile based on real-world data.
Transcranial magnetic stimulation (TMS) is a non-invasive treatment that uses magnetic fields to stimulate nerve cells in the brain to improve symptoms of depression. The FDA clearance for NeuroStar to be used in adolescents is a significant development in mental health treatment. The approval is based on real-world data indicating a high response rate among adolescents, which is noteworthy given the limited treatment options for this age group. The efficacy of TMS in adults has been established and the extension to adolescents could address a critical gap in mental health care.
The data showing a 78% clinically meaningful improvement is impressive and exceeds typical response rates for first-line treatments like SSRIs (selective serotonin reuptake inhibitors) in this demographic. It's important to note that TMS is generally considered when other treatments have failed or are not suitable, which means this could shift the current treatment algorithm. However, the cost of TMS and insurance coverage will be key factors in its adoption. The long-term benefits and any potential risks, especially in a younger population, will be closely monitored as broader use in this age group unfolds.
The FDA's clearance for NeuroStar's TMS therapy to treat adolescents with major depressive disorder could have significant implications for Neuronetics' market position. As the first and only TMS therapy cleared for this age group, Neuronetics has a temporary monopoly which could translate into a competitive advantage. The mental health market has been actively seeking innovative treatments, especially in the wake of the COVID-19 pandemic which has seen a rise in depression rates among adolescents.
Neuronetics' proprietary TrakStar® platform appears to be a key component in the FDA's decision, indicating the importance of data analytics in gaining regulatory approval. The company's focus on driving awareness and education is important for market penetration. Market adoption will depend on factors such as the therapy's integration into clinical practice, endorsement by psychiatric associations and the development of reimbursement policies by insurers. The company's stock could see increased investor interest as the market assesses the potential growth in revenue driven by this new indication.
03/25/2024 - 08:30 AM
NeuroStar is the first and only TMS therapy cleared as an adjunct treatment for patients ages 15 and older
MALVERN, Pa., March 25, 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 clearance from the U.S. Food and Drug Administration (FDA) for NeuroStar Advanced Therapy for use as an adjunct for the treatment of major depressive disorder (MDD) in adolescent patients aged 15-21. NeuroStar is the first and only transcranial magnetic stimulation (TMS) treatment FDA-cleared for this age group, making it the fourth FDA-cleared indication for NeuroStar.
"The prevalence of depression in adolescents and young adults has been accelerating since the COVID-19 pandemic. The current treatment options available for adolescents are extremely limited, compared to those available for adults," according to Dr. Kenneth Pages, Medical Director of TMS of South Tampa. "NeuroStar’s TMS therapy now offers a promising first-line treatment for adolescents, backed by real-world data and impressive response rates consistent with response rates for adults. This advancement has the potential to set a new treatment paradigm for how we address depression in our youth."
The FDA's decision to grant clearance for this new indication is based in part on analyzing real-world data collected through NeuroStar's proprietary TrakStar® platform. This platform provided crucial insights into the treatment's effectiveness and safety profile in adolescents. Among the 1,169 adolescents in the data analysis, 78% achieved clinically meaningful improvement in their depression severity. The FDA reviewed the comprehensive data set from TrakStar, along with clinical data from the published literature, and concluded that NeuroStar TMS was substantially equivalent in terms of safety and effectiveness when used as an adjunct to antidepressant therapy over antidepressant therapy alone in this population.
“Receiving FDA-clearance to treat the adolescent segment aged 15 and up is a treatment solution that is long overdue in the mental health industry,” said Keith J. Sullivan, President and CEO of Neuronetics. “We are excited to offer NeuroStar TMS therapy as a new option for young people and for their concerned parents who have struggled to find a treatment they can be confident in. As a company, we will be focused on driving even more awareness and education about NeuroStar given that this new clearance grows our total addressable market in MDD by 35% .”
NeuroStar is harnessing the versatility of its coil design, enabling providers to address the treatment needs of adolescents with MDD symptoms immediately, all without requiring additional hardware upgrades or purchases. For more information about NeuroStar TMS Therapy, please visit www.neurostar.com
About Adolescent Depression
NeuroStar Advanced Therapy is indicated as an adjunct for the treatment of MDD in adolescent patients aged 15-21.
About Neuronetics www.neurostar.com
Cautionary statement under the Private Securities Litigation Reform Act of 1995:
Statements in the press release regarding the Company that are not historical facts constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements may be identified by terms such as “outlook,” “potential,” “believe,” “expect,” “plan,” “anticipate,” “predict,” “may,” “will,” “could,” “would” and “should” as well as the negative of these terms and similar expressions. These statements are subject to significant risks and uncertainties and actual results could differ materially from those projected. The Company cautions investors not to place undue reliance on the forward-looking statements contained in this release. These risks and uncertainties include, without limitation, risks and uncertainties related to: the Company’s ability to execute its business strategy; the Company’s ability to achieve or sustain profitable operations due to its history of losses; the terms of the Company’s credit facility; the Company’s reliance on the sale and use of its NeuroStar Advanced Therapy system to generate revenues; the scale and efficacy of the Company’s salesforce; the Company’s ability to retain talent; availability of coverage and reimbursement from third-party payors for treatments using the Company’s products; physician and patient demand for treatments using the Company’s products; developments in competing technologies and therapies for the indications that the Company’s products treat; product defects; the Company’s ability to obtain and maintain intellectual property protection for its technology; developments in clinical trials or regulatory review of NeuroStar Advanced Therapy system for additional indications; developments in regulation in the U.S. and other applicable jurisdictions; our ability to successfully roll-out our Better Me Guarantee Provider Program on the planned timeline; our self-sustainability and existing cash balances; and our ability to achieve cash flow break-even on a full-year basis in 2025. For a discussion of these and other related risks, please refer to the Company’s recent filings with the U.S. Securities and Exchange Commission (SEC), which are available on the SEC’s website at www.sec.gov. These forward-looking statements are based on the Company’s expectations and assumptions as of the date of this press release. Except as required by law, the Company undertakes no duty or obligation to update any forward-looking statements contained in this press release as a result of new information, future events, or changes in the Company’s expectations.
Media Contact: NeuroStar@evolvemkd.com
What is the FDA clearance for NeuroStar Advanced Therapy?
The FDA granted clearance for NeuroStar Advanced Therapy to be used as an adjunct treatment for major depressive disorder in adolescents aged 15-21.
What is unique about NeuroStar Advanced Therapy?
NeuroStar is the first and only transcranial magnetic stimulation (TMS) treatment FDA-cleared for adolescents aged 15-21.
What data supported the FDA clearance for NeuroStar Advanced Therapy?
The FDA decision was based on real-world data collected through NeuroStar's TrakStar platform, showing 78% of adolescents achieving clinically meaningful improvement in depression severity.
Who commented on the FDA clearance for NeuroStar Advanced Therapy?
Dr. Kenneth Pages and Keith J. Sullivan both provided positive comments on the FDA clearance, highlighting the importance of this treatment for adolescents.
What is Neuronetics, Inc.'s stock symbol?
Neuronetics, Inc.'s stock symbol is NASDAQ: STIM.
