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Neuronetics, Inc. (NASDAQ: STIM) is a pioneering medical technology company renowned for its NeuroStar Advanced Therapy System, which uses transcranial magnetic stimulation (TMS) to treat psychiatric and neurological disorders. Headquartered in Malvern, PA, Neuronetics has established itself as a leading force in the non-invasive treatment of major depressive disorder (MDD), particularly for patients who have not found relief from standard antidepressant medications.
The company's flagship product, the NeuroStar Advanced Therapy System, is FDA-cleared for the treatment of MDD in adults and approved for additional indications, including obsessive-compulsive disorder (OCD) and anxious depression in patients exhibiting comorbid anxiety symptoms. Notably, NeuroStar recently received FDA clearance to treat adolescents aged 15-21, making it the first TMS therapy to be approved for this age group. This expanded clearance has significantly increased Neuronetics' market potential, addressing an underserved segment of the population.
Neuronetics continues to make strides in both product development and market reach. The recent advancements in their TrakStar® Patient Data Management System have enhanced the way healthcare providers manage and document patient treatment, improving workflow and patient outcomes. Furthermore, the company has forged strategic partnerships, such as the five-year exclusive agreement with Transformations Care Network, facilitating greater access to NeuroStar TMS across multiple states.
The company's commitment to enhancing mental health treatment accessibility is evident through its proactive health policy advocacy. Neuronetics is the only TMS company with a dedicated health policy team, actively working with providers and payors to update coverage criteria. This effort has yielded favorable changes in insurance coverage, making TMS therapy more accessible to those in need.
Financially, Neuronetics has shown promising growth. In the fourth quarter of 2023, the company reported a 12% increase in total revenue, driven primarily by an uptick in NeuroStar treatment session sales. The gross margin improved to 77.6%, bolstered by strong revenue growth and efficient expense management. The company's strategic initiatives, including the Better Me Guarantee Provider Program, aim to further enhance patient care and treatment accessibility. With a robust pipeline of projects and ongoing financial improvements, Neuronetics is well-positioned for sustained growth and innovation in the mental health sector.
Neuronetics, a medical technology company, announced expanded TMS (transcranial magnetic stimulation) access for adolescents aged 15 and older. BlueCross BlueShield (BCBS) of Michigan and Cambia Health Solutions updated their policies following NeuroStar TMS's FDA clearance as a first-line add-on treatment for major depressive disorder (MDD) in adolescents. BCBS Michigan covers 4.9 million lives, while Cambia Health Solutions, through its subsidiaries, covers 2.5 million lives in several states. These policy updates will be effective September 1, 2024. Neuronetics is the first TMS company with FDA clearance for adolescent treatment and a dedicated health policy team.
Neuronetics (NASDAQ: STIM) has launched the Better Me Provider (BMP) program nationwide, setting new standards for patient care in the mental health industry. The program, developed with TMS medical experts, aims to improve treatment accessibility for conditions like MDD, OCD, and anxious depression. During its pilot phase, BMP improved response times by 6.4x and enabled providers to treat 58% more patients. It also sped up patient engagement, achieving 3.6x more motor threshold determinations. Currently, 300 sites are active, with 125 more preparing to join.
Neuronetics announced its participation in the 12th Annual Clinical TMS Society (CTMSS) Meeting in London from June 13-15, 2024. They will present six posters and one oral presentation showcasing data from the NeuroStar TMS System. Highlights include early prediction of nonresponse in major depressive disorder, the impact of treatment timing, efficacy of accelerated TMS protocols, effectiveness in adolescents, and symptom sensitivity to TMS treatment. NeuroStar will also exhibit at booth #303, aiming to establish itself as the leading provider of TMS devices.
Neuronetics (NASDAQ: STIM) announced that its management team will present at the William Blair 44th Annual Growth Stock Conference on June 6, 2024, at 10:00am Central Time. The presentation will be accessible via a live audio webcast on their investor relations webpage. Neuronetics, a medical technology company, focuses on developing and marketing products to improve the lives of patients with neurohealth disorders.
Neuronetics (NASDAQ: STIM) announced that Humana is the first commercial payer to update its policy following the recent FDA clearance for NeuroStar TMS therapy for adolescents aged 15-21 with major depressive disorder (MDD). This policy change, effective April 25, 2024, comes just one month after the FDA's March 25, 2024 clearance. Humana's TMS coverage, previously to individuals 18 and older, now includes those aged 15-17, subject to medical director review. Humana covers around 600,000 commercial lives in the U.S. This significant advancement highlights the urgent mental health needs of the adolescent population and reinforces Neuronetics' strategic focus on advocating for health policy updates.
Neuronetics reported record first-quarter 2024 financial and operating results with revenue of $17.4 million, a 12% increase year-over-year. The U.S. treatment session revenue increased by 22%, and NeuroStar Advanced Therapy system revenue was $3.3 million. The company achieved a major milestone with FDA clearance for NeuroStar as a first-line adjunct treatment for adolescent major depressive disorder. Operating expenses decreased, resulting in a net loss of $(7.9) million for the quarter.
Neuronetics, Inc. granted inducement awards of Restricted Stock Units to thirteen new non-executive employees totaling 55,650 shares of common stock. The awards were approved under NASDAQ Listing Rule 5635(c)(4) as incentives for their employment. The RSU grants vest over four years subject to continued service, following the terms of the Neuronetics 2020 Inducement Plan.
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