Aetna policy update expands access to Neuronetics NeuroStar

[Image from Neuronetics]Neuronetics (Nasdaq:STIM) announced today that a healthcare policy update from Aetna increases access to its NeuroStar therapy.

Malvern, Pennsylvania-based Neuronetics develops products aimed at improving the life of patients with neuro health disorders. NeuroStar, a non-drug, non-invasive treatment can improve the quality of life for neuro health patients when traditional medication fails.

The transcranial magnetic stimulation (TMS) treatment holds FDA clearance for adults with major depressive disorder (MDD). It also has authorization as an adjunct for adults with obsessive-compulsive disorder (OCD). The company said the FDA also cleared it for adult patients with MDD that may exhibit comorbid anxiety symptoms (anxious depression).

Effective immediately, Aetna now allows TMS treatment under the supervision of behavioral health nurse practitioners for MDD patients. Additionally, the update removes a four-month psychotherapy trial be…

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FDA clears OCD therapy from Neuronetics

[Image from Neuronetics]Neuronetics (Nasdaq:STIM) announced today that it received FDA 510(k) clearance for its obsessive-compulsive disorder treatment.

The FDA cleared the company’s OCD motor threshold (MT) cap technology for NeuroStar advanced therapy for mental health.

According to a news release, determining a patient’s MT represents a critical step to establishing their prescription before starting treatment. NeuroStar, a transcranial magnetic stimulation (TMS) system, holds FDA clearance for MT caps for both OCD and major depressive disorder.

The MT cap simplifies the initial NeuroStar placement, Neuronetics says. It provides a consistent starting location and a step-by-step process to map a patient’s motor cortex. This effectively shortens the time needed and reduces the number of steps involved in the process.

Neuronetics said its MT cap features compatibility with Fast MT, providing up to 40% time savings for clinicians and…

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Neuronetics shares rise on Street-beating Q3 results

Neuronetics (NSDQ:STIM) this week posted third-quarter results that beat the consensus on Wall Street.

The Malvern, Pennsylvania-based psychiatric disorder treatment developer reported a net loss of $7.6 million, or -28¢ per share, on sales of $16.5 million for the three months ended Sept. 30, on sales growth of 19.56% compared with Q3 2021.

Earnings per share were 14¢ ahead of The Street, where analysts were looking for sales of $15.02 million.

“Our strong performance in the third quarter reflects the positive impacts of our ongoing strategic initiatives such as the revamped sales force, innovative marketing programs, and continued physician and patient education. Performance was highlighted by record US Treatment Sessions revenue and utilization, while also achieving 51% year-over-year growth in US NeuroStar System revenue,” President and CEO Keith Valentine said in a news release.

Valentine said Neuronetics will continue to concentrate on execu…

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FDA clears Neuronetics’ motor threshold detection tech

Neuronetics (Nasdaq:STIM) announced today that it received FDA 510(k) clearance for its D-Tect MT accessory for the NeuroStar platform.

Malvern, Pennsylvania-based Neuronetics designed its D-Tect accessory to simplify the motor threshold (MT) determination for physicians.

According to a news release, the now FDA-cleared technology gives clinicians a way to determine MT by visually reporting the magnitude of finger movements during MT mapping for the treatment of major depressive disorder (MDD).

D-Tect also allows the MT determination to be performed by just one person, Neuronetics said. The company will make D-Tect available through a limited commercial launch initially, with a national rollout slated for mid-September. Practices will be trained on the product at NeuroStar University, which recently opened in Charlotte, North Carolina.

“The FDA clearance for the D-Tect MT Accessory is the next chapter in our plan to simplify and accelerate the MT …

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Neuronetics stock rises on Street-beating Q2

[Image from Neuronetics]Neuronetics (Nasdaq:STIM) shares ticked up today on second-quarter results that beat the consensus forecast.

The Malvern, Pennsylvania-based company posted losses of $10.4 million, or 39¢ per share, on sales of $16.3 million for the three months ended June 30, 2022, for a bottom-line deeper into the red on sales growth of nearly 15%.

Neuronetics’ losses per share of 39¢ came in 2¢ ahead of expectations on Wall Street, where analysts were looking for sales of $15.5 million.

Sales for the company’s flagship NeuroStar advanced therapy system — a transcranial magnetic stimulation (TMS) treatment for major depressive disorder — increased by 70% year-over-year, helping Neuronetics to exceed its second-quarter guidance for revenues between $15 million and $16 million.

“We successfully worked through macro challenges and have continued to execute, highlighted by very strong capital system sales volumes and improving utiliz…

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Neuronetics inks deal with Alleviant to supply NeuroStar to mental health clinics

[Image from Neuronetics]Neuronetics (Nasdaq:STIM) announced today that it entered into a commercial partnership with Alleviant Health Centers.

Under the agreement, Malvern, Pennsylvania-based Neuronetics will be the exclusive supplier of new transcranial magnetic stimulation (TMS) equipment to Alleviant and its clinics.

According to a news release, an initial six NeuroStar advanced therapy systems — Neuronetics’ non-drug, non-invasive treatment that can improve the quality of life for people suffering from neuro health conditions when traditional medication hasn’t helped — have been delivered in 2022.

“We are delighted to partner with Alleviant to provide more people who need it with access to NeuroStar as a new possibility for non-drug depression treatment,” Neuronetics President and CEO Keith J. Sullivan said in the release. “Alleviant’s commitment to offering innovative solutions and their focus on making the world a better place by im…

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FDA clears Neuronetics’ therapy for anxious depression

[Image from Neuronetics]Neuronetics (Nasdaq:STIM) announced today that the FDA cleared a new indication for its transcranial magnetic stimulation (TMS) system.

The new indication for the NeuroStar advanced therapy for mental health allows the system to treat anxiety symptoms for adult patients who suffer from major depressive disorder (MDD), also known as anxious depression.

NeuroStar is a non-drug, non-invasive treatment that can improve the quality of life for people suffering from neuro health conditions when traditional medication hasn’t helped.

Malvern, Pennsylvania-based Neuronetics said in a news release that the FDA accepted its use of real-world data analyzed from its proprietary TrakStar platform, with that database containing digital data from patients treated with NeuroStar at over 1,000 centers, providing a large sample from a diverse patient group treated in a clinical practice setting.

“Today, we celebrate a big win for NeuroStar patie…

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Neuronetics ticks up before hours on mixed-bag Q1 results

Neuronetics (NSDQ:STIM) posted first-quarter results today that beat the revenue consensus on Wall Street and matched on earnings.

The Malvern, Pa.-based company reported losses of -$7.9 million, or -31¢ per share, on sales of $12.3 million for the three months ended March 31, for a sales growth of 7.08% compared with Q1 2020.

Earnings per share were -31¢, in line with estimates on The Street, where analysts were looking for sales of $11.58 million.

“The first quarter was very exciting. Not only did we drive strong double-digit growth in treatment session revenues, but we also implemented our new commercial strategy in conjunction with the launch of our expanded and realigned sales organization,” president and CEO Keith Sullivan said in a news release. “We’ve seen a 30% increase in patients requesting appointments and are expecting to see accelerating positive impact throughout the year from our new digital media strategies, advertising, and customer sup…

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Neuronetics rises on Street-beating Q2

Neuronetics (NSDQ:STIM) shares ticked up today on second-quarter losses that managed to top the consensus forecast.

The Malvern, Pa.-based psychiatric disorder treatment developer posted losses of $-7.8 million, or -41¢ per share, on sales of $9.7 million for the three months ended June 30, 2020, for a -9.5% bottom-line slide on a sales decline of -41.2%.

Adjusted to exclude one-time items, losses per share were also -41¢, 10¢ ahead of Wall Street, where analysts were looking for sales of $8.2 million.

Neuronetics, which develops a transcranial magnetic stimulation system to treat major depressive disorder, reported that its revenue decreases were primarily driven by the closure of practices or limited access in response to the COVID-19 pandemic.

“This quarter was negatively impacted due to the effects of COVID-19; however, our results were favorable to our internal expectations established at the beginning of the quarter,” Neuronetics CFO S…

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