Brainsway Archives - Medical Design Sourcing

BrainsWay initiates new studies of non-invasive neurostim

BrainsWay (Nasdaq:BWAY) announced plans for two new feasibility trials evaluating its neurostimulation technology.

The studies both involve BrainsWay’s patented rotational field TMS (or Deep TMS 360°). The company’s transcranial magnetic stimulation (TMS) method of stimulation enables the activation of more neurons in the brain.

With the new rotational field system under evaluation, two orthogonal TMS coils are placed perpendicular to one another. Operated with a time lag, they induce a circulatory rotating electric field. This results in uniform stimulation of neurons oriented along a wide variety of directions in the targeted brain region.

It all takes place within less than a millisecond.

BrainsWay wants to assess the potential clinical impact of this technology in two new studies. One tests the safety and efficacy in the field of rehabilitation following a stroke. The other looks at obsessive-compulsive disorder (OCD) with an accel…

BrainsWay launches study program to evaluate neurostim tech

BrainsWay (Nasdaq:BWAY) announced today that it launched an investigator-initiated study (IIS) program for its Deep TMS technology.

The company designed the program to support further research for Deep TMS (transcranial magnetic stimulation) by the clinical research community. According to a news release, BrainsWay plans to utilize data collaboration and equipment loan initiatives. The company accepts applications through July 3, 2023.

BrainsWay said it aims for the program to aid investigators interested in advancing current knowledge about Deep TMS. The company encourages early-career investigators and those utilizing BrainsWay’s patented Deep TMS H4 coil.

Deep TMS holds three FDA-cleared indications as a noninvasive neurostimulation treatment for mental health disorders. Current indications include major depressive disorder, obsessive-compulsive disorder and smoking addiction. BrainsWay has additional clinical trials underway for the platform in…

BrainsWay scores coverage win on neurostim treatment for OCD

BrainsWay announced today that Cigna is offering positive coverage for its neurostimulation treatment of obsessive-compulsive disorder (OCD).

Cigna provides commercial health coverage to approximately 17 million members in 13 states. It has Medicare Advantage plans in 16 states and is part of the Health Insurance Marketplace online exchange. It joins Centene, Highmark, Health Care Services Corporation, Blue Cross Blue Shield, Tricare, and Palmetto GBA Medicare as those offering coverage to BrainsWay’s treatment.

The coverage decision is applicable to BrainsWay’s proprietary deep transcranial magnetic stimulation (TMS) for treating OCD. Its patented H7 coil is designed to penetrate deeper and broader structures of the brain associated with OCD.

BrainsWay’s deep TMS system received FDA de novo clearance for treating OCD in 2018. The company launched it in a full-market release in 2019. As of June 30, 2022, it shipped 368 OCD coils as add-…

BrainsWay raises more than $45M

BrainsWay announced last month that it closed an underwritten public offering worth approximately $45.2 million in proceeds.

The non-invasive brain disorder treatment developer offered more than 5.3 million American Depositary Shares (ADSs), upsized to include 693,300 ADSs sold pursuant to the underwriters’ exercise in full of their option to purchase additional shares at $8.50 per share, according to a news release.

Oppenheimer & Co. Inc. acted as the sole book-running manager for the offering. Ladenburg Thalmann and Northland Capital Markets acted as the co-managers.

BrainsWay did not list an intended use of proceeds for the funds raised. The company develops neurostimulation products using its proprietary deep transcranial magnetic stimulation (Deep TMS) platform.

The company has marketing authorization from the FDA for its products for a range of patient populations, including indications for treating major depressive disorder, obses…