Brainsway Ltd. (NASDAQ: BWAY)

BrainsWay Ltd., with its ticker symbol BWAY, is a company that operates in the advanced non-invasive neurostimulation treatments industry for mental health disorders. The company is based in Israel and has a significant presence in the United States, where it generates around 75% of its revenues. BrainsWay is dedicated to leading through superior science and building on what it believes to be an unparalleled body of clinical evidence.

BrainsWay's main business activities revolve around the sale and lease of its Deep Transcranial Magnetic Stimulation (Deep TMS) systems, as well as the provision of related services. The company's primary products include the H-Coil Deep TMS system, which is designed to treat a range of psychiatric, neurological, and addiction disorders. BrainsWay's Deep TMS platform technology is intended for non-invasive treatment of psychiatric, neurological, and addiction disorders. The system includes an H-Coil uniquely designed to transmit electric current flows at varying rates, creating an electromagnetic field that serves to depolarize cortical neurons and activate neural networks in certain areas of the brain.

The company has received FDA clearance for its Deep TMS system for the treatment of major depressive disorder (MDD), obsessive-compulsive disorder (OCD), and smoking addiction. Its Deep TMS system for MDD is currently marketed to and installed at psychiatrists' offices and other facilities primarily in the United States and in certain other countries throughout the world. BrainsWay's Deep TMS system has been shown to be effective in reducing symptoms of these disorders, and has been approved by the FDA for use in treating MDD and OCD.

BrainsWay's primary customers are doctors, hospitals, and medical centers in the field of psychiatry. The company has a commercial track record for MDD and OCD, with an established footprint in the United States. The company has received reimbursement coverage for its Deep TMS system for MDD from Medicare, and has also received coverage from several private payors. BrainsWay is also expanding its commercialization efforts for Deep TMS for OCD, with reimbursement coverage now available from several payors.

In addition to its commercial activities, BrainsWay is also engaged in research and development efforts to advance its technology and expand its indications. The company is currently developing and initiating clinical testing of its next-generation multichannel device, which includes its patented "rotational field" TMS or "Deep TMS 360°" technology. This technology allows for simultaneous modulation of different areas of the brain with independent stimulation parameters, and the patented rotational field aspect employs a method of stimulation that enables activation of a greater number of neurons in the brain.

BrainsWay's Deep TMS system has several advantages relative to other TMS systems, including its flexible design, proprietary structure, and ability to stimulate a larger surface area of the head. The system is non-invasive, and unlike other treatments for mental health disorders, such as electroconvulsive therapy (ECT), Deep TMS does not require surgery or the insertion of electrodes into the brain. Instead, the system uses a coil to transmit magnetic pulses to the brain, which can help to stimulate areas of the brain that are involved in mood regulation.