Business operations poised to commence following FDA approval
The U.S. Food and Drug Administration (FDA) has approved an accelerated treatment protocol for Brainsway's Deep Transcranial Magnetic Stimulation (Deep TMS) technology. This approval is expected to revolutionize the treatment of depression, as it will enable Brainsway to bring the therapy to market much faster.
Brainsway's CEO, Hadar Levy, believes this FDA approval marks a significant shift in how depression can be treated. The approval is based on a large-scale, randomized multicenter study that demonstrated the safety and efficacy of the accelerated treatment protocol.
The new protocol, which is based on intermittent theta-burst stimulation (iTBS), has shown promising results. Patients in the accelerated group achieved remission on average after 21 days, a week faster than with the standard method. Fewer clinic visits and faster effects are expected for patients with the new protocol.
The approval comes as good news for Brainsway, as it may start monetizing the therapy sooner. The stock made a double-digit jump following the approval, indicating investor confidence. Brainsway's stock increased by 11.89% on Tuesday.
Brainsway further solidifies its market leadership position for non-invasive neurostimulation with the approval. The company is the only provider to have received three FDA approvals for the indications of depression, obsessive-compulsive disorder, and tobacco addiction.
However, there are still challenges to overcome. Current insurance only covers two sessions per day, and an adjustment could be key to widespread use. Brainsway plans to educate doctors and improve reimbursement rules to facilitate access to the therapy.
Depression is one of the leading causes of work disability and high healthcare costs worldwide. The accelerated U.S. market introduction is expected to lead to higher revenues for Brainsway, potentially contributing to a reduction in these costs. The approval strengthens the medical credibility of Brainsway's Deep TMS therapy, offering hope for those suffering from depression.
