May 15, 2023
BURLINGAME, Calif., May 15, 2023 — Magnus Medical, Inc., a medical device company and developer of brain stimulation technology for the treatment of neuropsychiatric disorders, today shared promising results from a clinical trial published in the Proceedings of the National Academy of Sciences indicating that treatment with SAINT™ Neuromodulation reverses abnormal brain signaling by changing the direction of brain signal flow in people with severe depression. Findings also reveal a new biomarker that may be helpful in the diagnosis and treatment of major depressive disorder (MDD).
“These findings have the potential to be a game-changer. This strongly supports the role of fMRI resting-state connectivity in our SAINT Neuromodulation System as a method of personalized targeting to treat underlying causes of depression, and suggests that this could be a fundamental biological signature of major depressive disorder,” said Brandon Bentzley, M.D., Ph.D., co-founder and chief scientific officer of Magnus Medical. “Identifying other neural pathways could lead to the discovery of additional biomarkers that characterize other highly debilitating neuropsychiatric disorders.”
The study’s senior authors are Marcus E. Raichle, M.D., a Wolff distinguished professor of medicine at Washington University in St. Louis, and Nolan R. Williams, M.D., an associate professor within the Department of Psychiatry and Behavioral Sciences at Stanford Medicine.
Researchers conducted the first investigation of the relationship between resting-state fMRI brain activity, major depression, and treatment response to the FDA-cleared SAINT Neuromodulation therapy. Findings show that treatment with SAINT for major depression produces changes in brain signaling by reversing the direction of abnormal brain signals in the bilateral anterior cingulate cortex (ACC)—the region that manages fundamental emotions, which predicts improvement in depression symptoms.
Notably, pre-treatment ACC signaling predicts depression severity and the likelihood of a person’s treatment response to SAINT therapy. This reverse signaling may also serve as a biomarker for diagnosing and treating major depressive disorder, the leading cause of disability worldwide.1
Data from 33 patients diagnosed with treatment-resistant major depression, 23 of whom received treatment with SAINT and 10 who received a sham treatment, were compared to 101 healthy individuals. The fMRI data revealed that the anterior insula in healthy people— the region of the brain that supports subjective feelings and sensation—sent signals to the ACC, whereas in 80% of the people with depression, the flow of activity was reversed—the ACC sent signals to the anterior insula. The results also indicate that the higher quantity of abnormal signaling in the ACC is related to the severity of major depression.
The SAINT Neuromodulation System uses structural and functional magnetic resonance imaging (MRI) to inform a proprietary algorithm that identifies the optimal anatomic target for focused neurostimulation in people with MDD. This new approach is delivered on an accelerated, five-day timeline with targeting of the stimulation precisely tailored to each person’s brain connectivity.
Major depressive disorder is an episodic disorder that can last months or years.1 According to the World Health Organization, over 280 million people suffer from MDD globally, nearly half of whom have treatment-resistant depression, and far too many experience suicidal thoughts with no rapidly acting treatment options available to them.2 More than 550,0003 adults in the U.S. alone are hospitalized annually for suicidal depression, and the highest peak in suicide attempt 4 and completion is immediately after discharge from the hospital, representing an unmet need for rapid and effective treatment in a hospital setting.
Magnus Medical, Inc., is a privately held medical device company driven to transform lives by restoring mental health. Magnus’ first FDA-cleared product is the SAINT Neuromodulation System, which received FDA Breakthrough Device Designation for its novel, rapid-acting therapy for treatment-resistant depression. The SAINT Neuromodulation System provides a new form of individualized neurostimulation for adults who have failed to achieve satisfactory improvement from prior antidepressant medications. For more information, visit magnusmed.com.