Today’s post is a few press releases…but they go together to tell a story…this newsletter is about what's next in health, and as a psychiatrist, a lot of that has to do with brain health. I write a lot. I write every day. I do that so I keep writing. It's easier to keep a habit. One of the things that keep me going is my excitement about accelerated brain stimulation. What follows are three press releases on topic, and a teaser at the end!
I’m co-hosting a Validation Institute webinar with the remarkable Al Lewis on how neuromodulation treatments can find their home in employer health plan design! It’s sponsored by Acacia Mental Health, where I’m SVP of Strategy. That on is up first:
Press Release Number I: Validation Institute Webinar
November 7 | 1-2:00 PM ET
In today's fiercely competitive employment landscape, offering comprehensive and innovative employee benefits is essential for attracting and retaining top talent.
Health and wellness initiatives have taken center stage, and one area garnering significant attention is mental health support. To improve health outcomes and control costs, employers must offer mental health benefits that go beyond symptom reduction, aiming for complete remission. These brain disorders now have treatments that are beyond “just talking” and “pills.”
In this webinar, gain insights into a transformative behavioral health program – BRAIN: Behavioral Response Augmented Intelligent Neuromodulation – that offers a rapid and outcomes-driven treatment for Obsessive-Compulsive Disorder (OCD)J recovery and beyond. Delve into the revolutionary world of BRAIN by Acacia Clinics, a pioneering treatment approach that sets a new benchmark for OCD and depression management. Attendees will discuss strategies to put these novel treatments into the context of sophisticated plan design and compliance with MHPAEA, ERISA, and Fiduciary Duty on the part of plan sponsors.
Actionable takeaways from this webinar include:
Achieving Remission: Explore how BRAIN by Acacia Clinics delivers the best possible outcome – complete remission of OCD, rather than just a standard “50% reduction in symptoms.” Learn how this approach is reshaping the way we view mental health recovery.
Rapid Treatment: Discover the revolutionary treatment timeframe of just five days, offering a swift and effective solution for individuals suffering from depression, addiction, and OCD. Learn how this accelerated approach can significantly improve patient outcomes.
Medication-Free Therapy and “We Don’t Have to Talk About:” The unique advantage of BRAIN therapy is that it doesn’t rely on oral medications or talk therapy alone. Explore how neuromodulation techniques can provide relief without the side effects of traditional drug therapies and extensive–and sometimes exhausting– talk therapy.
Comprehensive Assessment: Gain insights into the benefits of a comprehensive assessment process, ensuring each patient’s personalized and tailored treatment plan. Learn how this approach optimizes treatment effectiveness.
Durable Effects: Explore the long-lasting impact of BRAIN therapy, with an average duration of remission lasting 12 months. Discover how this durability contributes to the overall well-being and stability of patients.
Compliant for Fiduciaries: Learn How these treatments provide a bulwark against ERISA claims in a complex regulatory landscape.
Don’t miss this transformative session that sheds light on evidence-based approaches to treat and manage OCD, ADHD, and depression – a true game-changer in mental healthcare. Discover how this innovative approach can enhance your employee benefits program, supporting your workforce’s mental health and well-being while positioning your organization as a leader in employee care and support.
Number II: SAINT OLO Comes to Brooklyn, New York.
BROOKLYN, N.Y., Oct. 25, 2023 /PRNewswire/ -- Fermata, an outpatient psychiatric center of excellence, today announced a new clinical trial to study the SAINT™ Neuromodulation System for treating major depressive disorder (MDD) as part of a larger multi-site trial to further develop a more rapid, personalized treatment option for treatment-resistant major depression.
The prospective, multi-site open-label optimization study (OLO) is designed to further evaluate the effectiveness of the investigational SAINT Neuromodulation System for the treatment of adults with MDD. The SAINT Neuromodulation System may yield a new form of personalized, focused neurostimulation in adults with major depression.
Drs. Owen Muir and Carlene MacMillan to Study SAINT Neuromodulation for Treatment-Resistant MDD at Fermata
The OLO trial will enroll up to 1,000 adults in a major depressive episode who have failed to receive satisfactory improvement from a prior antidepressant medication in the current episode. 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.1
"Major Depressive Disorder (MDD) is one of the most common mental disorders in the United States. Treatment-resistant depression (TRD) can leave sufferers feeling out of options," said Owen Scott Muir, M.D., a co-founder at Fermata and an ABPN dual-board certified Child and Adult Psychiatrist. "There is an enormous need for improved treatments for MDD. This trial will go a long way toward gathering more data to help us treat people with severe, even intractable, depression." In his influential newsletter and podcast, TheFrontierPsychiatrists.com, Dr. Muir writes about health, accessible payment models, and neuromodulation.
This study is the first time the SAINT Neuromodulation System has been studied at multiple sites in a large sample of individuals with major depression.
"We are entering a remarkable new era in mental health care," said Carlene MacMillan, M.D., co-founder of Fermata and chief medical officer of Osmind, an electronic health record company for mental health providers. "This targeted, rapid neuromodulation protocol has the potential to reach patients across different levels of care."
The SAINT Neuromodulation System uses MRI images of brain activity to identify the most strongly connected portions of the left dorsolateral prefrontal cortex with regard to a deeper subregion called the subgenual cingulate. In people who have MDD, the subgenual cingulate becomes overactive, and the ability to prevent negative thoughts is reduced. This study is investigating if SAINT will reduce the activity in the subgenual cingulate and restore mood regulation.2
Study treatment with the SAINT Neuromodulation System is delivered on an accelerated timeline—10 sessions a day, comprising 10-minute treatments with 50-minute breaks for five consecutive days.
To learn more about the OLO study, visit— https://www.magnusmed.com/clinical-trials/
1 Friedrich MJ. Depression Is the Leading Cause of Disability Around the World. JAMA [Internet]
2017;317(15):1517–1517. Available from:
http://jama.jamanetwork.com/article.aspx?doi=10.1001/jama.2017.3826
2 Liston et al. 2015; Weigand et al. 2017.
Number III: Magnus Medical Announces American Medical Association Issues New CPT Category III Codes for Targeted, Accelerated Intermittent Theta-Burst Stimulation
Author’s note: Carlene MacMillan, sometimes co-editor and frequent wife of the primary author of this fine publication, is quoted below; she has been instrumental in the advocacy to have CPT codes to describe accurately—and thus pay for—the future.
BURLINGAME, Calif., October 23, 2023 — Magnus Medical, Inc., a medical device company and developer of brain stimulation technology for the treatment of neuropsychiatric disorders, today announced that the American Medical Association (AMA) has issued new Category III Current Procedural Terminology (CPT) codes for targeted, accelerated intermittent theta burst stimulation (iTBS) for depression, encompassing Magnus’ SAINT™ targeted treatment. The new codes will be published January 1, 2024, and effective July 1, 2024.
“The new AMA codes represent a significant milestone for Magnus, validating the impact of SAINT. Moreover, these new codes will provide increased access across sites of service to SAINT treatment for the millions who suffer from major depressive disorder (MDD),” said Dave Vort, president of Magnus. “When these codes are active, hospitals using the SAINT neuromodulation system can submit claims directly for SAINT treatment, further expanding the adoption of our novel, rapid-acting therapy for treatment-resistant major depression.”
CPT codes are maintained and granted by the AMA CPT Editorial Panel, which is responsible for ensuring CPT codes reflect the latest medical care available to patients. These codes are widely used by government payers, including Medicare and Medicaid, and commercial insurance companies to describe healthcare services and procedures for reimbursement.
“We are entering a remarkable new era in mental health care,” said Carlene MacMillan, M.D., co-founder of Fermata, a company with novel approaches to psychiatric treatment, and chief medical officer of Osmind, an electronic health record company for mental health providers. “With these new codes, this targeted, rapid neuromodulation protocol has the potential to reach patients far and wide across different levels of care. The AMA’s approval of these codes for neuro-navigated accelerated iTBS is a vital recognition that this is a distinct therapy for patients suffering from difficult-to-treat depression.”
Magnus’ SAINT technology uses structural and functional magnetic resonance imaging (MRI) to build a proprietary algorithm that identifies the optimal brain region to target for neurostimulation in people with MDD. Whereas traditional transcranial magnetic stimulation typically involves four-to-six weeks of treatment, this new approach is delivered on an accelerated, five-day timeline. It is precisely tailored to each person’s brain circuitry. Patients have 10 sessions daily, comprising 10-minute treatments with 50-minute breaks for five consecutive days.
Previous clinical studies evaluating the SAINT therapy have been extremely promising, with approximately 80-90% of people achieving remission of depression symptoms following the treatment protocol.1 The SAINT neuromodulation system was granted Breakthrough Device Designation in 2021 and 510(k) clearance by the U.S. Food & Drug Administration (FDA) in 2022.
About Magnus
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 Magnus neuromodulation system, which delivers targeted SAINT treatment and provides a new form of individualized neurostimulation for adults who have failed to achieve satisfactory improvement from prior antidepressant medications. SAINT was developed at Stanford University and licensed exclusively to Magnus Medical in October 2021 for commercialization. For more information, visit https://www.magnusmed.com
And the teaser…to be announced in its full glory soon…The Frontier Psychiatrists is hosting its first real-world event!
More details coming about that soon. But it's the night before JPM starts, and will be announcing tickets and speakers next week. The event is a fundraiser for BrainFutures, a 501 (c ) 3 not-for-profit.
Thanks for reading!
Excited to attend the IRL event