First customer sites include the University of
Arkansas for Medical Sciences, MUSC Health, and Calif.-based Acacia
Clinics and Kaizen Brain Center
Magnus Medical, Inc., a pioneering therapeutic neuromodulation
company transforming the treatment of neuropsychiatric disorders,
today announced the commercial launch of the SAINT® neuromodulation
system, a groundbreaking, rapid-acting therapy for
treatment-resistant major depressive disorder (MDD).
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The commercially available SAINT®
neuromodulation system from Magnus Medical provides a new form of
individualized neurostimulation therapy for treatment-resistant
major depression in adults who have failed to achieve satisfactory
improvement from prior antidepressant medications. (Photo: Business
Wire)
Treatment with SAINT changes a person’s brain circuitry to treat
MDD more effectively by modifying activity in brain networks that
are related to depression. Granted Breakthrough Device Designation
and 510(k) clearance by the U.S. Food & Drug Administration
(FDA), SAINT therapy has led to dramatic improvements in people’s
symptoms of severe depression in a clinical setting.
“We are thrilled to be the first site in the nation to offer the
breakthrough, FDA-cleared SAINT neuromodulation system for
individuals suffering from depression, and I am very optimistic
that this new approach will change people’s lives,” said Laura B.
Dunn, M.D., chair, Department of Psychiatry and director of the
Psychiatric Research Institute at the University of Arkansas for
Medical Sciences. “The innovative SAINT protocol provides
neuroscience-based, targeted, personalized, non-invasive rapid
treatment for patients with one of the most disabling psychiatric
conditions - major depression. As a practicing psychiatrist, I know
firsthand how important it is for patients to have new options to
help them get their lives back. At the UAMS Psychiatric Research
Institute, our mission is to provide outstanding, expert-driven
psychiatric care for our patients.
“With our interventional psychiatry program, Helen L. Porter and
James T. Dyke Brain Imaging Research Center, and our inpatient and
outpatient treatment programs all housed under one roof, our teams
of mental health experts will work seamlessly together to implement
the SAINT protocol, tailored to each patient’s individual needs,”
continued Dr. Dunn. “We are excited to bring the future of brain
science directly to the people of Arkansas and the entire
region.”
SAINT therapy works by leveraging structural and functional
magnetic resonance imaging (MRI) scans to inform a proprietary
algorithm that pinpoints the optimal anatomical target for precise
neurostimulation in individuals with major depression. The
innovative treatment is performed on an accelerated, five-day
timeline, ensuring that stimulation targeting is meticulously
customized to each person’s unique brain connectivity.
“We’re more than thrilled by the successful launch of the SAINT
neuromodulation system, which represents an enormous shift in the
treatment landscape for clinical depression,” said Brandon
Bentzley, M.D., Ph.D., co-founder and CSO of Magnus Medical, who
was also trained by Dr. George at MUSC, the birthplace of clinical
TMS for the treatment of neuropsychiatric disorders. “This is the
first step in making SAINT therapy accessible to everyone, making
it possible for people who have suffered too long to reclaim their
lives and find dramatic relief much more quickly. By offering a
rapid-acting, clinically proven, highly effective treatment, SAINT
has the potential to completely transform the way major depression
is treated, particularly for individuals who have been
ineffectively treated by prior antidepressant medications.”
The company also announced that it received approval for a New
Technology Add-on Payment (NTAP) from the Centers for Medicare
& Medicaid Services (CMS) for its SAINT neuromodulation system.
This is the first time CMS has approved an NTAP for Interventional
Psychiatry. The NTAP is available for the commercial launch of the
SAINT therapy and is eligible for additional reimbursement of up to
$12,675 per hospital inpatient treatment.
The American Medical Association (AMA) issued new Category III
Current Procedural Terminology (CPT) codes for targeted,
accelerated iTBS for depression, encompassing the SAINT
neuromodulation system, effective July 1, 2024. The company is
actively pursuing robust payment for SAINT therapy through Medicare
in the hospital outpatient setting and working directly with
private insurance companies. Magnus Medical expects to have
selective insurance coverage in both the hospital inpatient and
outpatient setting and the physician’s office. The company
anticipates that coverage will grow over the next several
years.
About Treatment-Resistant Major Depressive Disorder
(TR-MDD)
Major Depressive Disorder, or MDD, is an episodic disorder that
can last months or years.1 Treatment-resistant MDD is a condition
that impacts over 50% of people with depression who don’t respond
to medications and psychotherapy.2 In the U.S., 20% of adults
experience depression at some point in their lives,3 which amounts
to approximately 52 million people out of 260 million adults.4
Research shows that 10.4% of adults experience MDD within a
12-month period and 20.6% over their lifetime.5 Considering the
total adult population, this means an estimated 26 million
Americans struggle with depression each year.
About Magnus
Magnus Medical, Inc., is a privately held therapeutic
neuromodulation company driven to transform lives by restoring
mental health. Co-founded in 2020, the company’s first product is
the SAINT neuromodulation system, which provides a new form of
individualized neurostimulation for treatment-resistant depression
indicated for adults who have failed to achieve satisfactory
improvement from prior antidepressant medications. The SAINT
treatment protocol has shown high remission and response rates in
both prior open-label studies, with approximately 80-90% of people
achieving remission of depression symptoms following the five-day
treatment protocol.6 A double-blinded randomized controlled trial
(RCT) produced results that indicated a 79% remission of depression
symptoms in people in the active treatment arm following the
protocol.7 For more information, visit
https://www.magnusmed.com.
1.
https://apps.who.int/iris/bitstream/handle/10665/254610/WHO-MSD-MER-2017.2-eng.pdf
2. Pigott, H. E., Kim, T., Xu, C., Kirsch,
I. & Amsterdam, J. What are the treatment remission, response
and extent of improvement rates after up to four trials of
antidepressant therapies in real-world depressed patients? A
reanalysis of the STAR*D study’s patient-level data with fidelity
to the original research protocol. BMJ Open 13, e063095 (2023).
3.
https://jamanetwork.com/journals/jamapsychiatry/fullarticle/2671413#:~:text=Findings%20In%20this%20national%20survey,associated%20with%20comorbidity%20and%20impairment
4.
https://www.census.gov/library/stories/2021/08/united-states-adult-population-grew-faster-than-nations-total-population-from-2010-to-2020.html#:~:text=In%202020%2C%20the%20U.S.%20Census,from%20234.6%20million%20in%202010
5.
https://jamanetwork.com/journals/jamapsychiatry/fullarticle/2671413#:~:text=Findings%20In%20this%20national%20survey,associated%20with%20comorbidity%20and%20impairment
6. Cole EJ, Phillips AL, Bentzley BS, et
al. “Stanford Accelerated Intelligent Neuromodulation Therapy for
Treatment-Resistant Depression.” The American Journal of
Psychiatry. 2020;177(8):716–726.
7. Cole EJ, Phillips AL, Bentzley BS, et
al. “Stanford Neuromodulation Therapy (SNT): A Double-Blind
Randomized Controlled Trial.” The American Journal of Psychiatry.
Oct 29, 2021.
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Amy Cook Media resources amy@magnusmed.com +1 925.222-5094