The company holds exclusive rights to issued U.S. patents assigned to Stanford University
SAINT is the first FDA-cleared accelerated neuromodulation protocol in brain health proven to deliver rapid remission within a truly accelerated treatment window
BURLINGAME, Calif.–(BUSINESS WIRE)–#DepressionTreatment—Magnus Medical Inc., exclusive licensee of a collection of pioneering accelerated neuromodulation patents, today reaffirmed its commitment to protecting the intellectual property behind SAINT® (Stanford Accelerated Intelligent Neuromodulation Therapy) and to protecting patient safety in the rapidly evolving mental health treatment landscape by sending cease-and-desist letters to companies that it believes infringe its patents.
The company holds exclusive rights to issued U.S. patents assigned to Stanford University covering the systems and methods that enable accelerated theta-burst stimulation (aTBS) protocols for neurological conditions including major depressive disorder (MDD) and treatment-resistant depression (TRD). These patents, including U.S. Patent Nos. 10,595,735 and 11,839,455, represent years of rigorous research conducted within the university system and embody the kind of breakthrough innovation that has positioned U.S. academic medical centers as global leaders.
“The innovations protected by our patent portfolio represent fundamental breakthroughs in treating mental health conditions at the circuit level,” said Brandon Bentzley, M.D., Ph.D., co-founder and chief science officer of Magnus Medical, who co-developed SAINT at Stanford alongside the late Nolan Williams, M.D. “Protecting this IP ensures patients receive rigorously validated accelerated treatment. Patients deserve treatments backed by the highest quality peer-reviewed science and real-world outcomes.”
As an early innovator and recognized leader in accelerated neuromodulation for brain health conditions, Magnus Medical continuously monitors developments in the industry to ensure awareness and alignment with applicable intellectual property rights related to its patents and innovation. The delivery of cease-and-desist letters is consistent with this practice, and Magnus encourages other companies and providers to take the initiative to evaluate their technology and protocols for potential infringement.
“As others rush to catch up to SAINT’s clinical outcomes, we are seeing protocols and products emerge that raise significant concerns regarding the infringement of IP both licensed and developed by Magnus Medical,” said Christian Gormsen, chief executive officer of Magnus Medical. “Failure to respect IP undermines the American academic innovation system that produced SAINT, erodes trust in the research ecosystem, and most importantly, misleads patients and providers. We welcome those advancing this field through proper licensing and rigorous validation, but we will defend our IP against those who are commercializing accelerated neuromodulation protocols that we believe infringe upon our patented innovation. It is essential for companies and clinics to adopt approaches that respect intellectual property frameworks.”
More than 700 patients have been treated successfully with SAINT across research and commercial settings. The growing list of verified SAINT providers include healthcare leaders like Stanford Health, Sutter Health, Medical University of South Carolina (MUSC), University of Arkansas for Medical Sciences (UAMS), University Medical Center New Orleans (LSU Health) and leading private clinics nationwide.
SAINT is the first FDA-cleared accelerated neuromodulation protocol of its kind, supported by published clinical studies demonstrating rapid remission within a truly accelerated treatment window, achieving 79% remission rates1 with patients reaching remission in an average of just 2.6 days over five days of treatment2. SAINT combines functional MRI brain mapping with intelligently designed aTBS delivery and proprietary targeting algorithms that individualize treatment at the neural circuit level. Magnus Medical engages in customary IP discussions to promote awareness of its patents and innovation consistent with established intellectual property rights across the industry.
About Magnus Medical
Magnus Medical Inc. is a privately held therapeutic neuromodulation company co-founded in 2020 to advance precision medicine in brain health. Its platform technology combines neuroimaging, proprietary targeting algorithms and individualized neurostimulation to address complex brain conditions. Magnus’ first product, the SAINT neuromodulation system, is FDA-cleared for adults with major depressive disorder. For more information, visit https://www.magnusmedical.com.
About SAINT
The SAINT neuromodulation platform is the first FDA-cleared treatment for major depressive disorder that uses functional MRI data to guide personalized, noninvasive neuromodulation over an accelerated five-day schedule. SAINT has been designated a Breakthrough Device by the FDA and is the first mental health therapy to receive innovation support from CMS through the New Technology Add-on Payment and New Technology Ambulatory Payment Classification programs. In foundational studies, 79% of patients achieved remission in an average of 2.6 days. Clinical trials are ongoing for other neuropsychiatric conditions, including obsessive-compulsive disorder, bipolar depression and postpartum depression. These indications have not been cleared by the FDA. To learn more about SAINT, visit www.magnusmedical.com/depression-therapy/.
Certain statements in this release describe the company’s views regarding innovation, clinical research, and intellectual property in the neuromodulation field. These statements are general in nature, do not reference any specific third-party products or companies, and are not intended as assertions regarding the legal status, regulatory compliance, comparative superiority, infringement, liability, or clinical performance of any other products or protocols.
1Cole EJ et al., Stanford Neuromodulation Therapy (SNT): A Double-Blind Randomized Controlled Trial, American Journal of Psychiatry 179(2):132-141 (2022), doi:10.1176/appi.ajp.2021.20101429.
2Cole EJ, Stimpson KH, Bentzley BS, et al. Stanford Accelerated Intelligent Neuromodulation Therapy for Treatment-Resistant Depression, American Journal of Psychiatry 177(8):716-726 (2020), doi:10.1176/appi.ajp.2019.19070720.
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