neurocare group AG מודיעה על אישור MDMA למכשירי TMS בערב הסעודית
מטופל מקבל טיפול בדיכאון
באמצעות מערכת Apollo
TMS של
neurocare
צילום neurocare group AG.
מטופל שעובר טיפול בגירוי מגנטי על-גולגולתי (TMS) לטיפול בדיכאון באמצעות מערכת Apollo TMS של neurocare בסביבה קלינית
מינכן, גרמניה וריאד,
ערב הסעודית, 5 במאי 2026, GLOBE NEWSWIRE:
neurocare group AG
("neurocare ",
"החברה"), פלטפורמה המתמקדת בשיטות עבודה מומלצות לבריאות הנפש ותפקוד
תקין, שמחה להודיע כי רשות המזון והתרופות הסעודית (SFDA)
העניקה לחברה אישור לשיווק מכשור רפואי (MDMA)
למכירת מכשירי ה-TMS שלה בערב הסעודית.
neurocare group
AG announces MDMA approval of TMS Devices in Saudi Arabia
Patient
Receives Depression Treatment Using neurocare’s Apollo TMS System
A patient undergoing Transcranial Magnetic
Stimulation (TMS) therapy for depression with neurocare’s Apollo TMS System in
a clinical setting.
Munich, Germany and Riyadh, Saudi Arabia, May 5, 2026, GLOBE NEWSWIRE:
neurocare group AG (“neurocare” or the
“Company”), a best practice platform for mental health and performance, is
pleased to announce the Saudi Food & Drug Authority (SFDA) has granted the
Company Medical Device Marketing Authorization (MDMA) approval to sell its TMS
Devices in the Kingdom of Saudi Arabia.
A core part of neurocare’s best practice
platform is TMS technology which offers a safe, non-invasive, and drug-free
alternative for mental health indications such as depression, yet with no black
box warning and no medication-related side effects. As part of the neurocare
platform, TMS is embedded into structured clinical workflows and supported by
digital tools and measurement-based care, enabling clinicians to deliver more
consistent, personalized and sustainable outcomes.
Clinical studies show that approximately 60%
of patients achieve remission with TMS, making it a promising new treatment
option for adolescents who have not found success with other treatments for
depression.
This milestone marks a significant step
forward in neurocare’s efforts to expand access to its advanced best practice
platform across the Middle East. With this approval, neurocare becomes one of
the first TMS manufacturers authorized to operate in Saudi Arabia, positioning
the Company at the forefront of a rapidly developing mental healthcare
landscape.
Saudi Arabia is investing heavily in evidence-based, technology-enabled care
through its Health Sector Transformation Program, creating strong momentum for
the adoption of innovative treatments such as TMS. Across the wider Gulf
region, neurocare has seen growing interest specifically in its integrated
platform approach, uniting neuromodulation, digital processes and standardized
protocols, which is well aligned with the needs of clinicians and health
systems seeking reliable alternatives.
With MDMA approval now secured, neurocare is
uniquely positioned to bring its proven, state-of-the-art platform led by TMS
technology to providers in the Kingdom. This enables clinics to expand their
service offerings, improve treatment outcomes, and deliver personalized,
nonpharmacological care to patients who need it most.
“We see tremendous potential across the
region for adopting innovative, evidence-based methods such as TMS,” said Tariq
El-Titi, Senior Vice President for neurocare in MENA. “Healthcare leaders in
Saudi Arabia are increasingly looking for advanced, nonpharmacological
solutions to support patients. We look forward to forming new partnerships
across the Kingdom and supporting clinicians as they integrate best-practice
TMS therapies powered by German-engineered technology.”
“This approval reflects our broader mission
to empower clinicians through our best practice platform with our TMS
technology first,” said Thomas Mechtersheimer, Founder and CEO of neurocare
group AG. “By combining advanced neuromodulation, digital tools, and integrated
processes, we enable providers to deliver more personalized care and achieve
better outcomes for patients across the region.”
“With SFDA approval in place, the priority now is execution—embedding TMS
within clinical pathways and expanding access beyond traditional hospital
settings,“ added Dr. Helmut Schuehsler, CEO and Chairman of TVM Capital
Healthcare. “We look forward to continuing to work closely with partners and
regulators to adapt and scale proven platforms such as neurocare’s to the
Kingdom’s needs and support growing mental health demand.”
neurocare has been active in the MENA region
since 2024 through strategic partnerships that support the expansion of
best-practice mental healthcare, complementing the company’s established
clinical footprint across Europe, the US, the UK, the Netherlands and
Australia. Following TVM Capital Healthcare’s investment, the Company has
accelerated its regional expansion, working closely with local partners and
regulators to establish and scale its integrated platform that provides
neuromodulation and neurofeedback technologies and clinical care in Saudi
Arabia. In parallel, neurocare continues to advance access to evidence-based
neuromodulation by supporting global efforts to secure reimbursement pathways
for TMS and related technologies.
At a time when regional dynamics underscore
the importance of resilient healthcare systems that are inclusive of mental
well-being, neurocare’s platform can support patients and providers during
periods of heightened need with reliable, locally accessible, and personalised
care solutions.
About neurocare group AG
neurocare group AG has developed a best
practice mental health platform, empowering clinicians to offer their patients,
through personalized therapy, the best care for a variety of psychological or
neurological conditions with more sustainable clinical outcomes. These therapy
plans integrate innovative methods and tools, such as psychotherapy,
neuromodulation, and sleep hygiene, as well as medication. Following a detailed
assessment of the patient's condition, neurocare supports clinicians in
developing personalized therapy plans that improve self-regulation, resilience
and social skills, while being cost-effective for the healthcare system.
The key technology elements of neurocare’s
platform are developed in-house, including leading TMS and EEG devices, a
cloud-based software platform, as well as an online academy to give
professionals the tools and neuroscientific understanding to properly apply
these approaches in clinical practice.
neurocare’s platform is currently applied
throughout the company’s own clinics across the US, the UK, the Netherlands and
Australia, as well as in a growing number of third-party clinics.
About TVM Capital Healthcare
TVM Capital Healthcare is a global private
equity investor and operator focused on specialty care and healthcare growth
capital across emerging markets. With nearly 40 years of global investment and
operational experience and 15 years in emerging markets, the firm builds and
scales companies in Southeast Asia and the Middle East while also investing in
healthcare innovators from the US and Europe and guiding their expansion into
these markets. TVM Capital Healthcare’s portfolio companies advance access to care,
improve patient outcomes, and align with national healthcare transformation
agendas.
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