neurocare group AG announces MDMA approval for its TMS devices in Saudi Arabia

(SeaPRwire) –   Munich, Germany and Riyadh, Saudi Arabia – neurocare group AG (“neurocare” or the “Company”), a leading provider in mental health and performance enhancement, is pleased to announce that the Saudi Food & Drug Authority (SFDA) has granted the Company Medical Device Marketing Authorization (MDMA) approval to market its TMS Devices within the Kingdom of Saudi Arabia.

Central to neurocare’s best practice platform is TMS technology, which provides a safe, non-invasive, and medication-free treatment option for mental health conditions such as depression—without the need for a black box warning or associated drug-related side effects. Within the neurocare platform, TMS is integrated into structured clinical workflows and enhanced by digital tools and measurement-based care, helping clinicians deliver more consistent, personalized, and sustainable patient outcomes.

Clinical research indicates that approximately 60% of patients achieve remission following TMS treatment, making it an effective new therapeutic approach for adolescents who have not responded well to other treatments for depression.

This milestone represents a major advancement in neurocare’s strategy to broaden access to its advanced best practice platform throughout the Middle East. With this authorization, neurocare becomes one of the first TMS manufacturers officially approved to operate in Saudi Arabia, positioning the company at the forefront of a rapidly evolving mental healthcare sector.

Saudi Arabia is significantly investing in evidence-based, technology-driven healthcare through its Health Sector Transformation Program, fostering strong momentum for innovative treatments like TMS. Across the broader Gulf region, there has been growing interest in neurocare’s comprehensive platform approach, which combines neuromodulation, digital solutions, and standardized protocols—aligning closely with the needs of clinicians and health systems seeking reliable alternatives to traditional care.

With MDMA approval now secured, neurocare is uniquely prepared to introduce its proven, cutting-edge platform—centered on TMS technology—to providers throughout the Kingdom. This enables clinics to expand their service offerings, enhance treatment outcomes, and deliver personalized, nonpharmacological care to patients who require 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 seeking advanced, nonpharmacological solutions to better support their 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 TMS technology at the core,” 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 superior outcomes for patients across the region.”

“With SFDA approval now in place, our immediate focus is on execution—embedding TMS into 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 meet the Kingdom’s needs and address rising demand for mental health services.”

neurocare has been active in the MENA region since 2024 through strategic partnerships aimed at expanding access to high-quality mental healthcare. Complementing its established clinical presence across Europe, the US, the UK, the Netherlands, and Australia, the company has accelerated its regional expansion following TVM Capital Healthcare’s investment. Through close collaboration with local partners and regulators, neurocare is establishing and scaling its integrated platform that delivers neuromodulation and neurofeedback technologies alongside clinical care in Saudi Arabia. In parallel, neurocare continues to advance global efforts to secure reimbursement pathways for TMS and related technologies.

In an era where regional dynamics highlight the importance of resilient healthcare systems that include mental well-being, neurocare’s platform can support both patients and providers during periods of heightened need by offering reliable, locally accessible, and personalized care solutions.

About neurocare group AG

neurocare group AG has developed a best practice mental health platform designed to empower clinicians to deliver personalized therapy and optimal care for a range of psychological or neurological conditions, resulting in more sustainable clinical outcomes. Following a thorough assessment of each patient’s condition, neurocare assists clinicians in creating customized therapy plans that improve self-regulation, resilience, and social skills—while also being cost-effective for the healthcare system.

Key technological components of neurocare’s platform are developed in-house, including leading TMS and EEG devices, a cloud-based software platform, and an online academy that equips professionals with the tools and neuroscientific knowledge needed to effectively apply these approaches in clinical practice.

Currently, neurocare’s platform is implemented in the company’s own clinics across the US, the UK, the Netherlands, and Australia, as well as in an increasing number of third-party clinics.

neurocaregroup.com

Contact:

Sally Remington
neurocare group AG
media@neurocaregroup.com

About TVM Capital Healthcare

TVM Capital Healthcare is a global private equity investor and operator specializing in specialty care and healthcare growth capital across emerging markets. With nearly 40 years of global investment and operational experience and 15 years focused on 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 regions. TVM Capital Healthcare’s portfolio companies advance access to care, improve patient outcomes, and align with national healthcare transformation agendas.

tvmcapitalhealthcare.com

Contact:

Holly Radel
TVM Capital Healthcare
radel@tvmcapitalhealthcare.com

Attachment

• Patient Receives Depression Treatment Using neurocare’s Apollo TMS System