Key Points
- Neumous is developing focused ultrasound technology to help deliver therapeutics across the blood-brain barrier.
- The South Korea–based company is conducting clinical studies in Alzheimer’s disease and glioblastoma.
Neumous Inc. is a clinical-stage medical device company developing a noninvasive focused ultrasound platform for blood-brain barrier (BBB) opening and targeted central nervous system (CNS) drug delivery. Founded in 2022 by Juyoung “Jay” Park, PhD, the Seoul-based company is studying Alzheimer’s disease and recurrent glioblastoma, with the goal of improving therapeutic delivery for serious brain diseases.
We recently spoke to Dr. Park about Neumous’ focused ultrasound platform, research, and the company’s vision for improving drug delivery to the brain.
How was the company started?
I have been working with therapeutic ultrasound, pharmacology, and brain drug delivery for more than 20 years. I have led and contributed to many government-funded research programs that have given evidence-based support for the safety and efficacy of ultrasound–mediated BBB opening across multiple CNS disease models. These efforts led to the establishment of Neumous.
The company was founded to address one of the most pressing unmet needs in neuroscience and drug development: the blood-brain barrier, which limits the delivery of effective therapeutics to the brain and leaves many serious neurological conditions without adequate treatment. Neumous was built by a multidisciplinary team with complementary expertise in neuroscience, biomedical engineering, hardware development, and medical device development, unified by the mission to develop a noninvasive, clinically scalable focused ultrasound platform for safe and targeted BBB opening.
Where do you see Neumous in the broader focused ultrasound landscape?
Our long-term vision is to become a global leader in focused ultrasound–mediated BBB opening and targeted CNS drug delivery, enabling effective treatment of intractable CNS disorders worldwide.
How many years has your treatment platform been in development, and what are its origins? Does it have a name?
The Neumous focused ultrasound platform is built upon more than two decades of technological development in focused ultrasound. It originates from translational research in focused ultrasound–mediated BBB opening and CNS drug delivery.
Our current platform portfolio includes two focused ultrasound systems:
- A clinical-stage, noninvasive focused ultrasound system developed specifically for safe and targeted BBB opening in human patients
- A preclinical, research-use-only focused ultrasound system designed for translational research and used by research institutes to evaluate BBB opening and drug delivery approaches
Tell us about your clinical studies and the results.
We are actively conducting clinical studies in two priority indications:
- Alzheimer’s disease: A clinical study evaluating the safety and feasibility of focused ultrasound–mediated BBB opening as a standalone intervention. Initial patients have been treated, and preliminary data support the safety and technical feasibility of the approach, with ongoing evaluation of clinical outcomes.
- Recurrent glioblastoma (rGBM): A clinical study evaluating the Neumous focused ultrasound–mediated BBB opening device in combination with anticancer therapy.
What are the benefits of your technology over companies?
We differentiate our focused ultrasound device through clinically meaningful innovations that enhance safety, accessibility, and treatment reproducibility:
- MRI-Free Procedure: The system uses neuronavigation-guided targeting, which eliminates dependence on real-time MRI guidance and helps improve procedural accessibility and cost-efficiency in clinical settings.
- Real-Time Cavitation Monitoring: A proprietary cavitation monitoring technology provides real-time feedback during sonication, supporting safety control and effective BBB opening.
- Automated Power Modulation: The system dynamically adjusts ultrasound exposure during treatment to support consistent and reproducible BBB opening while maintaining an optimal safety profile.
- Noninvasive and Repeatable: The device enables noninvasive, repeatable BBB opening across multiple treatment sessions without surgical intervention, supporting longitudinal treatment strategies.
- Broad Therapeutic Applicability: The system is designed to enable targeted delivery of a wide range of therapeutics across the BBB, including small molecules, large molecules, and antibodies.
- Multiple Disease Applications: With potential applications across various indications, including neurodegenerative disease and brain cancers, our platform may also be extended to brain metastases, where drug delivery remains significantly limited by the BBB.
Is there anything else we should know about your company?
Neumous has received two important regulatory recognitions that underscore its clinical significance and innovation:
- Innovative Medical Device Designation (Korea): Neumous’ focused ultrasound–mediated BBB opening device has been designated as an Innovative Medical Device by the Korean Ministry of Food and Drug Safety (or “MFDS”). This designation, analogous in intent to the US Food and Drug Administration’s (FDA) Breakthrough Device Designation, recognizes the system’s potential to address significant unmet medical needs and supports an expedited regulatory review pathway.
- US FDA Orphan Drug Designation (ODD): Neumous has received the FDA’s ODD for a drug-device combination approach involving focused ultrasound–mediated BBB opening and doxorubicin for malignant glioma. This designation highlights the potential of the Neumous device as an enabling technology for improving drug delivery in rare and serious brain diseases.
Together, these recognitions reflect the scientific foundation and clinical promise of Neumous’ focused ultrasound platform, validating its potential role in the treatment of brain diseases.
Where can readers learn more?
More information is available at www.neumous.com.