NeuroOne Medical Technologies Corporation (Nasdaq: NMTC) announced today the release of a new white paper titled "StereoCED™ - A Scalable Platform for CNS Drug Delivery," which outlines how the company's upcoming drug delivery platform is designed to address key barriers to the commercial scalability of brain therapeutics. The white paper is available for download from the Scientific Resources section of nmtc1.com.
The white paper highlights that advances in cell and gene therapies, biologics, and other central nervous system (CNS) therapeutics are driving demand for efficient, reproducible methods of delivering therapies directly to the brain. While convection-enhanced delivery (CED) has shown promise in bypassing the blood-brain barrier and achieving targeted drug distribution, current approaches may present challenges as these therapies move toward broader commercial use. NeuroOne’s StereoCED™ platform is being designed to tackle these challenges by leveraging robotic stereotactic systems already established in neurosurgical operating rooms.
Instead of requiring specialized workflows and lengthy sequential infusions, the StereoCED™ platform is designed to support simultaneous, multi-trajectory intracranial drug delivery through a streamlined robotic workflow. This approach has the potential to significantly reduce procedure time while enabling reproducible, scalable therapeutic delivery. It is important to note that the StereoCED™ drug delivery platform is currently under development and has not been cleared or approved by the U.S. Food and Drug Administration for commercialization.
Dave Rosa, President and Chief Executive Officer of NeuroOne, commented on the announcement, stating, "Brain-delivered therapeutics are approaching an important inflection point. As these therapies move toward commercialization, certain intracranial infusion procedures lasting 8 to 12 hours may become a significant bottleneck to commercial adoption. We believe healthcare systems will need solutions that leverage established neurosurgical workflows, significantly reduce procedure time, and support scalable delivery across hospitals. StereoCED™ is being designed with those needs in mind, and we look forward to device availability for research and investigational clinical studies by fiscal year-end."
The implications of this announcement are significant for the field of CNS drug delivery. Current infusion procedures can take up to 12 hours, which could limit the adoption of new brain therapies as they move from clinical trials to widespread use. By potentially reducing procedure time and utilizing existing robotic systems, StereoCED™ could help hospitals integrate advanced brain therapeutics more efficiently, lowering costs and improving patient access. The platform's design for simultaneous multi-trajectory delivery may also enhance drug distribution precision, which is critical for treating complex neurological disorders.
NeuroOne is a medical technology company focused on improving surgical care for neurological disorders. The company markets a minimally invasive electrode technology platform with four FDA-cleared product families: Evo® Cortical Electrodes, Evo® sEEG Electrodes, OneRF® Ablation System (for brain), and OneRF® Trigeminal Nerve Ablation System. These solutions aim to reduce hospitalizations and surgical procedures while improving patient outcomes. Beyond drug delivery, NeuroOne is also engaged in research and development for basivertebral nerve ablation and spinal cord stimulation programs.
Device availability for research and investigational clinical studies is expected by the end of NeuroOne's fiscal year, marking a potential milestone for the platform's development. As the company moves forward, its success will depend on regulatory approvals and the ability to demonstrate that StereoCED™ can meet the scalability needs of the emerging CNS therapeutics market.
