NeuroOne Medical Technologies Corporation (Nasdaq: NMTC), a medical technology company specializing in surgical diagnosis and treatment of neurological disorders, announced today that it has received ISO 13485-2016 certification. This international standard for Quality Management Systems in the medical device industry emphasizes risk management, design controls, and continuous improvement, demonstrating the company's robust quality system and strong compliance capabilities.
The certification covers the design, development, manufacture, and distribution of electrosurgical generators, electrosurgical lesioning instruments, diagnostic neurophysiological instruments, anchor bolts, and cable assemblies used for recording, monitoring, stimulation, and radiofrequency lesioning of nervous system tissue. This achievement allows NeuroOne to pursue international marketing opportunities for its Evo® Cortical and Evo® sEEG Electrodes, as well as the OneRF® Brain Ablation System. Some geographies may have additional requirements before commercialization, but the certification is a key step toward global expansion.
Dave Rosa, President and CEO of NeuroOne, expressed excitement about the milestone, stating, "We are excited to have received ISO 13485 certification as it opens the door for international revenue growth. While we have other technologies to help accelerate growth, this provides us nearer term revenue potential." The company will work with its distribution partner, Zimmer Biomet, to formulate a plan for entering markets with short-term paths to entry, and will also explore independent distributor partnerships for geographies held solely by NeuroOne.
The certification is significant for NeuroOne's growth strategy, providing a foundation for international commercialization and a new revenue stream. It also reinforces the company's commitment to quality and safety, which is critical in the medical device industry. For patients and healthcare providers, this could mean broader access to innovative technologies that offer diagnostic and therapeutic functions, potentially reducing hospitalizations and surgical procedures, lowering costs, and improving patient outcomes.
NeuroOne markets a minimally invasive, high-definition 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. The company is also engaged in research and development for drug delivery, basivertebral nerve ablation, and spinal cord stimulation programs.
The ISO 13485 certification underscores NeuroOne's ability to ensure safe product design, quality traceability in manufacturing, and regulatory compliance. This achievement may enhance the company's reputation and competitiveness in the global market, potentially leading to increased adoption of its technologies. As NeuroOne continues to innovate and expand internationally, it aims to improve surgical care options and outcomes for patients suffering from neurological disorders worldwide.
