Press Release – TargTex Partners with EdgeOne Medical for Drug-Device Combination Assessment
TargTex Partners with EdgeOne Medical to Advance Independent Technical and Regulatory Assessment of Its Novel Drug–Device Delivery System for Brain Cancers
TargTex, a biotechnology company developing first-in-class therapies targeting the TRPV2 channel in oncology and cardiovascular diseases, today announced a strategic collaboration with EdgeOne Medical to provide an independent technical and regulatory assessment of its innovative drug–device combination delivery system for brain cancers.
Under this agreement, EdgeOne Medical will provide comprehensive regulatory and technical expertise to evaluate and optimize TargTex’s dual-syringe hydrogel delivery platform. This comprehensive assessment is designed to ensure alignment with FDA combination product requirements and global pharmaceutical best practices, while accelerating clinical readiness and future commercialization.
TargTex’s lead program introduces a differentiated approach to Glioblastoma (GBM) treatment, enabling localized delivery of a therapeutic hydrogel directly into the brain cavity during tumor resection surgery. This strategy is designed to maximize drug exposure at the tumor site while minimizing systemic toxicity—addressing one of the most critical challenges in neuro-oncology.
Dr. João Seixas, CEO of TargTex, commented:
“This collaboration with EdgeOne Medical represents a key step in advancing the development of our drug–device combination platform. Their deep expertise in regulatory strategy and device engineering strengthens our ability to implement a robust, scalable, and clinically practical solution. Importantly, it ensures that our delivery system meets the highest standards expected for seamless integration into surgical workflows and future commercialization.”
EdgeOne Medical brings extensive experience in supporting pharmaceutical and biotechnology companies in the development, independent assessment, and regulatory positioning of complex medical device systems.
Mr. Jim McGough, Co-founder of EdgeOne Medical, added:
“TargTex is tackling one of the most challenging cancers with a highly innovative approach that integrates drug and device into a single therapeutic solution. We are excited to support the evaluation and optimization of their delivery system, ensuring it aligns with regulatory expectations while maintaining practical usability in the clinical setting. Our goal is to help de-risk development and enable a clear path toward regulatory clearance and adoption in real-world practice.”
Through this partnership, TargTex aims to establish an independently assessed, regulatory aligned delivery system that not only supports clinical development but also ensures readiness for broad adoption across neurosurgical centers worldwide.
About TargTex
TargTex is a biotechnology company focused on the development of innovative therapies targeting the TRPV2 calcium channel in oncology and cardiovascular diseases. Its lead program is a localized treatment for glioblastoma, designed for administration during surgical tumor resection, combining a novel therapeutic agent with a proprietary hydrogel-based delivery system.
About Edge One Medical
EdgeOne Medical stands as the only true Independent and Integrated Device Partner for Combination Products. Its cross-functional device team, complemented by in-house, FDA-inspected device testing labs operated by experienced device engineers, enables clients to deliver safe, effective, and patient-centric solutions.
