London, UK, and CALIFORNIA, USA, 14 JULY 2026: Focalis Bio, a biotechnology company developing cutting-edge gene therapies to treat refractory epilepsy, and ClearPoint Neuro (“ClearPoint”), a global therapy-enabling company offering precise navigation and delivery to the brain, today announced a partnership to support the targeted delivery of Focalis Bio's lead gene therapy candidate, EPY201, for focal refractory epilepsy (FRE).
Under the agreement, Focalis Bio will use the ClearPoint SmartFlow Cannula and the ClearPoint Neuro Navigation system to administer EPY201 in its upcoming first-in-human Phase 1/2a clinical trial for FRE. ClearPoint’s MRI-guided stereotactic navigation and delivery platform is designed to support sub-millimetric accuracy for delivery to defined targets in the brain, enabling intraprocedural visualisation of delivery to the intended seizure focus. The ClearPoint Navigation System is installed in over 100 active clinical sites globally for the delivery of gene and cell therapies to the central nervous system within the scope of preclinical studies, approved clinical trials, and commercial procedures.
Focal epilepsy describes a group of disorders in which seizures arise from a specific part of the brain. When seizures persist following trials of at least two tolerated and appropriately chosen antiseizure medications, epilepsy is deemed refractory, or pharmacoresistant. FRE affects approximately 10 million patients worldwide1, including two million patients in the US, UK, and EU. EPY201 is designed to be delivered directly into the seizure focus, with the aim of reducing neuronal hyperexcitability locally while limiting exposure beyond the target region in the brain. If successful, this approach will offer patients a single, minimally invasive option that does not require resection or ablation of brain tissue
Nicolas Koebel, Chief Executive Officer of Focalis Bio, commented: “Accurate delivery to the seizure focus is central to the potential of EPY201 in FRE. ClearPoint’s guided navigation system provides the precision and intraprocedural visualisation we need as we prepare to evaluate EPY201 in first-in-human trials. We look forward to working with ClearPoint to support safe, targeted administration of EPY201 for people living with focal refractory epilepsy.”
Jeremy Stigall, Chief Business Officer & General Manager of Biologics and Drug Delivery at ClearPoint Neuro, stated: “Focalis Bio is developing a targeted gene therapy approach for focal refractory epilepsy, a devastating condition affecting millions of patients. We are pleased to partner with them as the team advances this important programme into clinical evaluation.”
1. Vaughan et al (2019): https://thejns.org/doi/abs/10.3171/2018.3.JNS171722.
