TAP (Total Product Life Cycle Advisory Program) provides early and frequent strategic engagement from the FDA, patients, providers and payers. It facilitates rapid development and widespread access to medical devices. Acceptance into the program comes just weeks after the company won FDA breakthrough device designation for Brain Interchange.
Freiburg, Germany-based CorTec designed Brain Interchange to deliver fully implantable, closed-loop BCI to clinicians to investigate therapies. The company believes the closed-loop functionality enables new possibilities for individualized treatments.
Brain Interchange continuously records brain activity, instantly interprets signals and delivers targeted electrical stimulation in real time. It enhances neuroplasticity — the brain’s ability to reorganize neural networks. The implant delivers neuroplasticity-inducing stimulation during rehabilitation. This can help regain control of the upper limbs enabling more independence and quality of life for patients. The company believes its BCI could potentially accelerate and improve patient rehabilitation through the integration of engineering, neurophysiology, and machine learning.
CorTec currently has its BCI under evaluation in a clinical trial, announcing its second implantation in February. It won FDA investigational device exemption (IDE) to conduct the trial for its closed-loop BCI platform in May 2024.
According to the company, along with the latest FDA milestone, a third patient successfully received the Brain Interchange implant as part of its ongoing trial, with the implantation taking place at Harborview Medical Center in Seattle.
The company currently has Brain Interchange under evaluation for epilepsy. It intends to explore indications like paralysis and depression, with development ongoing for those areas.
Dr. Frank Desiere, CEO of CorTec, said:
“TAP acceptance places CorTec at the forefront of a field dominated by U.S. players and confirms that European deep-tech innovation can compete at the highest level of global medtech development. Beyond the competitive significance, TAP as well as the recently received Breakthrough Device Designation highlight a strong regulatory momentum and mark the beginning of a structured path toward making Brain Interchange™ accessible to stroke patients worldwide. With closer FDA engagement and early interaction with payers, we can now build the clinical evidence and reimbursement framework for this entirely new therapy class.”
