Neurosoft Bioelectronics closer to clinical studies

Neurosoft Bioelectronics is a neurotechnology spin-off from EPFL developing soft implantable electrodes to record from or electrically stimulate the surface of the brain. These devices can be used to monitor or treat severe neurological disorders. The company’s current focus are two brain implants: 1) invasive monitoring of patients who suffer from drug-resistant epilepsy, in order to identify the location of their seizures, and 2) a closed-loop neuromodulation system for treating severe tinnitus.

The first milestone of the EPFL spin-off which was incorporated in 2020 was to transfer all the materials used in the devices from "research grade" to "medical grade" materials, and to put in place a medical-grade production line. “Having in-house manufacturing is very unique for a start-up company, but due to the unconventional processes we use, we had to do it ourselves”, explains Neurosoft CEO Nicolas Vachicouras.

The production line with Good Manufacturing Practices in an ISO 6 and ISO 7 cleanroom environment at the Campus Biotech, has been set up with the help of the Neural Microsystems Platform (NMP). Since 2021, the cleanroom has repeatedly met and exceeded environmental bioburden requirements for the manufacturing of invasive neural interfaces.

In addition, Neurosoft has now obtained ISO 13485:2016 Certification by TÜV SÜD for its Quality Management System. The ISO 13485:2016 is the latest version of an internationally recognized quality standard that specifies requirements for a quality management system: the company needs to demonstrate its ability to provide medical devices and related services that meet customer and regulatory requirements. Michaël Stoeckel, the head of the NMP, commented “This certification proves that R&D processes and medical device development can evolve inside the same environment. Another huge milestone reached with the certification for the Neurosoft team.”

The materials used in the implantable electrodes, that are stretchable, makes Neurosoft unique. The devices are overall 1'000x softer and 2x thinner than current electrodes on the market. This allows the implant to seamlessly interface with the brain, promoting long-term bio-integration of the devices in the body, reducing surgical and implantation risks and overall allow to perform more minimally invasive procedures. “Moreover, we are capable of making electrode sites that are up to 50x smaller than current devices on the market, which allows us to improve recording and stimulation precision”, says Nicolas Vachicouras.

The company has already demonstrated the use of its devices in multiple animal models, including rats, pigs and monkeys, to show that they are capable of both recording from the brain, and stimulating the spinal cord and brain. The longest implantation duration which has been tested for was 6 months.

The first in human clinical study will start in the next few months. Neurosoft is currently raising more funds (CHF 12M) to push the development of the products and to expand the team.

(Press release / ES / SK)