Single use device for neurophysiological monitoring receives CE mark

WISE Srl, a medical device company developing next-generation implantable electrodes for neuromonitoring, neuromodulation and brain-machine interfacing (BMI), has announced the CE marking of its WISE Cortical Strip (WCS), a single use medical device intended to be used on the surface of the brain for intraoperative neurophysiological monitoring (IONM).

The WISE Cortical Strip is the first product receiving CE mark within the company’s WISEneuro Monitoring product family. The CE mark follows the successful conclusion of the WIN study, a multi-centre pre-market clinical study that demonstrated safety, performance and usability of WISE’s device. The data showed better performance in terms of electrical impedance in physiological conditions of the WISE Cortical Strip compared to other traditional cortical electrodes.

The WISE Cortical Strip can be used both to stimulate (MEP) and record (ECoG and SEP) the brain’s electrical activity, supporting intraoperative monitoring during resection of brain tumours or epileptogenic lesions. Unlike traditional cortical electrodes, which are made of stiff metal discs enclosed in a thick silicone foil, the WISE Cortical Strip is composed of stretchable platinum contacts embedded in a soft and thin film of silicone. As a result, the WISE Cortical Strip is highly ergonomic and conformable to the brain surface.

Leveraging the capabilities of WISE’s patented Supersonic Technology, the WISEneuro Monitoring product family will comprise strips and grids with varying thickness, and with embedded contacts of a wide range of shapes, density, numbers or sizes (from the micro to the macro scale).

During intraoperative neuromonitoring, the functional integrity of neural circuits is monitored to minimise neurological damages during surgical lesions resection, thus avoiding or limiting significant post-operative impairments. However, since the brain surface is folded into ridges and grooves, only highly conformable electrodes can fully adhere to the entire brain surface and monitor its functional integrity.

After the successful CE approval, the company is now aiming for FDA clearance of the device.

Luca Ravagnan, CEO of WISE said: “The CE mark is a crucial milestone for the company, enabling us to bring the first IONM electrode with extreme compliance to the brain cortex to the European market. With this, we are also officially launching our WISEneuro Monitoring product family. Our mission is to revolutionise electrode manufacturing utilising our unique technology, all this to improve treatment quality for patients.”

Sandro Ferrari, director of operations added: “It has been an exciting journey moving from a lab-scale and radically new technology to a CE marked class III medical device. This approval validates the application of our technology to invasive neuro-electrodes, underpinning our current development of chronic implants for neuromodulation and BMI.”

WISE’s Supersonic Technology allows the development of thin, pliable and conformable electrodes allowing an effective stimulation and recording for a range of applications. In addition to neuromonitoring, WISE is also active in the field of neuromodulation, developing its WISEneuro Modulation product family. The first product of this line will be the SCS Expert lead, the first expandable percutaneous paddle lead for Spinal Cord Stimulation that pain therapists and neurosurgeons will be able to implant percutaneously.

WISE recently closed a financial round of €15 million, led by major European VC funds. The company also received an EIC Accelerator grant from the European Commission worth €2.3 million.