MILAN & BERLIN--(BUSINESS WIRE)--WISE Srl, a medical device company developing next-generation implantable electrodes for neuromonitoring, neuromodulation and brain-machine interfacing (BMI), today 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 multicentric pre-market clinical study that demonstrated safety, performance and usability of WISE’s device (NCT03731455). The data showed better performance in terms of electrical impedance in physiological conditions of the WISE Cortical Strip compared to other traditional cortical electrodes available on the market.
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 tumors 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 minimize 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 revolutionize electrode manufacturing utilizing 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 unique Supersonic Technology allows the development of extremely thin, pliable and conformable electrodes allowing a very effective stimulation and recording for a wide 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 €15M, led by major European VC funds. The Company also received an EIC Accelerator grant from the European Commission worth €2.3M. For more information, please visit: www.wiseneuro.com
WISE Srl has developed a genuinely new generation of electrodes for neuromonitoring, neuromodulation and brain machine interfacing by means of its proprietary Supersonic Technology.
Neuromonitoring and neuromodulation require electrodes and leads to be surgically implanted on neural tissues (as for instance the brain and the spinal cord) to apply electrical stimuli or to record the electrical activity. The electrodes produced using WISE’s Supersonic Technology consist of stretchable electronic circuits integrated in very thin elastomeric foils. As a result, WISE’s electrodes are highly ergonomic, conformable, soft and thin, thus allowing great adhesion, minimal invasiveness and excellent adaptability on neural tissues.
Founded by a team of material scientists coming from the University of Milan, WISE received initial funding from Agite!, Atlante Seed and Atlante Ventures, b-to-v, HTGF, Principia SGR, New Frontier and private investors, and closed a Series C funding round in 2020 with new investors (CDP Venture Capital SGR, Indaco Ventures I Fund and EUREKA! Venture SGR). Since 2016, the Company established its production plant in Cologno Monzese, Milan, Italy, and has an office in Berlin, Germany.
For more information, please visit: www.wiseneuro.com.