Milan and Melbourne, 7 December 2023.

WISE S.r.l..rl, a pioneering medical device company specializing in advanced implantable electrodes for neuromonitoring, neuromodulation, and brain-machine interfacing (BMI), proudly announces the signing of an exclusive agreement with Neuroclast Pty Ltd for the distribution of the WISE Cortical Strip (WCS®) in the Australian market.

Neuroclast, a novel & industry-leading distributor of cutting-edge clinical neuroscience technologies, is set to distribute the WISE Cortical Strip, a groundbreaking single-use medical device designed for Intraoperative Neurophysiological Monitoring (IONM).

CE marked, FDA cleared, and TGA approved (ARTG #413731) for the Australian market, the WISE Cortical Strip marks the debut of the WISEneuro® Monitoring family in the Asia Pacific region. This innovative product utilizes stretchable platinum contacts embedded in a soft and thin silicone film, making it highly ergonomic and conformable to the brain surface. Unlike traditional cortical electrodes with stiff metal discs, the WISE Cortical Strip’s design ensures unique softness, thinness, conformability, and stability on the brain surface, revolutionizing intraoperative neurophysiological monitoring technology.

Commenting on the partnership, Luca Ravagnan, CEO of WISE, expressed his enthusiasm, stating, “We are thrilled to have reached this agreement with Neuroclast. Combining the unique characteristics of our product with Neuroclast’s vision, leadership, and unique clinical expertise in the Australian clinical electrophysiology market sets the stage for bringing our product’s clinical benefits to an even larger number of patients.”

Ryan Hamer, Founder and Managing Director of Neuroclast, added, “This partnership perfectly aligns with our strategic vision related to the continued clinical and academic exploration of onco-functional insight in neurosurgery. We are optimistic that neurosurgeons and electrophysiology teams will experience a radical improvement in signal quality and stability thanks to the pioneering manufacturing capabilities from WISE, who have developed a hyper-thin electrode with unparalleled pliability that safely moulds to the gyri of the brain. We look forward to developing clinical and academic opportunities with this highly novel product in conjunction with WISE and neurosurgical teams throughout Australia.”

With this exclusive distribution agreement, WISE and Neuroclast Pty Ltd are poised to make the WISE Cortical Strip available to clinical centers throughout Australia, contributing to elevate the standard of care for patients by the use of state-of-the-art brain monitoring technology in Asian continent.

For media inquiries or further information, please contact:
WISE Srl
Dr. Luca Ravagnan, CEO
T: +39 3337657189
E: [email protected]

For Australian clinical inquries, please contact
Neuroclast
Ryan Hamer
Managing Director
[email protected]

WISE will exhibit at the Medica 2023 fair in Düsseldorf, Germany on 13-16 November 2023. Visit our booth in Hall 15 H32-7.

We’re delighted to announce that WISE S.r.l. and Soinde Neuro S.L. are joining forces to introduce the cutting-edge WISE Cortical Strip (WCS®️) for Intraoperative Neurophysiological Monitoring (IONM) to the Spanish market.
CE marked and FDA cleared, the WISE Cortical Strip marks the debut of the WISEneuro®️ Monitoring product family. This innovative product utilizes stretchable platinum contacts embedded in a soft and thin silicone film, making it highly ergonomic and conformable to the brain surface. Unlike traditional cortical electrodes with stiff metal discs, the WISE Cortical Strip’s design ensures unique softness, thinness, conformability, and stability on the brain surface, revolutionizing brain monitoring technology.
The efficacy of the WISE Cortical Strip has been validated through a successful multicentric pre-market clinical study in Europe, known as the WIN study (NCT03731455). The study demonstrated the product’s safety, superior performance in terms of electrical impedance under physiological conditions, and exceptional usability. These results have been published in the journal Clinical Neurophysiology (https://lnkd.in/dsAeEJUB).
With this exclusive distribution agreement, WISE and SOINDE NEURO are poised to make the WISE Cortical Strip available to clinical centers throughout Spain, contributing to elevate the standard of care for patients by the use of state-of-the-art brain monitoring technology.

Milan, 6 September 2023. WISE Srl, a pioneering medical device company specializing in advanced implantable electrodes for neuromonitoring, neuromodulation, and brain-machine interfacing (BMI), proudly announces the signing of an exclusive agreement with EB Neuro SpA for the distribution of the WISE Cortical Strip (WCS®) in the Italian market.

EB Neuro, a leading Italian provider of cutting-edge neurophysiological and neurodiagnostic solutions, is set to distribute the WISE Cortical Strip, a groundbreaking single-use medical device designed for Intraoperative Neurophysiological Monitoring (IONM).

CE marked and FDA cleared, the WISE Cortical Strip marks the debut of the WISEneuro® Monitoring product family. This innovative product utilizes stretchable platinum contacts embedded in a soft and thin silicone film, making it highly ergonomic and conformable to the brain surface. Unlike traditional cortical electrodes with stiff metal discs, the WISE Cortical Strip’s design ensures unique softness, thinness, conformability, and stability on the brain surface, revolutionizing brain monitoring technology.

The efficacy of the WISE Cortical Strip has been validated through a successful multicentric pre-market clinical study in Europe, known as the WIN study (NCT03731455). The study demonstrated the product’s safety, superior performance in terms of electrical impedance under physiological conditions, and exceptional usability. These results have been published in the journal Clinical Neurophysiology (https://doi.org/10.1016/j.clinph.2022.07.497).

Commenting on the partnership, Luca Ravagnan, CEO of WISE, expressed his enthusiasm, stating, “We are thrilled to have reached this agreement with EB Neuro. Combining the unique characteristics of our product with EB Neuro’s leadership in the Italian neuromonitoring market sets the stage for bringing our product’s clinical benefits to an even larger number of patients.”

Marco Rossi, CEO of EB Neuro, added, “This collaboration represents a significant step forward for Italian market of advanced neurophysiology solutions.  WISE’s innovative technology aligns perfectly with our mission to provide top-notch neurodiagnostic products and services. Together, we will equip physicians with an additional and innovative device for stronger patient care and outcomes.”

With this exclusive distribution agreement, WISE and EB Neuro are poised to make the WISE Cortical Strip available to clinical centers throughout Italy, contributing to elevate the standard of care for patients by the use of state-of-the-art brain monitoring technology.

For media inquiries or further information, please contact:

WISE Srl

Dr. Luca Ravagnan, CEO

T: +39 3337657189

E: [email protected]

Milan, 31 August 2023. – Leading the change in neuromonitoring, WISE Srl has reached another significant milestone in its journey. The company is elated to announce that its groundbreaking WISE Cortical Strip has received approval for commercialization in Australia. This approval marks the WISE Cortical Strip’s association with ARTG #413731, further expanding its global footprint.

Widely recognized for its revolutionary Supersonic Technology enabling highly ergonomic and conformable medical electrodes, WISE continues its mission of transforming the landscape of intraoperative and implantable electrodes for neuromonitoring, neuromodulation, and brain-machine interfacing (BMI). The WISE Cortical Strip, a part of the WISEneuro® Monitoring product family, stands out as an innovative single-use medical device designed explicitly for Intraoperative Neurophysiological Monitoring (IONM).

With a unique design, the WISE Cortical Strip employs stretchable platinum contacts enveloped in a soft, thin silicone film. This pioneering approach ensures ergonomic and seamlessly conform to the brain surface. Standing in stark contrast to conventional cortical electrodes that use rigid metal discs, the WISE Cortical Strip promotes unique softness, thinness,and stability on the brain’s surface, heralding a new era in brain monitoring technology.

The WISE Cortical Strip’s innovation is not just in its design; the efficacy of the WISE Cortical Strip has been validated through a successful multicentric pre-market clinical study in Europe (NCT03731455). This rigorous study demonstrated the product’s safety, superior performance in terms of electrical impedance under physiological conditions, and exceptional usability. These results have been published in the journal Clinical Neurophysiology (https://doi.org/10.1016/j.clinph.2022.07.497).

Luca Ravagnan, CEO of WISE, commented on this achievement, “This approval in Australia is a further demonstration of our commitment to elevating patient care worldwide. By making our products available in new markets, we’re ensuring that more healthcare professionals have the tools they need to offer superior patient care.”

Australia’s commercialization approval paves the way for WISE to introduce its state-of-the-art brain monitoring technology to a broader audience, reaffirming its position as a trailblazer in the medical device sector.

For more information, please visit: www.wiseneuro.com

For media inquiries or additional information regarding this announcement, please contact:

WISE Srl

Dr. Luca Ravagnan, CEO

T: +39 3337657189

E: [email protected]

WISE is sponsoring and will exhibit at the ASNM 2023 Annual Meeting, the Annual Congress of the American Society of Neurophysiological Monitoring (ASNM). ASNM2023 will take place on 19-21 May 2023 at the Adolphus Hotel in Dallas (TX, USA).
Visit us at the Exibition.

Mr. Rodrigo Bianchi was appointed on 28/04/2023 as the new Chairman of the Board of Directors of WISE S.r.l. within the renewal of the Company’s governance.

Rodrigo Bianchi is a Senior Global Executive with more than 30 years’ experience of the Medical Devices industry, including 26 years with Johnson & Johnson where he had the roles of President Worldwide DePuy Mitek and President Worldwide Ethicon.

Rodrigo Bianchi succeeds to Mr. Mario Zanone Poma, who cofounded WISE and chaired the Board for over 10 years. The company pledges a strong thanks to Mario Zanone Poma who supported the growth of the management team and contributed to the development of the company from basic research to product approval and market access.

Rodrigo Bianchi’s extensive expertise in the medtech sector will support WISE in scaling the sales of the company’s IONM portfolio (as for instance the FDA cleared and CE marked WISE Cortical Strip) and to boost the pathway to market of the Heron lead – the FIRST Directional Percutaneous multicolumn SCS lead made to conform to the dura mater.

• WISE Cortical Strip is the first cortical strip embedding the electrodes in a highly compliant thin film of silicone to receive FDA clearance
• The thin and pliable WISE Cortical Strip provides unprecedented conformability to the brain surface for neuromonitoring during brain surgeries
• WISE’s proprietary Supersonic Technology allows the manufacture of extremely thin, stretchable and conformable electrodes, capable of highly effective stimulation and recording

MILAN, Italy, 1 December 2022 – WISE Srl, a medical device company developing next-generation implantable electrodes for neuromonitoring, neuromodulation and brain-machine interfacing (BMI), today announced the FDA clearance (K221123) of its WISE Cortical Strip (WCS®), a single use medical device intended to be used on the brain surface for Intra Operative Neurophysiological Monitoring (IONM).

The WISE Cortical Strip is the first product receiving FDA clearance within the Company’s WISEneuro® Monitoring product family. The FDA clearance follows the CE mark already received by the product in May 2021.

The WISE Cortical Strip is intended for intraoperative use with recording, monitoring and stimulation equipment for the recording, monitoring, and stimulation of electrical signals on the brain surface. 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.

WISE is sponsoring and will exhibit at the EANS2022 Belgrade, the Annual Congress of the European Association of Neurosurgical Societies (EANS). EANS2022 will take place on 16-20 October 2022 in Belgrade (Serbia).
Visit us at the Exibition.

The results of the WIN clinical study have been published on the peer-reviewed journal Clinical Neurophysiology.

Full reference:
Johannes Sarnthein, Kathleen Seidel, Marian Christoph Neidert, Andreas Raabe, Francesco Sala, Joerg Christian Tonn, Niklas Thond, Andrea Szelenyi, Evaluation of a new cortical strip electrode for intraoperative somatosensory monitoring during perirolandic brain surgery, Clinical Neurophysiology, 142 (2022) 44–51