Soft brainstem implant delivers high-resolution hearing LSBI researchers have developed a flexible auditory brainstem implant (ABI) that closely conforms to the curved surface of the brainstem. The technology has been successfully demonstrated as a high-resolution “prosthetic hearing” in macaques. Learn More

Neurosoft Bio awarded 2.5 MCHF Swiss Accelerator Grant

Neurosoft Bioelectronics was selected as one of 53 projects (out of 752 applications) and will receive funding to continue development of innovative minimally-invasive Brain Computer Interfaces.

Innosuisse launched a call for projects for the Swiss Accelerator in 2022 as a transitional measure for Horizon Europe. Following a three-stage assessment process, Innosuisse has now approved 53 innovation projects by SMEs and start-ups with significant innovation potential.

Three independent experts evaluated each of the 752 short applications and the 128 full applications. Of these, 64 selected companies gave an application presentation in the third round before the Innovation Council made a final decision. The total funding granted amounts to CHF 112 million.

The 53 approved innovation projects within the framework of the Swiss Accelerator are divided thematically as follows:

  • 20 in Life Sciences, 8 in Engineering, the rest being spread across Energy & environment, ICT and Social sciences and business management
  • One third are from the French speaking part of Switzerland (other two thirds from the German speaking part)

Congratulations for this new milestone on the path to making the Neurosoft Bioelectronics technology to patients!

New real-time guidable-tip wire for surgically treating strokes

Our brains contain an intricate network of arteries that carry blood throughout the organ along winding paths. For neurosurgeons, following these paths with a wire – which is just a third of a millimeter in diameter and enters the body through the femoral artery – to reach an obstructed blood vessel can be tricky. For instance, if they want to point the wire in a different direction, they often have to pull the instrument out and then reinsert it, lengthening surgery times and increasing the risk of complications. But the new wire developed by Artiria is set to change all that. Its tip can be controlled by pressing a button on its handle, through an apparatus that runs entirely on mechanical forces. Artiria just received FDA clearance to test and market its system in the US.

The figures on strokes are startling. According to the World Health Organization, strokes are the leading cause of disability and the second-leading cause of death worldwide. One-fourth of people over 25 can expect to experience one during their lifetime. And when a stroke occurs, time is of the essence – rapid treatment can improve a patient’s prognosis considerably. “While strokes can be caused by a ruptured aneurysm, 80% of the time they’re due to a blood clot in the brain,” says Guillaume Petit-Pierre, Artiria co-founder and CEO. In combination with drug treatments to dissolve the clot, the surgical act, facilitated by the real-time visualization of the instruments by x-rays, makes it possible to extract the clot mechanically. The wire serves as a guide so that the other instruments needed for the operation can be inserted. Before creating their company, Petit-Pierre and Marc Boers – the other Artiria co-founder – spoke with several neurosurgeons and watched them operate several times in order to gain a thorough understanding of the techniques they use. The founders’ goal was to develop a device that would fit in seamlessly with existing procedures. “We were able to get the FDA clearance so quickly because our wire is similar to existing ones in so many respects,” says Petit-Pierre.

These micro-cuts, just a few tens of microns in size, are made from a superplastic alloy, ensuring the necessary flexibility of the wire tip while avoiding injury to the arterioles of the brain.

Guillaume Petit-Pierre

Useful for other types of post-stroke surgeries, too

Petit-Pierre and Boers tested their system on 3D-printed, clear-silicone models of cerebral arteries, and found that it didn’t create any major differences for neurosurgeons. It simply has an extra button on the handle that neurosurgeons can press when they want the tip to bend. A tiny pull wire relays the (slight) mechanical force created from pressing the button all along the structure of the instrument all the way to its 2-centimeter-long deflectable tip. The tip is reinforced on the side connected to the pull wire, and the other side is designed to follow the movement easily. The system may appear simple to the human eye, but fabricating its microscopic-scale parts was a considerable feat of engineering. "These micro-cuts, just a few tens of microns in size, are made from a superplastic alloy, ensuring the necessary flexibility of the wire tip while avoiding injury to the arterioles of the brain. The technological feat also consists in integrating a radio-opaque element into an extremely small volume, enabling the tip of the tool to be visualized during x-ray navigation", explains Guillaume Petit-Pierre. In order to guarantee flawless product cleanliness, the first versions of this system were assembled in EPFL's clean room.

Marc Boers and Guillaume Petit-Pierre © 2023 EPFL

The two founders are also exploring other applications for the underlying technology, which came out of EPFL’s Microsystems Laboratory 4 (LMIS4). “For example, we worked with the Wyss Center in Geneva to see if our wire could be used to lower spasms observed during hemorrhaging storkes,” says Petit-Pierre. Here, the wire could be used to target a specific artery using flexible thin-film electrodes. “There’s currently no effective way to treat cerebral vasospasms, even though they’re known to be a leading cause of disability and death after aneurysm-triggered strokes.”

Petit-Pierre and Boers are old friends and decided to create a startup around ten years ago, while on a backcountry skiing trip. At the time, Petit-Pierre worked in the medtech industry and Boers was already involved in other startups. Petit-Pierre did his PhD at LMIS4 – headed by Philippe Renaud, who was recently named professor emeritus – and the atmosphere there convinced him to try his hand at entrepreneurship. Some 25 businesses have spun off from Prof. Renaud’s lab, so there were plenty of role models to learn from. The core elements of Artiria’s system came from Petit-Pierre’s PhD thesis at LMIS4. With Boers he filed a patent application and created the company in 2019.

Artiria was awarded 2.7 million francs in funding under the European Innovation Council Accelerator Program – although the financing actually came from the Swiss government (SEFRI) since Switzerland no longer has a framework agreement with the EU – and has raised 4.1 million francs from investors. The medtech firm is ranked among Switzerland’s top 100 startups. The two founders plan to launch a more substantial funding round in the coming months, the proceeds of which will be used to expand its seven-person team and validate the product's clinical use.

Neurosoft Bioelectronics receives ISO 13485 Certification by TÜV SÜD

Neurosoft Bioelectronics SA, a startup developing implantable brain-computer interfaces, announces that it has received 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.

This is a major milestone for Neurosoft Bioelectronics as it brings the company one step closer to its first clinical studies and regulatory approval of their first product : SOFT ECoG. The SOFT ECoG is the first high-density and stretchable subdural electrode that can be used to record from and stimulate the surface of the brain. This device holds promise for providing monitoring and diagnostics for drug-resistant epilepsy patients as well as patients suffering from brain tumors. In addition to these indications, the device will help advance future therapies currently in development, starting from the treatment of Severe Tinnitus through closed-loop cortical neuro-stimulation of a brain region that is currently impossible to safely target without these soft electrodes.

The Quality Assurance Manager of Neurosoft Bioelectronics, Chloé Fattebert, commented the milestone: “We strive to achieve the highest standards for all our activities. Therefore, we decided to set the tone as early as possible for the design and development of our subdural electrodes, by being compliant to ISO 13485:2016”. Dr. Nicolas Vachicouras, CEO & Co-Founder, added that “this certification is a collective achievement of all the employees at Neurosoft Bioelectronics, indicative of our commitment to quality, and brings us closer to our ambitious goals.”

Besides their certified Quality Management System, Neurosoft Bioelectronics has implemented and finalized a medical grade production line with Good Manufacturing Practices in an ISO 6 and ISO 7 cleanroom environment at the Campus Biotech, 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. 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.”.

In addition to the NMP, Neurosoft Bioelectronics would not have achieved these goals without the constant help from the Wyss Center for Bio and Neuroengineering, who provided support for implementing the infrastructure and Quality Management System, and from the Laboratory of Soft Bioelectronic Interfaces headed by Prof. Stéphanie P. Lacour at EPFL who highlighted “this certification as a milestone in our efforts of translating academic innovation towards clinical medical devices”.

About Neurosoft Bioelectronics SA

Neurosoft Bioelectronics Ltd. is a Swiss neurotech spin-off from the Swiss Federal Institute of Technology in Lausanne (EPFL). Neurosoft Bioelectronics is developing the next generation of soft implantable electrodes to interface with the brain for the treatment of severe neurological disorders. Its main product is a fully implantable closed-loop Brain-Computer Interface (BCI) to treat severe tinnitus, a condition that affects 7M people in the US and Europe, of which 7% attempt suicide every year. It is also developing a family of subdural electrodes intended for monitoring during brain tumor and epilepsy resection surgery.

About the Neural Microsystems Platform (NMP) at Campus Biotech

The Neural Microsystems Platform (NMP) is a 400 m2 ISO 7 Micro-nanofabrication facility that provides a range of microfabrication and characterization equipment and technical expertise to the Campus Biotech community as well as, to date, external academic users. The core mission of the NMP is to enable research and development in wearable and implantable neurotechnologies. Unique to the NMP is the shared thin-film, organic and inorganic fabrication and imaging facilities. The NMP supports research in Soft Bio and Physical devices and systems bringing experts in engineering, life sciences and medical sciences to design the next generation technology, devices and systems for human benefits. The NMP operates via hands-on training and a shared user environment. Users benefit from a close partnership with the platform staff to optimize and improve processes and design innovative process flows.

Contact:

Neurosoft Bioelectronics SA

media@neurosoft-bio.com

Tel.: +41 78 876 14 69