Axoft launches ‘soft’ brain-implant technology, gains US FDA Breakthrough Device designation

Neurotechnology start-up Axoft has launched and announced US Food and Drug Administration (FDA) Breakthrough Device designation for its brain-machine interface (BMI) technology intended to better the treatment of neurological disorders.

The company secured US$8 million in capital to fund preclinical studies with the FDA and to scale up prototypes of its neural implants that it says are ‘as soft as the brain’. This seed-round investment was led by The Engine—a venture firm spun out of the Massachusetts Institute of Technology (MIT) that invests in early-stage ‘tough tech’ companies—and included investors Ab Initio Capital, Decent Capital, Alumni Ventures, Safar Partners, AIBasis, LiquidMetal VC, Taihill Venture, AMINO Capital, Blindspot Ventures and Mintz. This capital will also be used to expand the Axoft team, a company press release states.

The company was founded in 2021 by CEO Paul Le Floch and chief technology officer Tianyang Ye, alongside Jia Liu (Harvard School of Engineering and Applied Sciences, Boston, USA). Axoft’s novel technology was born out of Liu’s work developing materials and designs of ultra-flexible nanoelectronics to mimic the mechanical and structural properties of the brain, and was further researched by Le Floch while he was completing his Mechanical Engineering and Material Sciences PhD at Harvard.

The novel implants they developed are gliosis-free, meaning they can reside in the central nervous system for the long term without harm. Axoft’s implants also exhibit electrical stability to track brain signals over the long term, and deliver an ultra-high density of sensors to maximise the information that can be exchanged between the brain and electronics, the release notes.

According to Axoft, current BMIs have not been developed to fully exploit the brain’s potential and are limited by the mechanical mismatch between electronics and brain tissues. Even ultra-thin wires are stiff, unlike brain tissue, and pose the danger of scarring and infection to the local brain region in which they are embedded. Axoft solves this issue by using a bioinspired material, malleable yet resilient, to make high density (large electrode count) probes with long-term stability and biocompatibility in the brain.

Axoft says its minimally invasive implants create a “seamless interface” with the nervous system, allowing ultra-high bandwidth and stable, single-neuron measurements. Whereas current implants have limited longevity and ability to track the same neurons in the brain over time, Axoft’s implant material enables it to stay functional as the brain shifts or grows, minimising the need for replacement and offering a long-term BMI to connect the brain to electronics. This is relevant because future applications in neuroprosthetics and closed-loop neuromodulation will require communication with a large number of neurons in the brain, the company claims.

Having confirmed participation in the FDA Breakthrough Device programme, Axoft will introduce its technology in a staged approach, with the primary focus on improving quality of life—first addressing illnesses that have large patient populations that are underserved by current medical technology as well as diseases like paediatric cerebral palsy and epilepsy where patients undergo treatment for lifelong conditions. The company also notes the potential its technology could hold in neurodegenerative conditions like Parkinson’s and Alzheimer’s diseases, seizures, and movement disorders.

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Original Article: (https://neuronewsinternational.com/axoft-launches-soft-brain-implant-technology-gains-us-fda-breakthrough-device-designation/)