The neurotechnology start-up also raised $8m in a seed round to fund pre-clinical studies with the FDA and to scale up prototypes of its neural implants
The Axoft founding team (Credit: Business Wire)
Axoft has announced securing the breakthrough device designation from the US Food and Drug Administration (FDA) for its brain-machine interface (BMI) for the treatment of neurological disorders as well as its launch.
The neurotechnology start-up also raised $8m in capital for financing pre-clinical studies with the FDA and for scaling up prototypes of its neural implants. The funds will also be used to expand its team, Axoft said.
The seed round was led by The Engine, a venture firm spun out of Massachusetts Institute of Technology (MIT). It also saw the participation of other investors like Ab Initio Capital, Decent Capital, AIBasis, Alumni Ventures, Safar Partners, Taihill Venture, LiquidMetal VC, AMINO Capital, Mintz, and Blindspot Ventures.
Axoft said that its implants are gliosis-free and safe to stay in the central nervous system for an extended period of time.
The implants are also said to show electrical stability in the long-term tracking of brain signals. Besides, they provide an ultra-high density of sensors for maximising the information that the brain and electronics can exchange, said the company.
Axoft co-founder and CEO Paul Le Floch said: “Technology leaps in the semiconductor industry, development of novel advanced materials, chip design improvements, and progress in minimally invasive surgical approaches have opened opportunities for neurotechnology to be brought into the clinic and really help patients.
“The pursuit of elevated quality of life, compounded by the increasing financial burden of neurological disorders due to an aging population are driving the demand for less invasive, more powerful neurological tools.”
Axoft’s implants are claimed to form a seamless interface with the nervous system for ultra-high bandwidth and stable, single-neuron measurements.
The neurotechnology firm uses a bioinspired material, which is malleable and resilient, for making high-density probes with long-term stability and biocompatibility in the brain.
The material of the implants enables them to remain functional as the brain shifts or grows, thereby minimising the necessity for replacement and providing a long-term BMI.
The implants can also embed up to 1,024 electrodes in a single strand and are constructed of materials that are 10,000 times softer than flexible electronics, the company added.
According to the firm, the FDA Breakthrough Devices Program will expedite the development, assessment, and review of its BMI technology.