Brain implant company Neuralink aims to generate $1bn by 2031 following the implantation of its brain-computer interface (BCI) chips in 20,000 people.
According to internal documents and a recent presentation shown to Neuralink investors that have been reviewed by Bloomberg, the company plans to have five large clinics in operation by 2031, with three versions of its brain-computer interface (BCI) chip available.
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The BCIs are Neuralink’s Telepathy, a device designed to enable communication between the brain and machines, Blindsight for restoring vision in blind individuals, and Deep for treating tremors and Parkinson’s disease.
While Telepathy has not officially been named as such, the device likely refers to Neuralink’s BCI that is designed to give paralysed people the ability to use a computer using brainwave prompts. The documents reveal that Neuralink expects to gain US Food and Drug Administration (FDA) approval for Telepathy by 2029 and undertake 2,000 implantation procedures per year that are expected to generate $100m in annual revenue.
The Elon Musk-backed company received Health Canada approval in November 2024 to start the CAN-PRIME trial (NCT06700304) evaluating the BCI likely to be marketed as Telepathy. In the same month, Neuralink gained approval to launch CONVOY (NCT06710626), a feasibility trial to evaluate a BCI – that may inform the development of Neuralink’s Telepathy – with an assistive robotic arm.
Neuralink’s Blindsight BCI secured a breakthrough device designation from the FDA in September 2024. The internal documents reveal that Neuralink expects Blindsight to launch in 2030 and scale up to 10,000 procedures per year that are touted to bring in $500m annually.
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By GlobalDataAccording to Bloomberg, the documents state that the mooted figures assume a “conservative reimbursement” of $50k per surgery.
No BCI from Neuralink to address tremors and Parkinson’s disease has previously been publicly reported.
Neuralink has also received an FDA breakthrough device designation for a BCI for the treatment of individuals with severe speech impairment that is currently under evaluation in the first-in-human PRIME study (NCT06429735) in the US.
In June, Neuralink raised $650m in a Series E financing round to continue the development of its BCIs.
Medical Device Network has reached out to Neuralink for comment.
In April, a trio of Democratic senators inked a letter to US Federal Trade Commission (FTC), urging the agency to address the potential risk of neural data misuse amid the “rapid” development and commercialisation of brain-computer interface (BCI) technologies. Spearheaded by Democratic leader Chuck Schumer, the letter to FTC chair Andrew Ferguson warned that due to its “extremely sensitive” nature, neural data can reveal mental health conditions, emotional states, and cognitive patterns, even when anonymised – all realities that make the data ‘strategically sensitive’.
