With OpenAI-backed startup Merge Labs poised to develop brain-computer interface (BCI) technologies, leadership in the space is “far from settled”, an expert has said.

Morgan Stanley estimates that the BCI space has an early total addressable market (TAM) of $80bn across three million US adults. Potentially reaching $320bn with further advancements, patients with conditions such as multiple sclerosis and spinal cord injuries represent a significant portion of the market.

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As first reported by the Financial Times, Sam Altman’s OpenAI plans to invest $250m in Merge Labs, which is targeting an $850m valuation. Altman will co-found the startup with Alex Blania, the CEO of cryptocurrency blockchain World, to develop less invasive, high-bandwidth BCIs for human–artificial intelligence (AI) integration, according to the report. The development would effectively put Altman in direct competition with fellow billionaire entrepreneur and former business associate Elon Musk, who owns Neuralink.

Scott Meek, head of R&D at BCI developer Subsense, comments that the arrival of a well-funded company like Merge Labs could “quickly shift” the current dynamics of the BCI space.

Meek told Medical Device Network: “Neuralink may dominate the conversation now, but with no devices commercially available, leadership in this space is far from settled.”

Since being founded in 2016, Musk’s Neuralink has captivated much of the public attention in the BCI space. The company’s products in development include a BCI paired with an assistive robotic arm that is designed to give paralysed people the ability to control external secondary devices through thoughts alone.

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The device is currently under evaluation in the CAN-PRIME (NCT06700304) study in people who have difficulty moving their arms and legs.

While other entrants are significantly further ahead in BCI development, Neuralink is the most well-capitalised.

Since concluding a $650m Series E fundraising round at a $9bn valuation in June, reports have emerged that Neuralink aims to generate $1bn by 2031 following the implantation of its BCI chips in 20,000 people.

According to internal documents reviewed by Bloomberg, Neuralink plans to have five large clinics in operation by 2031, with three versions of its BCI chip available. The documents reveal that Neuralink expects Telepathy – the company’s BCI for limbic control through ‘thoughts alone’ – to be FDA-approved by 2029.

While Neuralink pushes on with its ambition to be the first company with a BCI on the US market for the external control of a device through thought alone, Meek explains that Merge Labs could be set for rapid growth.

“Well-capitalised entrants help validate the field in the public eye, similar to how Apple’s recent move with Synchron signalled that BCIs are ready for prime time, and can accelerate regulatory, clinical, and consumer adoption. It’s the notion that a rising tide lifts all boats,” Meek comments.

With its reported capital allocation, Merge Labs will be able to rapidly build R&D infrastructure, run parallel clinical programmes, and recruit ‘top-tier’ neuroscience and engineering talent, according to Meek.

Meek said: “In a market where the first widely adopted BCI is still to be determined, decisive execution and regulatory success will matter more than who started first.

“The influx of resources also broadens the range of potential use cases, from medical to consumer applications. In this race, the winners will be those who deliver high-quality neural data with minimal barriers to user access.”

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