Michel Maharbiz, the UC Berkeley engineer who co-invented neural dust and ran iota Biosciences through its 2020 acquisition by Astellas, has launched a new brain-computer interface company called Epia Neuro after stepping down as iota’s CEO on 1 April. The San Francisco-based company, which announced its exit from stealth on 2 April, is building a minimally-invasive implant for post-stroke upper-limb rehabilitation, with first-in-human implantation planned later this year at Lenox Hill Hospital in New York and an FDA submission targeted for February 2027. Co-founder Gil Mandelbaum, a neuroscientist, is CTO; the company currently has 45 employees. Funding has not been disclosed.
The commercial positioning is the more interesting part of the announcement. Most stroke-rehabilitation BCI programmes — CorTec’s Brain Interchange, the spinal-cord stimulation work at EPFL and Brown, and several earlier academic efforts — sell the promise of neurological recovery: signals going in, plasticity coming out, function restored. Epia Neuro is explicitly not anchoring its value proposition on that promise. Maharbiz told Bio-IT World, in what he described as the company’s “Hello World talk,” that the product is designed to deliver reliable assistive function through a motorised glove regardless of whether any rehabilitation benefit accrues. “I don’t know how your recovery journey is going to turn out,” he said, framing what a surgeon could tell a patient pre-implant, “but I can tell you that this glove will do what this glove does.”
The device
The implant is a 64-channel electrode array placed epidurally above the motor cortex through a one-hour outpatient procedure that does not pierce the dura. The implant sits under the scalp and is externally invisible. Recording is read-write — the system can both sense cortical activity and stimulate, with deep-brain stimulation as an optional secondary feature the company says is available for later clinical scenarios. Power and data flow through a wearable headset that charges the implant wirelessly and receives neural signal, which is decoded into movement intent and relayed to a lightweight motorised glove the patient wears on the affected hand. The glove is described as potentially disposable.
The technical positioning places Epia Neuro between two established clinical-stage architectures. Neuralink, Paradromics, and Blackrock all use penetrating intracortical arrays for high-resolution neural decoding. Synchron and Precision Neuroscience use non-penetrating surface or vascular-entry approaches for lower-resolution but less-invasive access. Epia Neuro’s 64-channel epidural placement sits in the middle: surface electrodes that do not penetrate the dura, but sit closer to cortex than Synchron’s intravascular stentrode or Precision’s subdural thin-film array. For upper-limb motor decoding in chronic stroke — a population with variable cortical reorganisation and a less demanding signal-quality bar than speech decoding — the trade-off may be appropriate.
Why stroke, and the commercial number
The company estimates roughly 60,000 US patients annually are immediately eligible for an upper-limb rehabilitation device of this class. That number frames a defensible initial addressable market rather than the speculative total-addressable-market figures that typically accompany stealth exits. Around nine million ischemic strokes occur globally each year, and eighty per cent of stroke survivors experience upper-limb impairment, which gives a long expansion runway behind the initial cohort. The second programme the company has disclosed is cognitive-decline detection, which would place it in the territory that neurodegenerative-disease monitoring companies have been trying to open for the past decade.
CorTec received FDA Breakthrough Device Designation for stroke motor rehabilitation on 8 April, the first any BCI company has received for that indication. Epia Neuro’s timeline places its FDA IDE submission several months behind CorTec’s current clinical stage, but the two companies are not directly overlapping — CorTec is pursuing closed-loop neuroplasticity-driven recovery; Epia Neuro is selling assistive function first and treating recovery as a possible bonus rather than a promise. Whether regulators and payers treat those as the same indication or as distinct product categories is a question neither company can answer yet.
Separation from iota
Maharbiz confirmed to Bio-IT World that Epia Neuro is “totally independent” of any corporate parent. Iota Biosciences, which develops peripheral-nerve ultrasonic stimulation for organ targets far from the brain, continues to operate under Astellas with its own active clinical programmes. Epia Neuro’s cortical BCI technology is not a spinout of iota. The decision to leave an established Astellas subsidiary running multiple trials in order to start a new company from scratch is the strongest implicit signal in the announcement: Maharbiz thinks the next decade of value creation in neurotechnology is in cortical interfaces, not in the peripheral-nerve bioelectronic-medicine path iota established.
The 45-person team, the specific FDA submission date, the identified surgical site, and the absence of a disclosed funding figure together describe a company that is further along than a typical stealth exit but that is electing not to trade on a valuation peg. The full commercial profile will become clearer at the first-in-human demonstration later this year and at the February 2027 regulatory filing.