For a patient with treatment-resistant depression, the standard of care is a series of escalating interventions, each with its own trade-offs. There are medications, which can take weeks to show effect and often cause side effects. There is transcranial magnetic stimulation (TMS), which is non-invasive but requires daily clinic visits for weeks. For the most severe cases, there is electroconvulsive therapy (ECT), which can be effective but carries risks of memory loss and requires anesthesia. It is a long, difficult road, and for millions, it ends without remission. Inner Cosmos, a neurotech startup operating quietly in Portola Valley, is betting that a fingernail-sized computer implanted under the skin of the skull could chart a new path [Neurotech Center, ~2024-2025].
The Digital Pill's Clinical Wedge
The company's device, called the "Digital Pill," is a brain-computer interface (BCI) designed to be minimally invasive. It sits on top of the skull, beneath the skin, and delivers precise micro-stimulations to specific brain networks associated with mood regulation. The core bet is that this targeted neuromodulation can outperform existing therapies like TMS, ECT, and ketamine without penetrating the brain tissue [Neurotech Center, ~2024-2025]. The company's primary regulatory and clinical milestone came with FDA approval of an Investigational Device Exemption (IDE), greenlighting its first human depression trial in what the company claims is two decades for a BCI of this kind [Neurotech Center, ~2024-2025]. Early, interim data from this ongoing study has been promising, if preliminary. In a May 2025 update, Inner Cosmos reported that its first patient showed a 41% improvement in depressive symptoms from baseline, which it framed as a 27% gain over that patient's best prior response to TMS. A second patient reportedly achieved an 83% improvement over 17 months [Inner Cosmos, May 2025]. The company announced completion of its FDA Early Feasibility Study in November 2025 [Inner Cosmos, Nov 2025].
A Team Built for the Long Neurotech Haul
Founding and advising the effort is a group with deep, complementary roots in neuroscience and hard tech commercialization. CEO Meron Gribetz is a serial entrepreneur known in augmented reality circles, who has described the device as aiming to be a "cochlear implant for depression" [Neurotech Center, ~2024-2025]. The clinical co-founder and Chief Medical Officer is Eric Leuthardt, a neurosurgeon and researcher. Perhaps the most significant credibility signal is the involvement of Ed Boyden, a pioneer in optogenetics and temporal interference brain stimulation, who serves as Head of the Advisory Board [Dealroom.co]. The board was further bolstered in mid-2025 with the appointment of medtech veteran John Freund, and Greg Schulte joined as Advisory CTO [Inner Cosmos, Jul 2025]. This collective expertise is aimed at navigating the decade-long development cycles typical of regulated neurotechnology.
| Role | Name | Key Background |
|---|---|---|
| CEO & Co-Founder | Meron Gribetz | Serial entrepreneur, AR pioneer |
| Chief Medical Officer & Co-Founder | Eric Leuthardt | Neurosurgeon, researcher |
| Head of Advisory Board | Ed Boyden | MIT Professor, optogenetics pioneer |
| Board Member | John Freund | Medtech executive (appointed July 2025) |
| Advisory CTO | Greg Schulte | Technology executive (appointed July 2025) |
Capital, Competition, and the Road Ahead
The company has raised a total of $10 million in seed funding, led by Lool Ventures with participation from KittyHawk VC and Loup Ventures [Neurotech Center, ~2024-2025]. This capital is intended to fuel the lengthy and expensive clinical validation process. While the early data points are encouraging, they come from a very small number of patients in an early feasibility study, not a large-scale pivotal trial. The path to widespread commercial use remains long, expensive, and fraught with regulatory scrutiny. Inner Cosmos also operates in a space with a high-profile, well-capitalized competitor: Neuralink. However, the companies appear to be targeting different initial wedges. While Neuralink has focused on motor restoration and human-computer symbiosis, Inner Cosmos is squarely aimed at psychiatry, starting with major depressive disorder [Bloomberg, 2022].
The risks facing Inner Cosmos are substantial but characteristic of ambitious neurotech.
- Clinical validation. The reported patient improvements are compelling anecdotes, but they must be reproduced in larger, controlled trials to meet FDA standards for approval.
- Capital intensity. The $10 million seed round is a start, but the cost of running full-scale clinical trials and building a commercial infrastructure will require significantly more funding.
- Market adoption. Even with approval, convincing psychiatrists and patients to adopt a surgically implanted device for depression represents a profound shift in clinical practice. The standard of care for treatment-resistant depression today is a fragmented landscape of medication, therapy, TMS, and ECT. It is often a process of trial and error, with variable efficacy and significant burdens on the patient. Inner Cosmos is proposing a more permanent, personalized, and continuously active intervention. The next twelve months will be critical for translating early feasibility results into a robust dataset that can support a larger trial and attract the next round of funding necessary to walk the long road to patients.
Sources
- [Neurotech Center, ~2024-2025] Inner Cosmos Raises $10 Million To Treat Depression With BCI Implant | https://www.neurotechcenter.org/media-pr/forbes-magazine/inner-cosmos-raises-10-million-treat-depression-bci-implant
- [Inner Cosmos, May 2025] Clinical Study Update | Q2 2025 | https://innercosmos.ai/2025/05/13/clinical-study-update-q2-2025/
- [Inner Cosmos, Nov 2025] Clinical Trial Update | FDA Early Feasibility Study Completion | https://innercosmos.ai/2025/11/26/clinical-trial-update-fda-early-feasibility-study-completion/
- [Dealroom.co] Inner Cosmos company information funding investors | https://app.dealroom.co/companies/inner_cosmos
- [Inner Cosmos, Jul 2025] Leadership Announcements | https://innercosmos.ai
- [Bloomberg, 2022] Inner Cosmos Makes Brain-Computer Interface to Rival Elon Musk’s Neuralink | https://www.bloomberg.com/news/articles/2022-03-30/inner-cosmos-makes-bci-to-rival-neuralink-elon-musk
- [MassDevice, pre-2026] Inner Cosmos shares data for psychiatric BCI tech | https://www.massdevice.com/inner-cosmos-data-psychiatric-bci-tech/