Inner Cosmos Psychiatric Implant Completes Early Feasibility Trial

The two parts of the Inner Cosmos Digital Pill device

Inner Cosmos

I’ve covered the XR and wearable technology spaces for a long time as a technology industry analyst, including healthcare wearables and brain-computer interface products that integrate with XR headsets for therapy and other mental health applications. While I’ve tested many BCI devices, none are quite like Inner Cosmos’ patented Digital Pill. I recently spoke with Inner Cosmos CEO Meron Gribetz while researching a huge milestone for the company — completion of its FDA early feasibility trial — and what it means for the broader neurotech space.

What Is The Inner Cosmos Digital Pill?

To understand the significance of Inner Cosmos’ recent early feasibility trial, it helps to know what the company’s Digital Pill is and how it works. Inner Cosmos, named for the deep and mysterious expanse of the human mind, has developed a minimally invasive implantable device for treatment-resistant depression. The Digital Pill device stimulates the brain using signals similar to those in transcranial magnetic stimulation, a therapy that’s been used for decades with moderate success. TMS typically shows a 50% to 60% efficacy rate but requires patients to visit a hospital or clinic daily for dozens of treatment sessions, limiting access and long-term adherence.

Inner Cosmos’ device is implanted subdermally (beneath the skin but outside the skull), in a procedure that typically takes 30 minutes. The company’s technology determines which part of the brain to target within a few millimeters of accuracy. Because the outer pod magnetically attaches to the implanted device, patients can initiate treatment themselves without outside assistance. After implantation, patients can undergo 30-minute stimulation treatments to deliver a TMS-like therapy on their own schedule with the guidance of their psychiatrist. Inner Cosmos says that the treatment is currently used for TRD, but could have broader applications depending on the issue and its location in the brain.

Completion Of The Early Feasibility Trial

Completing the FDA-approved early feasibility trial is a significant event for Inner Cosmos and the industry as a whole. The trial required 46 patient-months of data and, according to Inner Cosmos, makes the company the first and only firm in the psychiatric BCI space to reach this milestone. The next phase involves scaling operations and working toward full FDA approval, which will likely take three to four years. It’s possible (even highly probable) that Inner Cosmos could be acquired before approval; regardless, FDA approval is the final step before commercialization for patients with TRD. There are no guarantees in this next stage of development, but I believe that Inner Cosmos has entered a new chapter now that it’s proven the technology’s effectiveness in a small population of patients.

According to Inner Cosmos, no serious adverse effects have been reported to date. The company highlighted several case studies from the feasibility trial, showing significant improvements compared to each patient’s baseline — and even over their best TMS outcomes. One participant reportedly achieved full remission for more than a year and chose to continue long-term use.

Possible Expanded Applications For Inner Cosmos’ Technology

If Inner Cosmos is successful in treating TRD with its Digital Pill device, other conditions might eventually be treated with similar efficacy. Potential targets include obsessive-compulsive disorder, post-traumatic stress disorder, borderline personality disorder, Parkinson’s disease and generalized anxiety disorder. Studies are even exploring the use of TMS for multiple sclerosis and Alzheimer’s disease.

The implications are significant: Inner Cosmos’ Digital Pill could one day support treatment for multiple conditions and improve the quality of life for many people. While clinical availability is still several years away, completion of the FDA early feasibility trial is a meaningful step toward that goal.

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