- By Dr. Darin Dougherty, Chief Medical Officer
I am pleased to share a clinical update regarding the Early Feasibility Study (EFS) evaluating the Inner Cosmos minimally invasive neurostimulation system for the treatment of treatment-resistant depression (TRD). The FDA approved EFS has now been completed, and the study has met all predefined safety and feasibility endpoints, with more than 47 patient months of cumulative data.
While we have previously reported that all of our patients have shown meaningful clinical improvement, this marks the first time we are announcing that our third patient has now achieved full remission. They have achieved a 70% improvement in depressive symptoms from baseline, representing a 48% gain over their best prior TMS outcome.
This also marks a key milestone; both patients in the study that had a previous course of TMS and responded (over 50% symptom improvement) but did not reach remission (a MADRS score of 10 or less) with TMS, have now reached full remission with Inner Cosmos treatment.
This milestone highlights continued momentum in the trial and reinforces the therapeutic potential of Inner Cosmos’ psychiatric brain-computer interface.
Study Population and Design
The ongoing clinical study includes adult participants diagnosed with treatment-resistant depression (TRD), defined as an inadequate response to at least two classes of antidepressant therapies.
Inner Cosmos aims to deliver a safe, mobile (at-home), minimally invasive TMS-like therapy for patients who have exhausted traditional therapeutic options. This approach will markedly increase compliance and access for patients in need.
Safety and Device Performance
Across all implanted participants, the system operated reliably with no serious adverse events (SAEs) related to the device or the procedure. Stimulation was well-tolerated, and no unanticipated adverse device effects were observed. The device maintained stable performance over months of daily use.
Clinical Results
Meaningful, sustained clinical improvements were observed across participants:
- All participants demonstrated notable reductions in depressive symptoms based on standardized rating scales (MADRS).
- Two patients achieved remission, with one sustaining remission for 18 months, and the second recently achieving remission. Both elected to continue device use beyond the formal trial window.
- All participants exceeded their best prior TMS outcomes, suggesting that minimally invasive, continuous-access stimulation may overcome key limitations of conventional TMS delivery (access, burden, and adherence).
- Improvements were observed not only on clinician-administered scales but were also supported by functional gains reported by patients and corroborated by family members, including enhanced mood regulation, motivation, and day-to-day functioning.
Patient 1: With Inner Cosmos, the patient achieved a 41% improvement in depressive symptoms from baseline, representing a 27% gain over their best prior TMS outcome.
Patient 2: Patient 2 achieved an 83% improvement from baseline with Inner Cosmos, representing a 60% gain over their best prior TMS outcome. This patient has remained in the remission range for over a year despite significant life stressors. Given the strong and sustained therapeutic benefit, the patient elected to continue long-term use.
Patient 3: Patient 3 has recorded a 70% improvement in depressive symptoms from baseline, representing a 48% gain over their best prior TMS outcome. The patient is currently classified as being in clinical remission following the Inner Cosmos treatment.
Improvements in mood, motivation, and daily functioning have been documented through structured assessments and independently confirmed by family reports. Treatment continues under close observation.
These early findings provide encouraging evidence that targeted, minimally invasive cortical stimulation may offer a durable therapeutic option for individuals with long-standing treatment resistance.
Regulatory Path Forward
Following an FDA Pre-Submission, Inner Cosmos has been cleared to proceed to a pivotal clinical trial in the United States and Australia. This next phase will further evaluate safety and the therapeutic impact of individualized stimulation protocols.
Dr. Darin Dougherty is the Co-Founder and Chief Medical Officer of Inner Cosmos, a neurotechnology company pioneering minimally invasive brain-computer interfaces to treat depression and other cognitive disorders. A leading figure in neuropsychiatry, Dr. Dougherty also serves as Director of the Neurotherapeutics Division in the Department of Psychiatry at Massachusetts General Hospital (MGH) and as an Associate Professor of Psychiatry at Harvard Medical School.
With over two decades of experience, Dr. Dougherty has led numerous clinical trials and research initiatives focused on neuromodulation therapies, including deep brain stimulation (DBS) and transcranial magnetic stimulation (TMS), for treatment-resistant psychiatric conditions such as major depressive disorder, obsessive-compulsive disorder (OCD), and post-traumatic stress disorder (PTSD). His work has been instrumental in advancing the understanding and application of neurotherapeutic interventions in psychiatry.
About Inner Cosmos: Pioneering the field of Psychiatric BCI
Inner Cosmos is advancing psychiatric care by creating a first-of-its-kind, neurotechnology device that is embedded on the top of the bone to transmit neurostimulation that can treat cognitive disorders and mental health diseases like depression. Similar the bi-directional nature (capable of both sensing and stimulation) of a pacemaker, Inner Cosmos has created a penny-sized chip that is capable of monitoring and stimulating the brain in ways that can strengthen the weakened response networks that contribute to psychiatric disorders like depression.
While most brain-computer interface systems to date have focused on restoring physical or sensory function, Inner Cosmos is pioneering a new use case for BCI/psychiatric intervention. This category targets dysfunction within large-scale brain networks responsible for emotional regulation, attention, and cognitive flexibility.