Inner Cosmos Completes FDA Early Feasibility Study

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The Inner Cosmos Team

Founders

Meron Gribetz​

Chief Executive Officer

Neuroscience & engineering, deep tech visionary, spatial computing pioneer, creator of Meta Augmented Reality

Darin Dougherty, MD

Chief Medical Officer

Pioneer of brain chips 
for depression, trialist; implanted highest number of depression patients

Susan Alpert, PhD MD​

Chief Regulatory Officer

Regulatory expert; Ex-head of FDA device approvals (approver of DBS), ex-head of Medtronic regulatory

Eleanor J. Cole, PhD

Chief Scientific Officer

Neuroscientist and leader in neuromodulation innovation, specializing in treatment-resistant depression and accelerated protocols

Ed Boyden, PhD ​

Head of Advisory Board​

One of the leading neuroscientists, pioneer of optogenetics, MIT synthetic neurobiology​

Ted Kucklick​

Product​

Multiple exit medtech entrepreneur, designer, wrote the Medical Device R&D Handbook​

Dan Moran, PhD​

Engineering​

Pioneer of ECoG and creator of core motor BCI algorithms​

Board Of Directors

Avichay Nissenbaum

Board Member

John Freund

Board Member

Joseph Baron

Board Member

William Shor

Board Member

Core Team​

Yvette Dzumaga, MD MBA​

VP Trials, Investors​

AI for depression diagnosis, online therapy, psychiatry training​

Tal Ein-Gar, MBA

Head of Engineering​

Ex-Intel, ex-Meta Augmented Reality leader in deep tech, sensor fusion, computer vision​

Greg Schulte

Advising CTO

Aharon Grossman

Program Management, Clinical and Manufacaturing

Ex-Company, Life-sciences bla blah

Matan Kiczales​

VP Marketing​

Ex-Samsung, ex-Meta Augmented Reality, spatial computing​

Andrew Czarnecki​

Head of Hardware​

Ex-Draper, ex-Cambridge Consultants, bioelectrical engineering, advance chip technology​

Arthur Gribetz, PhD​

Head of Operations​

Operational management in gov and private sector​

Nestor Perez

Office of the CEO

Company Milestones

In 2011 Inner Cosmos co-founder psychiatrist Darin D. Dougherty of Harvard MGH co-authored an 11-subject study, demonstrating that an ECoG device has similar efficacy to TMS. Published paper of ECoG In 2016 Meron Gribetz, Dr. Eric Leuthardt, Dr. Dan Moran and Ted Kucklick came together with the idea of the Digital Pill, a minimally invasive in-bone device, that can be implanted in a one-hour outpatient procedure and provides results similar to or even better than TMS. Digital Pill invented Preclinical study #1 In 2016 co-founder Dan Moran’s lab used animal models to demonstrate how a thinned layer of bone can enable high gamma 75-105Hz range. In 2018 a second animal study led by Dr. Eric Leuthardt and Dr. Dan Moran quantified the stimulation parameters required by the Inner Cosmos device to elicit a response equivalent to TMS. Preclinical Study #2 In 2019 a one -year tissue resistance​ study was conducted showing bone and brain dynamics. Ovine Longitudinal Study (Preclinical #3) In 2021 the FDA approved the first Investigational Device Exemption (IDE) study for depression in almost 20 year, since Vagus Nerve Stimulation (VNS). FDA IDE-approval for Early Feasibility Study In 2022 Inner Cosmos implanted its first patient at the Washington University School of Medicine in St. Louis. The study proved that the device was safe and three different parameters were studied (DBS, ECoG and TMS). Early feasibility study, patient #1 In 2023 Inner Cosmos implanted its second patient, demonstrating the treatments effectiveness, leading the patient into remission after 17 years with severe depression. Early feasibility study, patient #2 In 2024 Inner Cosmos implanted its third patient, Studied 3 TMS prescriptions and personalized parameters. Early feasibility study, patient #3

Company Milestones

In 2011 Inner Cosmos co-founder psychiatrist Darin D. Dougherty of Harvard MGH co-authored an 11-subject study, demonstrating that an ECoG device has similar efficacy to TMS. Published Paper Of ECoG In 2016 the Inner Cosmos came together with the idea of the Digital Pill, a minimally invasive in-bone device, that can be implanted in a 1 hour outpatient procedure and provides results similar to or even better than TMS. Digital Pill Invented Preclinical Study #1 In 2016 Co-Founder Dan Moran’s lab used animal models to demonstrate how a thinned layer of bone can enable high gamma 75-105Hz range. In 2018 a second animal study led by Dr. Eric Leuthardt and Dr. Dan Moran quantified the stimulation parameters required by the Inner Cosmos device to elicit a response equivalent to TMS. Preclinical Study #2 Tissue resistance​ Study, showing bone and brain dynamics (1 yr) Longitudinal Study (Preclinical #3) Ovine Model First in almost 20 years since VNS First FDA IDE approved study for depression in 20 years activated at WashU. FDA IDE Approval For Early Feasibility Study In 2022, Inner Cosmos implanted its first patient at the Washington University School of Medicine in St. Louis. The study proved that the device was safe. Studied 3 prescriptions, DBS, ECoG and TMS parameters. Early Feasibility Study Patient #1 In 2023, Inner Cosmos implanted its second patient, demonstrating the treatments effectiveness, leading the patient into remission after 17 years with severe depression. Early Feasibility Study Patient #2 In 2024, Inner Cosmos implanted its third patient, Studied 3 TMS prescriptions and personalized parameters Early Feasibility Study Patient #3