Inner Cosmos, a neurotechnology company that implants treatment devices in human brains, said its neurostimulation technology can be used to treat depression.
The company said it has had promising findings from the initial phase of its human trials, marking a significant step forward in the treatment of treatment-resistant depression, said Meron Gribetz, CEO of Inner Cosmos, in an interview with me.
The trials, conducted in collaboration with Washington University School of Medicine in St. Louis, Missouri, have yielded encouraging results regarding the safety and efficacy of Inner Cosmos’ novel neuro device, said Gribetz. Just a couple of people have the implant so far, and one has benefited, while a couple more will get them in coming months.
This device, a small chip implanted in the skull, aims to monitor and stimulate the brain to alleviate symptoms of depression. He said it is a very small implant, in the form of a small disk, that is embedded in the outer layer of the bone of your skull, right under the skin.
After a doctor implants the device in your head, it becomes level with the layer of skin on your head. It can transmit data from your brain and upload it to a device that your doctor can read. That means data from your brain is directly readable by the doctor treating you for depression, Gribetz said. The data can be uploaded in a matter of minutes each day.
Over the course of 21 months, the study has demonstrated the safety and feasibility of the Inner Cosmos device, with no serious adverse effects reported among participants. Moreover, preliminary data suggests that the device is at least as effective, if not more effective, than Transcranial Magnetic Stimulation (TMS), a standard treatment for depression.
Using Inner Cosmos device during the optimized stimulation parameters, the two patients on average saw reductions in their symptoms. With these improvements, the preliminary data suggests that the Inner Cosmos device is at least as effective, if not more effective, than TMS as treatment.
For these two initial subjects, the optimal treatment with Inner Cosmos’ device showed comparable or superior efficacy when compared to each patient’s previous TMS treatment.
Darin Dougherty, chief psychiatrist at Inner Cosmos, said in a statement that the company’s neurotech device has potential in addressing treatment-resistant depression. He highlighted the dedication to further research and expansion of human trials to make this transformative therapy accessible to a wider range of patients.
“We are dedicated to furthering our research and expanding our human trials to bring this transformative and promising therapy to a broader set of patients who are affected by this debilitating mental health
disease,” said Dougherty, a pioneer of Neuropsychiatric BCI & Neurotherapeutics for Depression.
Unlike traditional TMS treatment, which often requires daily hospital visits over several months, Inner Cosmos’ device offers the promise of broader access to effective therapy. By delivering precise electric pulses to targeted areas of the brain, the device aims to rebalance neural networks and alleviate severe depression symptoms.
The research efforts are led by Dougherty, along with leaders from Washington University School of Medicine, including Eric Lenze, Eric Leuthardt and Jon Willie.
Looking ahead, Inner Cosmos plans to expand its trial with additional participants, building upon the positive outcomes observed thus far.
Inner Cosmos is pioneering the development of a revolutionary device designed to address cognitive disorders and mental health diseases like depression, Gribetz said. With its innovative approach to neurostimulation, the company aims to offer new hope to individuals struggling with treatment-resistant depression.
Origins
I’ve covered Gribetz’s companies before. In 2016, he raised $50 million for an early augmented reality company called Meta. That company didn’t make it. But he’s back for more now.
Inner Cosmos started in 2016 and it has been working for eight years now. It has done three large animal studies and now it’s doing human studies. Gribetz said he feels like the firm is years ahead of its competition.
“Our roadmap is we start with treatment resistant depression, and then we go to mild, major depressive disorders after that,” he said.
“This company is building the smallest and least invasive brain-computer interface, or BCI,” he said. “We are starting out by treating the biggest disorder in the world: chronic depression. That’s where we’re starting. We’re building a platform that will actually go after other use cases that are exciting. But we’re hyper focused on helping patients in this state of depression right now.”
He noted that other BCI companies like Elon Musk’s Neuralink are relying on extremely invasive techniques, like cutting through the skull and “shoving stuff into our brains.” They’re targeting people with paralysis who have challenges getting certain parts of their brains to work.
But Gribetz said he believes the mental health market is a lot bigger, and it can be treated more easily. He teamed up with Dougherty, a pioneer in implants from Harvard University.
They developed a small disk that is less invasive than a cochlear implant for your ears, Gribetz said. And it’s a bit like LASIK surgery, where you shave off the top of a bone in a 30-minute outpatient procedure.
“We’re super excited,” he said. “We think this will open up the era of brain computer interfaces. We see that succeeding for the masses one day, but you have to get humanity ready for BCI by doing less invasive surgeries.”
While AR didn’t have a killer app at the time, Gribetz said that treating depression is important, as it’s the No. 1 killer of men under 45 because of suicide. In particular, Inner Cosmos is going after treatment-resistant patients, who have failed two courses of antidepressants.
A treatment for the future
Current treatments are done using large helmets, which can transmit electrical signals into your brain once they’re hooked up properly. You have to go to a doctor for 30 days in a row, often, and that’s not possible for many working people.
“This is the smallest [and least invasive] brain ship in the world. It’s [about] five times smaller by volume than Neuralink. And it’s not even a brain chip. It just gets slipped under the skin in a 30-minute outpatient procedure. And we shave a little bit of the outer layer of the bone, so it’s flush with the skull,” he said. “It’s like a nose job in terms of the bone we take out of the skull.”
If you aren’t bald, most people wouldn’t notice the half-inch scar from the implant in your skull, Dougherty said in an interview with me. You charge the device for 10 minutes a day with a magnetic power source, and then you upload the data while you’re doing that. From that, your psychiatrist can read data, seeing your mood or depression graph and analyzing it with AI. Then the psychiatrist can decide on a stimulation frequency for treatment.
Dougherty has run a TMS clinic for 20 years, and his other labs would typically put more invasive implants into people in order to treat people with depression by stimulating parts of their brain.
“Every patient that has been using our device so far has had better scores on average than their TMS,” he said. “If I want to show you the long-term vision, it’s really to change of the world of pharma more generally.”
There are a lot of side effects to drugs on the market, he said. About 50% of men can lose their libido.
“For 50% of patients, they will fail to benefit from the first drug and need to go through the process again with [a second drug],” he said. “That’s the world that we live in now, where 20 million people in America are going through this experience. And the world we’re envisioning in the future with this prescription pot is actually quite radical. You go to the hospital for 30 minutes. And for the rest of your life, your depression is managed on your iPhone. You have your daily mood graph, and you interact with your psychiatrists asynchronously.”