Neurosoft Bioelectronics: Implantable Electrodes to Treat Tinnitus

[Christiaan]

Neurosoft Bioelectronics has just received 3 million USD from the European Innovation Council Accelerator Grant for the development of next-generation soft implantable electrodes with the aim to tackle neurological disorders such as epilepsy and tinnitus.

The following article gives a summary of what Neurosoft Bioelectronics' device exactly entails.
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Neurosoft Bioelectronics receives nearly USD 3 million in funding to advance treatment for epilepsy and tinnitus (Tinsel, 2022)

Monies Will Fund Clinical Study and Regulatory Approval for Epilepsy and Advance Development for Tinnitus Application

GENEVA, Switzerland, and NEW YORK, N.Y., April 5, 2022 - Neurosoft Bioelectronics, an early-stage company developing tools for unmet needs in epilepsy and tinnitus, was awarded nearly $3 million USD, from the SERI-Funded European Innovation Council Accelerator Grant and a share of the $165,000 USD through the European Research Council Proof-of-Concept Grant.

Proceeds will fund continued development of the company's soft flexible electrodes to be marketed as SOFT ECoG™, a family of implantable devices which can seamlessly interface with the brain. The novel devices are up to 1000x softer and 2x thinner than clinical electrodes, with integrated electrode sites up to 100x smaller, making them suited for high-resolution recording and stimulation of the brain for up to thirty days. Their conformability and softness make them ideally suited for placement in the sulci of the brain – hard to reach areas of the brain where many disorders may best be treated. The deep folds of a sulcus are inaccessible for other electrodes while SOFT ECoG can be safely and precisely placed for stimulation and recording.

"Given that 70% of the surface of the brain is buried in sulci, it was critical to develop a technology that could safely and effectively work in those spaces," said Neurosoft Bioelectronics' CEO, Nicolas Vachicouras, Ph.D. "We're eager to put these significant funds toward clinical testing and regulatory approval of SOFT ECoG in the upcoming months, which will simultaneously drive progress of SOFT TINNIT. Together, these products have the potential to bring relief to epilepsy, brain tumor, and tinnitus patients, and in the future will impact those living with other neurological disorders such as deafness, blindness, tetraplegia, and chronic pain."

Vachicouras will present an update about the company and technology at the Bioelectronic Medicine Forum in New York today.

Most of the funds are designated for the further development of SOFT ECoG however, the innovations made will simultaneously advance the company's second product, SOFT TINNIT™. SOFT TINNIT is a chronic implant to perform closed-loop neuromodulation of the cortex to provide relief for patients suffering from severe tinnitus. Severe tinnitus, which has no cure, affects more than 7 million people in the U.S. and Europe.

About Neurosoft Bioelectronics

Neurosoft Bioelectronics Ltd. is a Swiss medtech spin-off from the Swiss Federal Institute of Technology in Lausanne (EPFL). Neurosoft Bioelectronics develops next generation soft implantable electrodes to interface with the brain for the treatment of severe neurological disorders. Its main product is a fully implantable closed-loop Brain-Computer Interface (BCI) to treat severe tinnitus, a condition that affects 7M people in the US and Europe, of which 7% attempt suicide every year. It is also developing a family of subdural electrodes intended for monitoring during brain tumor and epilepsy resection surgery.

Learn more:
https://www.neurosoft-bio.com/technology

 

[David S]

Ugh, sounds invasive.

 

[AnthonyMcDonald]

Well I'd have something implanted in my brain if I knew it worked for sure.

 

[Uklawyer]

What is the brain structure that they want to stimulate with this? DCN?

 

[Gb3]

 

[blamingeverything]

Ugh, sounds invasive.

Put it in my head, I don't care anymore!

 

[Jerad]

Put it in my head, I don't care anymore!

Ya, I feel this way sometimes, too—when you get debilitating tinnitus, you're willing to go to extremes to alleviate the suffering. Cutting your head open for a brain-stimulating implant, taking riskier, hard meds (like Trobalt or mushrooms), anything that works. Even if the treatment is potentially dangerous or cuts your overall lifespan short. Because your quality-of-life is already so poor that you feel like there's nothing left to lose in trying. And if trying kills you, well then that's okay, too.

Honestly, if I had a drug, solution, or device that would make tinnitus manageable, but would, in return, shorten my life by 10-20 years, it would still be worth it. I'm 36 now and I'd rather live 20 more good years than 40 with this severe suffering.

That's why it's sad that the medical establishments and FDA are so restrictive in everything, worrying about themselves at the expense of those hanging by the thinnest of threads. If a patient wants to undergo a risky procedure or treatment, it ought to be up to the patient. It's their life on the line. Sign a waiver or whatever.

I've been researching the old Trobalt threads and a recurring theme was that many sufferers were unable to get it prescribed by a doctor for off-label tinnitus use. Because the doctors were afraid of losing their medical licenses if something went amiss. These were sufferers that felt they truly had nothing left to live for—it was that bad. And there's one account of someone taking their life because they ultimately couldn't get the med prescribed, and felt that all hope was lost.

So it's sad because a lot of the potential tinnitus treatments or drugs on the horizon are for something else (like epilepsy) and would be off-label for tinnitus. So hopefully we could get someone who'd be willing to prescribe them. If the newer drugs are safer with better side-effect profiles, that should hopefully help.

 

[Brian Newman]

Nice find. Since we're getting farther in the future, I think these implants definitely have potential. If drugs fail we can always fall back on these. I would definitely get it.

 

[Gb3]

What is the brain structure that they want to stimulate with this? DCN?

"SOFT TINNIT is a chronic implant to perform closed-loop neuromodulation of the cortex to provide relief for patients suffering from severe tinnitus."

 

[hopes]

"making them suited for high-resolution recording and stimulation of the brain for up to thirty days."

It only stimulates the brain for thirty days? I don't get it.

 

[Gb3]

"making them suited for high-resolution recording and stimulation of the brain for up to thirty days."

It only stimulates the brain for thirty days? I don't get it.

That's in reference to the other product. Please read carefully.

 

[DimLeb]

So this also needs to take 10-20 years for us to know IF it works, right?

 

[Christiaan]

So this also needs to take 10-20 years for us to know IF it works, right?

For high-risk medical devices, the EMA and FDA follow similar procedures.

Here's a summary of an article that explains how long it would take to get a medical device approved by the FDA

Summary
As with new drugs, the U.S. Food and Drug Administration's approval process is intended to provide consumers with assurance that, once it reaches the market place, a medical device is safe and effective in its intended use. Bringing a device to market takes an average of 3 to 7 years, compared with an average of 12 years for drugs. However, there are concerns that Food and Drug Administration processes may not be sufficient to meet the assurances of safety and efficacy as intended. This second part of a 2-part series reviews the basic steps in development and Food and Drug Administration approval of medical devices, and summarizes post-marketing processes for drugs and devices.

Link:
Drugs, Devices, and the FDA: Part 2: An Overview of Approval Processes: FDA Approval of Medical Devices

 

[Padraigh Griffin]

So this also needs to take 10-20 years for us to know IF it works, right?

I think Neuralink will be here a long time before these guys will help us. Just my opinion.

 

[Christiaan]

What is the brain structure that they want to stimulate with this? DCN?

Neurosoft Bioelectronics is planning to place soft implantable electrodes in the area of the lateral sulcus, which is a deep fissure of the brain. The lateral sulcus is located near the auditory cortex. The goal is to use electrical stimulation of that region to suppress tinnitus.

 

[Gb3]

So this also needs to take 10-20 years for us to know IF it works, right?

Prof. Dirk de Ridder is part of their team. Someone should ask him.

 

[Joey72]

It will be cost prohibitive for me.

 

[hopes]

"Bringing a device to market takes an average of 3 to 7 years, compared with an average of 12 years for drugs."

Well there is a huge difference between a device used outside the body like Auricle aim for and a device that requires an invasive surgery that need to open the skull and implement electrodes deep in the brain.

3 to 7 years seem really optimistic in the last case imo.

However, there are already at least 2 clinical trials as far as I know for DBS in Phase 2 that are currently ongoing.

Maybe they don't need to redo the full trial process if one of those trials gets FDA approved for invasive tinnitus.

But I doubt it, I think they'll need to do a full clinical trial, from scratch.

 

[David S]

When are they planning to do human trials?

 

[Uklawyer]

Thanks @Christiaan. Looks like they might be targeting the area where it becomes "heard" rather than where the signal is actually created.

 

[Gb3]

Looks like they might be targeting the area where it becomes "heard" rather than where the signal is actually created.

Where is tinnitus created? Those are all theories, not facts.

 

[AfroSnowman]

I'd do it if it were proved to be safe and effective but boy being the Guinea pig for the trial would be pretty frightening.

 

[Jerad]

I'd do it if it were proved to be safe and effective but boy being the Guinea pig for the trial would be pretty frightening.

Yeah, it is frightening. Unfortunately, with tinnitus, nothing is guaranteed "safe" because an overwhelming trend is that people react differently to meds or treatments. So a brain implant might spike one and cure another.

That's one of the many things that makes tinnitus so puzzling and maddening. Trying to exist in its world is like navigating through a universe that lacks laws of physics—there are no "sequential" rules or barriers, no obvious thresholds, and anything—absolutely anything—is possible. So good luck and may the force be with you. Lol.

But seriously, I'd be a guinea pig for this treatment, as I'm one of those sufferers who feels my quality-of-life is too unreasonable at the moment.

 

[CricketEars]

Where is tinnitus created?

In the depths of hell.

 

[Athens]

In the depths of hell.

I recall that in approximately 1998 they discovered where tinnitus originates from and there was a lot of excitement about the groundbreaking treatments that would follow.

It is now 2022 and we are still waiting on said treatments.

 

[Jerad]

I recall that in approximately 1998 they discovered where tinnitus originates from

Do you recall where they determined it originates from?

 

[Athens]

Do you recall where they determined it originates from?

No, but you should be able to find it with a Google search. If I find it, I will let you know.

 

[Athens]

Do you recall where they determined it originates from?

I found the article. It says that tinnitus sensations are from the central auditory system and not the cochlea.

 

[antonio77]

@Jerad, what you say I raised it here. Imagine a pill that cures deafness and also tinnitus, but is not prescribed for tinnitus but only for deafness. Imagine that no one gives you that pill because you are not deaf but "just" have tinnitus. Change the deafness to epilepsy or Alzheimer's or something else. It is essential that everything is tested for tinnitus and if it works, it is prescribed for tinnitus, regardless of whether it works for other things. Any disease is considered more important than tinnitus.

 

[Gb3]

Do you recall where they determined it originates from?

They don't know or can't prove where tinnitus originates from. They believe it is caused by a lack of auditory input which causes the brain (auditory cortex) to become hyperactive.