BrainQ raises $40M to gain FDA Breakthrough Device designation

BrainQ uses machine learning and a vast data set to better understand how to target brain's complex machinery and strokes affect networks.

Main Highlights

Surgery can assist if you hurt your elbow. Prostheses are offered if you lose a limb. However, abnormalities within the brain are more difficult to address, and rehabilitation for stroke sufferers is primarily left to the body’s own repair mechanisms.

BrainQ hopes to alter that with a device that stimulates the injured area of the brain and encourages self-repair, which has shown significant improvement in trials to gain FDA Breakthrough Device designation, and the firm has just secured $40 million to bring it to market.

It should be noted right away that skepticism about the usefulness of any brainwave-emitting wonder gadget is natural. BrainQ conceded that the technology was mostly theoretical at the time (2017), but the team has since continued its work, secured some funds, and what was a promising if not a well-supported thesis at the time has evolved into one backed by actual data and clinical outcomes. The resultant technology might represent the most significant advancement in stroke therapy in decades, if not centuries.

Strokes can cause visible deficits in grip strength or coordination, but the harm is to the networks in the brain that regulate those parts, not the hand or leg itself. However, medical science does not have a means for directly recreating such networks; the brain must do it on its own, in its own time.

To help with this, frequent physical therapy and brain health examinations are utilized, sometimes for years on end, to ensure that the brain is still working on it and that the components of the body do not fall into disrepair.

The most intriguing advancements in this process in recent years have been the incorporation of technology into the loop to offer instant feedback, such as that one’s balance is tilted to one side, and the provision of stimulation to counterbalance that. But, in the end, it’s still focused on physical therapy.


Drechsler and BrainQ perceive the issue in slightly different ways. It’s not just an injury, but a disruption to the brain’s carefully maintained equilibrium, which it has no way of correcting. He compared a stroke to a preterm infant whose body is incapable of self-healing. What should you do in such a situation? You don’t try to “repair” the body so it can work at lower temperatures or boost the heat production; you simply place the child in an incubator and everything goes as it should.

BrainQ’s gadget accomplishes something similar by altering the brain’s immediate environment.

“We map and compare the channels in healthy and unhealthy brains. Once we have identified these, we employ a low-intensity magnetic field treatment to resonate in the brain and promote its endogenous healing mechanisms,” Drechsler stated.

This sort of stimulation has been proven in various situations to increase neuroplasticity, or the ability of the central nervous system to reprogram itself. BrainQ’s gadget increases neuroplasticity in stroke-affected regions by carefully targeting them, resulting in faster recovery.

However, it is not as simple as stating, “The stroke injured the ventral half of the right occipital lobe; point the magnets there.” A brain is a complex machine, and strokes affect networks rather than simply a single cubic centimeter. BrainQ used machine learning and a vast data set to better understand how to target those networks.

Without going into too much detail about how the brain works, suffice it to state that particular networks operate locally at very precise spectral signatures or frequencies as measured by EEG measurements. The left hand and left foot may share the same motor cortex area, but the hand may function at 22 Hz while the foot operates at 24 Hz, for example.

The innovative aspect of BrainQ’s experimental therapy 

The innovative aspect of BrainQ’s experimental therapy is the data-driven technique we used to guide the ELF-EMF frequency settings. Our goal in selecting these parameters is to pick frequencies that define motor-related neural networks in the CNS and are connected to the impairment that a person feels after a stroke or other neurological damage.

To do this, we examined the brainwaves of a huge number of healthy and unhealthy people (electrophysiology data). Explanatory machine learning algorithms are used in our technology to monitor natural spectrum features and extract unique therapeutic ideas. BrainQ’s technology uses these to target the recovery of damaged networks.

The gadget they’ve devised to deliver the therapy is unique. It features a somewhat big cylindrical headpiece since it is a whole-brain magnetic field generator, but the rest of it fits into a type of back brace and hip pack. This is due to the fact that, unlike the more commonly used magnetic brain imaging technology, MRI, the fields and currents involved are exceedingly tiny.

“We utilize very, very low intensity, roughly the same as natural brain activity,” Drechsler explained. “It is not about producing an action potential or a spike in activity; it is about creating the appropriate conditions for recovery mechanisms.”

Findings of the simulation

The findings of this stimulation were confirmed in a small (25 patient) but pivotal research that is now being evaluated and published (preprint abstract here). Patients who received the BrainQ treatment in addition to standard therapy had significantly improved recovery evaluations, which look at metrics such as improvements in balance and strength; 92 percent saw significant improvements over just therapy, and 80 percent achieved what could be called recovery (though this term is inexact).

In general, the therapy would take approximately an hour at a time, during which the patient would perform various physical activities while wearing the device, and it would need to be performed five days a week for around two months. The headgear sends the patient’s own patterns to BrainQ’s cloud-based service, which does the necessary crunching and matching to provide a personalized therapy pattern.

Everything is controlled via a tablet app, which may be used by a caregiver (such as an outpatient nurse) or by a built-in telemedicine platform. According to Drechsler, this technique was not well accepted at first, and not only by one reporter.

“In 2017, we began laying the groundwork for a cloud-connected therapy gadget that can treat the patient wherever she or he is,” he explained. “At the time, no one was ready to even discuss treating patients outside of the hospital’s regulated setting. Then COVID arrived in 2020, and everything changed.”

​​During the epidemic, many people recuperating from strokes who would typically go to the hospital for regular care were (and still are) unable to do so. A low-risk, possibly high-results home-based therapy would be very beneficial to the hundreds upon thousands of people who are now recuperating from a stroke. Furthermore, he emphasizes that it does not divert resources away from existing treatment programs, but rather enhances their outcomes. (“We never move anyone’s cheese.”)

Normally, here is where you would read something like, “but it may be five years before the FDA authorizes it for insurance and usage.” However, BrainQ just achieved Breakthrough Device certification, an accelerated approval procedure that, as of the beginning of this year, also confers eligibility for Medicare coverage. This means that, while it is still a year or two away, BrainQ may start delivering devices very soon.

How will the funds be used?

The company’s next move, very conservatively, is larger-scale research, to which it wants to commit a major amount of its recent financing, $40 million headed by Hanaco Ventures, with participation from Dexcel Pharma and Peregrine Ventures.

“We raised all of this money because we are about to embark on a one-of-a-kind research with 12 sites,” Drechsler explained. While he could not yet identify the hospitals or research institutions with which they collaborated, he stated that they were the cream of the stroke rehabilitation crop and that “really, we couldn’t strive for more than obtaining all these top locations in the same study.”

“There is a sense of excitement that something fresh in stroke rehabilitation is on the way; there has been practically no advancement in the previous two or three decades, and physical therapy has been the standard for two centuries.” Without making any guarantees, he hinted that this line of study may lead to medication not only reducing but also reversing some impairments, a feat whose worth cannot be overstated.

“I was going over my pitch decks from 2016,” Drechsler remarked. “As a CEO, you have huge aspirations early on. We were met with a lot of skepticism early on in the process, but I was pleased to discover that many of those wishes had come true.”

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