Bench Talk

(Source: axel / stock.adobe.com; generated with AI)

Based on an interview with Leo Petrossian

Introduction

Brain-computer interfaces (BCIs) are in the headlines as innovations and high-profile advocates have caught the public’s imagination. To understand their practical applications, Mouser Electronics spoke with Leo Petrossian, Chief Executive Officer of Neurolutions, to learn how his company has become a key innovator in the field of non-invasive BCIs through its IpsiHand therapeutic device.

Leo Petrossian is the current Chief Executive Officer of Neurolutions, Inc. Previously, he co-founded Neural Analytics and was also the CEO of Nile AI, Inc.

Dr. Petrossian earned his MBA from the UCLA Anderson School of Management in 2014 and earned his PhD and MS in Biomolecular Nanotechnology & Solid-State Device Physics as an NSF IGERT fellow at Arizona State University in 2007. He also holds a double BS in Electrical Engineering and Biomedical Engineering from California State University, Long Beach.

To begin, Petrossian explained what makes Neurolutions different: "The world of BCIs has two key differentiators. The first is between invasive and non-invasive technologies. The invasive concept has been popularized by science fiction—the idea of a neural implant that allows the user to manipulate technology by thought alone. The alternative way to approach BCIs is to use external or non-invasive technology."

"The second key difference is the use case. Many of the companies that are investing in BCI research are looking at prosthetic solutions—the idea of a permanent device that replaces or enhances a user’s abilities. Think of an artificial limb controlled by a direct link to the brain."

Petrossian explained the thinking behind the Neurolutions product: "We chose to address the therapeutic applications for BCIs. When you compare this to permanent BCIs typical of prosthetic solutions, we believe that the therapeutic applications offer a more compelling and significant opportunity. We think patients are far more likely to adopt a therapeutic solution that they can take off when they want instead of a permanent implant."

Developing the IpsiHand

Petrossian told us more about the impetus for the Neurolutions IpsiHand, a brain-activated therapeutic device that helps recover motor control in people who have had a stroke. "If you see a stroke victim who has lost the use of an arm, your first impression is that the arm itself is impaired. But the arm is perfectly fine—it’s inside the brain where the stroke has done the damage."

Petrossian gave us a practical demonstration. "If I ask you to raise your hand, your first step is to imagine the action you must take. The brain thinks about moving the hand before translating that thought into movement. This is the intent, or pre-motor planning, that happens in the brain. Stroke survivors no longer have the link between the intent and the control of the hand. The stroke has destroyed the part of the motor circuit that allows it to move the hand."

The IpsiHand uses an external electroencephalogram (EEG) worn on the head. When the patient thinks about moving their hand, the EEG headset detects the correct signal within the brain and sends instructions to the IpsiHand, which then uses motors to move the patient’s hand (Figure 1). The patient senses that movement and the brain starts to rebuild the link between the intent and the movement of the hand.

Figure 1: IpsiHand detects brain activity with an EEG headset and sends instructions to the handpiece, which then uses motors to assist the patient with hand movement. (Source: Neurolutions)

"The plasticity of the human brain means that it can reorganize itself by building new pathways that bypass the damaged sections, and over time it can restore the motor control. This process is known as Hebbian learning," noted Petrossian.

When discussing the effectiveness of the treatment, Petrossian said, "If the patient uses the IpsiHand for the recommended hour per day, that patient typically recovers 1 percent of the mobility of the hand for every week of use. The great thing is that the results are cumulative and permanent. If the patient uses the IpsiHand for ten weeks and responds to therapy, they can expect to recover 10 percent functionality, even if the device is turned off and never used again."

Applying Long-Established Knowledge

While Neurolutions is focused on the next generation of stroke recovery technologies, the detection technology behind the IpsiHand is not new. The EEG that detects brain activity was first demonstrated a century ago. In fact, the EEG is the easy part. Petrossian explained, "The technology is well established, but what makes the IpsiHand work is how we interpret the signals that we detect in the brain. It’s that decoding step that is the biggest challenge in the field of BCI infrastructure."

Petrossian continued, explaining why this decoding step is so important. "We’ve known for a long time which parts of the brain control the functions of the body. What differs for every patient is how the stroke has affected the brain—each patient has unique symptoms and underlying motor circuit damage. For the IpsiHand to work, it must be customized to the patient. This mapping process takes an hour, and the sophistication of artificial intelligence plays a role—the signals collected from the patient’s brain during mapping are used to train the IpsiHand to best suit that patient."

Petrossian believes that the non-invasive approach has won over Neurolutions customers. "Many companies investing in BCIs are led by engineers, not clinicians. This might mean they adopt a technology-first view that may not prioritize the clinical needs of users. You need to make the patient the focus of the solution—without their acceptance, IpsiHand would not be a success."

Neurolutions obtained US Food and Drug Administration (FDA) De Novo market authorization for the IpsiHand. "You might think that this is the gateway to commercial success, but you have to understand that it is just a stepping stone on the path to launching a product. The FDA has a very clear responsibility: to be sure of the safety and effectiveness of a treatment. Any new device needs to demonstrate that the risks involved are outweighed by the results."

Petrossian acknowledged that research is still vital. "Our solution was only made possible by the work done on invasive techniques by the University of Washington. Once that technology was validated, Neurolutions was able to develop a viable non-invasive solution. Without that initial research, I can’t see how any product of this type would succeed."

Working with the FDA and Medicare

After the initial success with the FDA, Neurolutions's work with the US Centers for Medicare & Medicaid Services (CMS) made the IpsiHand a scalable product. The IpsiHand now has a novel billing code that allows medical professionals to prescribe it as a therapy and for health insurance to potentially cover the cost of the therapy, significantly increasing access to the intervention.

While various companies are currently working with the FDA, Petrossian cannot say if anyone else has yet submitted a comparable device for clearance. Petrossian explained the challenge: "The FDA needs to know or believe that a device isn’t going to be causing long-term harm to the patient. Implanting electrodes into the brain is perceived as high risk. The bar must be set so high when considering risk versus reward that it may be a long time before there is a successfully commercialized solution on the market."

Finally, Petrossian offered three pieces of advice to anyone wanting to develop a new BCI technology. "Don’t think like an engineer; think like a clinician or a patient. If you focus on the tech, you’ll lose sight of the end goal. Second, an FDA clearance is not a guarantee of success. It’s important, sure, but it is just one step on a long journey. Finally, without concentrating on the clinical needs of the patient, the economic needs of the payers, or the practical needs of clinicians, you’ll never obtain the widespread adoption you need to succeed."