Dr. Gualtiero Guadagni is the CEO of Bionic Power. We put a few questions to him about  future products and expanded markets for the Agilik.

Why did Bionic Power decide to focus on the pediatric market, which is typically considered a niche characterized by small numbers and higher regulatory burden?

GG: The first version of the Agilik is intended to help pediatric patients with crouch gait to walk better and more efficiently. (Crouch gait affects as many as 80 percent of all children with cerebral palsy; and although crouch gait afflicts others as well, kids and adults with cerebral palsy are primarily who is affected.) This version can support people weighing 70 kilograms (154 pounds) or less. This encompasses the purely pediatric population but doesn’t cover the whole spectrum of possible patients.

The market for supporting crouch gait (pediatric and adult) is relatively open as there are no other devices that provide the benefits provided by the Agilik. There is no competition in our targeted segment, despite all of the clinical stakeholders: orthopedic surgeons, physical therapists, pediatricians and of course patients. This means that the Agilik has the potential for resolving a vast unmet rehabilitation need.

What do you see as the evolution of the Agilik—from a device used for crouch gait to one that broadens in its applications into knee problems?

GG: We are already working on the adult Agilik, which takes even more from our original military exoskeleton, including a larger motor to support larger people. We envision that the adult model will likely use a different strapping system and not rely on KAFOs. The strapping will be more streamlined and lightweight, like our Amplify military device.

What’s exciting is that the Agilik has so many other potential possibilities in terms of who can benefit from it. The Agilik could help those who need just a bit of a boost to walk further or climb stairs more easily. According to the National Center for Biotechnology Information, knee pain affects approximately 25 percent of American adults, with osteoarthritis being the most common among people 50 or older.

We also plan to add specific features, such as a sit-to-stand option, which will help the elderly get up from low-set chairs, couches, etc. These additional features are the result of the vast body of research, and the clinical trials we’ve done. It’s our belief that the knowledge the Agilik has given us will also allow us to further refine the device, greatly expanding the number of people who can benefit from it.

What are the challenges of this evolution? Are they technical? Or is it more of a marketing issue? Or both?

GG: The market is there, with more than 80 million new people per year worldwide experiencing knee-related gait issues. We have mastered the technology that we developed while working on the military product. Our challenges are related to bandwidth, cash position, and personnel: we are very close to bringing the pediatric device to the market and proving our business proposition. Unfortunately, we cannot afford the luxury of developing two products at the same time.

I learned a few years back that the main causes of failure for a startup are external holdups and internal distractions. COVID-19 taught us that external holdups are sometimes difficult to control, so we need to manage distractions as well as we can! That said, we know many people have been hoping for a technological enhancement in this field for years, and we are eager to satisfy them as soon as possible.

What sort of shift needs to occur for the Agilik to make the leap from crouch gait users to people with knee issues? Is it a shift that will need to happen among potential consumers? Or will it come from investors?

GG: The shift will really be for the product itself and its controlling software.

What sorts of products usually make the shift from military applications and government investment to consumer products?

GG: Many products that we use every day have made this leap from military applications to daily consumer use. Duct tape, cyanoacrylate glue (Super Glue), sanitary napkins, and bug spray all started out as military inventions. (Even Pringles potato chips—!—were a collaboration between the U.S. Army and the USDA.) Basically, anything that has a broader use outside of military maneuvers or tactics.

Is this background in development—with the military, with government trials—a positive or something Agilik will need to overcome?

GG: Definitely a positive, as it gave us funds and a motivated group to test out our technology, which we have pivoted to the medical arena.

Where is the biggest open space in the market?

GG: We envision the Agilik becoming a medical consumer product that will help the aging population maintain their mobility and independence beyond walking: the Agilik will help them to sit or get up from a chair and help them to stand for a longer time, which is essential in many daily activities such as ironing or cooking.

If price is the primary obstacle in the way of more people adopting its use, what needs to happen to get past this?

GG: I don’t think price will be too limiting a factor. The Agilik is much less expensive than exoskeletons and should be covered by most insurance plans. The biggest limiting factor may simply be getting the right people to know of its existence!

Is production also an issue? If so, what sort of benchmark needs to be reached for production not to be an obstacle?

GG: No, the manufacturing of the Agilik is scalable by design. The product is going to be assembled inhouse with most of the crucial components being manufactured in Canada.

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