The views and opinions expressed in the interviews published on Made in CA are those of the interviewees and do not reflect the official policy or position of Made in CA.

The information provided through these interviews is for informational purposes only and does not constitute an endorsement or recommendation of any products, services, or individuals featured. We strongly encourage readers to consult with appropriate professionals or authorities in the relevant fields for accurate information and advice.

Gualtiero Guadagni

Bionic Power’s purpose is to design and develop lower-body smart orthoses that improve quality of life by enhancing personal mobility and walking abilities. Stand Taller, Walk Stronger™

Tell us about yourself?

I have spent all of my career, almost 25 years, in medical devices. During this time, I have worked in research and development, regulatory and commercialization, in academia first and then the private sector beginning in 2003. Both in Europe and in North America. Prior to joining Bionic Power in 2021, I was President of Dialco Medical Inc. I received my Ph.D. in bioengineering and a master’s degree in mechanical engineering from Politecnico di Milano University in Italy.

If you could go back in time a year or two, what piece of advice would you give yourself?

I only joined Bionic Power a year ago, so maybe check in with me in a few months after I have more time to make mistakes and realize the ones I have already made!

What problem does your business solve?

Agilik

Bionic Power has the mission to improve mobility impairments due to knee-related pathologies.

Our first commercial product, the Agilik, will help children suffering from crouch gait improve their gait and their mobility. More than 300,000 children suffer from crouch gait in the U.S. alone. Despite available treatments, 44% of them will see their walking abilities worsen in their adult life. Our goal is to keep people mobile and independent by helping to alleviate some or all of their crouch, increasing their knee extension and strengthening their legs, enabling them to Stand Taller, Walk Stronger.™

What is the inspiration behind your business?

This is a great serendipity story… Bionic Power started with the idea of harnessing “wasted” energy at the knee during a normal stride. Turning this concept into a device resulted in 10 years of R&D funded by the military, engineering a lightweight exoskeleton that harvests this energy and converts it into usable electrical energy, without creating discomfort or limiting movement.

Despite positive reviews from field testing, the device was not adopted by the armed forces due to continued, increasing energy requirements and improvements in battery technologies. In 2017 our CTO Clive Mullins read a paper published by a research team from the National Institutes of Health Clinical Centre (“NIH”) featuring a powered orthosis with an innovative sensor-based control system. Their system had been successfully used to improve the gait of children with cerebral palsy.
The Idea appeared to be absolutely great, although their “mechatronic” technology looked very much like a prototype.

Bionic Power’s technological platform was perfectly suited to support this group of researchers, and we began discussing it with the NIH. The result is Bionic Power’s initial product, the Agilik™. It is the result of a Cooperative Research and Development Agreement between the NIH and Bionic Power. The Agilik is a smart orthosis: a gait state driven, powered, pediatric gait rehabilitation device. The pediatric version of Agilik has been designed to improve crouch gait commonly seen in children with cerebral palsy (“CP”), spina bifida, and other knee-extension-deficiency disorders.

What is your magic sauce?

A huge difference between our smart orthosis and existing exoskeletons is that we actively change the wearer’s posture without forcing them into a pre-determined trajectory. Traditional gait-assist devices and robotic exoskeletons use an assist-as-needed approach and guide the user toward a specific physiological trajectory. The Agilik, on the other hand, requires engagement as the wearer is still the one walking. We aren’t holding them up, we aren’t forcing a particular movement. So the users must adapt while integrating their own control.

Another huge difference is our price, which is less than a fifth of similar devices!

What is the plan for the next 5 years? What do you want to achieve?

Gualtiero with Amplify

In the next five years, I plan to bring BPI into the global market and expand into models that can help every person, with or without a specific gait issue.

Our future plans include developing an even less expensive version, designed for mass manufacturing and expanding the Agilik to an adult crouch gait model. Our current model is limited to a user weight of 70kg, as we have been focused on pediatric use. We also plan on developing a device that combines even more of the technology from our military exo into the medical device, resulting in a knee-based orthosis that everyone could benefit from. Whether it is for assistance getting up from a seated position or for an extra boost on a long hike, this device could help everyone.

What is the biggest challenge you’ve faced so far?

The list is extremely long…. Switching from being an engineering lab to a medical device manufacturing company is a big jump in terms of regulatory requirements, implementation of a quality management system, and getting all necessary certifications. Like any other manufacturer, we are dealing with staffing and supply chain issues. Last but not least, we are a startup company, and as such, we burn a substantial amount of cash funding our product and clinical development as well as getting ready to commercialize our products.

How can people get involved?

We are always interested in hearing from people with crouch gait or their parents/caregivers as to what their specific and unique needs are or from medical professionals who have input or think that one of their patients may be a good fit for the Agilik. We’d love to hear from orthotists about our assembly process, which was designed with orthotists but we know that there are varying practices and processes and we want to make assembling the Agilik as simple for them as possible.

Bionic Power is of course always looking for interested investors who want their investments to help society.

Please contact us at [email protected] or sign up for our newsletter on our website to stay updated.