Earlier this month I had the pleasure of speaking with three highly innovative exoskeleton companies, two of which are start-ups in the process of achieving approval: Able Human Motion with their lower limb device, and Harmonic Bionics with their upper-extremity device, and a key player in the market, Ekso Bionics. These companies are all contributing to changing the landscape of Med Tech, each with their own unique and pioneering solutions, providing paralysed patients with life-changing rehabilitation solutions, and empowering them with greater mobility and independence in a way that has never been possible before.

The robotic exoskeleton market has gained eminence over the past few years, with a rising geriatric population, and millions of patients around the world suffering with debilitating conditions such as spinal cord injury, paraplegia, cerebral palsy, and the effects of strokes and brain injuries.

Exoskeletons are external frames that can be worn to support the body, either to help a person overcome an injury or to enhance their biological capacities, providing physically disabled people the freedom to stand, move and interact. These powerful wearable devices work in tandem with the user, taking into consideration their posture and body weight distribution, some of which can even allow people with disabilities such as lower-limb paralysis to experience walking again.

With the global wearable robotic exoskeleton market value set to reach $8,841.6 Million, and a CAGR of 32.68% forecast between 2021-2031, this is without a doubt an industry with huge opportunity for growth, and these devices are yet to achieve their full potential.

Firstly, I spoke with Alfons Carnicero Carmona, Co-founder, and CEO of 2018 Barcelona start-up, ABLE Human Motion to discuss their ABLE Exoskeleton, a lightweight, affordable and easy-to-use device for paraplegic patients. ABLE was founded off the back of a research project at the Polytechnic University of Catalonia (UPC). After scoping the market, Alfons realised an opportunity for an intuitive, lightweight, and affordable lower limb exoskeleton, which then drove him and Co-Founder Alex Garcia Farreny to start up ABLE Human Motion.

ABLE is also driven by an element of personal motivation, resulting from Alfons’ father’s stroke, where he witnessed first-hand the debilitating effects of this condition. This drove Alfons to gain experience in business management along with Co-founder, Alex and to then turn the lab prototype into the ABLE Exoskeleton, which enhances patients’ ability to walk naturally and intuitively, boosting self-confidence and autonomy.

Having an education and career path based in biomechanical engineering I thought it was apt to ask Alfons how his experience gives him a competitive advantage in the Exoskeleton market?

“My experience in biomechanical engineering was helpful in showing me the interaction between advanced technology and the human body – but to turn this into a company I did several courses in business management to help prior to founding ABLE”.

Off the back of this, I wanted to know what differentiates ABLE as a company in comparison to their rivals in such a competitive market?

“When scoping the market, we witnessed that many products were very heavy, weighing 20/25kg, making it difficult for a patient to move. Many competitors’ devices are also extremely expensive and only large hospitals would be able to afford them, with specialised hospitals usually only having one device for all patients”.

“Our research also translated that currently, the patients can only benefit from these devices at a very early stage of their rehabilitation, rather than on a continuous basis. This was the problem, and we approached it by developing the first lower extremity exoskeleton to weigh under 10KG and it’s a device that can be used by the patient autonomously. They can walk without needing physiotherapy and we put a lot of effort into reducing the cost of this technology – simplifying the technology to the max to keep the price low”.

ABLE’s Exoskeleton device is still in the development stages in process of receiving feedback to determine how useful the device will be in hospitals. In terms of achieving CE Marking, I asked Alfons to tell me how they are going about attaining this certification, and whether the pandemic had an impact on the development of the product at all?

“First of all, we started the clinical trials. The aim of these trials is to demonstrate that the device is safe and usable in a hospital environment. We are testing the device with 40 people, and they are completing a training programme that lasts around one month each, so they are using the device quite intensively for three times a week for one month – and the regulatory process will begin around the beginning of next year”.

“Luckily the only thing that affected operations was that we were running clinical trials in the Heidelberg University Hospital in Germany where the pandemic really slowed down the recruitment process, so we had to delay the clinical trials slightly. They finished in September when they were expected to in July”.

Being a start-up that was born in Europe, this is currently the market that ABLE is focused on, being the place where most of their partners exist, including hospitals, distributors, and key clinical doctors. Furthering on from this I asked Alfons what their plans are to expand outside of Europe into other markets, and whether they will develop their product range beyond the lower-extremity device?

“We plan to enter the European market in 2023 following CE Certification, but later we hope to expand to the North American market. The US would be a key market for us because of their high expenditure of medical devices, and they have only one language for the whole country which can be challenging in Europe”.

“In terms of our product portfolio, our current device is specifically for people with spinal cord injuries, and we’ve only tested the product with these kinds of patients. But we are already creating a second product for people who have Hemiplegia resulting from a stroke. This is a different challenge because with spinal cord injuries patients normally lose all their mobility. With a stroke, it is more like a partial weakness of half of the body, and the device needs to understand which part of the motor functions to assist with – it’s expected to be tested after summer”.

Next up, I had the chance to speak with Stephani Shipman, Marketing Director at Harmonic Bionics, a start-up based in the U.S. who was founded in 2016 and is augmenting human movement with intelligent robot technology that facilitates data-driven treatment. Unlike ABLE, Harmonic Bionic’s preliminary product is an upper-extremity device, dynamically designed to provide treatment in neuroscience, movement science research, and disorder rehabilitation.

Founded by Dr. Ashish Deshpande at the University of Texas in Austin, along with one of his Ph.D. students at the time, Dr. Youngmok Yun. The pair developed the Harmony SHR as a more efficient rehabilitation solution for patients suffering from upper body movement disorders after winning multiple grants and awards. Being a Roboticist, Ashish realised the vast opportunity in this field for automation and robotics to help with outcomes for patients and this was further recognized following his hand injury for which he underwent occupational therapy. Now Harmonic Bionics are on the path to commercialising their first device – Harmony SHR.

All the system’s data capabilities enable researchers and caregivers to optimize the treatment process for patients suffering from movement disorders by measuring functionality at baseline and throughout the recovery process. Harmony SHR’s different modes of therapy also help address patients throughout the care continuum, from highly impaired patients with no motor function to progressing patients in a post-acute setting, or outpatient rehabilitation facility.

Firstly, I asked Stephani to explain what Harmonic Bionics’ USPs are, and how the Harmony SHR device has a competitive edge in the industry?

“The main difference is its bilateral design, so for upper extremity robots, there’s a lot of unilateral devices that address the arm. Harmony SHR stands for Scapulohumeral Rhythm – and that is because the design of the system mimics the glenohumeral joint in the shoulder and it’s the first system to do that”.

“We’re incorporating the scapular component which some would say is really important when you’re rehabbing the arm. So, it’s focusing on the entire extremity as opposed to just certain joints in the arm, and that’s really what sets it apart and what we see people getting really excited about – offering patients a much larger range of motion in an upper extremity exoskeleton than they have seen before”.

Artificial Intelligence is a phenomenon that is proving to be useful in many areas of Med-Tech In terms of data capabilities, and its wider use has recently extended to exoskeletons. Despite there not yet being a specific regulatory framework for AI in Medical Devices, I asked Stephani whether this was an aspect that they plan to incorporate into their devices in the future?

“With over 80 sensors recording measurements at 2,000 times per second, Harmony SHR is already capturing tonnes of data. We’re really excited about that because there are a lot of subjective assessments in occupational/rehab therapy right now, so we know that data-driven care is really where things are headed. We want to be able to measure baseline throughout progress to see what’s really helping patients so we think Harmony will assist in data-driven care and the capability of a therapist to see what can help the patient”.

“In terms of AI – yes, definitely. We see harmony as a smart/intelligent device and I think we’ll continue to move in that direction, where robots will not necessarily replace therapists but will really enhance their understanding and knowledge of the patient so they can better provide treatment to them”.

Harmonic Bionics are still in their development phase and are on the path to commercialising their device, and having secured $7M in series A funding earlier this month, I was intrigued to find out how this investment will support the company’s future clinical research and development?

“This year with the Series A, we just completed one of our first clinical studies at a hospital in Austin, where we’re based which was testing safety and usability. We will soon start another clinical study at a major facility in the U.S.”.

“We hope to freeze design and commercialise next year, and really prioritise getting the word out about the device and getting in front of people. We’ve been doing virtual demos for so long so now; we look forward to physically getting in front of therapists so they can get their hands on it too”.

Finally, I spoke with Rachael Adams, Global Director of Marketing & Strategic Growth at Ekso Bionics. Ekso Bionics is a key player in the market, having been founded in 2006 and offering both upper and lower extremity wearable exoskeletons. Ekso Bionics initially created exoskeletons for the military and was backed by a lot of early research development through R&D grants.

They initially developed their first commercially available medical device, the Ekso 1.1 which was shortly thereafter renamed EksoGT. Now Ekso’s medical device portfolio consists of newly approved lower and upper extremity devices: EksoNR and EksoEU, some of the few that are currently FDA cleared in the U.S.

These cutting-edge devices can be controlled depending on the patients’ needs through the power, velocity, and step length. The EksoEU offers 180 degrees of motion to assist patients in upper limb rehabilitation and is a spring-powered exoskeleton – it can keep up clinical use all day without needing a power source. The EksoNR is a lower extremity exoskeleton that supports upright posture and teaches the wearer how to walk again and regain a more natural gait. I asked Rachael to tell me a bit more about Ekso Bionics as a whole.

“Originally our medical exoskeleton was a lower extremity device called Ekso 1.1, which was renamed EksoGT, which stands for gait trainer, so really early on it was more geared toward the spinal cord injured community – getting people up and walking”.

“The device was driven by feedback from physical therapists and what kind of tool they find to be most useful in treatment, and with that our exoskeleton became more of a rehabilitative tool in 2013. Ever since then it’s been continuously improving. We’ve expanded to being able to work with stroke patients in 2016 and then in 2020 we got brain injury clearance from the FDA and we’re the only exoskeleton company to have that clearance”.

Following this, I then asked Rachael what Ekso Bionics’ competitive strengths are and how these differentiate them from their main competitors, Indego and ReWalk?

“There are a few big things that differentiate us – our devices are clinically proven; we are the most researched exoskeleton out there so there’s a lot of proof that the device itself is helping patients recover. Another component is with our change to Ekso NR, we really went from being more of a gait training tool (which was just focused on walking) to now having a whole pre-gait suite. A lot of balance components, weight shifting, and squats can be done in the device.”

“I think the biggest differentiator is our advanced features. The component that’s the coolest to see in action is added resistance, so after a patient has gotten used to using our device and they’re starting to gain strength, you can add high or low resistance on one or both legs and work on strengthening even more. Our competitors don’t have a resistance option, their devices don’t automatically adapt to the patient as they’re walking, and they don’t allow for assisted backward walking or side-stepping”.

We then discussed the repercussions of the pandemic, and Rachael explained how COVID impacted business operations:

“COVID definitely impacted us because access is a huge factor. Our sales team goes into the hospitals and provides demonstrations of the device so the physical therapists can get their hands on it and with COVID there was much less of that because of restrictions on visitors to the hospitals. Another impact was that advanced technologies were not top of mind for most hospital executives, but we did well, regardless. It’s hard to sell a piece of technology like Ekso virtually, mostly because PT’s want to get their hands on the device and see how it works with their patients”.

I then asked Rachael her thoughts on incorporating other technologies such as AI with exoskeletons to gather data, and what trends she predicts in the coming years for exoskeletons?

“I think incorporating exoskeletons with other technologies will definitely be something that happens in the near future – I know virtual reality, augmented reality and AI are definitely some of the “up and coming” trends in rehabilitation”.

“At Ekso Bionics, we do already have a lot of data that is provided with Ekso from every session. For example, you can see how many steps a patient takes, how they’re standing, how many reps they did of squats, and what the symmetry between their feet looks like. Continuing to provide more data on the patients’ recovery with advanced technology will be a big focus in the future”.

“In terms of trends, in my personal opinion having been in this industry for as long as I have, about 5/10 years down the road, I’d love to see exoskeletons incorporated into people’s clothing. For example, if someone has a spinal cord injury, it would be fascinating to advance the technology so they could wear a device under their clothes discretely – I think that would be incredibly exciting”.

It was a real pleasure connecting with each of these companies and gaining an insight into their cutting-edge devices. It is without a doubt that these exoskeletons are a ground-breaking solution to patients, as well as having the potential to make life significantly easier for medical staff, assisting doctors during long hours of surgery, and reducing the physical strain for nurses who may have to carry heavier patients. I look forward to witnessing exoskeletons continue to proliferate in the healthcare industry and how these companies will expand and innovate in a highly driven market.