Then, last year we completed seed funding with a €500,000 investment of EIT Health (European Institute of Innovation & Technology) to clinically validate the exoskeleton for paraplegia in leading clinical institutions like Institut Guttmann and Heidelberg University Hospital and obtain the CE certification.
By the way, another thing that we have not stopped doing since the very beginning is writing project proposals to achieve public funding, and it takes time but it works!
IH: How have managed the growth of the company?
AC: By understanding very well the needs of the company at each phase and maximizing the resources available. And here the help of advisors that have been serial entrepreneurs such as Bart Huisken, PhD or John Collins, PhD has been critical.
In the initial stage, all our efforts were put into R&D to quickly develop prototypes and test them with patients. Later, we incorporated experience in clinical affairs to prepare the protocols of the clinical studies to validate our technology in a hospital environment with larger patient populations. The next step has been to add regulatory and quality expertise to the team, in order to prepare all documentation for regulatory authorities towards certification and implement a rigorous quality management system in the company. So, in just two years, we have gone from being only the three founders to employing 12 full-time people (and growing). But what is great is that the atmosphere and the company culture stays the same as the first day, and we maintain the same core values: curiosity, humbleness and fearlessness.
IH: What were some of the main challenges you faced along the way and how did you resolve these?
AC: We have found many challenges and difficulties along the way, the important thing is to learn from mistakes and persist. For example, I cannot remember how many times investors rejected us when we initially pitched the project. But we improved the message and looked for more specialized investors who understood the peculiarities of the medical sector, especially its longer time-to-market and commercialization strategies. Once the first investors were convinced, closing the round was much easier. In fact, we exceeded our expectations and we decided to increase the size of the seed investment round. Another challenge has been to involve the right people and partners. Being young, it was very important for us to select a group of expert advisors with an extensive network of contacts and the ability to support us in solving the problems that arise. In order to move forward, it has been key to engage the best-inclass partners, with leading hospitals such as Institut Guttmann, Heidelberg University Hospital or ASEPEYO, technological partners like Ingenia Motion Control or Harmonic Drive and research institutions like the UPC Biomedical Engineering Research Centre.
A huge challenge we face and will face in the coming years is the lack of innovation in the area of rehabilitation. Thus, options available to patients for standing and gait training are sub-optimal and have not changed much in the last 50 years. Therefore, it is a challenge to introduce an innovative device like ours in to clinical practice, when, for example, therapists are used to doing mobilizations manually. Disincentives such as fragmented markets, regulatory requirements, and reimbursement difficulties are not helping this change.
Finally, a challenge that we overcome every day is that, although there are criteria to classify injuries, each person is different. For this reason, we are trying to adapt our technology to the needs and evolution of each user, both ergonomically and functionally.
But this is just the beginning, and we have many challenges ahead for when we start the commercialization. First, is the lack of brand awareness, as key industry players in the market are well-established companies, so it is difficult for incoming small enterprises to generate trust and traction with key clinical opinion leaders. And second, there are very few existent reimbursement policies for exoskeletons: the cost of medical exoskeletons is currently not reimbursed (or co-paid) by public health systems. Economic and clinical studies, providing a systematic evaluation of their effects over the long-term, need to be performed to boost reimbursement on a wider basis and comprehensive decision-making by regulatory institutions and healthcare professionals.
IH: Can you give us some detail about the ABLE device?
AC: Yes, it is a powered exoskeleton: an external supporting structure placed on the user’s body to reinforce or restore human motor function with powered movement. The device is attached through straps to the lower-body and has a motor in each knee joint that acts as an artificial muscle, flexing and extending the leg to actively help the user to stand up, walk and sit down, mimicking natural movement. It embeds smart sensors and algorithms that seamlessly detect the user’s intention to take a step, without performing unnatural postural cues.