ExoAtlet Enters the US Market
ExoAtlet, a Skolkovo (VEB.RF Group) resident and portfolio company of RVC Biofund, received FDA approval for its medical exoskeleton, ExoAtlet II. The certification confirms the device’s compliance with standards set by national regulations and opens up the American market for it.
ExoAtlet opened its US office in 2018 and it began the process of gaining FDA approval. Part of the certification process for ExoAtlet II’s clinical safety and efficacy clinical trials. To run the trials, the company underwent an ethics committee evaluation as to its compliance with Good Clinical Practice.
ExoAtlet developments: Bambini, ExoAtlet I, and ExoAtlet II. Photo: Sk.ru
The potential size of the US market for exoskeletons is one of the main factors in ExoAtlet’s efforts to gain FDA approval. The annual number of strokes in the US numbers 795,000, approximately four times greater than in Russia. Over 18,000 Americans a year suffer from severe spinal injuries and the number of operations for endoprosthesis replacement is forecast to reach 4 million by 2030.
Ekaterina Berezii, the co-founder of ExoAtlet, stated: “Our dream is to give people around the world the possibility to recover. For that, we are creating new exo-rehabilitation methods and new exoskeletons, with which we will enter new markets. And each time we do this, we have to confirm their safety and efficacy in accordance with regulatory requirements. These are always different quests that require different resources and don’t always have a predetermined time. The FDA is our latest big victory.”
Apart from the preparation stage, laboratory tests and clinical trials, ExoAtlet added the CGMP (Current Good Mood Manufacturing Process) quality system to its production. In preparation for the FDA inspection of the system’s compliance with CGMP requirements, the company trained specialists and improved the quality of its management system, while simultaneously gaining the international certification standard ISO 13485:2016. In line with FDA requirements, special attention was paid to the software component of ExoAtlet II and its resilience to cyberthreats. The company’s production in South Korea will now be audited for CGMP compliance on a regular basis.
Natalia Polushkina, vice president and deputy CEO of the biotechnologies cluster at the Skolkovo Foundation stated: “ExoAtlet is one the few companies that is changing perceptions of Russian producers of medical technologies. In gaining FDA certification, our resident now has powerful proof of the safety and quality of its most complex medical device, ExoAtlet II. Thanks to built-in functional electrical stimulation and biological feedback due to the ability to detect a patient’s efforts, the new version of the exoskeleton, which is now certified by the American regulator, will allow for more effective rehabilitation training for patients with partially preserved functions in the lower limbs. We are proud of ExoAtlet’s successes and wish it success in entering a new, large market.”
ExoAtlet II previously underwent medical certification in Europe (CE Mark), South Korea (KFDA), and Russia (RU), which confirmed that the product “meets the high safety, health and environmental protection requirements” (European Commission 2015).
The next step for the company on the international market is to launch the first exoskeleton in the world that is designed for rehabilitating children and teenagers – ExoAtlet Bambini. In 2021, the device was certified in Russia and is already helping children with cerebral palsy to learn how to walk properly so that they can be independent as adult members of society.