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(English) Skolkovo Biomed Company ExoAtlet Gains CE Mark Allowing Export to EU Countries

22 августа 2020

(English)

ExoAtlet, a Skolkovo resident company from the biomedical technologies cluster, recently gained CE certification allowing the company to export its rehabilitative exoskeleton technology to all EU countries as well as some non-EU states. This is a major leap for the company, because the process of gaining CE certification takes time and incurs large expenses but the benefits are manifold. The next step is to get FDA approval, which would allow export to the US market.

ExoAtlet exoskeletons are used in over fifty medical centers in Russia, Asian countries, as well as scientific centers in Portugal and the Netherlands. By improving physical strength, muscle development, walking stability, gastrointestinal tract and genitourinary system function, they are designed to rehabilitate stroke patients, patients with spinal cord injury, cerebral palsy, multiple sclerosis and other diseases.

The company’s co-founder Ekaterina Berezy stated, “We are up there with the major manufacturers of medical equipment. The CE marker will open borders not just in the European Union, but also certain non-European countries, particularly the Middle Eastern states, which accept the CE marker as a standard. Local certification is required in addition to it, but it is simplified. Globally, this certificate gives doctors the right to use the exoskeletons in their routine medical practice.”

ExoAtlet is unusual in that the number of startups producing complex medical technology is small, while the number with CE certified medical technologies is even smaller. The company’s production facility is located in South Korea where it also received its ISO-13485 certificate – a certificate that producers of medical devices require.’

The market for exoskeleton technologies has seen steady growth in recent years, with trials taking place across multiple sectors such as automotive production, worker safety, and even running. As of 2019, the North American market alone was valued at $297 million and Reports and Data expects the global market to reach $4 billion by 2026.

“The company ExoAtlet is developing dynamically and has come a long way from being a resident of the robotics center at the IT cluster to being a participant in the biomedical technologies cluster. Exoskeletons found their own practical application in rehabilitation first rather than in industry or the military, and that is happening all over the world. Now ExoAtlet will be able to take a large share of this growing market,” said Vladimir Egorov, the head of operations at the Skolkovo Foundation Biomedical Technologies Cluster.

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