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ExoAtlet II achieves medical certification in Russia

25.02.2021
ExoAtlet II achieves medical certification in Russia

ExoAtlet, an RVC Biofund portfolio company, successfully completed trials and received a registration certificate for the ExoAtlet II exoskeleton, which was previously certified by the European Union. The training apparatus is the second exoskeleton in the company's lineup to achieve medical certification in the Russian market.

The ExoAtlet II, a robotic biofeedback trainer for relearning how to walk, is a second-generation exoskeleton that the Skolkovo resident developed for rehabilitation of adults and adolescents. The exoskeleton's number of anthropometric settings increased from 8 to 13. The training apparatus's new spinal brace is more durable and can be used in combination with body weight relief systems. What's more, thanks to improved adjustment mechanisms, the designers achieved a 20% reduction in the time required to reconfigure the exoskeleton.

The ExoAtlet II settings provide 8 options for a step's trajectory and interval, as well as 3 walking speeds. The level of support adapts to the patient's efforts, and the exoskeleton enables the patient to negotiate stairs and walk on other uneven surfaces. The exoskeleton's step initiation mode facilitates active mechanotherapy, which has a proven efficacy in treating strokes and other diseases associated with a cerebrovascular disorder. Thanks to the foot's external attachment, patients can train in their own orthopedic shoes. This technical solution makes it possible to expand the list of indications for exo-rehabilitation.

Vladimir Egorov, Director of Operations of the Cluster of Biomedical Technologies of the Skolkovo Foundation:
“In the five years since receipt of the registration certificate for the first-generation ExoAtlet, the Foundation's resident has conducted numerous trials proving the system's effectiveness. Today, roughly one hundred clinics in Russia and abroad successfully use the exoskeleton in rehabilitation of their patients. Considering the accumulated experience, the new version of the ExoAtlet has proven to be even more convenient, durable and versatile. I am sure that the new model of ExoAtlet has great prospects.”

One of model's key features is the built-in synchronized electrostimulation system, which allows the use of functional- and neuroelectrostimulation while walking in the exoskeleton. This makes the rehabilitation process more effective and significantly reduces the patient's recovery time.

According to recently approved standards for the provision of equipment at specialized medical institutions, exoskeletons are now included in the list of gym equipment for medical rehabilitation. The Ministry of Health of the Russian Federation's order “On Approval of the Procedure for Organizing Medical Rehabilitation of Adults” entered into force on January 1, 2021.

Mikhail Fedotov, Director of RVC Subsidiary Funds:
“The emergence of government exoskeleton procurement standards in the Russian Federation creates a market for all exoskeleton manufacturers. That said, ExoAtlet's good prospects are due to the fact that the company's entire line of equipment is in final development or is already being sold. We will continue to support the company, including in its international expansion in medical and other areas.”

The telemetry system implemented in ExoAtlet can digitize, analyze and, in the future, forecast the effectiveness of the training.

Ekaterina Bereziy, co-founder of ExoAtlet:
“For our company, certification and product improvement processes go in parallel. Certification of our products and their preparation for certification enhances the internal development culture, and positively affects the team's growth and the understanding of the regulator's internal logic. Product quality only increases because of this.”


Information

The rehabilitation exoskeleton is an innovation from the international company ExoAtlet, essential for working with such diagnoses as spinal cord injuries, strokes, multiple sclerosis, cerebral palsy, cerebrovascular disorders, and musculoskeletal disorders.

The company's products include commercially available medical exoskeletons for adults (ExoAtlet I, II) and a novel pediatric exoskeleton (ExoAtlet Bambini) that has no equivalents or competitors on the market and is in the process of being certified as a medical device. The telemetry solutions used in the products enable the company to more efficiently and quickly provide after-sales service through remote diagnostics and modular design principles.

Since 2014, ExoAtlet has been a Skolkovo innovation center resident, and since 2015 — an RVC Biofund portfolio company. In 2017, the project entered the Korean market, and in 2018 — the EU market. The company has already received, or is in the process of receiving, the certifications required for sales to public companies in international markets.

ExoAtlet II's registration certificate affirms the exoskeleton's compliance with norms and standards established by national legislation and that it can be used for its intended purpose without the risk of harm to the life and health of users. The CE mark confirms that the product “meets high requirements for safety, health and environmental protection” (European Commission 2015).

The Ministry of Health of the Russian Federation's Order No. 788n of July 31, 2020 “On Approval of the Procedure for Organizing Medical Rehabilitation of Adults” entered into force on January 1, 2021 and also provides for equipping gyms with exoskeletons for medical rehabilitation.

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