Tokyo – August 25, 2023 – BionicM, an innovative Japanese medical device startup, is pleased to announce that it has received U.S. Food and Drug Administration (FDA) 510(k) exemption registration for Bio Leg™; its robotic prosthetic knee. This registration marks a significant milestone in the company’s commitment to deliver its robotic prosthetic knee to the USA market in 2024 with Japanese-proven technologies.

“Having your limbs amputated severely limits your life,” says Xiaojun Sun, CEO of BionicM, and an above-knee amputee. “While prosthetic limbs have been developed there are many new ways to improve the lives of amputees with advanced technology. This milestone of achieving our FDA registration underscores our dedication to developing state-of-the-art prosthetic solutions that have the potential to revolutionize mobility of people who have limb loss.”

BionicM started research in 2015 and developed Bio Leg™ over a period of 10 years, a robotic prosthetic knee, to restore mobility to people who have lost their legs due to lower limb amputation and have limited mobility. Bio Leg™ allows a more natural gait to walk long distances more efficiently along with stability using ramps and inclines among other features. The technology used with Bio Leg™ will bring an advanced and affordable technology to all clinics, facilities and institutions in all regions.

“Bio Leg™ is a groundbreaking prosthetic knee joint which can help improve the daily activities of limb loss in transfemoral patients. We have done several trial fittings in my New York facility with very good results,” says Gary Marano, CPO, LPO and CEO of OTF Prosthetics and Orthotics in New York. “Bio Leg™ allows a more natural gait to walk long distances more efficiently along with stability using ramps and inclines. Another functional benefit is to provide an easier sit to stand feature giving the user a quicker and smoother transition when standing up from a chair.”

Bio Leg™ features include:

– Bio Leg™ assists a wide range of movements with power, such as ascending and descending stairs and sitting on and standing up from a chair. This helps users with active lifestyles.
– Bio Leg™ bends the knees with power. Actualizes graceful walking without stumbling, even when walking slowly or in small steps, by using power to bend the knees and lift the toes from the ground during the swing phase.
– Bio Leg™ prevents knee buckling by assisting the stretching of the knee during the stance phase. Users can safely put their weight on the prosthetic leg.
– Another functional benefit is to provide an easier sit to stand feature giving the user a quicker and smoother transition when standing up from a chair; this feature will also assist those who have had a stroke, weakness, or arthritis in the hip or knee joint on the contralateral side.

To get more information about Bio Leg™ visit www.bionicm.com, the company will also be showcasing Bio Leg™ at the upcoming AOPA Conference in Indianapolis in September 6-9. Contact marketing_usa@bionicm.com or visit booth #224.

https://youtu.be/lJzIfDz5BvI?si=c2wtuDUXkNMCdSRo

About BionicM

BionicM has been researching on innovative technologies since 2015 at the University of Tokyo’s Information Systems Engineering Laboratory (JSK) under the guidance of Professor Inaba, utilizing the world’s most advanced robotics research. Selected for the “Program for Creating STart-ups from Advanced Research and Technology” (START) by the Japan Science and Technology Agency in 2016, the company was established in 2018. BionicM won several research grants and awards for start-ups, i.e., Japan – U.S. Innovation Awards, EPiC by Hong Kong Science and Technology Parks Corporation, International Creatineer Competition 2019, and so on. The powered prosthetic knee Bio Leg™ also won the Grand Prix “Luminary” in the design concept category of the 2020 “Red Dot Award”, one of the world’s highest design awards.