Artelon Granted U.S. FDA 510(k) Clearance for FlexBand, FlexPatch & FlexBand Plus

Artelon Inc. has received U.S. FDA 510(k) clearance for FlexBand, FlexPatch and FlexBand Plus for ligament repair surgery in addition to tendon repairs.
 
This new clearance expands the indications for these products to now include reinforcement of medial, lateral and ulnar collateral ligaments, spring ligaments, deltoid ligaments, and extra-articular ligaments in the ankle, knee, and other joints around the body.
 
This closely follows the closing of a $20 million in Series B funding for Artelon, led by Vensana Capital, permitting expanded leadership in the $2 billion U.S. ankle instability market.
 
“This new regulatory clearance establishes a unique and specific framework of U.S. marketing claims for reinforcement of ligaments,” said CEO Aaron Smith. “Recent innovation in our space has been mostly focused on fixation of ligaments to bone, but little has been done to address failure of the ligament tissues themselves, which are often diseased and may lead to poor surgical outcomes. We are currently a leader in the large and growing U.S. ankle instability market. This new set of claims permits us to take on a multitude of unmet clinical challenges in the ankle and other joints and dramatically expand our addressable market.”
 
Artelon’s Dynamic Matrix technology used in Flexband products is a proprietary polymeric bio-textile for musculoskeletal soft tissue reinforcement. Dynamic Matrix is designed to mimic the natural mechanical and biological properties of healing tendon and ligament tissue. It has been proven in clinical studies to protect the surgical repair during early healing, quickly restore the mechanics of motion, and support development of regenerating tissue before dissolving over several years.