Wednesday, June 07, 2023
Artelon Inc. has announced that their ligament repair devices, namely FlexBand®, FlexPatch®, and FlexBand Plus®, have received FDA 510(k) clearance for ligament repair surgery, as well as tendon repairs*. This clearance expands the approved uses of these products to include reinforcement of medial, lateral, and ulnar collateral ligaments, spring ligaments, deltoid ligaments, and extra-articular ligaments in the ankle, knee, and other joints in the body.
This development comes shortly after Artelon successfully concluded a Series B funding round, raising $20 million led by Vensana Capital. This funding will enable Artelon to further establish its presence in the U.S. ankle instability market, which is valued at $2 billion.
CEO Aaron Smith stated that this new regulatory clearance provides a distinctive framework for marketing claims related to ligament reinforcement. While recent advancements in the field have primarily focused on fixing ligaments to bone, little attention has been given to addressing issues with the ligament tissues themselves, which can be diseased and contribute to suboptimal surgical outcomes. Artelon is already a leader in the expanding U.S. ankle instability market, and this clearance allows them to address various unmet clinical challenges in the ankle and other joints, significantly expanding their market opportunities.
Artelon's FlexBand products utilize their proprietary Dynamic Matrix® technology, which is a polymeric bio-textile designed for reinforcing musculoskeletal soft tissues. The Dynamic Matrix is engineered to mimic the mechanical and biological properties of healing tendon and ligament tissue. Clinical studies have demonstrated its effectiveness in protecting surgical repairs during the initial healing phase, restoring motion mechanics, and supporting the development of regenerating tissue before gradually dissolving over several years.