Artelon Inc., announced U.S. FDA 510 clearance of FlexBand®, FlexPatch®, and FlexBand Plus® for ligament repair surgery in addition to tendon repairs.
Clearance includes extra-articular ligaments in various joints and substantially increases addressable market
MARIETTA, Ga., June 6, 2023 /PRNewswire/ -- Artelon Inc., announced today U.S. FDA 510(k) clearance of 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 $2B 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.
About Artelon
Artelon, Inc. was founded on expertise in synthetic materials for real-world success in orthopedic soft tissue reconstruction. Since its inception, Artelon’s Dynamic Matrix has delivered on its promise of enhanced biological and mechanical reconstruction with more than 60,000 implantations worldwide. Artelon is headquartered in Marietta, GA, and is committed to an innovative focus on joint stability and kinematics through novel soft tissue reconstructive products and procedures.
Connect with us at Artelon.com and SprainedAnkle.com. Follow us on LinkedIn, Instagram, and on Twitter.
*FlexBand®, FlexPatch®, and FlexBand® Plus are intended for use in surgical procedures for reinforcement of soft tissue where weakness exists.
FlexBand®, FlexPatch®, and FlexBand® Plus are also intended for reinforcement of soft tissues that are repaired by suture or other fixation devices during tendon and ligament repair surgery including reinforcement of rotator cuff, patellar, Achilles, biceps, quadriceps tendons, medial collateral ligament, lateral collateral ligament, spring ligament, deltoid ligament, ulnar collateral ligament or other tendons or extra-articular ligaments.
FlexBand®, FlexPatch®, and FlexBand® Plus is not intended to replace normal body structure or provide the full mechanical strength to support the rotator cuff, patellar, Achilles, biceps, quadriceps tendons, medial collateral ligament, lateral collateral ligament, spring ligament, deltoid ligament, ulnar collateral ligament or other tendons or extra-articular ligaments. Sutures, used to repair the tear, and sutures or other fixation devices, used to attach the tissue to the bone, provide mechanical strength for the tendon repair. The products reinforce soft tissue and provides a degradable scaffold that is incorporated into the patient’s own tissue.
CONTACT:
Chris Gale
Chris@GaleStrategies.com
View original content:https://www.prnewswire.com/news-releases/artelon-incs--flexband-flexpatch-and-flexband-plus-earn-fda-clearance-for-ligament-reinforcement-301842669.html
SOURCE Artelon
