Sparta Biomedical was granted FDA's Breakthrough Device Designation. SBM-01 is intended to replace damaged knee cartilage in patients having single or multiple chondral or osteochondral defects in the knee.
SBM-01 mimics the properties of native cartilage and provides a smooth articulating surface, offering support to surrounding cartilage while stabilizing subchondral bone, thereby limiting further exacerbation of the disease.
"The Breakthrough Device Designation reflects our team's drive to develop a truly unique solution to address a large clinical need," said Dushyanth Surakanti, Co-Founder & CEO of Sparta Biomedical. "This new treatment option is designed for the hundreds of thousands of patients who experience persistent knee pain and compromised mobility after failing conservative care, but who are too young for a total knee replacement."
"This Designation will enable us to interact with the FDA more frequently to accelerate preclinical and clinical development for SBM-01," Co-Founder and COO Dimitrios Angelis added. We look forward to making this game-changing technology available to orthopedic surgeons so they may help their patients suffering from knee pain and immobility."