March 18, 2021
Sparta Biomedical Receives FDA Breakthrough Device Designation for Biomimetic Implant
DURHAM, N.C., March 17, 2021 /PRNewswire/ — Sparta Biomedical Inc., a developer of orthopedic solutions, today announced that its SBM-01 Biomimetic Implant has been granted a Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA). SBM-01 is intended to replace damaged knee cartilage in patients having single or multiple chondral or osteochondral defects in the knee.
The Breakthrough Device Program is designed to accelerate patient access to promising technologies that have the potential to provide more effective treatments for debilitating conditions. The Program provides patients and health care providers timely access to these medical devices by assisting sponsors in their development, assessment, and review, consistent with the FDA’s mission to protect and promote public health.
“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.”
Osteoarthritis (OA) is one of the most common and debilitating joint disorders. The condition is characterized by progressive, irreversible articular cartilage degeneration, resulting in significant joint pain, joint motion limitations, and the formation of bony osteophytes. Most commonly, OA in the knee is first treated conservatively with non-pharmacological management, viscosupplementation injections, and anti-inflammatory medications. Patient-specific conditions, behaviors, or preferences make these options challenging to administer or achieve a high level of regimen compliance. Those who go through these interventions, often only achieve marginal temporary, palliative success.
SBM-01 Biomimetic Implant is a minimally invasive treatment for chondral or osteochondral defects of the knee cartilage. It mimics the properties of native cartilage and provides a smooth articulating surface, providing support to surrounding cartilage while stabilizing subchondral bone, and thereby limiting further exacerbation of the disease.
“SBM-01 has the potential to have a significant impact on patients who are suffering from knee cartilage damage,” said Adam Yanke, MD, Ph.D., Assistant Director of the Cartilage Restoration Center for Rush University Medical Center and Assistant Professor, Department of Orthopedics. “I’m delighted that the FDA will be collaborating with us to bring this novel technology to the market as quickly as possible.”
About Sparta Biomedical, Inc
Sparta’s mission is to empower orthopedic surgeons with advancements that fundamentally restore movement for their patients. More information at www.sparta-biomedical.com
SOURCE Sparta Biopharma, Inc.