Sparta Biomedical, Inc. Obtains Colombia Approval for Clinical Study
Bogotá, Colombia. On June 12, 2024, INVIMA, the regulatory agency of Colombia, approved Sparta Biomedical, Inc.’s study, which will be conducted at one research site in Bogotá. This first-in-human study aims to recruit 15 subjects in Colombia and will last approximately 2 years. Sparta Biomedical is a developer of orthopedic solutions. With its innovative, award-winning cartilage-like material called Galene (a Sparta proprietary bionic cartilage), their goal is to build a solution that meaningfully improves the standard of care for people with osteoarthritis by providing pain reduction and preserving range of motion without some of the limitations associated with current treatments such as limited effectiveness, temporal relief, surgical complexity and long recovery times. Osteoarthritis is a medical condition that affects joints in the body and results in pain and limited ranges of motion.
Source: INVIMA’s Medical Device Committee, June 12, 2024 meeting minutes.