Medical device company Sparta Biomedical has announced the successful implantation of its Ormi device in a first-in-human clinical trial.
Designed to treat knee osteoarthritis, the device has received breakthrough device designation from the US Food and Drug Administration (FDA).
The ongoing study, which is prospective, multi-centre, and single-arm, is being conducted at Clinica de la Mujer in Bogota, Colombia, and HOMS in Santiago de los Caballeros, Dominican Republic. Patients have been enrolled and treated as part of this trial.
This study's primary focus is to evaluate the safety of the Ormi device in patients suffering from knee pain due to articular cartilage loss in the femoral condyle.
The device's design allows for the treatment of cartilage damage, with or without underlying bone involvement.
Post-implantation, investigators will monitor the patients through imaging, physical examinations, and patient-reported outcome measures.
Sparta Biomedical co-founder and CEO Dushyanth Surakanti said: “Our goal is to provide orthopaedic surgeons with a simple, highly effective solution that is not dependent on patient biology. No approved device today has Ormi's features.
“The reality is focal lesions in the knee affect the lives of hundreds of millions worldwide, and surgeons, depending on geography, have few to no solutions to treat their patients. We are excited to be one step closer to showcasing Ormi's clinical benefits and helping clinicians get their patients feeling better soon."
The Ormi device is based on Sparta Biomedical's Galene platform, a synthetic cartilage that mimics natural hyaline cartilage. It combines Galene with a titanium stemmed base for secure fixation during cartilage lesion repair.
Ormi is aimed at overcoming the drawbacks of existing conservative and surgical interventions for knee osteoarthritis. It aims to serve as a solution that supports weight-bearing and a complete range of motion while reducing pain quickly.
In August 2023, Sparta Biomedical secured two new patents for the Ormi implant from the US Patent and Trademark Office.
