Sparta Biomedical has announced the successful implantation of its Ormi device in patients with focal knee lesions as part of a first-in-human clinical trial. The prospective, multi-center, single-arm study is currently underway in the Dominican Republic and Colombia.
The trial focuses on evaluating the safety of Ormi in patients experiencing knee pain due to articular cartilage loss in the femoral condyle. The device is designed to address cartilage damage irrespective of underlying bone involvement. Post-implantation, researchers will monitor patients through imaging, physical exams, and patient-reported outcome measures.
Galene Platform and Device Design
The Ormi device incorporates Sparta Biomedical’s Galene platform, a synthetic cartilage intended to replicate the properties of native hyaline cartilage. Galene is combined with a titanium stemmed base to ensure stable fixation during cartilage lesion repair. According to Sparta Biomedical, Ormi aims to overcome the limitations of existing conservative and surgical treatments for knee osteoarthritis by supporting weight-bearing and full range of motion while minimizing pain.
Addressing Unmet Needs in Osteoarthritis Treatment
"Helping patients with knee focal lesions restore mobility and reduce pain quickly has been a long-standing issue," said Dushyanth Surakanti, Co-Founder & CEO of Sparta Biomedical. "Our goal is to provide orthopedic surgeons with a simple, highly effective solution that is not dependent on patient biology. No approved device today has Ormi’s features."
Knee osteoarthritis affects an estimated 651 million people worldwide, creating a substantial burden on healthcare systems. Current treatments often involve cartilage regeneration approaches, which can be lengthy and may not fully restore the original strength of the cartilage. Ormi is designed to mimic the properties of healthy human cartilage from the outset, potentially offering a more immediate and effective solution.
Investigator Perspectives
Dr. Andres Garcia Martinez, Investigator and Head of Orthopedic Surgery at HOMS, noted the encouraging early signs of patient recovery. Dr. Jeremen Silva, Investigator at Clinica de la Mujer, expressed optimism about Ormi's potential to meet the needs of patients who may not be suitable for other treatments, highlighting the ease of implantation and robust fixation.
Ormi has received Breakthrough Device Designation from the US FDA. However, it is currently in development and not yet approved for commercial use. Approvals and clearances are contingent upon further testing, results, and FDA review.
