Sparta Pre-clinical, Clinical Trials - Patient Education Portal

Sparta Biomedical's journey toward innovative orthopedic solutions has been marked by thorough pre-clinical testing and clinical trials. With a focus on improving patient outcomes and transforming treatment approaches, Sparta introduces Galene, its biomimetic cartilage platform, and the groundbreaking Ormi implant. Let's explore the progression of Ormi and Galene from initial validation in the lab to trials in real-world settings.

Galene

Galene, a biomimetic cartilage platform designed to address knee osteoarthritis, is leading the charge. Galene offers immediate pain relief and restores joint function. Dushyanth Surakanti, CEO and Founder of Sparta Biomedical, underscores Galene's groundbreaking nature and emphasizes its ability to mimic natural cartilage properties.

Navigating Clinical Trials

Sparta dedicated significant efforts to pre-clinical validation, ensuring the safety and effectiveness of Ormi and Galene. Through meticulous lab experiments and animal studies, Sparta assessed the implant integration into tissues, their mechanical properties, and overall biocompatibility. The Ormi implant, recognized with Breakthrough Device Designation by the FDA in 2021, represents a significant milestone in Sparta's journey. With promising results from pre-clinical studies on Ormi for Femoral condyle and animal trials demonstrating safety and efficacy, Sparta moves forward with human trials to secure regulatory approval. This September, Sparta Biomedical received funding to accelerate preparations for the Investigational Device Exemption study, which is scheduled to begin in early 2024.

The Phases of Clinical Trials

The initial phase will focus on assessing the safety and tolerance of an implant in a small group of patients. Data from Phase I trials will inform subsequent phases and guide further implant design and surgical technique refinement. Phase II trials will expand the patient pool to assess safety while evaluating the implants' effectiveness. These trials will provide critical data on implant performance, patient responses, and potential adverse effects. The largest and most comprehensive phase, Phase III trials, will involve a broader patient population to confirm the effectiveness of Ormi implants compared to existing standards of care. Data from Phase III trials will support regulatory approval and market access.

Ormi offers hope for individuals with moderate osteoarthritis and presents a less invasive alternative to total knee replacement. Sparta's expansion plans extend beyond knee applications, envisioning Galene's utility across various orthopedic settings, including toe, thumb, hip, and shoulder interventions.