OssDsign AB (publ.) announced that the Western Institutional Review Board (WIRB), one of the largest institutional research review organizations in the U.S., has approved the company's application to establish PROPEL, a multi-centre, prospective spinal fusion registry, providing opportunity to study real-world data from patients who have been treated with OssDsign Catalyst. OssDsign Catalyst received FDA clearance in 2020 and was launched in the U.S. in August 2021. During 2022, clinics will gradually be enrolled to the registry, with the objective to evaluate the use and outcome of OssDsign Catalyst in a real-world clinical practice.

The primary endpoint of the study will be measuring the rate of spinal fusion, using computer tomography (CT) or radiography, 12 months postoperatively. Additionally, patients' quality of life and neurological function, as well as the clinical safety profile of the spinal implant will be recorded. PROPEL will play an important role in bridging the gap between the device performance in clinical trials and their use in routine practice over time.

The registry is the latest step in OssDsign's strategy to collect clinical evidence of its synthetic bone graft OssDsign Catalyst. Concurrently, the company's clinical study TOP FUSION, evaluating the long-term safety and efficacy of OssDsign Catalyst in patients, is continuing to enroll subjects in Hungary.