OssDsign’s Spinal Fusion Registry Reaches Patient Enrollment Goal

OssDsign AB has reached its 300-patient enrollment target in the multi-center, prospective spinal fusion registry PROPEL. Initiated in 2022, the registry collects real-world data from patients treated with OssDsign Catalyst.

“When we initiated the PROPEL registry, we communicated a target of 300 patients. Reaching this milestone already confirms our capability to gather clinically relevant data and the successful enrollment is a direct result of surgeons’ high interest in collaborating with OssDsign to evaluate OssDsign Catalyst,” OssDsign CEO Morten Henneveld said. “Collecting solid clinical evidence is a strategic priority for us to demonstrate the effectiveness of OssDsign Catalyst in real-world clinical settings and we will therefore continue to enroll patients in the registry to build more and stronger evidence over time.”

PROPEL is closing the gap between the device’s performance in pre-clinical animal models and its application in routine clinical practice over time. The study’s primary endpoint is to measure the spinal fusion rate using computed tomography (CT) or radiography 12 months post-operatively. Additionally, the study will assess patients’ quality of life and neurological function, as well as record the clinical safety profile of the spinal implant.

Related: OssDsign Marks PROPEL Spinal Fusion Registry Milestone

OssDsign Catalyst is a nanosynthetic bone graft that stimulates healthy bone tissue formation in spinal fusion surgeries. The graft is composed of a proprietary nanocrystalline structure, which is resorbed and replaced by new and healthy bone tissue. The product was launched in the U.S. in August 2021. The market clearance in the U.S. is based on preclinical results that surpass what is typically seen with other synthetic bone grafts in the most demanding preclinical model for spinal fusion—the Boden model. OssDsign continues to accelerate a robust program of gathering clinical evidence anchored by PROPEL, a U.S.-based multi-center prospective spinal fusion registry, and TOP FUSION, in which patient enrollment was completed in April 2022.

OssDsign is a developer and global provider of next-generation orthobiologics products. Based on cutting-edge material science, the company develops and markets products that support the body’s own healing capabilities. The company has a strong presence in the U.S. market. OssDsign’s share is traded on Nasdaq First North Growth Market in Stockholm, Sweden.