OssDsign Marks PROPEL Spinal Fusion Registry Milestone

OssDsign AB has enrolled 200 patients in its multi-center, prospective spinal fusion registry, PROPEL. The company initiated the registry in March 2022 to gather real-world data from patients treated with OssDsign Catalyst.
 
“This important milestone reflects our ability to collect clinically relevant data and is a direct result of the high level of interest from surgeons to continue using OssDsign Catalyst, resulting in a growing number of patients being included in PROPEL. The collection of robust clinical evidence is a strategic priority for us, in order to demonstrate OssDsign Catalyst’s effectiveness in real-world clinical practice,” OssDsign CEO Morten Henneveld said.

PROPEL is bridging the gap between the device’s performance in pre-market clinical trials and its use in routine practice over time. The registry is an essential step in OssDsign’s strategy to collect clinical evidence of its nanosynthetic bone graft OssDsign Catalyst. Since the initiation of the PROPEL registry in 2022, clinics have gradually enrolled patients, with the objective of evaluating the use and outcome of OssDsign Catalyst in real-world clinical practice. The primary endpoint of the study is measuring the rate of spinal fusion, using computer tomography (CT) or radiography, 12 months postoperatively. Additionally, patients’ quality of life, neurological function, and the clinical safety profile of the spinal implant are recorded.

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 that is resorbed and replaced by new and healthy bone tissue. OssDsign launched the product 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 and the clinical study TOP FUSION, in which patient enrolment was completed in April 2022.

OssDsign develops and provides next-generation bone replacement products. Based on cutting-edge material science, the company develops and markets products that support the body’s own healing capabilities and thereby improve the clinical outcome in a wide range of orthopedic areas with high medical needs. With a product portfolio consisting of patient-specific implants for cranial surgeries and an off-the-shelf synthetic bone graft for spine surgeries, OssDsign has a strong commercial presence in the United States, Europe, and selected Asian countries. OssDsign’s share is traded on Nasdaq First North Growth Market in Stockholm, Sweden.

Read more: OssDsign’s PROPEL Registry Surpasses 100 Patients