OssDsign’s PROPEL Registry Surpasses 100 Patients

OssDsign AB has enrolled more than 100 patients in the multi-centre, prospective spinal fusion registry, PROPEL, the company announced.

OssDsign began the registry in March 2022 to gather real-world data from patients been treated with OssDsign Catalyst, a nanosynthetic bone graft that stimulates the formation of healthy bone tissue in spinal fusion surgeries.

“I am very pleased with the continuously growing number of patients being included in PROPEL. The large interest from surgeons to try OssDsign Catalyst has accelerated the patient enrollment. The sooner we collect real-world data, the faster we can publish clinical evidence to support the already very convincing pre-clinical data we have,” CEO Morten Henneveld said.
 
During 2022, clinics have gradually enrolled patients to the PROPEL 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 is 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, is recorded. 
 
PROPEL is bridging the gap between the device performance in pre-market clinical trials and its use in routine practice over time. The registry is an important step in OssDsign’s strategy to collect clinical evidence of its synthetic bone graft OssDsign Catalyst. 
 
Similar to the body’s own bone mineral structure, the patented nanocrystalline structure of OssDsign Catalyst provides a favorable bone biology environment inducing rapid and reliable bone formation. The product received US. Food and Drug Administration clearance in 2020 and was launched on the U.S. market in August 2021.
 
Data from a recently published pre-clinical study show that OssDsign Catalyst instructs rapid and reliable bone formation and that successful fusion was achieved in 100% of the studied subjects at 26 weeks, compared to 60% in the group where a comparable market-cleared device was used. In hypoxic environments OssDsign Catalyst engages the endochondral ossification pathway, leading to rapid bone formation at the center of a fusion mass, even in challenging, poorly vascularized environments.

In well vascularized environments OssDsign Catalyst engages the intramembranous ossification pathway via the recruitment of endogenous mesenchymal stem cells. The engagement of these dual bone formation pathways results in rapid and reliable bone formation throughout the fusion mass. 
 
OssDsign is a Swedish innovator, designer and manufacturer of personalized bone replacement technology for cranial repair.