Uppsala/November 9, 2022 — OssDsign AB announced the company has reached the milestone of 100 patients in the multi-center, prospective spinal fusion registry, PROPEL. The registry was initiated in March 2022, to gather real-world data from patients who have been treated with OssDsign Catalyst.
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.
“I am very pleased with the continuously growing number of patients being included in PROPEL. We set an ambitious goal to include 100 patients before the end of the year, but 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,” commented Morten Henneveld, CEO of OssDsign.
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.
OssDsign Catalyst is a nanosynthetic bone graft that stimulates the formation of healthy bone tissue in spinal fusion surgeries. 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 FDA clearance in 2020 and was launched on the U.S. market in August 2021.
