Uppsala, August 17, 2023 – OssDsign AB (publ.) today announces that the company has enrolled 200 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.
“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,” commented Morten Henneveld, CEO of OssDsign.
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 the formation of healthy bone tissue 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 and the clinical study TOP FUSION, in which patient enrolment was completed in April 2022.
For further information, please contact:
Morten Henneveld, CEO, OssDsign AB
Tel: +46 73 382 43 90, email: morten.henneveld@ossdsign.com
Certified Adviser:
Erik Penser Bank AB is the company’s Certified Adviser. Contact information: Erik Penser Bank AB, Box 7405, 103 91 Stockholm, Sweden, phone: +46 (0)8-463 80 00, email: certifiedadviser@penser.se
About OssDsign
OssDsign is a developer and global provider of 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 give patients back the life they deserve. The company has a strong commercial presence in the U.S., Europe and selected Asian countries. OssDsign’s share is traded on Nasdaq First North Growth Market in Stockholm, Sweden.
