Uppsala, April 4, 2022 — OssDsign AB announced that the first patient has been enrolled to the company’s multi-center, prospective spinal fusion registry in the U.S., PROPEL, with the objective to evaluate the use and outcome of OssDsign Catalyst in real-world clinical practice.
The patient recruitment follows on the March 18 initiation of the first clinical site in PROPEL, a spinal fusion registry that initially will evaluate the rate of fusion, twelve months following treatment with the company’s nanosynthetic bone graft, OssDsign Catalyst. Additionally, the clinical safety profile, as well as the patient’s quality of life and neurological function will be recorded. OssDsign expect to include several more clinical sites to the registry over the coming quarters.
“We are very pleased that the process of adding clinical sites and enrolling patients to PROPEL has been achieved according to plan. The registry is one of the core pillars in our long-term strategy and will, over time, generate a large amount of relevant data on both performance and safety of OssDsign Catalyst. Through the registry we will also have a close and continuous dialogue with surgeons, which is invaluable during our ongoing launch of OssDsign Catalyst in the U.S.,” comments Morten Henneveld, CEO, OssDsign.
The first patient case was performed by Joseph O’Brien, MD, the Principal Investigator for the PROPEL registry. Dr O’Brien is currently MD for Ortho Bethesda at Virginia Hospital Center and was previously Associate Professor at The George Washington University. He is also the author of numerous publications within the field of Spine.
“It’s an honor to initiate the PROPEL registry in the U.S. I’m confident that OssDsign Catalyst will provide a world-class fusion solution to my patients, and I look forward to collecting the data prospectively,” comments Joseph O’Brien.
OssDsign Catalyst is an innovative synthetic bone graft used to help promote bone growth in spinal fusions. 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.
related /
Spinal Devices, Electronics, & Collaboration: AM News Roundup for October 3-14
Patient-Specific Devices Regulation and Questions
Why Guam Might be the Next Additive Manufacturing Center of Excellence
