Uppsala, June 26, 2025. OssDsign AB (publ.) today announces that the company has published one-year results from the first 108 patients in its prospective, multi-center, spinal fusion registry PROPEL. The results show an outstanding fusion rate of 88.4% in the real-world setting in a highly complex patient cohort, demonstrating that OssDsign Catalyst® shows strong performance even in challenging patient populations with high BMI, previous failed fusion surgeries, smokers, multi-level procedures and several comorbidities.
"Typically, I would expect to see dramatically lower fusion rates for such a complex real world patient population with 48% of the patients in the study having three or more comorbidities increasing their risk for a potential non-union. Most clinical studies exclude these difficult patients which unfortunately represent the majority of patients in need of spinal fusion. The OssDsign Catalyst fusion rate of 88.4% achieved in the PROPEL study significantly exceeded my expectations," comments K. Brandon Strenge, M.D., Orthopedic Spine Surgeon, STRENGE Spine Center.
The results are based on 108 patients and the studied population is considered a highly complex patient cohort with the following profile:
- Average BMI of 31.9 (obese)
- 93.6% of patients had at least one comorbidity with 48% having three or more comorbidities
- 50% had previous spine fusion surgery performed
- 48.0% were active or previous smokers
- 20.3% of all procedures involved three or more levels of the spine
At the 12-month follow-up, all patients showed improvement in each health status category assessed, with no unexpected device-related adverse events and a successful fusion rate of 88.4%, and between 84.7% and 93.4% in high-risk subgroups.
"These results are a crucial building block in OssDsign's clinical strategy, showing OssDsign Catalyst to be a robust, differentiated nanosynthetic bone graft that performs as intended regardless of patient profile. Previously, our TOP FUSION first-in-human study reported a 93% fusion rate and improvements in all health status categories at the 12-month follow-up. Although we anticipated strong real-world performance, the remarkable consistency with our clinical trial results exceeds our expectations.
These results prove that OssDsign Catalyst completely transforms expectations for fusion surgery outcomes, offering comfort and confidence that all patients, whether complex or simple, can return to an active life," says Morten Henneveld, CEO of OssDsign.
About the study
PROPEL is a prospective spinal fusion registry that aims to bridge the gap between the device's performance in a controlled clinical trial and its use in everyday clinical practice over time. To date, over 300 patients are enrolled. 108 patients were included in this analysis across six sites; surgery dates ranged from April 25, 2022, to August 21, 2023. Any patient aged 21 years or older, requiring spinal fusion surgery for which OssDsign Catalyst was being used, was considered appropriate for inclusion if, in the investigator's opinion, the patient could comply with the registry protocol requirements. The primary endpoint was the fusion (bridging bone) assessment at 12 months ± 60 days post-surgery. Clinical outcomes were assessed as secondary endpoints, with success defined as any improvement from baseline scores for the following: Quality of Life Questionnaires (VAS and ODI/NDI, as applicable, and SF-36) and the maintenance or improvement of neurological function. A safety review was also conducted for all Adverse Events (AEs).
The study is published in the latest issue of the BioMedRes Journal and is accessible here: https://biomedres.us/pdfs/BJSTR.MS.ID.009734.pdf
The results will also be presented at a webcast on June 30th at 11:00 CET, and can be accessed through the following link: https://www.finwire.tv/webcast/ossdsign/study-update/
About OssDsign Catalyst®
OssDsign Catalyst is a nanosynthetic bone graft that shows rapid and robust bone formation, even in poorly vascularized environments. OssDsign Catalyst's patented nanocrystalline structure and incorporated silicate ions, which mimic the body's natural bone, enable bone formation in the centre of the fusion mass. OssDsign Catalyst is designed to deliver a decreased non-union risk, making it highly applicable for both simple and complex patients.
About OssDsign®
OssDsign is a developer and global provider of next generation orthobiologics products. Based on cutting edge material science, the company develops and markets products that support the body's own healing capabilities, giving patients back the life they deserve. The company has a strong presence in the U.S. market. OssDsign's share is traded on Nasdaq First North Growth Market in Stockholm, Sweden.
The use of OssDsign Catalyst described in the publication may not be cleared in all markets. Please refer to the IFU for a full list of indications, contraindications, warnings, and precautions.
