Program provides a replacement product kit to qualifying U.S. facilities if a nonunion1 occurs after on-label use of OssDsign Catalyst® in spine fusion
OssDsign Launches Catalyst Commitment Fusion Warranty Program, Backed by Real-World Evidence of 88.4% Fusion Success in Complex Spine Patients
3 min read Premium comments
UPPSALA, Sweden, November 3, 2026. OssDsign® AB, a next generation orthobiologics company, today announced the launch of the OssDsign Catalyst® Commitment Fusion Warranty Program. The program reflects the company’s confidence in OssDsign Catalyst nanosynthetic™ bone graft substitute, which is supported by published real-world outcomes data.
The program follows the publication of results from PROPEL, OssDsign’s prospective, multi-center, observational real-world registry. OssDsign Catalyst achieved an 88.4% fusion success rate in real-world settings, including challenging patients. Nearly half of the patients in the registry’s first published cohort had three or more comorbidities that are widely associated with a higher risk of pseudoarthrosis.2
“Spinal fusion is among the most resource-intensive procedures performed today, and a nonunion places a significant clinical, emotional and financial burden on patients and health systems alike,” said Mark Waugh, CEO of OssDsign. “As bundled payments and episode-based care models expand, proven performance in real-world, high-risk patients matters more than ever. With the Catalyst Commitment, OssDsign is not only delivering a next generation nanosynthetic product; we’re standing alongside the hospitals and surgeons who trust it. Our real-world evidence gives us strong confidence in Catalyst’s performance.”
How the Catalyst Commitment Fusion Warranty Program works
Under the terms of this new program, OssDsign will provide a replacement product to a qualifying surgical facility if a patient undergoes an on-label spinal fusion procedure using OssDsign Catalyst nanosynthetic bone graft substitute and subsequently does not develop bridging bone within a specified postoperative window.
The program is available now to hospitals and ambulatory surgery centers (ASCs) across the United States. Facilities must enroll and meet the program’s eligibility requirements and documentation standards to qualify for replacement product.
Full warranty terms, eligibility criteria and onboarding details can be obtained from your regional OssDsign account manager.
For further information on this release, please contact:
Anders Svensson, CFO
Anders.svensson@ossdsign.com
Certified Adviser
The Company’s Certified Adviser is DNB Carnegie Investment Bank AB (publ)
1 For purposes of the Program, a qualifying outcome is the absence of bridging bone at the treated level or levels on computed tomography (“CT”) imaging obtained at 12 months following the index surgery, as determined by the Company’s designated independent medical reviewer.
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 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 400 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).
2 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
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.
Author
TH
TJ Halvorson
The De Angelis Group | Orthopedics This Week | MSK Innovations
Why This Matters
Two Perspectives
MBA Lens: Economic and industry impact
OssDsign launched its Catalyst Commitment Fusion Warranty Program, offering replacement product if nonunion occurs post-spinal fusion with OssDsign Catalyst. This strategic move leverages real-world evidence of 88.4% fusion success, addressing the financial burden of nonunions in an era of bundled payments. It aims to boost surgeon confidence and product adoption by mitigating risk for healthcare facilities.
- The program mitigates financial risk for hospitals and ASCs, aligning with evolving bundled payment models.
- It enhances market confidence and competitive positioning by demonstrating commitment to product performance and outcomes.
PhD Lens: Clinical and outcomes impact
OssDsign launched a warranty program for its Catalyst nanosynthetic bone graft, supported by real-world data from the PROPEL registry. This prospective study demonstrated an 88.4% fusion success rate at 12 months in complex spine patients, many with significant comorbidities, highlighting the product's robust bone formation capabilities even in challenging clinical scenarios.
- OssDsign Catalyst is a nanosynthetic bone graft with a patented nanocrystalline structure and silicate ions, promoting bone formation.
- The PROPEL registry, a prospective, observational study, reported 88.4% fusion success via CT imaging at 12 months in 108 complex patients.
React:
Discussion
This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?
Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.
We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.
Join the conversation
Orthopedic professionals are discussing this. Sign in and upgrade to read every comment and add your voice.