OssDsign® Catalyst receives clearance from FDA for major new indication for use in interbody cages
Uppsala, Sweden, September 18, 2023. OssDsign AB (publ.) today announces that the company’s innovative nanosynthetic bone graft OssDsign Catalyst has received clearance for use in interbody cages in spinal surgery from the U.S. Food and Drug Administration (FDA), allowing surgeons to use OssDsign Catalyst on-label in any interbody cage cleared for use with synthetic bone grafts. OssDsign Catalyst is the first synthetic bone graft to be cleared to market for interbody use based on bone graft data alone.
“This decision by the FDA represents one of the most important events in the history of OssDsign. It establishes OssDsign Catalyst in the exceptional class of synthetic bone grafts that may be used by surgeons on-label in the interbody space. As there is a huge demand for interbody use of synthetic bone grafts, believed to represent as much as 50% of all bone graft usage in spine surgeries, the new clearance marks a major market opportunity and sets us up for further commercial acceleration. The FDA clearance is based on our compelling data and it clearly strengthens and differentiates us in the market. We look forward to working with all hospitals and surgeons on this opportunity,” said Morten Henneveld, CEO of OssDsign.
OssDsign Catalyst is a nanosynthetic bone graft designed to stimulate the formation of healthy bone tissue in spinal fusion surgeries. In most spinal fusion surgeries a cage is used to stabilize the anterior spinal column. This new FDA clearance expands the indicated use to the interbody space and means that OssDsign Catalyst can now be used as a filler in cages cleared for use with synthetic bone grafts. OssDsign Catalyst is the first nanosynthetic bone graft to obtain FDA clearance for use in interbody cages solely based on its intrinsic safety and efficacy data.
The extended FDA clearance of OssDsign Catalyst is based on its outstanding bone regeneration results which surpass those typically seen with other synthetic bone grafts in challenging evaluation models. OssDsign continues to accelerate a robust program of gathering clinical evidence for OssDsign Catalyst anchored by PROPEL, a U.S.-based multi-center prospective spinal fusion registry in which more than 200 patients are enrolled, 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.
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