Additive Manufacturing (AM)

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    OssDsign Reaches Milestone of 500 Patients Treated with OssDsign® Catalyst in the U.S.

    OssDsign AB announced that 500 patients have now been treated in the U.S. with the nanosynthetic bone graft, OssDsign Catalyst.

    Uppsala,/January 9, 2023 — OssDsign AB announced that 500 patients have now been treated in the U.S. with the nanosynthetic bone graft, OssDsign Catalyst. Since the launch, awareness of the product has increased exponentially, which is reflected in the growing number of patients who benefit from the treatment. Reaching the 500-patient milestone is a significant achievement in the effort to expand the product’s presence in the U.S. market.

    OssDsign Catalyst is a synthetic 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.

    “Since June 2022, where we reached the first 100 patients, momentum has significantly accelerated. The rapid growth in the number of patients treated emphasizes the traction of OssDsign Catalyst and the increasing interest from surgeons in using the product for spinal fusion surgeries. Together with the post-market safety report and recent clinical data published on OssDsign Catalyst, reaching the 500-patient milestone is creating a stronger basis for the continued commercialization,” says Morten Henneveld, CEO of OssDsign.

    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 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, a U.S.-based multi-center prospective spinal fusion registry and TOP FUSION (NCT05114135), the premarket clinical trial, in which patient enrolment was completed in April 2022, run under the leadership of world-leading experts in spinal surgery.

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  • OssDsign AB announced the company has reached the milestone of 100 patients in the multi-center, prospective spinal fusion registry, PROPEL. Spinal Fusion Registry: OssDsign Reaches Milestone of 100 Patients in its PROPEL Registry Ahead of Time
  • OssDsign Enrolls the First Patient to the Multi-center Prospective Spinal Fusion Registry PROPEL in the U.S.
  • Data, based on 1,995 surgeries, shows the frequency of infections leading to cranial implant removal was 1.4%. Post-Market Surveillance Continues to Show Low Observed Complication Rates with OssDsign Cranial PSI