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The cranial implant is made from 3D printed medical-grade titanium covered by a regenerative calcium phosphate composition.
June 21, 2022
By: Michael Barbella
Managing Editor
OssDsign AB has completed its first sales of OssDsign Cranial PSI in Japan. The launch marks an important strategic milestone, following a period of postponed commercial activities due to the Covid-19 pandemic. “Japan constitutes an important strategic market to our implant technology. While we foresee a gradual ramp-up in the market over the coming quarters and years, I am pleased that our continued perseverance during the pandemic has resulted in the first sales and a formal launch. We will now accelerate our commercial efforts towards more Japanese hospitals,” OssDsign CEO Morten Henneveld said. OssDsign Cranial PSI is a patient-specific cranial implant made from 3D printed medical-grade titanium covered by a regenerative calcium phosphate composition. While the titanium skeleton reinforces the implant and resists physical and mechanical stress, the unique calcium phosphate composition provides healing and regenerative properties, allowing regrowth of the patient’s own bone. Over time, the calcium phosphate composition degrades and is replaced with bone, leaving the patient with a well-integrated implant, potentially lasting a lifetime. The global market for OssDsign’s cranial implants is estimated at $400 million, with a 7% compound annual growth rate during 2021–2025. The product is commercially available in more than 10 markets worldwide through OssDsign’s direct sales force as well as distributors and independent sales agents. The most recent clinical data from long-term follow-up of the OssDsign Cranial PSI, based on 1,480 implants across 214 hospitals worldwide, showed that the frequency of infections leading to implant removal was 1.6% after a median follow-up time of 22 months. This positive outcome exceeded what has been observed in previous follow-ups, highlighting the exceptional performance of OssDsign Cranial PSI. OssDsign develops and provides 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. The company boasts a product portfolio consisting of patient-specific implants for cranial surgeries and an off-the-shelf synthetic bone graft for spine surgeries. The company has a commercial presence in the U.S., Europe and selected Asian countries.
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