
OssDsign announced that it 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.
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.
“Japan constitutes an important strategic market to our implant technology,” said Morten Henneveld, CEO, OssDsign. “Whilst 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.”
The product is commercially available in more than ten markets worldwide through OssDsign’s direct salesforce 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.