Swedish designer and manufacturer of implants for bone regeneration, OssDsign has filed for Japanese regulatory approval of OssDsign Cranial.
Subsequent to the filing, the company plans to initiate preparations for the launch of OssDsign Cranial in the country.
Before compiling a regulatory submission for Japan, OssDsign carried out pre-clinical testing to comply with stringent Japanese requirements.
The Japanese Pharmaceutical and Medical Device Agency (PMDA) will now review the complete file.
After securing approval, OssDsign Cranial will be the first product of its kind on the Japanese market, combining the company’s calcium phosphate composition with a supporting titanium skeleton in an innovative patient-specific design.
The end result, which is an implant solution, provides cranioplasty patients with protection, aesthetics and reliability.
OssDsign CEO Anders Lundqvist said: “We are very excited to have taken this big step towards establishing OssDsign in Japan, one of the most important markets for us, and we will now intensify our efforts to find an appropriate Japanese commercial partner.
“Our early work together with key opinion leading neurosurgeons in Japan has been very positive and we are certainly appreciative of the reception they have given the product and our technology.
“Going forward our intention is to build more clinical experience in Japan prior to launch so that we can hit the ground running once we have a PMDA approval in place.”
The company is planning to introduce OssDsign Cranial to the Japanese market next year.