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.

Go deeper with GlobalData

Data Insights

The gold standard of business intelligence.

Find out more

Related Company Profiles

View all

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.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

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.

Ossdsign Cranial is the result of collaborations between surgeons and scientists at Karolinska University Hospital and Uppsala University.