Swedish manufacturer of innovative implants for bone regeneration OssDsign has filed for a regulatory approval of OssDsign Cranial in Japan.
Subsequent to the filing, OssDsign has initiated commercial planning for a market entry in Japan.
OssDsign is engaged in design and manufacture of regenerative implants for improved healing of bone defects to improve the outcome for patients with severe cranial and facial defects.
OssDsign CEO Anders Lundqvist: “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.”
OssDsign spent significant resources for the regulatory submission
The company said that it has submitted the complete file on 28 June 2019, and the work required further pre-clinical testing in order to comply with the stringent Japanese requirements.
The Japanese Pharmaceutical and Medical Device Agency (PMDA) is expected to review the company’s proposal for approval.
Once approved, OssDsign Cranial would be the first product in the Japanese market that combines OssDsign’s calcium phosphate composition and features internal titanium mesh reinforcement.
In addition, Japanese market for cranioplasty implants will be one of its prioritized markets as it is being second only to the US market.
According to the company, selected Japanese neurosurgeons have already acquired experience in using OssDsign Cranial for cranial reconstructions, and have performed surgeries under an ethical approval.
Based on the positive experiences, OssDsign is planning for a market introduction in Japan during 2020.
OssDsign claims that it manufactures and sells an expanding range of patient-specific solutions for treating cranial defects and facial reconstruction, through combining clinical knowledge with technology.
Furthermore, the company’s technology is a product of its collaboration with clinical researchers at Karolinska University Hospital in Stockholm and material scientists at the Ångström Laboratory at Uppsala University. – NS Medical Devices