STOCKHOLM, Aug. 9, 2019 /PRNewswire/ -- OssDsign AB (publ) ("OssDsign" or the "Company"), the Swedish designer and manufacturer of innovative implants for bone regeneration, has filed for a Japanese regulatory approval of OssDsign Cranial. Subsequent to the filing, OssDsign initiates commercial planning for a market entry in Japan.
OssDsign has, as previously communicated, spent a significant amount of time and resources in order to compile a regulatory submission for Japan. This work has required further pre-clinical testing in order to comply with the stringent Japanese requirements. The complete file was submitted on June 28thand will now be reviewed by the Japanese Pharmaceutical and Medical Device Agency (PMDA). If granted approval, OssDsign Cranial will be the first product of its kind on the Japanese market, combining OssDsign's proprietary calcium phosphate composition with an internal titanium mesh reinforcement.
The Japanese market for cranioplasty implants is one of OssDsign's prioritized markets due to its value being second only to the US market. As communicated in the Company's prospectus, selected Japanese neurosurgeons have already gained experience from using OssDsign Cranial for cranial reconstructions. Surgeries to date have been performed under an ethical approval. OssDsign intends to build on these positive experiences when planning for a market introduction in Japan during 2020.
Anders Lundqvist, CEO at OssDsign: "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."
Certified Adviser
The Company's Certified Adviser is Erik Penser Bank AB. Contact information: Erik Penser Bank AB, Box 7405, 103 91 Stockholm, Sweden, phone: +46 (0)8-463 80 00, email: certifiedadviser@penser.se.
For further information, please contact:
Anders Lundqvist, CEO, OssDsign AB
Tel: +46 73 206 98 08,
email: al@ossdsign.com
About OssDsign
OssDsign is a Swedish medical technology company that develops and manufactures regenerative implants for improved healing of bone defects. Providing neuro and plastic surgeons with innovative implants, OssDsign improves the outcome for patients with severe cranial and facial defects worldwide. By combining clinical knowledge with proprietary technology, OssDsign manufactures and sells a growing range of patient-specific solutions for treating cranial defects and facial reconstruction. OssDsign's technology is the result of collaboration between clinical researchers at Karolinska University Hospital in Stockholm and material scientists at the Ångström Laboratory at Uppsala University.
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