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Monday 30 March, 2020

Karolinska Development AB (pub

Karolinska Development’s portfolio company OssDsign receives regulatory approval and prepares for launch in Japan

Karolinska Development’s portfolio company OssDsign receives regulatory approval and prepares for launch in Japan

STOCKHOLM, SWEDEN, 30 mars 2020. Karolinska Development AB (Nasdaq Stockholm: KDEV) today announces that its portfolio company OssDsign has received regulatory approval for the implant product OssDsign Cranial PSI in Japan. OssDsign plans to launch the product together with a local distribution partner immediately following formal reimbursement approval, which is expected in the second half of 2020.

Discussions are currently ongoing with local partner candidates that fit OssDsign’s defined go-to market strategy. The strategy has included a successful pre-launch phase during which leading Japanese neurosurgeons have been able to use OssDsign Cranial PSI clinically. This has resulted in valuable product awareness and positive clinical experiences that were presented at the 78th Annual Meeting of the Japan Neurosurgical Society held in Osaka in 2019.

”The notice of approval from the Japanese regulatory authority, PMDA, is highly significant for OssDsign as the Japanese market for cranial reconstruction is the second largest among the OECD member countries”, said Viktor Drvota, CEO, Karolinska Development.

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.

For further information, please contact :

Viktor Drvota, CEO, Karolinska Development AB
Phone: +46 73 982 52 02, e-mail: [email protected]


About Karolinska Development AB

Karolinska Development AB (Nasdaq Stockholm: KDEV) is a Nordic life sciences investment company. The company focuses on identifying breakthrough medical innovations in the Nordic region that are developed by entrepreneurs and leadership teams. The Company invests in the creation and growth of companies that advance these assets into commercial products that are designed to make a difference to patients' lives while providing an attractive return on investment to shareholders.

Karolinska Development has access to world-class medical innovations at the Karolinska Institutet and other leading universities and research institutes in the Nordic region. The Company aims to build companies around scientists who are leaders in their fields, supported by experienced management teams and advisers, and co-funded by specialist international investors, to provide the greatest chance of success.

Karolinska Development has a portfolio of ten companies targeting opportunities in innovative treatment for life-threatening or serious debilitating diseases.

The Company is led by an entrepreneurial team of investment professionals with a proven track record as company builders and with access to a strong global network.

For more information, please visit


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