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Monday 14 October, 2019

Karolinska Development AB (pub

Karolinska Development’s portfolio company OssDsign receives US FDA clearance for Cranial PSI Accessories

Karolinska Development’s portfolio company OssDsign receives US FDA clearance for Cranial PSI Accessories

STOCKHOLM, SWEDEN – October 14, 2019. Karolinska Development (Nasdaq Stockholm: KDEV) announces today that its portfolio company, OssDsign AB, has been granted 510(k) clearance by the US Food and Drug Administration (FDA) to market OssDsign Cranial PSI Accessories in the US. The cleared products are a set of 3D-printed, patient specific accessory devices designed to support and expand clinical use of OssDsign’s patient specific cranioplasty implant already cleared by the FDA.

The new FDA clearance will enable OssDsign to continue to drive growth in the US by gaining access to additional cohorts of patients with complex cranial defects. The new accessories, along with OssDsign’s novel implant technology, will provide US neurosurgeons the possibility to remove bone tumors or otherwise diseased bony tissue and perform cranial reconstruction in a single stage procedure. One less surgical intervention can greatly reduce patient trauma while saving time and resources for hospitals.

“We welcome the approval of these patient- and user-friendly accessories to OssDsign’s established cranioplasty implants. This will further enhance the company’s opportunities to strengthen its business position in the US,” says Viktor Drvota, CEO at Karolinska Development.

For further information, please contact:

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

TO THE EDITORS

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 established 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 www.karolinskadevelopment.com


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