STOCKHOLM, SWEDEN – November 7, 2019. Karolinska Development (Nasdaq Stockholm: KDEV) announces that its portfolio company OssDsign has released updated outcome data which reveals that the rate of infections leading to implant removal of OSSDSIGN Cranial PSI remained low (2.4%) after a median follow-up time of 17 months.

Reconstruction of cranial defects can be a complex surgical procedure associated with an underestimated morbidity. This post-market surveillance report describes the outcome of 670 cranioplasties using OSSDSIGN Cranial PSI, a patient-specific implant made from a calcium phosphate material reinforced with 3D-printed titanium. All data was collected as part of post-market surveillance of product performance.  

One of the most common causes of explantation of implants are early post-operative infections. In the medical literature, explantation rates due to infection with traditional implants range between 7 and 12%. The OssDsign post-market-surveillance data however shows that at a median follow up time of 17 months (range: 0-58 months) only 16 (2.4%) of the implants were explanted due to early postoperative infections.  A peer-reviewed clinical study of OSSDSIGN Cranial reported similarly low rates of infections leading to implant removal (1.9%), as has previously reported post-market surveillance data.

Histological analysis of several implants explanted ≥ 9 months following surgery revealed bony integration between the implant and the native bone, as well as new bone formation within and around the remaining calcium phosphate material. The capacity of OssDsign’s material to remodel into living bone tissue has been documented in previous peer-reviewed scientific literature as well.

For further information, please contact:

Viktor Drvota, CEO, Karolinska Development AB
Phone: +46 73 982 52 02, e-mail: viktor.drvota@karolinskadevelopment.com

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 nine 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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• KD PM OssDsign 2019-11-07 ENG