STOCKHOLM, SWEDEN, January 9, 2024. Karolinska Development AB (Nasdaq Stockholm: KDEV) announces that the portfolio company OssDsign reports positive data from the clinical study TOP FUSION. Top-line results show a 93% spinal fusion rate at 12 months as assessed with CT by independent radiological review after surgery with the novel nanosynthetic bone graft OssDsign Catalyst.
The data, that has been submitted to a peer-reviewed scientific journal, indicates that the use of OssDsign Catalyst leads to consistent and rapid bone healing and remodeling, with improved patient outcomes as a result. They also confirm the previously reported best-in-class pre-clinical results.
TOP FUSION is a first-in-patient open-label, prospective, single-center clinical study led by Dr Péter Pál Varga and Dr Àron Lazary at the National Center for Spinal Disorders at the Buda Health Clinic in Budapest, Hungary.
"These outstanding clinical data confirm the unique potential of OssDsign Catalyst. It is a well-known challenge for orthopedic surgeons to establish spinal fusion, with unsuccessful fusions leading to a lot of failed surgeries and suffering for the patients. A spinal fusion rate of 93% after 12 months is exceptionally good and the results show that OssDsign Catalyst is a very competitive alternative for spinal fusions," says Viktor Drvota, CEO of Karolinska Development.
OssDsign Catalyst is a nanosynthetic bone graft that stimulates the formation of healthy bone tissue in spinal fusion surgeries. The product was launched in the U.S. in August 2021. The market clearance is based on preclinical results that surpass what is typically seen with other synthetic bone grafts in the most demanding preclinical model for spinal fusion - the Boden model. OssDsign Catalyst recently received clearance for use in interbody cages in spinal surgery from the U.S. Food and Drug Administration (FDA). OssDsign's shares are listed on Nasdaq First North Growth Market in Stockholm.
Karolinska Development's shareholding in OssDsign AB, including indirect ownership via KCIF Co-Investment Fund, amounts to 9.5 percent.
For further information, please contact:
Viktor Drvota, CEO, Karolinska Development AB
Phone: +46 73 982 52 02, e-mail: viktor.drvota@karolinskadevelopment.com
Johan Dighed, General Counsel and Deputy CEO, Karolinska Development AB
Phone: +46 70 207 48 26, e-mail: johan.dighed@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 a portfolio of eleven 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.
