STOCKHOLM, SWEDEN, September 19, 2023 – Karolinska Improvement AB (Nasdaq Stockholm: KDEV) proclaims that its portfolio firm OssDsign has acquired clearance from FDA for using OssDsign Catalyst in interbody cages in spinal surgical procedure. The FDA clearance creates prospects in a brand new indication with main market potential for the corporate’s revolutionary nanosynthetic bone graft.
The clearance from the U.S. Food and Drug Administration (FDA) permits surgeons to make use of the OssDsign Catalyst on-label in any interbody cage cleared to be used with artificial bone grafts. OssDsign Catalyst is the primary artificial bone graft to be cleared to marketplace for interbody use based mostly on bone graft information alone.
The choice by the FDA relies on OssDsign’s excellent bone regeneration outcomes which surpass different artificial bone grafts in difficult analysis fashions.
“There’s a enormous demand for using artificial bone graft in interbody cages, assumed to characterize as a lot as 50 % of all use of bone graft in spinal surgical procedures. The FDA clearance marks a terrific alternative for our portfolio firm to increase its enterprise and speed up its commercialization in the usfurther,” says Viktor Drvota, CEO, Karolinska Improvement.
Karolinska Improvement’s shareholding in OssDsign, together with oblique possession by way of KCIF Co-Funding Fund, quantities to 10.4 %.
OssDsign is a developer and international supplier of next-generation bone alternative merchandise. Primarily based on cutting-edge materials science, the corporate develops and markets merchandise that help the physique’s personal therapeutic capabilities and thereby enhance the scientific consequence in a variety of orthopedic areas with excessive medical wants. With a product portfolio consisting of patient-specific implants for cranial surgical procedures and an off-the-shelf artificial bone graft for spine surgical procedures, OssDsign offers again sufferers the life they deserve. The corporate has a robust industrial presence within the US, Europe and chosen Asian nations. OssDsign’s share is traded on Nasdaq First North Development Market in Stockholm, Sweden.
For additional info, please contact:
Viktor Drvota, CEO, Karolinska Improvement AB Telephone: +46 73 982 52 02, e-mail: firstname.lastname@example.org
Johan Dighed, Common Counsel and Deputy CEO, Karolinska Improvement AB Telephone: +46 70 207 48 26, e-mail: email@example.com
TO THE EDITORS
About Karolinska Improvement AB
Karolinska Improvement AB (Nasdaq Stockholm: KDEV) is a Nordic life sciences funding firm. The corporate focuses on figuring out breakthrough medical improvements within the Nordic area which might be developed by entrepreneurs and management groups. The Firm invests within the creation and progress of corporations that advance these property into industrial merchandise which might be designed to make a distinction to sufferers’ lives whereas offering a gorgeous return on funding to shareholders.
Karolinska Improvement has entry to world-class medical improvements on the Karolinska Institutet and different main universities and analysis institutes within the Nordic area. The Firm goals to construct corporations round scientists who’re leaders of their fields, supported by skilled administration groups and advisers, and co-funded by specialist worldwide traders, to supply the best likelihood of success.
Karolinska Improvement has a portfolio of 11 corporations concentrating on alternatives in revolutionary remedy for life-threatening or severe debilitating illnesses.
The Firm is led by an entrepreneurial staff of funding professionals with a confirmed monitor document as firm builders and with entry to a robust international community.
For extra info, please go to www.karolinskadevelopment.com.