Karolinska Development's portfolio company OssDsign has received FDA clearance for a new major indication
19 September 2023 - 4:00PM
Karolinska Development's portfolio company OssDsign has received
FDA clearance for a new major indication
STOCKHOLM, SWEDEN, September 19, 2023. Karolinska Development AB
(Nasdaq Stockholm: KDEV) announces that its portfolio company
OssDsign has received clearance from FDA for the use of OssDsign
Catalyst in interbody cages in spinal surgery. The FDA clearance
creates possibilities in a new indication with major market
potential for the company’s innovative nanosynthetic bone
graft.
The clearance from the U.S. Food and Drug Administration (FDA)
allows surgeons to use the OssDsign Catalyst on-label in any
interbody cage cleared for use with synthetic bone grafts. OssDsign
Catalyst is the first synthetic bone graft to be cleared to market
for interbody use based on bone graft data alone.
The decision by the FDA is based on OssDsign’s outstanding bone
regeneration results which surpass other synthetic bone grafts in
challenging evaluation models.
“There is a huge demand for the use of synthetic bone graft in
interbody cages, assumed to represent as much as 50 percent of all
use of bone graft in spinal surgeries. The FDA clearance marks a
great opportunity for our portfolio company to expand its business
and accelerate its commercialization in the U.S further," says
Viktor Drvota, CEO, Karolinska Development.
Karolinska Development's shareholding in OssDsign, including
indirect ownership via KCIF Co-Investment Fund, amounts to 10.4
percent.
OssDsign is a developer and global provider of next-generation
bone replacement products. Based on cutting-edge material science,
the company develops and markets products that support the body’s
own healing capabilities and thereby improve the clinical outcome
in a wide range of orthopedic areas with high medical needs. With a
product portfolio consisting of patient-specific implants for
cranial surgeries and an off-the-shelf synthetic bone graft for
spine surgeries, OssDsign gives back patients the life they
deserve. The company has a strong commercial presence in the US,
Europe and selected Asian countries. OssDsign’s share is traded on
Nasdaq First North Growth Market in Stockholm, Sweden.
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 ABPhone: +46 70 207 48 26, e-mail:
johan.dighed@karolinskadevelopment.com
TO THE EDITORS
About Karolinska Development ABKarolinska
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.
- KD OssDsign FDA interbody cages
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