Karolinska Development's portfolio company OssDsign receives expanded FDA market clearance for OssDsign Cranial PSI
04 October 2021 - 11:16PM
Karolinska Development's portfolio company OssDsign receives
expanded FDA market clearance for OssDsign Cranial PSI
STOCKHOLM, SWEDEN, 4 October 2021 Karolinska Development AB
(Nasdaq Stockholm: KDEV) today announces that its portfolio company
OssDsign AB has received an expanded marketing authorization from
the U.S. Food and Drug Administration (FDA) for the company's
patient-specific cranial implant product OssDsign Cranial PSI. The
approval underlines that OssDsign's patented calcium phosphate
composition has osteoconductive properties inducing resorption and
formation of new bone tissue.
The new 510(k) clearance is based on the previous market
clearance from 2017 and means that the FDA has now cleared the
osteoconductive component of the ceramic material in OssDsign
Cranial PSI that is resorbed and replaced with bone tissue during
the healing process.
OssDsign's titanium-reinforced calcium phosphate implant is
designed for the reconstruction of cranial bone defects, an area of
treatment where post-operative infections are considered one of the
most common complications. Both published data and clinical
documentation show that the OssDsign Cranial PSI is associated with
a low risk of infection in the early postoperative stage, which may
otherwise lead to the need for implant removal.
"The expanded approval from the FDA highlights the important
ability of OssDsign Cranial PSI to induce bone healing. The
announcement strengthens our portfolio company's commercial
position on the market and its possbility to provide patients
suffering from complex bone defects with a high-quality treatment
option," said Viktor Drvota, CEO, Karolinska Development.
Karolinska Development's shareholding in OssDsign AB, including
an indirect ownership via KCIF Co-Investment Fund, amounts to 10.4
per cent.
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 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.
- PM KD OssDsign ENG 2021-10-04
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