Karolinska Development’s portfolio company OssDsign announces that its latest product Cranioplug has received 510(k) clearance by the FDA, which allows marketing and sales of the product in US. The implant is the first product of its kind in the US market.
STOCKHOLM, October 22, 2018. Karolinska Development’s portfolio company OssDsign announces that its latest product Cranioplug has received 510(k) clearance by the FDA, which allows marketing and sales of the product in US. The implant is the first product of its kind in the US market.
Cranioplug is an implant used during neurosurgical procedures. The product is intended to cover and plug holes drilled into the skull during surgery and to reattach cranial bone removed during surgery. Cranioplug resorbs and is replaced with bone during the healing process.
Anders Lundqvist, CEO of OssDsign, said: “Receiving clearance for Cranioplug is an important step for OssDsign. This motivates us to increase our presence in the US market and continue to build our US organization throughout 2018 and beyond. The regenerative features of OssDsign’s calcium phosphate composition are now getting recognized, and it’s our mission to turn them into real benefits for patients, surgeons and hospital systems.”
“It is always encouraging when one of our portfolio companies makes good progress. The clearance from the FDA for Cranioplug is a milestone for OssDsign”, said Viktor Drvota CEO of Karolinska Development.
Karolinska Development has an ownership of 21 per cent (fully diluted) in OssDsign.
For more details please visit:
For further information, please contact:
Viktor Drvota, CEO, Karolinska Development AB
Phone: +46 73 982 52 02, e-mail: viktor.drvota@
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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
