STOCKHOLM, December 14, 2017. Karolinska Development announces today that the portfolio company Promimic has received approval from the U.S. Food and Drug Administration (FDA) for the use of HAnano Surface as a dental implant coating. Promimic's partner S.I.N. is currently preparing a U.S. launch of Unitite (TM) - a line of dental implants coated with HAnano Surface.
The approval of HAnano Surface in the United States has been executed in accordance with the new 510(k) legislation for medical devices. After this approval several other submissions will be filed to the FDA during 2018, particularly in the orthopedic area.
"The FDA approval allows for a rapid launch in the United States of dental implants coated with HAnano Surface - a unique technology that improves the integration of the implant into bone tissue and allows the patient to rapidly regain normal dental function after the surgical procedure," says Viktor Drvota, CEO, Karolinska Development.
In 2016, Promimic's partner S.I.N. launched the dental implant line Unitite(TM) in Brazil.
For further information, please contact:
Viktor Drvota, CEO, Karolinska Development AB
Phone: +46 73 982 52 02, e-mail: viktor.drvota@karolinskadevelopment.com
Fredrik Järrsten, CFO, Karolinska Development AB
Phone: +46 70 496 46 28, e-mail: fredrik.jarrsten@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 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
