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Schlieren (Zurich), Switzerland, October 18, 2018 – Kuros Biosciences AG (SIX: KURN) announced today that the Company has reached a key milestone in its Fibrin-PTH (KUR-113) spinal fusion product candidate development program with the submission of a 510(k) regulatory package for its enabling lumbar intervertebral body fusion device to the U.S. Food and Drug Administration (FDA).
Kuros Biosciences will include this news in its program update to the North American Association of Spinal Surgeons (NASS) orthobiologics course ‘2018 Biologic Interventions for Spinal Pathologies: Stem Cells, Growth Factors & Novel Therapeutics’ being held in Chicago on Friday October 19.
“The submission of this US FDA 510(k) regulatory package keeps our KUR-113 spinal fusion product candidate development on track. Completion of the lumbar intervertebral body fusion device development is an important corporate milestone as the device will be used in the upcoming clinical trials in combination with Kuros’ spinal fusion product candidate KUR-113,” said Joost de Bruijn, CEO of Kuros. “Coupled with the invitation to present an update at such a highly focused spine meeting of acknowledged experts in orthobiologics science marks the successful progress of our Company.”
KUR-113 consists of a natural fibrin-based healing matrix with an immobilized targeted bone growth factor (truncated human parathyroid hormone (PTH) analog). KUR-113 is designed to be applied directly into and around an intervertebral body fusion device as a gel, where it polymerizes in situ. KUR-113 will be combined with the interbody spacer device in the upcoming clinical trial for interbody spinal fusion.
About the NASS ‘2018 Biologic Interventions for Spinal Pathologies’ Meeting
The field of spinal biologics is rapidly evolving as patients, researchers, and clinicians are recognizing its potential to treat challenging painful conditions. While the roles of both nonoperative and surgical treatment are relatively well-defined in the spine care treatment landscape, the indications, risks, and concerns regarding biologics for a variety of spinal conditions have not been agreed upon. Because of the differences in regulatory pathways for many of these products, the availability of data is variable making administrative decision-making difficult. This meeting will bring together exciting minds from academia and industry to discuss pertinent technologies and relevant issues in biologics use for spinal conditions.
For further information, please contact:
Kuros Biosciences AG
Chief Financial Officer
Tel +41 44 733 47 47
Media & Investors
Tel +41 79 598 7149
About Kuros Biosciences AG
Kuros Biosciences is focused on the development of innovative products for tissue repair and regeneration and is located in Schlieren (Zurich), Switzerland and Bilthoven, The Netherlands. The Company is listed according to the International Financial Reporting Standard on the SIX Swiss Exchange under the symbol KURN. Visit www.kuros.18a.co for additional information on Kuros, its science and product pipeline.
Forward Looking Statements
This media release contains certain forward-looking statements that involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. You are urged to consider statements that include the words “will” or “expect” or the negative of those words or other similar words to be uncertain and forward-looking. Factors that may cause actual results to differ materially from any future results expressed or implied by any forward-looking statements include scientific, business, economic and financial factors, Against the background of these uncertainties, readers should not rely on forward-looking statements. The Company assumes no responsibility for updating forward-looking statements or adapting them to future events or developments.