Targeted & controlled bone healing
18 Oct 18
Kuros Biosciences advances its Fibrin-PTH (KUR-113) spinal fusion product candidate program

MEDIA RELEASE

Kuros Biosciences advances its Fibrin-PTH (KUR-113) spinal fusion product candidate program

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.”

 

About KUR-113

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.



Kuros Biosciences AG
Wagistrasse 25, 8952 Schlieren, Switzerland
Tel: +41 44 733 47 47   Fax: +41 44 733 47 40   Email: info@kurosbio.com

About Kuros

  1. Overview
  2. Executive Committee
  3. Board
  4. Careers

Products

  1. MagnetOs

Pipeline

  1. Pipeline
  2. Spinal fusion
    KUR-113
  3. Fracture repair
    KUR-111
    KUR-113
  4. Surgical Sealants
    Neuroseal (KUR-023)

Technologies

  1. Surface Science Technology
  2. Fibrin-Based
  3. Synthetic Cross-Linking Technology
  4. Immune Modulation

Partnerships

  1. Collaborations
  2. Business Development

Investors

  1. Share price
  2. Regulatory filings
  3. Reports & Presentations
  4. Analysts
  5. Calendar
  6. Corporate governance
  7. Stay informed

News

  1. Press releases
  2. Conferences & Events

Contact

  1. Location
Article
18 Oct 18
Kuros Biosciences advances its Fibrin-PTH (KUR-113) spinal fusion product candidate program

MEDIA RELEASE

Kuros Biosciences advances its Fibrin-PTH (KUR-113) spinal fusion product candidate program

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.”

 

About KUR-113

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.