Copyright © Inderes 2011 - present. All rights reserved.
  • Latest
  • Markets
    • Stock Comparison
    • Financial Calendar
    • Dividends Calendar
    • Research
    • Articles
  • inderesTV
  • Portfolio
  • Forum
  • Q&A
  • About Us
    • Our Coverage
    • Team
Regulatory press release

Bonesupport Holding AB: BONESUPPORT receives "breakthrough device designation" for CERAMENT G for the indication trauma

Bonesupport
Read the release

Lund, Sweden, 10:00 CET, 17 06 21 BONESUPPORT™, an emerging leader in orthobiologics for the management of bone injuries, today announced that the company's antibiotic eluting product CERAMENT G has been categorized as a breakthrough device for the indication trauma by the US Food and Drug Administration (FDA).

The categorization "breakthrough device" can be assigned to products that are considered to provide a more effective treatment of severe disease states, where there is no comparable equivalent on the market. The categorization is intended to expedite the regulatory review of medical devices so that patients receive faster access to new treatment options.

"We will submit a regulatory application including trauma by the end of 2021. The decision from the FDA is of course important regarding the upcoming reimbursement process and with which priority our application will be processed," said Emil Billbäck, CEO of BONESUPPORT.

CERAMENT G has been classified as a breakthrough device for the indication osteomyelitis (bone infection) since March 2020 and BONESUPPORT is currently working to supplement previously submitted application, with the aim of reaching a potential approval for bone infection during the first quarter of 2022. A potential approval for the indication trauma may become effective at the end of 2022.

 

For more information contact:

BONESUPPORT HOLDING AB
Emil Billbäck, CEO
+46 (0) 46 286 53 70

Håkan Johansson, CFO
+46 (0) 46 286 53 70
ir@bonesupport.com

Cord Communications
Charlotte Stjerngren
+46 (0) 708 76 87 87
charlotte.stjerngren@cordcom.se
www.cordcom.se

About BONESUPPORT™

BONESUPPORT (Nasdaq Stockholm: BONEX) develops and commercializes innovative injectable bio-ceramic bone graft substitutes that remodel to the patient's own bone and have the capability of eluting drugs. BONESUPPORT's bone graft substitutes are based on the patented technology platform CERAMENT (https://bonesupport.com/en-eu/products/). The company is conducting several clinical studies to further demonstrate the clinical and health economic benefits its products deliver. The company is based in Lund, Sweden, and the net sales amounted to SEK 181 million in 2020. Please visit www.bonesupport.com (https://bonesupport.com/en-eu/) for more information.

BONESUPPORT and CERAMENT are registered trademarks (https://bonesupport.com/en-eu/trademarks/) of BONESUPPORT AB.

Find us on social media
  • Inderes Forum
  • Youtube
  • Instagram
  • Facebook
  • X (Twitter)
Get in touch
  • info@inderes.se
  • +46 8 411 43 80
  • Vattugatan 17, 5tr
    111 52 Stockholm
Inderes
  • About us
  • Our team
  • Careers
  • Inderes as an investment
  • Services for listed companies
Our platform
  • FAQ
  • Terms of service
  • Privacy policy
  • Disclaimer
Inderes’ Disclaimer can be found here. Detailed information about each share actively monitored by Inderes is available on the company-specific pages on Inderes’ website. © Inderes Oyj. All rights reserved.