Integrum's OPRA™ Implant System gets FDA approval for clinical study on below-knee amputations

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MÖLNDAL, Sweden, Oct. 30, 2023 /PRNewswire/ -- Integrum (publ) (Nasdaq First North Growth Market: INTEG B) today announces that the company's OPRA™ Implant system is approved by FDA to be used in a clinical study on below-knee amputations in the US.

Metadata
Provider: 
PR NewswirePR Newswire
Retrieved on: 
Monday, October 30, 2023
Information
Tags: 
FDA, Walter Reed National Military Medical Center, Trial of the century, Amputation, Restitutio ad integrum, Medical device
Geotags: 
SWEDEN
⚠ partially generated by AI ↴
Organisation: 
INTEGRUM, INTEGRUM AB
Stock Symbol: 
ISIN:SE0009807266
Stockholm:INTEGB
Summary
Key Points: 
  • MÖLNDAL, Sweden, Oct. 30, 2023 /PRNewswire/ -- Integrum (publ) (Nasdaq First North Growth Market: INTEG B) today announces that the company's OPRA™ Implant system is approved by FDA to be used in a clinical study on below-knee amputations in the US.
  • The clinical study will be important for the future approval of the OPRA™ Implant System on the below-knee amputation level, which is the most frequent amputation level.
  • The study will be performed by the Walter Reed National Military Medical Center.
  • "This is an important milestone in the expansion of indications for our OPRA™ Implant System," said Rickard Brånemark, CEO of Integrum.




Integrum's OPRA™ Implant System gets FDA approval for clinical study on below-knee amputations

MÖLNDAL, Sweden, Oct. 30, 2023 /PRNewswire/ -- Integrum (publ) (Nasdaq First North Growth Market: INTEG B) today announces that the company's OPRA™ Implant system is approved by FDA to be used in a clinical study on below-knee amputations in the US.

The clinical study will be important for the future approval of the OPRA™ Implant System on the below-knee amputation level, which is the most frequent amputation level. The study will be performed by the Walter Reed National Military Medical Center.

"This is an important milestone in the expansion of indications for our OPRA™ Implant System," said Rickard Brånemark, CEO of Integrum.

For more information please contact:
Rickard Brånemark, CEO
Phone: +46 (0) 70 846 10 61
E-mail: [email protected]

Jörgen Svanström, CFO
Phone: + 46 (0) 70 734 96 60
E-mail: [email protected]

Certified Adviser

Erik Penser Bank is Certified Adviser.

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Cision View original content:https://www.prnewswire.com/news-releases/integrums-opra-implant-system-gets-fda-approval-for-clinical-study-on-below-knee-amputations-301971151.html

SOURCE Integrum AB



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