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

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Integrum's OPRA™ Implant system receives FDA approval for a clinical study on below-knee amputations in the US. The study will be conducted by the Walter Reed National Military Medical Center and is crucial for future approval of the system. CEO Rickard Brånemark considers this a significant milestone.

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: rickard.branemark@integrum.se

Jörgen Svanström, CFO
Phone: + 46 (0) 70 734 96 60
E-mail: Jorgen.svanstrom@integrum.se

Certified Adviser

Erik Penser Bank is Certified Adviser.

The following files are available for download:

https://mb.cision.com/Public/17531/3865375/ae332572d5827e27.pdf

2023-10-30 Integrum PR IDE TTA

 

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

FAQ

What is the news about Integrum?

Integrum's OPRA™ Implant system has received FDA approval for a clinical study on below-knee amputations in the US.

Who will be conducting the clinical study?

The clinical study will be performed by the Walter Reed National Military Medical Center.

Why is the clinical study important?

The study is crucial for the future approval of the OPRA™ Implant System on the below-knee amputation level, which is the most frequent amputation level.

Who is the CEO of Integrum?

The CEO of Integrum is Rickard Brånemark.

Who is the Certified Adviser for Integrum?

Erik Penser Bank is the Certified Adviser for Integrum.