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Clinical study of Integrum's OPRA™ Implant System on below-knee amputations will include up to 30 patients and is fully funded by the Department of Defense

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Integrum (NASDAQ First North Growth Market: INTEG B) announces full funding from the US Department of Defense for a clinical study of OPRA™ Implant System on up to 30 patients with transtibial amputations. The study will be conducted at the Walter Reed National Military Medical Center. The FDA-approved study will provide crucial data for future regulatory processes.
Positive
  • US Department of Defense funding demonstrates recognition of Integrum's product potential
  • FDA approval for the study is a positive sign for the OPRA™ Implant System
  • Future regulatory process will benefit from the data collected in the study
Negative
  • None.

MÖLNDAL, Sweden, Nov. 10, 2023 /PRNewswire/ -- Integrum (publ) (NASDAQ First North Growth Market: INTEG B) today announces that the US Department of Defense has decided to fully fund a clinical study of OPRA™ Implant System on up to 30 patients with transtibial (below-knee) amputations. As previously announced,  the study will be performed by the Walter Reed National Military Medical Center in Bethesda, Maryland. Integrum will supply OPRA™ Implant Systems to Walter Reed on commercial terms.

The OPRATM Implant System clinical study on the below-knee amputation level recently received FDA approval, and recruitment to the study will start as soon as the protocol is approved by the Investigational Research Board (IRB). Once the study is finalized, Integrum will be able to use the data in any future regulatory process.

"We are fully committed to broadening the use of our innovative implant system to improve the lives of as many amputees as possible. We see it as a great recognition of our products' potential that the US Department of Defense has decided to fully fund the study and that top surgeons at the Walter Reed Military Hospital will perform the surgical procedures. The results will be instrumental for a future Pre-Market Approval application for use in transtibial amputations, and we look forward to supplying OPRATM Implant Systems to the study," says 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

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The following files are available for download:

https://mb.cision.com/Public/17531/3873253/9ee7db3052513550.pdf

2023-11-10 RB Integrum PR clinical study Walter Reed

 

 

Cision View original content:https://www.prnewswire.com/news-releases/clinical-study-of-integrums-opra-implant-system-on-below-knee-amputations-will-include-up-to-30-patients-and-is-fully-funded-by-the-department-of-defense-301984440.html

SOURCE Integrum AB

The ticker symbol for Integrum is INTEG B on the NASDAQ First North Growth Market.

The clinical study aims to evaluate the OPRA™ Implant System on transtibial amputations and gather data for future regulatory processes.

The study will be performed by top surgeons at the Walter Reed National Military Medical Center in Bethesda, Maryland.

The FDA approval is a positive indicator for the OPRA™ Implant System and its potential use in transtibial amputations.
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