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
Certified Adviser
Erik Penser Bank is Certified Adviser.
The following files are available for download:
https://mb.cision.com/Public/17531/3873253/9ee7db3052513550.pdf
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2023-11-10 RB Integrum
PR clinical study Walter Reed
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SOURCE Integrum AB