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
Mölndal, Sweden – November 10, 2023 — 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.
ABOUT INTEGRUM
Integrum AB is a publicly traded company (INTEG B: Nasdaq First North Growth Market) based outside of Gothenburg, Sweden, with a U.S. subsidiary in San Francisco. Since 1990, its OPRA™ Implant System has helped improve the quality of life for hundreds of people who are amputees by directly attaching a prosthesis to the bone and musculoskeletal system, therefore avoiding the need for a socket. Based on osseointegration, the bone-anchored implant system offers a range of benefits, including improved mobility and function, enhanced comfort, reduced pressure, a stable attachment and more. The OPRA™ System was approved by the U.S. Food and Drug Administration (FDA) in 2020 and is the only FDA-approved bone-anchored implant system specifically designed for use in amputees available in the U.S. Today, Integrum continues to perform research and develop custom-made medical device solutions in close collaboration with scientists and clinicians. To learn more, please visit https://integrum.se/.