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

Mölndal, Sweden – October 30, 2023 — 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

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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/.