Integrum's OPRA™ Implant System demonstrates superior treatment outcomes in two-year follow-up study by Walter Reed National Military Medical Center

Rhea-AI Summary

Integrum AB (INTEG B) has announced compelling results from a two-year follow-up study conducted by Walter Reed National Military Medical Center on their OPRA™ Implant System for transfemoral amputees. The Level II Evidence study, focusing on the latest version introduced in 2017, demonstrates significant advantages over traditional socket prostheses.

The study revealed several key achievements:

• 100% implant survival rate
• Reduced infection and complication rates compared to previous data
• Increased prosthetic use
• Improved mobility and quality of life for patients

The research, published in Clinical Orthopaedics and Related Research (CORR), was conducted by a team led by Dr. Benjamin K. Potter and Dr. Jonathan Forsberg. The findings are expected to drive further adoption among US health providers and potentially increase insurance provider reimbursement coverage.

Positive

• 100% implant survival rate in two-year follow-up study
• Reduced infection and complication rates compared to previous data
• Independent validation from prestigious military medical center
• Potential expansion of insurance coverage could increase market access

Negative

• None.

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MÖLNDAL, Sweden, March 18, 2025 /PRNewswire/ -- Integrum AB (publ) (Nasdaq First North Growth Market: INTEG B) announces today that a newly published independent study from the Walter Reed National Military Medical Center in Bethesda, Maryland, U.S., provides compelling evidence of OPRA^™ Implant System's treatment effectiveness in transfemoral amputees. The study demonstrates significant functional improvements over traditional socket prostheses, an important validation of Integrum's innovative technology and its clinical benefit in patients who have undergone amputation.

The two-year follow-up study (Level II Evidence) includes the latest and most advanced version of the OPRA^™ Implant System, which was introduced in 2017. The study results highlight several key benefits for patients using the implant system, including increased prosthetic use, improved mobility, and enhanced quality of life. Importantly, the study reveals improved outcomes compared to previously published data, including fewer infections and complications, and a 100% implant survival rate.

"This study confirms the safety, durability, and positive impact of the OPRA Implant System for individuals who have undergone amputation. We are honored to support the men and women who have served their country and are excited to see growing evidence supporting its role in improving mobility and overall well-being for amputees globally," comments Scott Flora, acting CEO of Integrum.

Collectively, the insights gathered from this study will be useful in driving further adoption of the technology by US health providers, as well as to increase the awareness of the OPRA™ Implant System among health professionals and potential patients.

"We need high quality prospective clinical trials like this to confirm not only the benefits of transdermal bone anchored implants, but also the complication profile over the long-term. By further proving safety and effectiveness of The OPRA Implant System, we hope this growing body of evidence will encourage exponential acceptance among US insurance providers for reimbursement, making this life-changing technology more accessible to patients in need," Dr. Jonathan Forsberg, MD, PhD currently practicing at Memorial Sloan Kettering in New York, retired from the military after 32 years of service.

"We were excited to see that our results further confirmed the benefits of direct skeletal attachment for improving function and quality of life for patient with limb loss, while maintaining better than expected infection and major complication rates," says Dr. Benjamin K. Potter, MD, currently Chair, Department of Orthopaedic Surgery at Penn Medicine in Philadelphia, PA. Dr. Potter retired from the Army after over 22 years of service.

The study was authored by Benjamin K. Potter, MD, Jonathan A. Forsberg, MD, PhD, LCDR Ashley B. Anderson, MD, Jason M. Souza, MD, and Julio Rivera, PhD, and recently published in Clinical Orthopaedics and Related Research (CORR).

Read the full article: https://journals.lww.com/clinorthop/abstract/2025/03000/what_functional_outcomes_can_be_expected_with.24.aspx.

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

Certified Adviser
Carnegie Investment Bank AB (publ) is Certified Adviser.

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Integrum PR TFAOS 2025-03-18 eng

 

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SOURCE Integrum AB

FAQ

What are the key outcomes of the 2025 Walter Reed study on Integrum's OPRA Implant System (INTEG)?

The study showed 100% implant survival rate, fewer infections and complications, increased prosthetic use, and improved mobility and quality of life for transfemoral amputees compared to traditional socket prostheses.

How long was the follow-up period for the INTEG OPRA Implant System study at Walter Reed?

The study followed patients for two years, providing Level II Evidence on the latest version of the OPRA Implant System introduced in 2017.

What impact could the Walter Reed study have on INTEG's OPRA System insurance coverage?

The positive study results are expected to encourage greater acceptance among US insurance providers for reimbursement, potentially making the technology more accessible to patients.

Who conducted the 2025 clinical study on Integrum's OPRA Implant System (INTEG)?

The study was conducted by researchers at Walter Reed National Military Medical Center, led by Dr. Benjamin K. Potter and Dr. Jonathan Forsberg, and published in Clinical Orthopaedics and Related Research.