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.
Insights
The Walter Reed National Military Medical Center's newly published study on Integrum's OPRA™ Implant System represents a significant clinical validation milestone that addresses critical adoption barriers for this bone-anchored prosthetic technology.
The Level II evidence demonstrating superior functional outcomes in transfemoral amputees versus traditional socket prostheses provides Integrum with compelling data for discussions with healthcare providers and insurance companies. The documented improvements in prosthetic use, mobility, and quality of life - coupled with a 100% implant survival rate and fewer complications than previously reported - strengthen the clinical value proposition substantially.
What makes this study particularly impactful is its focus on the latest OPRA™ version (introduced 2017), ensuring the data reflects the current commercial product. This eliminates concerns about outdated technology assessment that often plague medical device studies.
The reimbursement implications cannot be overstated. As Dr. Forsberg notes, this evidence could "encourage exponential acceptance among US insurance providers for reimbursement" - potentially removing a primary commercial barrier in the US market where coverage decisions significantly impact adoption.
The credibility factor is exceptional, with validation coming from both a prestigious military medical center and investigators who now hold positions at Memorial Sloan Kettering and Penn Medicine. The military connection is particularly valuable as veterans represent a key patient population for advanced prosthetics, with the Department of Defense/VA system constituting a major potential customer.
For Integrum, this publication creates a compelling narrative for both clinical adoption and insurance coverage that could accelerate market penetration for their differentiated technology in the prosthetics space.
The Walter Reed study results represent a significant commercial catalyst for Integrum's OPRA™ Implant System by addressing the two critical barriers to wider market adoption: clinical evidence and reimbursement approval.
From a commercialization perspective, the Level II evidence demonstrating superior functional outcomes versus traditional socket prostheses - particularly the 100% implant survival rate and reduced complications - provides Integrum with precisely the validation needed to drive insurance coverage decisions. The US medical device market operates on a reimbursement-driven adoption model, and as Dr. Forsberg explicitly states, this evidence could "encourage exponential acceptance among US insurance providers for reimbursement."
The military connection creates a dual-pathway commercial opportunity: enhanced credibility for broader market adoption and a direct channel to the Veterans Affairs healthcare system, which serves a significant population of amputees and operates under different reimbursement structures than commercial insurance.
The study's focus on the latest system version (introduced 2017) ensures the data supports the current commercial product, eliminating potential objections related to outdated technology assessment that often plague reimbursement discussions.
For investors, this represents a potential inflection point where clinical validation meets commercial opportunity. The reimbursement barrier has likely been suppressing adoption despite the technology's clinical advantages, and this study directly addresses that bottleneck. If insurance coverage expands as suggested, Integrum could see accelerated market penetration for its differentiated technology in the prosthetics space.
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
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
"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
"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
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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The following files are available for download:
https://mb.cision.com/Public/17531/4120587/b0c62df5fe2c8cbf.pdf | Integrum PR TFAOS 2025-03-18 eng |
View original content:SOURCE Integrum AB
FAQ
What are the key outcomes of the 2025 Walter Reed study on Integrum's OPRA Implant System (INTEG)?
How long was the follow-up period for the INTEG OPRA Implant System study at Walter Reed?
What impact could the Walter Reed study have on INTEG's OPRA System insurance coverage?
Who conducted the 2025 clinical study on Integrum's OPRA Implant System (INTEG)?
