Integrum

Leading bone-anchored technology with proven track record
Integrum's OPRA® Implant System is a revolutionary bone-anchored implant system that re-establishes freedom of mobility for individuals who have suffered limb loss. To date, more than 700 patients globally have been successfully treated with Integrum's technology. OPRA® Implant System is the only FDA-approved bone-anchored system available for amputees in the U.S.

Business assessment confirms market potential
The OPRA® Implant System revenue model is typically based on a two-stage surgical procedure followed by the integration of a safety device (Axor II) that connects the system to customized prosthetics. The first stage of the surgical procedure (S1) generates more than 50 percent of the total system revenue. The second stage (S2), generally performed one to two quarters after S1, together with the Axor II safety device comprises the remaining revenue streams.

The Axor II safety device enables a long-term revenue generation model through recurring sales and an aftermarket ecosystem of clinics, partners, and Certified Prosthetists/Orthotists (CPOs). During the last years, more than 1,000 Axor II units have generated significant revenue from US and Europe, with Axor II sales accounting for over 20 percent of total U.S. revenue in the past quarters.

As part of a comprehensive business assessment initiated by the Board of Directors and conducted jointly with management, analyses of revenue streams and cost structure have demonstrated an underlying market demand for the OPRA® Implant System. Notably, a significant part of revenue is generated through a few specialized clinics. In clinics where the OPRA® Implant System has gained a foothold, the business model generates healthy, recurring revenue streams, with all three components (S1, S2 and Axor II) delivering robust gross margins.

Commercial strategy focused on centers of excellence
The business assessment has led to the implementation of a commercial strategy with two main focus areas: establishing a limited number of centers of excellence across the U.S. and prioritized markets in Europe to drive further market penetration of the OPRA® Implant System, while strengthening the aftermarket business through enhanced CPO engagement and increased Axor II sales. This focused approach will build on the proven success of clinics where the OPRA® Implant System has already gained foothold.

Evaluating options for R&D projects
As part of maximizing shareholder value, the Board of Directors is evaluating strategic alternatives for Integrum's long-term R&D pipeline, including a potential separation in whole or in parts. This would enable a more distinct valuation of Integrum's different business components while separating long-term R&D investments from the commercial operations. The evaluation aims to optimize resource allocation and create the best conditions for both the commercial and research operations to reach their full potential.

Cost efficiency measures to support growth
The strategic shift is expected to generate significant cost efficiencies amounting up to SEK 20 million annually when fully implemented. The efficiencies will be a key component of the strategic focus and target most areas. They are realized gradually and are expected to be fully implemented in the beginning of 2026.

Enhanced transparency through new KPI
As Integrum moves forward with its adjusted commercial strategy, revenue, earnings and cash flow may continue to vary between quarters. Quarterly outcomes can be influenced by the timing of S2 and Axor II revenues, as well as substantial one-time revenues from distributor orders of OPRA® Implant Systems, rather than directly reflecting the underlying growth in S1 procedures.

To provide clearer insight into the underlying business development, Integrum will introduce total number of completed S1 procedures as a new Key Performance Indicator (KPI) in future quarterly reports, starting in Q3-24/25.

Comments from the CEO and Board of Directors
"With extensive experience from the orthopedic market, I joined Integrum as a Board Director because I recognized the groundbreaking potential of the OPRA® Implant System. Following my transition to a role as Acting CEO, my initial assessment has been strongly validated, and the comprehensive business review conducted with the Board over recent months has resulted in a clear path forward focusing on commercial excellence. While our R&D pipeline holds significant potential, the OPRA® Implant System deserves our full focus to maximize value creation for both amputees and shareholders. I am convinced that the sharpened strategy announced today will accelerate our ability to help more amputees regain their mobility and quality of life," says Scott Flora, Acting CEO of Integrum.

"The recent business assessment has been reassuring regarding the company's potential. Through this focused strategy and clear priorities, we are creating the right conditions to unlock the full commercial potential of the OPRA® Implant System while improving transparency and building shareholder value. The proven business model and underlying demand in established clinics provides a solid foundation for accelerated growth," says Kristofer Westergren, newly elected Board Director and coordinator of the business assessment.