Strategy

As announced in September 2025, Bioretec has assessed its overall commercialization strategy, pipeline, and options to accelerate growth. Bioretec’s Board of Directors has approved on 16 December 2025 the company’s updated strategy for 2026–2028 and new financial targets for the strategy period.

To support the execution of the new strategy, Bioretec is also currently assessing financing options.

Bioretec’s strategy for the period 2026–2028:

Bioretec’s strategy and value creation for the next three years focuses on commercial performance and sales acceleration in both the United States and markets outside of the United States (OUS), enabled by continued R&D and expansion of the RemeOsTM product family.

The strategy is based on three pillars:

Industry leading innovation: pioneering world class materials science by demonstrating patient outcomes that validate healing through the absorption of our materials.

World-class clinical and economic evidence generation: expanding the patent portfolio for new and existing materials and research methods to build a sustained competitive market advantage.

Global excellence in commercialization: accelerate our focus on high value repeatable business and collaboration with best-in-class partners globally to achieve market success.

Strategic priorities for the period 2026–2028:

• Demonstrate industry leading innovation, clinical evidence generation, and commercial scale by progressing a strong R&D pipeline and introducing at least one new product or indication every 12–18 months, reflected by sustained R&D investments

• Build strong market presence and solidify our commercial position in the U.S. through direct distribution channels, targeted Key Opinion Leader engagement strategies, and high-impact training and education

• Upgrade our OUS commercial strategy through updated distribution partner selections with rigorous and clear commercial targets and a focused effort on RemeOsTM launches in high value markets.

• Establish RemeOsTM as the leading metal alloy absorbable solution in the implant market globally

By the end of the strategy period, Bioretec aims to have established itself as a recognized player in the global orthopedic market and a market leader in innovative metal absorbable implants with the RemeOsTM product family. Bioretec is of the strong view that reaching this position will enable the next strategic steps in order to maximize shareholder value.

Financial targets:

In line with its strategy and priorities for 2026–2028, Bioretec’s new financial targets are:

• Reach net sales exceeding EUR 10 million by the end of the year 2028

• Maintain an average sales margin exceeding 70% during the strategy period

While maintaining a healthy sales margin enables efficient scaling, Bioretec does not expect to reach cash flow positivity or profitability during the strategy period due to the planned strategic investments in R&D and commercialization. The financial targets do not include assumptions of revenue or funding from potential partnership or licensing opportunities within the strategy period.

Bioretec does not consider these financial targets as market guidance for any given year.

Pipeline update:

Bioretec offers two product families, Activa and RemeOsTM. The Activa product family is based on self-reinforced PLGA and facilitate healing in orthopedic indications where carrying capacity is not required. The RemeOsTM product family utilizes state-of-the-art absorbable metal alloy technology. RemeOsTM implants can carry more load and are well suited for treating larger bone fractures.

Bioretec has a strong pipeline for launching additional products. The Company is especially committed to expanding the RemeOsTM family with several synergistic products in the coming years, with new types of absorbables already in advanced development and clinical trials.

As highlighted in the strategic priorities for 2026–2028, Bioretec plans to introduce one new product every 12–18 months and establish RemeOsTM as the leading product family and metal alloys as the preferred solution in the absorbable implant market globally.

Bioretec has divided the introduction and commercialization of new products in the pipeline into three different timeframes:

Short term (<18 months):

• RemeOsTM Trauma Screws (US portfolio expansion)

• RemeOsTM DrillPins (“Nail”)

• Activa Headless Cannulated Screw

Medium term (18–36 months):

• A new, differentiated RemeOsTM absorbable trauma product (e.g. elastic stable intramedullary nails (ESINs), specialty screws, staples, anchors)

Long term (36+ months):

• RemeOsTM Spine portfolio

• RemeOsTM IM Nails

• RemeOsTM Plates

Since commercialization progress is dependent on customary regulatory approval timelines and subsequent prioritization of R&D resources, the Company is not in a position to give a specific order or estimated years for the commercialization of individual products.