Strategy

Our strategy is focused on the commercialization and development of new RemeOs products. It is based on expanding into high-potential market segments, maintaining world-class talent and capabilities in the organization, and achieving high profitability.

1. Expansion into market segments with high potential

Expansion into market segments with high potential can be divided into three steps:

Commercialization of the RemeOs™ Trauma Screw in the United States

We received a U.S. market authorization for our RemeOs Trauma Screw in March 2023 and started the launch of the RemeOs Trauma Screws in the world’s largest single market for orthopedic trauma products. We have progressed to the next phase of the commercialization, where we are expanding our distribution network and strengthening the role of Activa product line in the U.S. market.

Commercialization of the RemeOs™ Trauma Screw in Europe

In January 2025, Bioretec received CE-mark, covering all designs and a broad range of indications for the RemeOs™ trauma screw product portfolio. In Europe, we will use our existing distributor and / or direct sales network to efficiently distribute the products throughout Europe. The approval will accelerate the collection of real-world clinical evidence, which will enable the expansion of indications in the U.S., where the current approval is more limited. Furthermore, it will facilitate entry into non-European markets recognizing the CE mark.

Development and commercialization of other products in the RemeOs™ product series

We plan to commercialize the RemeOs product series in the following order: DrillPin in 2025, Staple in 2026, Plate in 2027, and the IM-Nail and the Spinal Cage after 2028.

In October 2024, we announced that we would accelerate the product development of the RemeOs Spinal Interbody Cage following the granting of the Breakthrough Device Designation status by the U.S, FDA in March 2024.

2. Maintaining world-class capabilities in the organization

Sustaining high performance and succeeding in a highly regulated, global market demands excellence. We foster a culture of innovation that not only drives differentiation and success but also supports retaining current talent and attracting new professionals.

3. Focus on achieving high profitability

In addition to sales growth targets, we consider it important to achieve a high level of profitability. The estimated higher gross margin of RemeOs products, the lean organizational structure and moderate operational expenses are expected to enhance our operational efficiency and profitability in the future.