Bioretec Ltd, received U.S. market authorization for its RemeOs trauma screw from the U.S. Food and Drug Administration (FDA). Following the market authorization, the Board of Directors of Bioretec has resolved to update and refocus the company's product portfolio to facilitate an accelerated commercialization strategy to provide a more synergistic offering responding to the market demand. Furthermore, Bioretec refines its U.S. go-to-market strategy to fit the company's resources better and provide enhanced possibilities to penetrate the vast U.S. market.

Consequently, financial targets are updated to reflect the aforementioned strategic changes. Additionally, Bioretec is also exploring possibilities to raise additional financing to accelerate the U.S. commercialization of RemeOs products, increasing manufacturing capacity, and enhancing product development, spearheaded by the RemeOs trauma screw. Additions to Bioretec's RemeOs product group pipeline Bioretec will focus on serving customers in the lower and upper extremities with products that have a faster commercialization strategy and provide a more synergistic offering.

To complement the RemeOs trauma screw product group, Bioretec has decided to add two new product groups, RemeOs staples and RemeOs plates to its product development pipeline. RemeOs staples are used individually or with RemeOs trauma screws to stabilize a fracture or osteotomy, promoting quick bone healing, and are used mainly in the foot and ankle area, whereas RemeOs plates are used for similar indications when additional support is needed, and further to be used together with RemeOs trauma screws if multiple fractures have occurred in the same anatomical location. RemeOs staples are expected to enter commercialization during the year 2026.

RemeOs plates are expected to follow RemeOs staples and enter commercialization during the year 2027. Additionally, RemeOs products will also be developed for pediatric use. Due to the expansion of the synergistic product portfolio, the commercialization of RemeOs DrillPin is transferred to 2025, and IM-nail and spinal cage are transferred to be launched after 2028, instead of earlier announced estimates of 2024, 2026, and 2027, respectively.