Business model

Our business model is based on the development, manufacture, marketing and sales of absorbable orthopedic implants. Our product portfolio consists of two product series, Activa and RemeOs, which are manufactured in our factory in Finland and sold to our customers globally, mainly via our distribution network. The Activa product series is well-established and sold in 40 countries worldwide.

The first RemeOs product, the Trauma Screw, is being commercialized in the US. The launch has now entered a phase, which involves expansion of the distribution network with new partners. RemeOs product portfolio has also received a CE-mark, covering all designs and a broad range of indications. The products are launched to the European market mainly using Bioretec’s existing distributor network. The CE-mark also enables commercialization in non-European countries that recognize the CE mark.

Our growth strategy for the coming years relies heavily on expanding the RemeOs product series with new synergistic products. Regulatory approval processes are an important part of product commercialization in our industry, and we have a long experience and a successful track record in these processes.

Production process

Most of our manufacturing is done in-house, with the exception of materials sourcing, where we rely on subcontractors. We aim to diversify our strategic sourcing of materials and components across several suppliers to reduce dependence on individual suppliers. Our manufacturing is carried out in our factory premises in Finland, which meets the strict quality requirements set by the authorities for medical devices.

Products are sterilized either in our production facility or by an external partner. Our packaging station is at the production facility, from where the manufactured products are shipped to distributors, customers or logistics centers worldwide.

Regulatory approvals

Our most important approval processes are carried out with regulatory bodies in the United States and Europe. In Europe, the CE mark is a prerequisite for market approval, while in the United States, it is FDA approval. We have long experience and a proven track record in successfully completing regulatory approval processes.

The first RemeOs product, the RemeOs Trauma Screw, received FDA approval in spring 2023, the first FDA approval for an absorbable metallic implant in the US. The market approval will accelerate the expansion of the RemeOs product series in the US since the safety of the material will no longer need to be demonstrated in subsequent clinical trials.

In January 2025, Bioretec received CE-mark, covering all designs and a broad range of indications for the RemeOs trauma screw product portfolio. This comprehensive approval enables the collection of real-world clinical evidence, supporting the expansion of indications in the U.S., where the current approval is more limited

Our Activa product series has several CE and FDA approvals.

Commercialization and distribution to end customers

Our end customers are public and private sector medical care units, hospital districts and orthopedic surgeons. Our sales strategy focuses on educating and training the users, showcasing the benefits to decision-makers, attending conferences, promoting research and creating a strong clinical evidence base that contributes to convincing opinion leaders in the orthopedic field.

We distribute our products in approximately 40 countries through regional distributors. These relationships will help us to commercialize the RemeOs product series. In addition to the distribution network, we are opening direct sales channels in Europe and the United States.

Our management team has extensive experience commercializing several orthopedic products globally. Additionally, our sales efforts are supported by our Scientific Advisory Board, which consists of world-renowned surgeons, professors and medical doctors from Europe, Asia, and the United States.