Bioretec Ltd, a pioneer in bioabsorbable orthopedic implants, announced on 30 March 2023 that it had 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 today 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.

Updated financial targets

• reach net sales of EUR 62 million by the end of the year 2027 (previous target: EUR 100 million by 2027); and
• reach positive cash flow from operating activities by the end of the year 2026 (previous target: by the end of 2025).

The previously communicated EUR 100 million net sales target has been postponed by one year until 2028 due to receiving FDA market authorization, which was granted approximately one year later than the original target.

U.S. commercialization and distribution strategy following the FDA market authorization for the RemeOs™ trauma screw

Bioretec's previous plan for the commercialization of RemeOS™ trauma screws in the U.S. has relied on the company's own distribution and sales organization. To ramp up the U.S. commercialization and distribution of its RemeOs™ products, spearheaded by the RemeOs™ trauma screw, Bioretec has evaluated alternative sales channels and strategies in the U.S. markets. These include appointing a nationwide sales partner with access to regional distribution networks, engaging a selection of individual regional distribution partners, or potentially appointing a single larger industrial player as a distribution or sales partner. Outside of the U.S., commercialization, and distribution will be conducted according to the previously announced plan by utilizing Bioretec's existing distribution network. In the U.S. the aforementioned strategy does not overrule the possibility of conducting sales and distribution as a hybrid model supported by the Company's own organization.

"Based on the feedback received from the market, including Key Opinion Leaders and surgeons, and after thoroughly evaluating the product pipeline, we are updating our portfolio to serve our customers better with a wider portfolio of trauma products concentrating on lower and upper extremities based on now authorized the RemeOs™ alloy material. This also enables us to use the FDA-granted market authorization to accelerate market entry for new products with a less burdensome approach and lower forthcoming R&D expenditure. A wider upper and lower extremities product portfolio will also be more globally competitive and attractive for our customers in public tender-based markets. To accelerate achieving our growth targets, we are exploring possibilities to raise additional financing for the U.S. commercialization of our RemeOs™ products, to facilitate the expansion of manufacturing capacity for RemeOs™ products, spearheaded by the RemeOs™ trauma screw, and to continue the development of other RemeOs™ products", says Timo Lehtonen, CEO of Bioretec.

Swedbank AB (publ), in cooperation with Kepler Cheuvreux SA, and Danske Bank A/S, Finland Branch are acting as the company's financial advisers in exploring possibilities to raise additional financing.

Bioretec is publishing an updated company presentation on its investor website today.

Further enquiries

Timo Lehtonen, CEO, +358 50 433 8493
Tomi Numminen, Chairman of the Board, +358 40581 2132

Certified adviser

Nordic Certified Adviser AB, +46 70 551 67 29

Information about Bioretec

Bioretec is a globally operating Finnish medical device company that continues to pioneer the application of bioabsorbable1 orthopedic implants. The company has built unique competencies in the biological interface of active implants to enhance bone growth and accelerate fracture healing after orthopedic surgery. The products developed and manufactured by Bioretec are used worldwide in approximately 40 countries. 

Bioretec is developing the new RemeOs™ product line based on a magnesium alloy and hybrid composite, introducing a new generation of strong bioabsorbable materials for enhanced surgical outcomes. The RemeOs™ implants are resorbed and replaced by bone, eliminating the need for removal surgery while facilitating fracture healing. The combination has the potential to make titanium implants redundant and help clinics reach their Value-Based Healthcare targets while focusing on value for patients through efficient healthcare. The first RemeOs™ product market authorization has been received in the U.S. during March 2023 and CE-mark is expected to receive in Europe during 2023. Bioretec is positioning itself to enter the addressable over USD 7 billion global orthopedic trauma market and to become a game changer in surgical possibilities.

Better healing - Better life.www.bioretec.com

1 In this company announcement, (bio)absorbable is interchangeable with (bio)resorbable and (bio)degradable.