FDA approves Bioretec's RemeOstm trauma screw as the first bioresorbable metal implant in the U.S. market

TAMPERE, Finland, March 30, 2023 /PRNewswire/ -- Bioretec Ltd., a pioneer in bioresorbable^[1] orthopedic implants, has today received market authorization for its RemeOstm trauma screw in the U.S. The RemeOstm trauma screw is the first and currently only bioresorbable metal implant approved by the U.S. Food and Drug Administration (FDA). The approved product range and indication align with the clinical trial conducted in the ankle.^[2]

The benefits of the RemeOstm trauma screw have been validated in clinical trials and have already previously been recognized by the FDA granting the Breakthrough Device Designation. Bioresorbable metals combine the surgical techniques of traditional metal implants and the patient-friendly care and benefits of last-generation bioresorbable polymer implants making implant removal operations redundant.

"This FDA market approval is the most important milestone in our company's history to date," comments Timo Lehtonen, CEO of Bioretec." The U.S. has the world's largest market for orthopedic implants. For the first time, that market is now offered a bioresorbable alternative to be used instead of titanium and steel implants. We are confident that RemeOstm trauma screw is the best option for a large share of patients considering the care and clinical outcome and from a health economics viewpoint thanks to making an additional removal operation unnecessary. We are also excited about this approval opening a less burdensome regulatory pathway for future RemeOstm product lines covering a wide array of indications."

Ankle fractures are one of the most frequently occurring fracture types among the adult patient population. There are 3.4 million^[3] patients treated each year in the U.S. for ankle fractures. Single-isolated ankle (malleolar) fractures are the most common type, accounting for 70% of the yearly incidence of all ankle fractures^[4]. The U.S. ankle and foot market is estimated to grow (CAGR) by 7.3% per year^[5]. Bioretec will launch the RemeOstm trauma screws in the U.S. in collaboration with several hospitals and clinical professionals specialized in ankle fractures. The company expects that RemeOstm sales will grow gradually as the clinics gain confidence in the innovative bioresorbable metal implant, as is customary for all new orthopedic products.

Online event for investors, analysts and media

Investors and media are invited to Bioretec's online event on today, 30 March 2023, 1.00 p.m. EEST, where CEO Timo Lehtonen and CFO Johanna Salko will comment on today's announcement and answer questions.

The Teams Live Event will be held in English. Questions can be presented during the event in English or Finnish using the Teams Q&A. A recording of the event will be available after the event on https://bioretec.com/investors/investors-in-english/reports-and-presentations.

To participate in the event, go to: https://www.bioretec.com/stream

Further inquiries:

Tomi Numminen, Chairman of the Board, +358 40 581 2132
Timo Lehtonen, CEO, +358 50?433 8493

Certified advisor:

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 bioresorbable 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 RemeOstm?product line?based on a magnesium alloy and hybrid composite, introducing a new generation of strong bioresorbable materials for enhanced surgical outcomes. The RemeOstm 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 RemeOstm 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 press release the term (bio)resorbable is interchangeable with (bio)absorbable and (bio)degradable}

^{[2] Holweg et. Al., Can Hardware Removal be Avoided Using Bioresorbable Mg-Zn-Ca Screws After Medial Malleolar Fracture Fixation? Mid-Term Results of a First-In-Human Study. Injury. 2022 Mar;53(3):1283-1288. doi: 10.1016/j.injury.2021.10.025. Epub 2021 Oct 30. PMID: 34758916.}

^{[3] An Updated Epidemiology of Foot and Ankle Fractures in the United States: Complications, Mechanisms, and Risk Factors. J Foot Ankle Surg. 2022 Sep-Oct;61(5):1034-1038. doi: 10.1053/j.jfas.2022.01.010. Epub 2022 Jan 20. PMID: 35181206}

^{[4] Ankle Fractures. [Updated 2022 Aug 15]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2022 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK542324/}

^{[5] https://www.marketdataforecast.com/market-reports/north-america-foot-and-ankle-devices-market}

The following files are available for download: