Bioretec is the first in the world to receive FDA approval for a bioresorbable metal product

TAMPERE, Finland, March 30, 2023 /PRNewswire/ -- Bioretec Ltd, a pioneer in bioresorbable^[1] orthopedic implants, has today announced receiving the market authorization of the U.S. Food and Drug Administration (FDA) for its pioneering RemeOstm trauma screw to be used for healing of bone fractures aligned with the clinical trial^[2]. Bioretec is the first and currently, the only medical device company to offer bioresorbable metal implants in the United States, the largest single market for orthopedic trauma products globally. The RemeOstm trauma screw aims to make traditional titanium and steel implants redundant, eliminating the need for implant removal surgery. RemeOstm supports orthopedic clinics in achieving their operational and healthcare goals, whilst strengthening the value proposition for patients suffering from ankle fractures.

RemeOstm trauma screws are based on a proprietary bioactive and osteopromotive magnesium alloy introducing a new generation of strong bioresorbable materials for enhanced surgical outcomes. Bioresorbable metals combine the surgical techniques of traditional metal implants and the patient-friendly care and benefits of last-generation bioresorbable polymer implants. The RemeOstm trauma screw is resorbed and replaced by new bone through the body's natural healing process, eliminating the need for removal surgery as the fracture and bone are healing.

The Breakthrough Device designation from FDA already recognized and validated the benefits of the RemeOstm trauma screws and furthermore showed that there is a clinical need in the U.S. market for a true alternative for traditional metallic implants and a game changer in the treatment of fracture fixation.

RemeOstm trauma screws support the human body's own natural healing processes without using substances foreign to the body. In a clinical environment, the screws have demonstrated the ability to promote extensive new bone growth in the treatment of fractures significantly better than traditional metal implants or other legacy bioresorbable implants on the market. In comparison to other clinically used products, Bioretec's bioresorbable orthopedic implant RemeOstm offers significant cost-savings and reduced risk of complications based on the elimination of redundant removal surgeries alone.

The United States is the most prominent market globally for orthopedic products, accounting for 65% of the market worldwide. The market for trauma products is among the largest segments for orthopedic products and the main segment for Bioretec's RemeOstm product lines. Some 5 million bone fractures occur every year in the United States. Ankle fractures are among the most frequently occurring fracture types in the adult patient population. Annually, 3.4 million^[3] patients are treated 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 are estimated to grow with a CAGR of 7.3% per year^[5]. The company expects that RemeOstm sales will grow gradually as the clinics and surgeons gain confidence in the innovative technology, as is customary for new orthopedic products.

"Regulatory market approvals are an integral and important part of the commercialization of the products in our industry. The market authorization for our RemeOstm trauma screw in the United States is a historic and strategically critical step for us, as it opens the door for us to the largest individual market for orthopedic trauma products. This presents a large opportunity for both the RemeOstm trauma screw and all other future products in our RemeOstm pipeline. Since the market authorization submission to the FDA in May 2022, market and surgeon feedback and anticipation have continued to validate the expected demand for our products in the United States and Europe. We are excited that we can now begin to establish key collaborations with hospitals and clinical professionals specialized in ankle fractures in the U.S. Through these collaborations, we can bring the benefits of our innovative RemeOstm trauma screw to patients healing from ankle fractures. A big thank you goes out to our excellent team for their hard work in reaching this historical milestone. I look forward to the next phase on our journey," says Timo Lehtonen, CEO of Bioretec Ltd.

In March 2021, Bioretec received Breakthrough Device status from the FDA for its RemeOstm trauma screws, which are intended for orthopedic surgeries for bone fracture fixation (osteosynthesis) and deformity correction (osteotomy). Bioretec submitted the De Novo market authorization request to the FDA for the RemeOstm trauma screw in May 2022. The De Novo request process is used when similar products do not yet have market authorization in the United States.

In addition to the United States, the FDA market authorization enables the sale and marketing of the RemeOstm trauma screw in several other countries. However, at this stage, Bioretec is primarily focused on selling and marketing the product to the U.S. market.

Online event for investors, analysts, and media

Investors and media are invited to Bioretec's online event on today 30 March at 1 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 enquiries

Timo Lehtonen
CEO
tel. +358 50 433 8493

Johanna Salko
CFO
tel. +358 40 754 8172

^[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

Bioretec in brief

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, which eliminates 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. in March 2023 and in Europe, CE-mark is expected to receive during 2023. Bioretec is positioning itself to enter the addressable USD 7 billion global orthopedic trauma market and become a game changer in surgical bone fracture treatment.

Better healing - Better life. www.bioretec.com

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SOURCE Bioretec