Bioretec is the first in the world to receive FDA approval for a bioresorbable metal product
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 RemeOs™ 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 RemeOs™ trauma screw aims to make traditional titanium and steel implants redundant, eliminating the need for implant removal surgery. RemeOs™ supports orthopedic clinics in achieving their operational and healthcare goals, whilst strengthening the value proposition for patients suffering from ankle fractures.
RemeOs™ 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 RemeOs™ 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 RemeOs™ 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.
RemeOs™ 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 RemeOs™ 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 RemeOs™ 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 RemeOs™ 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 RemeOs™ trauma screw and all other future products in our RemeOs™ 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 RemeOs™ 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 RemeOs™ 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 RemeOs™ 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 RemeOs™ 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.
Further enquiries
Timo Lehtonen, CEO, tel. +358 50 433 8493
Johanna Salko, CFO, tel. +358 40 754 8172
