FDA Approves Bioretec's Bioresorbable Metal Screw

The company said it's the only one offering bioresorbable metal implants in the United States.

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Bioretec, a provider of bioresorbable 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. 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 RemeOs™ 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 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. The U.S. ankle and foot market are estimated to grow with a CAGR of 7.3% per year. 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.

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