#Bioretec #Finland #Tampere #RemeOs #Trauma Screws

Bioretec Ltd. Achieves Significant Milestone with CE Mark Approval

Bioretec Ltd., a trailblazer in absorbable orthopedic implants, has recently announced an exciting development. The company has received CE mark approval for its innovative RemeOs™ Trauma Screw product line. This significant milestone not only allows Bioretec to commence the commercialization of these products within the European Union but also in other countries that recognize the CE mark market authorization.

Comprehensive Product Portfolio

The CE mark approval encompasses a variety of designs, including all cannulated and non-cannulated versions of the RemeOs™ screws. With diameters ranging from 2.0mm to 4.0mm and lengths from 8mm to 50mm, the versatile product range caters to numerous orthopedic applications. The approved indications include using these screws for fracture and misalignment fixations, addressing needs in both adult and pediatric populations, although they exclude hand and forefoot uses.

CEO Alan Donze expressed his enthusiasm regarding the approval, stating, "We are extremely pleased that the EU market approval includes all designs and a vast number of indications. We can now immediately begin offering all RemeOs™ Trauma Screws to patients across Europe." This advancement also lays the groundwork for expansion into non-European countries recognizing the CE mark, enhancing Bioretec's footprint in the global market.

Pioneering Biodegradable Implants

Bioretec has distinguished itself by developing advanced biodegradable orthopedic implants. The RemeOs™ product line is crafted from a magnesium alloy and hybrid composite, innovatively designed to enhance surgical outcomes. These implants are absorbed by the body and naturally replaced by bone, eliminating the need for removal surgeries and streamlining the recovery process by facilitating fracture healing. This unique approach positions Bioretec to potentially reduce reliance on traditional titanium implants, a promising prospect for orthopedic practices focused on efficiency and patient value.

The company’s expansion efforts are also geared towards contributing robust clinical evidence that can help broaden the indications for their products, particularly in the U.S. market, which currently has more restricted approvals.

Aiming for Global Impact

With its introduction of a strong portfolio backed by scientific advancements, Bioretec is entering a rapidly growing market valued over USD 9 billion, focusing on orthopedic trauma and spine solutions. The journey that began with the RemeOs™ product line's initial market authorization in the U.S. in March 2023 has now blossomed into a wider European rollout, showcasing Bioretec’s commitment to improving the quality of healthcare in surgical settings worldwide. As part of its vision, Bioretec seeks to revolutionize traditional approaches to treating bone fractures while emphasizing successful, value-based healthcare initiatives.

This milestone marks a new chapter of promise not just for Bioretec but for patients seeking innovative, safer, and effective orthopedic solutions. The mantra, 'Better healing – Better life,' embodies the company's mission to enhance surgical outcomes and patient recovery journeys across the globe.

For more information on Bioretec and its pioneering products, visit www.bioretec.com.