Finnish medical device company Bioretec is set to commercialise its CE mark-approved RemeOs Trauma Screw products portfolio in Europe through its existing distribution network.
Recently, Bioretec announced the CE mark approval for its RemeOs portfolio, designed to treat upper and lower extremities in both adults and children.
The CE mark approval covers a wide range of indications, allowing the company to enhance its potential market share in the European market.
The regulatory approval will advance the expansion of the RemeOs trauma screw product group in the US market, where current approval is more limited.
Also, the CE mark approval serves as a basis for local registration of the RemeOs products in almost all countries, except China, Japan, and the US.
Bioretec CEO Alan Donze said: “The recent CE mark approval for our entire RemeOs Screw Product Group marks a pivotal development in Bioretec’s history.
“Now equipped with the CE mark, we are strategically positioned to capture the European market and leverage this success globally.
“The broad scope of the CE mark significantly strengthens our capacity to gather essential real-world clinical evidence across a variety of indications.”
Manufactured from a unique magnesium alloy, RemeOs trauma screws represent a new generation of strong, absorbable materials that improve surgical outcomes.
The screws easily integrate traditional surgical techniques with the benefits of absorbable implants, promoting patient-friendly care and greater healthcare efficiency.
Their osteopromotive properties enhance bone growth and support the body’s natural processes while the fracture is healing.
The RemeOs screw product group consists of four distinct product lines, each product type customised to meet specific requirements and preferences of surgeons.
The product lines include RemeOs FT, RemeOs FC, RemeOs FL and RemeOs LAG Solid.
RemeOs FT are cannulated headless, fully variable threaded compression screws, and RemeOs FC are partially threaded ‘Herbert style’ compression screws.
RemeOs FL and RemeOs LAG Solid are partially threaded cannulated and non-cannulated LAG screws with a head.
All four product types are offered in 2 to 4mm diameters and 8 to 50mm lengths.
The RemeOs product portfolio facilitates precise, patient-specific treatment, covering a wide range of clinical needs, said the medical device company.
Alan added: “This data is instrumental as we seek to expand the range of our approved products and indications within the US market.
“With a solid network of distributors already in place in Europe and a medical community familiar with our technologies, we are poised for the RemeOs products to revolutionize bone fracture treatment standards.
“This approval represents more than a milestone; it is a crucial gateway to transforming patient care and enhancing the quality of life for individuals not just in Europe, but across the globe.”
