TAMPERE, Finland, Oct. 18, 2023 /PRNewswire/ -- The European market authorization process for Bioretec Ltd's RemeOs trauma screw, a pioneer in biodegradable orthopedic implants, still continues by the Notified body (Dekra). The company estimates that the CE mark for the trauma screw will not be obtained during the end of 2023, as previously expected. Bioretec now estimates that the European market authorization for the product will be obtained during the first quarter of 2024. The reason for the schedule change is not related to the company but to the Notified Body's prolonged response times and insufficient resourcing to support the company's CE mark application process, which has resulted in a very slow handling of the application process.
Bioretec submitted the CE mark application for the European market authorization at the end of 2021. The slow progress of handling of the company's CE mark application has continued at the Notified Body, as the increase in the number of applications caused by the change in the European Medical Device Regulation (MDR) of medical devices has kept the Notified Institutions still congested and has led in prolonged certification processes.
"Regulatory approvals are an integral and important part of a commercialization process in our industry. The approval processes and schedules of product registrations are always subject to uncertainty, and the company has limited opportunities to influence those. For our part, we will continue to work to obtain a market authorization and start commercialization in Europe", says Timo Lehtonen, CEO of Bioretec.
Further enquiries
Timo Lehtonen, CEO, tel. +358 50 433 8493
Johanna Salko, CFO, tel. +358 40 754 8172
Certified advisor
Nordic Certified Adviser AB, +46 70 551 67 29
Bioretec in brief
Bioretec is a globally operating Finnish medical device company that continues to pioneer the application of biodegradable 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 RemeOs?product line?based on a magnesium alloy and hybrid composite, introducing a new generation of strong biodegradable materials for enhanced surgical outcomes. The RemeOs implants are absorbed 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 RemeOs product market authorization has been received in the U.S. in March 2023, and in Europe, the CE-mark is expected to be received during the first quarter of 2024. 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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