(RTTNews) - Bioretec Oy (0TN.F, BRETEC.HE) has been granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA) for its magnesium alloy technology-based, biodegradable RemeOs DrillPin.
The designation applies to the RemeOs DrillPin for fixation of bone fragments in both pediatric and adult patients. It also covers the treatment of epi-metaphyseal fractures in pediatric patients aged two years and older with an open growth plate, including transphyseal indications where fixation across the growth plate is clinically required.
Breakthrough Device Designation is awarded to medical devices that may provide more effective treatment for life-threatening or irreversibly debilitating conditions. It recognizes technologies that represent a significant advancement over existing approved or cleared alternatives. The designation provides Bioretec with prioritized and more interactive communication with the FDA during the remaining development and review process, supporting an efficient clinical and regulatory pathway for the DrillPin.
This marks the third Breakthrough Device Designation granted to Bioretec by the FDA for its RemeOs product portfolio, underscoring the company's leadership in biodegradable implant technology.
Bioretec has announced that it will publish an updated commercialization strategy and product development pipeline, along with revised financial targets, by the end of 2025.
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