Bioretec has been granted Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for its magnesium alloy technology-based, biodegradable RemeOs DrillPin.

The designation covers the RemeOs DrillPin for fixation of bone fragments in pediatric and adult patients and to treat metaphyseal fractures in pediatric patients two years of age and under with an open growth plate, including transphyseal indications where fixation across the growth plate is clinically required.

The designation gives Bioretec prioritized and more interactive communication with the FDA during the remaining development and review process, which is expected to support an efficient clinical and regulatory pathway for the DrillPin. This is the third breakthrough status awarded to Bioretec by the FDA for its RemeOs product portfolio.

“Securing Breakthrough Device Designation for the RemeOs DrillPin is a major milestone for Bioretec and for patients,” said Sarah van Hellenberg Hubar-Fisher, CEO of Bioretec.” It confirms that there are no equivalent solutions addressing this unmet clinical need and recognizes the potential of our osteopromotive, magnesium based platform to change the way fractures are treated. Together with the CMS pass through status already granted for our RemeOs Trauma Screw, this designation strengthens our ability to build a commercially attractive and patient centric portfolio in the U.S. orthopedic market.”

The company said it will publish an updated commercialization strategy and product development pipeline, along with revised financial targets by the end of this year.

In October, Bioretec secured Centers for Medicare & Medicaid Services (CMS) Transitional Pass-Through Payment (TPT) status for its RemeOs Screw LAG Solid.