The US Food and Drug Administration (FDA) has awarded breakthrough device designation for Bioretec’s RemeOs Spinal Interbody Cage implant, marking a significant advancement in spinal surgery technology.
The designation is pivotal for the company’s strategy to introduce the product to the US market.
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Bioretec’s RemeOs implant is designed to restore intervertebral height and enable intervertebral body fusion in the cervical spine.
The company is now assessing the impact of this advancement on its product development timelines and capital requirements.
Bioretec CEO Timo Lehtonen said: “This designation gives us another validation of our expertise in creating innovative products for the unmet clinical needs in the orthopaedic field. I am enthusiastic about the future prospects and the market opportunities of this product, which is based on the patented hybrid technology.”
The FDA’s recognition confirms that the RemeOs Spinal Cage could potentially reduce hospital stays, enhance patient quality of life, and deliver long-term clinical benefits.
The Breakthrough Devices Program will facilitate priority discussions between Bioretec and the FDA to discuss the implant’s commercial availability in the US.
In 2022, Bioretec submitted an application seeking a CE mark for its bioresorbable RemeOs trauma screw to commercialise in the European Union (EU).
The magnesium alloy trauma screw is part of the company’s new RemeOs product family.
Bioretec’s new RemeOs product line is based on a magnesium alloy and hybrid composite. It offers a new generation of strong biodegradable materials for enhanced surgical outcomes.
The RemeOs implants are absorbed and replaced by bone to eliminate the need for surgery and enable fracture healing.
