Bioretec Reports FDA Grants Breakthrough Device Designation for Bioresorbable RemeOs™ Screw products

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Bioretec has received Breakthrough Device Designation for its bioresorbable RemeOs™ Screws from the US Food and Drug Administration, confirming that the product represents a breakthrough technology in traumatology and orthopedic surgery. Only a few companies in the field of medical devices have been granted with Breakthrough Device Designation in Finland.

Bioretec’s bioresorbable RemeOs™ Screws met the strict criteria set for FDA’s breakthrough technology. FDA requires breakthrough technology to provide more effective treatment or diagnosis for life-threatening or irreversibly debilitating conditions or diseases. In addition, breakthrough technology must either represent a completely new form of treatment or offer significant advantages over existing approved or cleared alternatives, including the potential to reduce the need for hospitalization, improve patients’ quality of life and create long-term clinical benefit, or alternatively represent a form of treatment that is in the best interest of patients.

Under the Breakthrough Devices Program, FDA will enable an ongoing and prioritized interactive discussion between Bioretec and the authorities regarding the commercial access of RemeOs™ Screws in the U.S. market.

“The approval of the RemeOs™ Screw products for the U.S. FDA’s Breakthrough Devices Program is a significant step for Bioretec in our efforts to commercialize the product in the United States. We are excited about this possible future opportunity for us to be able to offer patients and the healthcare system in the United States, a new, fully bioresorbable metal implant that will provide more effective care and improves the patient’s quality of life.Orthopedic surgeons would finally have access to a bioresorbable implant that follows current surgical techniques, and surgeons will not have to change or learn new procedures in surgeries,” says Timo Lehtonen, CEO of Bioretec.

Bioretec’s RemeOs™ Screw products are intended for use in traumatology and orthopedic surgery for the fixation of bone fractures and for the correction of deformities or malalignments.

The implant forms a temporary support for the fractured bone to ensure safe healing and allow the bone to reach its normal strength as the implant resorbs from the body. The bioactive properties of the implant and its natural degradation products assist in the development of new bone during the healing of the fracture.

The advantage of bioresorbable metal implants is that separate implant removal surgery is not required as the implants naturally resorb within the body after the fracture site ossifies. This shortens the recovery time and reduces potential adverse effects, thus also contributing to reducing the costs to the healthcare system. RemeOs™ Screws are made of a bioactive alloy that contains essential elements for new bone formation: magnesium, zinc and calcium. Implants consist only of materials that are naturally present in the human body.

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