Michael Barbella, Managing Editor03.18.24
Bioretec Ltd. has been granted U.S. Food and Drug Administration (FDA) Breakthrough Device Designation for its RemeOs Spinal Interbody Cage implant. RemeOs Spinal Interbody Cages are used to restore intervertebral height and facilitate intervertebral body fusion in the cervical spine.
Bioretec's biodegradable RemeOs Spinal Interbody Cage met the strict criteria set for entering the FDA's Breakthrough Device Designation program. FDA requires a breakthrough technology to provide more effective treatment 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 patient's quality of life, and create long-term clinical benefits, or alternatively represent a form of treatment that is in the best interest of patients.
"This designation gives us another validation of our expertise in creating products for the unmet clinical needs in the orthopedic field. I am enthusiastic about the future prospects and the market opportunities of this product, which is based on the patented hybrid technology", BIoretec CEO Timo Lehtonen said.
Bioretec's new RemeOs product line based on a magnesium alloy and hybrid composite, creating 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 occurred in the U.S. in March 2023; in Europe, CE mark is expected during the second quarter this year.
Bioretec is a global medical device company based in Finland that is developing biodegradable orthopedic implants. The company has built 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's biodegradable RemeOs Spinal Interbody Cage met the strict criteria set for entering the FDA's Breakthrough Device Designation program. FDA requires a breakthrough technology to provide more effective treatment 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 patient's quality of life, and create long-term clinical benefits, or alternatively represent a form of treatment that is in the best interest of patients.
"This designation gives us another validation of our expertise in creating products for the unmet clinical needs in the orthopedic field. I am enthusiastic about the future prospects and the market opportunities of this product, which is based on the patented hybrid technology", BIoretec CEO Timo Lehtonen said.
Bioretec's new RemeOs product line based on a magnesium alloy and hybrid composite, creating 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 occurred in the U.S. in March 2023; in Europe, CE mark is expected during the second quarter this year.
Bioretec is a global medical device company based in Finland that is developing biodegradable orthopedic implants. The company has built 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.