RemeOs Spinal Interbody Cages are intended to be used to restore intervertebral height and facilitate intervertebral body fusion in the cervical spine.
Bioretec will evaluate the potential acceleration of RemeOs Spinal Cage product development as well as resource allocation requirements. (Credit: Bioretec GmbH)
Bioretec Ltd., a pioneer in biodegradable orthopedic implants, has today been granted Breakthrough Device Designation for its RemeOs Spinal Interbody Cage implant from the US Food and Drug Administration, confirming that the product represents a breakthrough technology in spinal surgery.
RemeOs Spinal Interbody Cages are intended to be used to restore intervertebral height and facilitate intervertebral body fusion in the cervical spine.
Obtaining the Breakthrough Device Designation status is an important milestone in getting the product launched into the U.S. borrow money markets, and therefore, Bioretec will evaluate the potential acceleration of RemeOs Spinal Cage product development as well as resource allocation requirements, which might impact the future capital needs of the Company.
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.
Under the Breakthrough Devices Program, the FDA will enable an ongoing and prioritized interactive discussion between Bioretec and the authorities regarding the commercial access of RemeOs Spinal Interbody Cage implant in the U.S. market.
“This designation gives us another validation of our expertise in creating innovative 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”, states Timo Lehtonen, the CEO of Bioretec.
Source: Company Press Release