Subjects: PDT, FDA
Inside information: Bioretec has been granted FDA Breakthrough Device Designation status for its RemeOstm Spinal Interbody Cage
TAMPERE, Finland, March 14, 2024 /PRNewswire/ -- Bioretec Ltd., a pioneer in biodegradable orthopedic implants, has today been granted Breakthrough Device Designation for its RemeOstm 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. 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 RemeOstm 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 RemeOstm 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.
Further enquiries
Timo Lehtonen, CEO, +358 50?433 8493
Johanna Salko, CFO, +358 40 754 8172
Certified adviser
Nordic Certified Adviser AB, +46 70 551 67 29
Bioretec in brief
Bioretec is a globally operating Finnish medical device company that continues to pioneer the application of biodegradable orthopedic implants. The company has built unique 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 is?developing?the new RemeOstm?product line?based on a magnesium alloy and hybrid composite, introducing a new generation of strong biodegradable materials for enhanced surgical outcomes. The RemeOstm 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 RemeOstm product market authorization has been received in the U.S. in March 2023, and in Europe, CE mark is expected to be received during the second quarter of 2024. Bioretec is positioning itself to enter the addressable over USD 7 billion global orthopedic trauma market and to become a game changer in surgical bone fracture treatment.
Better healing ? Better life. www.bioretec.com
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SOURCE Bioretec
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