TAMPERE, Finland, March 14, 2024 /PRNewswire/ — Bioretec Ltd., a pioneer in biodegradable orthopedic implants, has right this moment been granted Breakthrough Gadget Designation for its RemeOs™ Spinal Interbody Cage implant from the US Food and Drug Administration, confirming that the product represents a breakthrough expertise in spinal surgical procedure. RemeOs Spinal Interbody Cages are meant for use to revive intervertebral peak and facilitate intervertebral physique fusion within the cervical spine.
Acquiring the Breakthrough Gadget Designation standing is a vital milestone in getting the product launched into the U.S. markets, and due to this fact, Bioretec will consider the potential acceleration of RemeOs Spinal Cage product growth in addition to useful resource allocation necessities, which could affect the long run capital wants of the Firm.
Bioretec’s biodegradable RemeOs™ Spinal Interbody Cage met the strict standards set for getting into the FDA’s Breakthrough Gadget Designation program. FDA requires a breakthrough expertise to offer simpler therapy for life-threatening or irreversibly debilitating circumstances or illnesses. As well as, breakthrough expertise should both symbolize a totally new type of therapy or supply important benefits over present authorised or cleared options, together with the potential to scale back the necessity for hospitalization, enhance affected person’s high quality of life, and create long-term medical advantages, or alternatively symbolize a type of therapy that’s in the very best curiosity of sufferers. Beneath the Breakthrough Gadgets Program, the FDA will allow an ongoing and prioritized interactive dialogue between Bioretec and the authorities concerning the business entry of RemeOs™ Spinal Interbody Cage implant within the U.S. market.
“This designation provides us one other validation of our experience in creating progressive merchandise for the unmet medical wants within the orthopedic subject. I’m enthusiastic in regards to the future prospects and the market alternatives of this product, which relies on the patented hybrid expertise”, states Timo Lehtonen, the CEO of Bioretec.
Additional enquiries
Timo Lehtonen, CEO, +358 50 433 8493
Johanna Salko, CFO, +358 40 754 8172
Licensed adviser
Nordic Licensed Adviser AB, +46 70 551 67 29
Bioretec in short
Bioretec is a globally working Finnish medical machine firm that continues to pioneer the appliance of biodegradable orthopedic implants. The corporate has constructed distinctive competencies within the organic interface of lively implants to boost bone progress and speed up fracture therapeutic after orthopedic surgical procedure. The merchandise developed and manufactured by Bioretec are used worldwide in roughly 40 international locations.
Bioretec is creating the brand new RemeOs™ product line primarily based on a magnesium alloy and hybrid composite, introducing a brand new era of robust biodegradable supplies for enhanced surgical outcomes. The RemeOs™ implants are absorbed and changed by bone, which eliminates the necessity for removing surgical procedure whereas facilitating fracture therapeutic. The mixture has the potential to make titanium implants redundant and assist clinics attain their Worth-Based mostly Healthcare targets whereas specializing in worth for sufferers by means of environment friendly healthcare. The primary RemeOs™ product market authorization has been obtained within the U.S. in March 2023, and in Europe, CE mark is anticipated to be obtained in the course of the second quarter of 2024. Bioretec is positioning itself to enter the addressable over USD 7 billion international orthopedic trauma market and to change into a sport changer in surgical bone fracture therapy.
Higher therapeutic – Higher life. www.bioretec.com
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SOURCE Bioretec
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