TAMPERE, Finland, Oct. 1, 2025 /PRNewswire/ -- Bioretec Ltd, a pioneer in absorbable orthopedic implants, announced today that the Centers for Medicare & Medicaid Services (CMS) has granted Transitional Pass-Through Payment (TPT) status for the company's RemeOs Screw LAG Solid, effective October 1, 2025.
"Building on the success of Breakthrough Device Designation and FDA De Novo grant, securing CMS TPT approval represents a remarkable milestone," said Sarah van Hellenberg Hubar-Fisher, CEO of Bioretec. "This recognition of the value of our innovative product and the support to accelerate its adoption in the US, further empowers hospitals, surgery centers, and surgeons to utilize RemeOs, the first-of-its-kind fixation technology that supports natural healing. With this new status, Bioretec is positioned to unlock growth opportunities as we aim to transform the standard of care in orthopedic fixation."
The approval is reflected in the October 2025 Healthcare Common Procedure Coding System (HCPCS) quarterly update, which establishes a new billing code, C1741, for absorbable anchor/screw implants. This designation makes RemeOs eligible for separate pass-through payment under both the Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) payment system, providing incremental reimbursement for Medicare patients.
RemeOs is the first and only osteopromotive absorbable metal implant for orthopedic use in the U.S. Made from a proprietary magnesium alloy, RemeOs provides strong and stable fixation during healing and gradually degrades as it is replaced by bone, reducing the risks and costs associated with permanent implants and subsequent hardware removal surgeries.
Clinical investigation data with RemeOs demonstrate that 90% of patients achieved fracture consolidation by 6 weeks, with complete healing observed by 12 weeks. In addition, the osteopromotive properties of the implant have been shown to support bone formation at the fracture site, reducing the need for secondary surgeries and eliminating the presence of permanent metal implants.
In March 2023, the RemeOs Screw LAG Solid received FDA De Novo market authorization, confirming its status as a truly novel technology in orthopedic fixation. Now, with CMS TPT Pass-Through approval, Bioretec has achieved a rare dual milestone reached by only a handful of medical devices- recognition by both regulators and payors as a breakthrough technology with proven clinical and economic value.
"This approval further validates RemeOs as a breakthrough in material science and clinical innovation," said Timo Lehtonen, Chief Technology Officer of Bioretec. "It represents the culmination of years of investment in world-class research, rigorous testing, and robust clinical evidence -and demonstrates our commitment to advancing faster recovery and improving outcomes for patients."
About Bioretec:
Bioretec is a globally operating Finnish medical device pioneer at the forefront of transforming orthopedic care with fully biodegradable implant technologies. 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's Activa product line features fully bioabsorbable orthopedic implants made from a proprietary, self-reinforced PLGA polymer. These implants deliver secure fixation through patented innovations and naturally degrade in approximately two years, eliminating the need for costly and invasive removal surgeries while supporting optimal bone regeneration. Activa products are both CE marked, and FDA cleared for a wide range of indications in adult and pediatric patients.
The company's latest innovation, the RemeOs product line, is based on a high-performance magnesium alloy and hybrid composite, introducing a new generation of strong absorbable materials for enhanced surgical outcomes. RemeOs implants are absorbed and replaced by bone, eliminating the need for removal surgery while facilitating fracture healing. The first RemeOs market authorization was received in the U.S. in March 2023 (via FDA De Novo), followed by CE Mark approval in Europe in January 2025.
To learn more about Bioretec, visit www.bioretec.com
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