Bioretec's RemeOs™ Screw Receives CMS Pass-Through Payment Approval
In a significant breakthrough for orthopedic care, Bioretec Ltd. has announced that the Centers for Medicare & Medicaid Services (CMS) has granted Transitional Pass-Through Payment (TPT) status to its innovative RemeOs™ Screw LAG Solid, effective from October 1, 2025. This approval marks an important milestone in the company's journey to enhance the adoption of its absorbable orthopedic implants in the U.S. market.
Sarah van Hellenberg Hubar-Fisher, the CEO of Bioretec, expressed her excitement over the announcement, highlighting that this transition builds upon the previously secured FDA Breakthrough Device Designation and De Novo grant. The CMS decision underscores both the clinical value and economic potential of RemeOs™, enabling hospitals, surgical centers, and surgeons to access a pioneering fixation technology that is designed to bolster natural healing processes.
The TPT designation was published in the October 2025 update of the Healthcare Common Procedure Coding System (HCPCS), which assigns a new billing code, C1741, specifically for absorbable anchor and screw implants. This new classification allows for separate pass-through payments under the Hospital Outpatient Prospective Payment System (OPPS) and the Ambulatory Surgical Center (ASC) payment schemes, providing additional reimbursement pathways for Medicare beneficiaries.
RemeOs™ stands out as the first and only osteopromotive absorbable metal implant available for orthopedic applications in the United States. Constructed from a proprietary magnesium alloy, this device offers strong and stable fixation during the healing phase, while also gradually degrading and being replaced by bone. This innovative approach not only mitigates the risks associated with permanent implants but also eliminates the costs and complications tied to hardware removal surgeries.
Clinical trials have shown impressive outcomes, with data revealing that 90% of patients achieved fracture consolidation within six weeks, and complete healing was noted by the twelve-week mark. Furthermore, the osteopromotive properties of RemeOs™ have proven advantageous, enhancing bone formation at the fracture site and decreasing the necessity for secondary procedures due to failed implants.
Back in March 2023, the RemeOs™ Screw LAG Solid was granted FDA De Novo market authorization, further punctuation its novel status in the realm of orthopedic fixation technologies. Now, with the CMS TPT Pass-Through approval, Bioretec has accomplished a rare dual milestone, gaining recognition from both the highest regulatory bodies and payors for its breakthrough technology that has solid clinical and economic merits.
Chief Technology Officer Timo Lehtonen remarked, “This approval validates RemeOs™ as a remarkable advance in material science and clinical innovation. It represents the culmination of extensive investment in leading-edge research, thorough testing, and robust clinical evidence, reinforcing our commitment to enhancing patient recovery times and overall outcomes.”
Based in Finland, Bioretec is a globally recognized leader in biodegradable orthopedic solutions, dedicated to transforming surgical care through pioneering technology. Their commitment extends beyond the development of implants; Bioretec also focuses on creating active implant solutions designed to enhance bone growth and expedite healing following orthopedic procedures.
The company's Activa product line features fully bioabsorbable orthopedic implants made from a unique, self-reinforced PLGA polymer, which not only enables secure fixation but also degrades naturally within two years, precluding the need for invasive removal surgeries while optimizing bone healing processes. With the advancements seen through the RemeOs™ series, forged from innovative magnesium alloys, Bioretec aims to push the boundaries of what's possible in orthopedic surgery. The road to extensive market penetration is promising, with the first market authorization for RemeOs™ achieved in the U.S. in March 2023, followed by CE Mark approval in January 2025 for European markets.
For further details on Bioretec and its products, please visit www.bioretec.com.
Sarah van Hellenberg Hubar-Fisher, the CEO of Bioretec, expressed her excitement over the announcement, highlighting that this transition builds upon the previously secured FDA Breakthrough Device Designation and De Novo grant. The CMS decision underscores both the clinical value and economic potential of RemeOs™, enabling hospitals, surgical centers, and surgeons to access a pioneering fixation technology that is designed to bolster natural healing processes.
The TPT designation was published in the October 2025 update of the Healthcare Common Procedure Coding System (HCPCS), which assigns a new billing code, C1741, specifically for absorbable anchor and screw implants. This new classification allows for separate pass-through payments under the Hospital Outpatient Prospective Payment System (OPPS) and the Ambulatory Surgical Center (ASC) payment schemes, providing additional reimbursement pathways for Medicare beneficiaries.
RemeOs™ stands out as the first and only osteopromotive absorbable metal implant available for orthopedic applications in the United States. Constructed from a proprietary magnesium alloy, this device offers strong and stable fixation during the healing phase, while also gradually degrading and being replaced by bone. This innovative approach not only mitigates the risks associated with permanent implants but also eliminates the costs and complications tied to hardware removal surgeries.
Clinical trials have shown impressive outcomes, with data revealing that 90% of patients achieved fracture consolidation within six weeks, and complete healing was noted by the twelve-week mark. Furthermore, the osteopromotive properties of RemeOs™ have proven advantageous, enhancing bone formation at the fracture site and decreasing the necessity for secondary procedures due to failed implants.
Back in March 2023, the RemeOs™ Screw LAG Solid was granted FDA De Novo market authorization, further punctuation its novel status in the realm of orthopedic fixation technologies. Now, with the CMS TPT Pass-Through approval, Bioretec has accomplished a rare dual milestone, gaining recognition from both the highest regulatory bodies and payors for its breakthrough technology that has solid clinical and economic merits.
Chief Technology Officer Timo Lehtonen remarked, “This approval validates RemeOs™ as a remarkable advance in material science and clinical innovation. It represents the culmination of extensive investment in leading-edge research, thorough testing, and robust clinical evidence, reinforcing our commitment to enhancing patient recovery times and overall outcomes.”
Based in Finland, Bioretec is a globally recognized leader in biodegradable orthopedic solutions, dedicated to transforming surgical care through pioneering technology. Their commitment extends beyond the development of implants; Bioretec also focuses on creating active implant solutions designed to enhance bone growth and expedite healing following orthopedic procedures.
The company's Activa product line features fully bioabsorbable orthopedic implants made from a unique, self-reinforced PLGA polymer, which not only enables secure fixation but also degrades naturally within two years, precluding the need for invasive removal surgeries while optimizing bone healing processes. With the advancements seen through the RemeOs™ series, forged from innovative magnesium alloys, Bioretec aims to push the boundaries of what's possible in orthopedic surgery. The road to extensive market penetration is promising, with the first market authorization for RemeOs™ achieved in the U.S. in March 2023, followed by CE Mark approval in January 2025 for European markets.
For further details on Bioretec and its products, please visit www.bioretec.com.
Topics Health）
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