#Bioretec #Finland #Tampere #RemeOs #Osteopromotive

Bioretec Secures a Vital Approval for RemeOs™ Screw LAG Solid

A Significant Step in Orthopedic Care

On October 1, 2025, Bioretec Ltd, a forefront player in the domain of absorbable orthopedic implants, has announced a landmark achievement. The Centers for Medicare & Medicaid Services (CMS) approved the Transitional Pass-Through Payment (TPT) for their innovative RemeOs™ Screw LAG Solid. This announcement not only reflects the efficacy of Bioretec’s latest technology but also marks a considerable milestone in the field of orthopedic surgery.

Sarah van Hellenberg Hubar-Fisher, the CEO of Bioretec, expressed elation regarding this approval, emphasizing how it sanholds the successful trajectory towards revolutionizing orthopedic care in the USA. The acknowledgment of the RemeOs™ product as a game-changer in fixation technology implies that hospitals and surgeons will be better positioned to utilize a solution that supports the natural healing processes of patients. With this new status, Bioretec envisions amplifying growth opportunities, aiming to set a new standard in orthopedic fixation technology.

CMS Approval and Its Implications

The CMS TPT approval, signifying a rare achievement, is prominently documented in the October 2025 Healthcare Common Procedure Coding System (HCPCS) quarterly update. As part of this designation, a new billing code, C1741, has been established specifically for absorbable anchor/screw implants. Consequently, RemeOs™ is now eligible for supplementary pass-through payment frameworks under both the Hospital Outpatient Prospective Payment System (OPPS) and the Ambulatory Surgical Center (ASC) payment system, leading to enhanced reimbursement opportunities for Medicare patients.

The Innovative Edge of RemeOs™

The RemeOs™ product stands as the very first osteopromotive absorbable metal implant tailored for orthopedic applications in the U.S. Crafted from a proprietary magnesium alloy, the implant provides robust and stable fixation during the healing phases. What sets RemeOs™ apart is its ability to gradually disintegrate, subsequently being substituted by bone, thus minimizing the risks typically associated with permanent implants alongside the costs linked to potential hardware removal surgeries.

Evidence from clinical investigations highlighted a remarkable 90% success rate in fracture consolidation within six weeks, with complete healing registered by the twelve-week mark. Moreover, the osteopromotive features of the implant demonstrate a significant enhancement in bone formation at fracture sites, directly correlating to a reduction in the necessity for secondary surgeries and the advantage of not having permanent metal implants.

A Dual Milestone Achieved

Earlier in March 2023, RemeOs™ Screw LAG Solid obtained FDA De Novo market authorization, laying the foundation for its recognition as a novel technology. With the addition of CMS TPT Pass-Through approval, Bioretec proudly celebrates a rare dual milestone, a distinction that has been reached by only a select few medical devices. This recognition not only by regulatory bodies but also by payors signifies an acknowledgment of a breakthrough technology, showcasing both its clinical and economic viability.

Timo Lehtonen, the Chief Technology Officer at Bioretec, underlined that this approval further underscores RemeOs™ as a leap forward in material science and clinical innovation. It embodies years of dedicated investment in leading research, extensive testing, and solid clinical evidence, ultimately showcasing Bioretec's unwavering commitment to enhancing recovery times and patient outcomes.

About Bioretec

Bioretec is a globally recognized Finnish company dedicated to pioneering biodegradable implant technologies for orthopedic applications. With a unique competence in the biological interfaces of active implants, the company works to bolster bone growth and foster faster recovery rates post-surgery. Bioretec’s innovative products are deployed across approximately 40 countries worldwide.

Particularly, the Activa product line, featuring bioabsorbable orthopedic implants generated from a proprietary self-reinforced PLGA polymer, reflects their commitment to patient safety and efficacy. The latest innovation, the RemeOs™ product line, aims to introduce robust absorbable materials that facilitate optimal surgical outcomes. The journey for RemeOs™, beginning with FDA De Novo approval in March 2023, and progressing towards CE Mark approval in Europe as of January 2025, exemplifies the company's dedication to excellence and innovation in orthopedic care. For more details, please visit Bioretec.