Bonesupport's Strategic Reimbursement Milestone for Cerament G: Unlocking Scalable Commercialization in Orthopedic Biomaterials

The orthopedic biomaterials sector is undergoing a quiet revolution, driven by companies that master the intersection of clinical innovation and reimbursement strategy. At the forefront is Bonesupport Holding AB (publ), whose flagship product, Cerament G, has secured landmark U.S. Medicare reimbursements through the New Technology Add-On Payment (NTAP) and Transitional Pass-Through (TPT) programs. These approvals are not just regulatory checkboxes—they are strategic levers that unlock scalable commercialization, investor value, and long-term market dominance in a sector poised for growth.

The NTAP/TPT Double Play: A Masterstroke in U.S. Reimbursement

The U.S. healthcare system is notoriously complex, but for orthopedic biomaterials, NTAP and TPT approvals are game-changers. NTAP, part of the Inpatient Prospective Payment System (IPPS), provides hospitals with $4,918.55 per case in supplemental Medicare payments for Cerament G when inpatient costs exceed standard thresholds. This ensures hospitals are incentivized to adopt the product, even in a cost-conscious environment. Meanwhile, the TPT program, effective January 1, 2024, extends this financial support to outpatient settings, reimbursing ambulatory surgical centers and hospital outpatient departments for the incremental cost of Cerament G.

These dual pathways are critical. For context, the average NTAP payment for orthopedic devices in FY2021–2024 was $4,292, with spine/bone technologies averaging $4,919—a range Cerament G comfortably fits into. By securing both inpatient and outpatient reimbursement, Bonesupport has created a 360-degree commercialization framework, ensuring Cerament G is accessible across all care settings where bone infection and void management are critical.

Clinical and Regulatory Synergy: Breakthrough Designation Fuels Reimbursement

Cerament G's success is underpinned by its FDA Breakthrough Device Designation, a status that fast-tracks regulatory review and, crucially, aligns with CMS's alternative pathways for NTAP/TPT eligibility. This designation bypasses the need to prove “substantial clinical improvement” over existing technologies—a high bar that often delays or derails reimbursement. Instead, Bonesupport leveraged its Breakthrough status to demonstrate novelty and cost alignment, criteria that CMS increasingly prioritizes in an era of value-based care.

The result? A product that is not only clinically differentiated (gentamicin-eluting, absorbable bone void filler) but also financially defensible in a system where hospitals and providers are incentivized to adopt cost-effective solutions. This synergy between clinical innovation and reimbursement strategy is rare and highly valuable.

Financial Validation: Sales Growth and Investor Sentiment

Bonesupport's 2023 financials tell a compelling story. For the full year, net sales surged 80% to SEK 591.1 million, with North America contributing 104% growth. The U.S. TPT approval in November 2023 likely accelerated this momentum, as hospitals and outpatient facilities began integrating Cerament G into standard protocols. Gross margins remained robust at 91.5%, and operating profits turned positive, jumping from -SEK 64.5 million in 2022 to +SEK 13.9 million in 2023.

Investor sentiment has followed suit. Bonesupport's shares have gained +120% year-to-date (as of August 2025), reflecting confidence in its U.S. strategy and product pipeline. The company's revised 2024 outlook—40%+ sales growth in constant currency—further underscores the transformative impact of Cerament G's reimbursement milestones.

Strategic Expansion: From Bone Infection to Spinal Fusion

Bonesupport is not resting on its laurels. With Cerament G firmly entrenched in the U.S. market, the company is now targeting spinal fusion, a $5 billion global market. In Q1 2024, it submitted an FDA application for Cerament BVF in spine interbody fusion, a move that could unlock a new revenue stream. Additionally, Cerament V received Breakthrough Device Designation in October 2023 for bone infection, positioning it for a 2025 U.S. launch.

This pipeline depth is critical. Orthopedic biomaterials are a high-margin, high-growth sector, with global demand driven by aging populations and rising surgical volumes. Bonesupport's ability to secure reimbursement while expanding into adjacent indications creates a multi-decade growth story.

Risks and Rewards: A Balanced Perspective

No investment is without risk. The U.S. reimbursement landscape is subject to policy shifts, and CMS could revisit NTAP/TPT criteria in future years. Additionally, competition in bone void fillers is intensifying, with players like Stryker and Medtronic offering established alternatives. However, Bonesupport's differentiated product profile (antibiotic elution, absorbability) and strategic reimbursement partnerships provide a moat.

For investors, the key question is whether Bonesupport can maintain its 50%+ EBITDA margins while scaling. The 2023 operating margin of +2.3% (SEK 13.9 million profit on SEK 591.1 million revenue) suggests there is room for improvement, particularly as economies of scale take hold.

Conclusion: A Buy for the Long-Term

Bonesupport's Cerament G is a textbook example of how strategic reimbursement planning can transform a niche orthopedic product into a scalable commercial success. By securing NTAP and TPT approvals, the company has removed financial barriers for hospitals and providers, creating a self-sustaining growth engine. With a strong balance sheet, a robust pipeline, and a clear path to spinal fusion, Bonesupport is well-positioned to capitalize on the $15 billion global orthobiologics market.

For investors seeking exposure to a company that excels at navigating the intersection of clinical innovation and reimbursement strategy, Bonesupport offers a compelling case. The stock's current valuation—12x 2024E EBITDA—is conservative given its growth trajectory and market access advantages. This is a buy for the long-term, with potential for 200%+ returns over the next three years.