Shifting CERAMENT V To FDA De Novo Review Might Change The Case For Investing In Bonesupport Holding (OM:BONEX)

• BONESUPPORT has already shifted its U.S. regulatory route for CERAMENT V for bone infection from a 510(k) submission to the FDA’s De Novo pathway, extending the formal review period from 90 to 150 days while transferring substantial existing clinical and pharmacological documentation.
• This move suggests CERAMENT V could, if cleared, create a new product category in the U.S., echoing how CERAMENT G previously established a distinct regulatory class and potentially underscoring the uniqueness of BONESUPPORT’s antibiotic-loaded bone graft platform.
• We’ll now examine how moving CERAMENT V into the FDA’s longer De Novo pathway may reshape BONESUPPORT’s investment narrative and risk profile.

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Bonesupport Holding Investment Narrative Recap

To own BONESUPPORT, you need to believe its antibiotic-loaded bone grafts can keep gaining clinical adoption while U.S. reimbursement and regulatory milestones broaden the franchise beyond CERAMENT G. The CERAMENT V shift to a De Novo review meaningfully affects the near term regulatory catalyst by lengthening timelines, while also sharpening regulatory risk if the FDA ultimately takes a more demanding view of the data package.

The most relevant recent announcement is the original April 2025 FDA submission of CERAMENT V for bone infection, which set expectations for a shorter 510(k) review as a key upcoming catalyst. With that path now converted to De Novo, the same application remains central to BONESUPPORT’s story, but sits alongside other moving parts such as potential NTAP decisions and evolving reimbursement codes for CERAMENT products that could influence the payoff from any eventual approval.

However, investors should be aware that reimbursement uncertainty for bone infection treatments could...

Read the full narrative on Bonesupport Holding (it's free!)

Bonesupport Holding's narrative projects SEK2.6 billion revenue and SEK843.6 million earnings by 2028. This requires 35.2% yearly revenue growth and an earnings increase of about SEK695.6 million from SEK148.0 million today.

Uncover how Bonesupport Holding's forecasts yield a SEK391.20 fair value, a 108% upside to its current price.

Exploring Other Perspectives

Four members of the Simply Wall St Community currently place BONESUPPORT’s fair value between SEK308.10 and SEK1,030.25, highlighting very different expectations. You can set those views against the extended De Novo review for CERAMENT V and consider how longer regulatory timelines might affect the company’s ability to convert its product pipeline into sustained growth.

Explore 4 other fair value estimates on Bonesupport Holding - why the stock might be worth just SEK308.10!

Build Your Own Bonesupport Holding Narrative

Disagree with existing narratives? Create your own in under 3 minutes - extraordinary investment returns rarely come from following the herd.

• A great starting point for your Bonesupport Holding research is our analysis highlighting 4 key rewards that could impact your investment decision.
• Our free Bonesupport Holding research report provides a comprehensive fundamental analysis summarized in a single visual - the Snowflake - making it easy to evaluate Bonesupport Holding's overall financial health at a glance.

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This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned.

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