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BONESUPPORT Shifts CERAMENT V Regulatory Pathway to De Novo Process

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BONESUPPORT Shifts CERAMENT V Regulatory Pathway to De Novo Process

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BONESUPPORT HOLDING AB ( (SE:BONEX) ) has shared an update.

BONESUPPORT announced a strategic shift in the regulatory process for its CERAMENT V product, aimed at treating bone infections, by moving from the 510(k) application to the De Novo process with the U.S. FDA. This move is expected to establish a new product category, similar to the company’s previous success with CERAMENT G, potentially strengthening BONESUPPORT’s market position by making CERAMENT V the sole product in its category, despite the longer review period.

The most recent analyst rating on (SE:BONEX) stock is a Hold with a SEK210.00 price target. To see the full list of analyst forecasts on BONESUPPORT HOLDING AB stock, see the SE:BONEX Stock Forecast page.

More about BONESUPPORT HOLDING AB

BONESUPPORT is a leading company in orthobiology, specializing in the development and commercialization of innovative injectable bio-ceramic bone graft substitutes. These products, which can elute drugs and remodel to the patient’s own bone, are based on a patented technology platform. The company is headquartered in Lund, Sweden, and reported net sales of SEK 899 million in 2024.

Average Trading Volume: 245,180

Technical Sentiment Signal: Hold

Current Market Cap: SEK13.29B

For a thorough assessment of BONEX stock, go to TipRanks’ Stock Analysis page.

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