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Bioventus Receives US FDA Clearance for BoneScalpel® Access

Bioventus Inc. (Nasdaq: BVS) (“Bioventus” or the “Company”), a global leader in innovations for active healing, announced the US Food and Drug Administration (FDA) has granted 510(k) clearance for the Company’s neXus® BoneScalpel® AccessTM handpiece.

The BoneScalpel Access handpiece is powered by the neXus Ultrasonic Surgical Aspirator System, a platform driven by a proprietary digital algorithm resulting in more power, versatility, and control. The neXus system combines all the features of soft and hard (e.g. bone) tissue next-generation integrated ultrasonic surgical removal into a single fully integrated offering.

“The BoneScalpel Access handpiece provides surgeons with a new option for confined spaces during minimally invasive surgery, enabling safe and powerful bone removal with maximum visualization. In addition, BoneScalpel Access allows for en-bloc resection and the shaving and sculpting of bone, with built-in irrigation and aspiration with improved ergonomics for the end user,” said Sharon Klugewicz, Senior Vice President, Quality and Regulatory Affairs, Bioventus.

“The BoneScalpel Access handpiece represents the latest innovation in our best-in-class ultrasonic surgical platform, and we anticipate that surgeons will want to leverage our portfolio of bone graft substitutes to achieve bone fusion for their patients,” she added.

Bioventus plans to launch BoneScalpel Access in 2022.

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