Calcivis’ bioluminescent dental imaging system. Credit: Business Wire/Calcivis.

Medical device company Calcivis is set to launch its new preventive bioluminescent dental imaging system in the US.

The move comes after the company secured final-stage US Food and Drug Administration (FDA) pre-market approval (PMA) for its new ergonomic, wireless, handheld imaging device, paving the way for commercialisation.

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The system utilises a patented photoprotein that emits a brief, low-level light flash in the presence of free calcium ions from decaying tooth surfaces. An integrated intra-oral sensor detects this luminescence and provides dentists with a real-time demineralisation map at the chairside.

Calcivis CEO Adam Christie said: “With our US commercial team in place and a very user-friendly, ready for market device, we are confident that the Calcivis Imaging System will significantly improve patient care and enable restorative dentistry to move to a more preventive approach.”

Deemed safe and effective for use in adults, and children aged six years or older, the system can be applied to all accessible coronal tooth surfaces.

The US rollout is scheduled to commence with a limited release in the greater Boston area early this year.

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The company also strengthened its commercial team with the addition of Ronald Frezel as vice-president of sales and marketing and Jill McGregor as chief financial officer.

Frezel said: “We are excited to bring the Calcivis Imaging System to market and are planning for our launch at the Yankee Dental Meeting, to be held in Boston, January 25–27 2024. For the first time dental professionals and their patients will be able to visualise active demineralisation due to carious lesions in real time, chairside.”

Frezel has been responsible for launching dental products to market in the US and Europe for more than 20 years.

McGregor has led financial management for multiple early-stage companies in the UK and US.