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FDA support

Regulator edges dental firm Calcivis closer to US market

Adam Christie: important step

A Scottish medical devices company focused on preventing tooth decay has moved a step closer to bringing its product to the US market following support from the Food and Drug Administration (FDA).

Calcivis intends to introduce its imaging system in the US next year with the aim of creating a preventive dentistry market, projected to be worth up to $500 million per year.

The system enables early detection of tooth decay and, for the first time, differentiate in real-time between active and inactive lesions on tooth surfaces.

This new approach is expected to change care planning and intervention for patients, leading to better preservation of their original teeth and improved oral health.

Calcivis is working towards a US test launch through its own commercial organisation in Boston, Massachusetts. A full US national rollout of the System is planned to begin in 2022.

Adam Christie, CEO, said an approvable letter received from FDA is an important step.

“We are confident that Calcivis can help to establish a new standard of preventive care in US dentistry,” he said.

Dr Sarah Hardy, chief investment officer at Archangels, said: “From the very beginning we have believed in the potential of Calcivis to make this step change in preventive dentistry.

“Today’s announcement is a major corporate milestone in achieving this goal.”

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