Edinburgh medical tech firm Calcivis has taken a major step towards marketing a device that can prevent tooth decay in the US.
Following a clinical study, the company has received an Approvable Letter for the Premarket Approval (PMA) of its CALCIVIS® Imaging System from the US Food and Drug Administration (FDA).
It remains subject to customary facilities inspections but the move puts it on course to launch in the States in 2021 through its base in Boston, tapping in to a preventive dentistry market worth up to $500 million a year. A full US rollout of would begin in 2022.
The Calcivis Imaging System shows up decay at an early stage by detecting free calcium ions. This allows dentists for the first time to differentiate in real-time between active and inactive lesions. They can then decide whether to use preventive treatments such as remineralisation agents and sealants.
Calcivis is working towards a US test launch of the system in 2021 through its base in Boston, Massachusetts. A full US national rollout is planned for 2022. The system is already approved for use in the EU.
Edinburgh-based Archangels and the Scottish Investment Bank are investors in Calcivis, which has raised £14 million equity and grants since its launch in 2012.
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