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.
Adam Christie, CEO of Calcivis, said: “The receipt of an Approvable Letter from FDA is a very important step as we prepare to launch the Calcivis Imaging System in the world’s largest dentistry market. We are confident that Calcivis can help to establish a new standard of preventive care in US dentistry.
“The system enables clinicians to implement preventive strategies for caries management early in the caries process when it is still reversible, before cavities form. We also know that Calcivis images help patients to understand their condition and to value preventive interventions by their dentist. Our technology helps dentists and patients to collaborate in promoting better oral health.”
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.
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, which will ultimately allow the Calcivis Imaging System to help dentists in the US to better preserve their patients’ teeth.
“Calcivis is now planning the US launch of this novel system via its own commercial organisation in the world’s largest dentistry market and we are confident of success that will bring significant return to shareholders.”
Kerry Sharp, director, Scottish Investment Bank, said: “The Approvable Letter from FDA for the Calcivis Imaging System is a massive achievement for Calcivis and rewards the faith in Adam and his team over many years. Given the clear benefits the system delivers to both dentists and patients, I am confident that the Calcivis commercial team will drive significant uptake of this novel technology once launched, heralding a new era in preventive dentistry in the US.”
