A Scottish company has received a preliminary FDA green light for an advanced dental imaging system that is able to highlight active tooth decay, giving dentists the chance to act preventively and stop cavities before they form.
Calcivis uses a novel combination of a medical device and a biologic protein to spot the presence of free calcium ions shed by teeth as they begin to deteriorate. This can help differentiate between an active lesion and an inactive one, and at their early stages.
The FDA provided the Edinburgh-based company with an approvable letter for the system’s eventual full premarket approval, pending the completion of the required facilities inspections.
Calcivis said it is preparing to begin rolling out its eponymous product to the U.S. in 2021, out of its stateside headquarters in Boston, with the goal of creating a new, $500 million market for preventive dentistry along with a new standard of care.
“The system enables clinicians to implement preventive strategies for caries management early in the caries process when it is still reversible, before cavities form,” CEO Adam Christie said in a statement.
The free calcium ions are captured using a proprietary, bioluminescent protein, which produces tiny, near-invisible flashes of light when the two come into contact. The company’s imaging device then provides a map of active tooth erosion, allowing dentists to apply remineralisation agents and sealants to areas of decay while avoiding healthy enamel.
“We also know that Calcivis images help patients to understand their condition and to value preventive interventions by their dentist,” Christie added. “Our technology helps dentists and patients to collaborate in promoting better oral health.”
Calcivis is backed by the local angel investment syndicate, Archangels, and the Scottish National Bank as well as Innovate UK’s Biomedical Catalyst and the EU’s Horizon 2020 research program. Last September, the company raised £4.5 million ($5.85 million) in equity funding to support its final regulatory push.
“From the very beginning we have believed in the potential of CALCiViS to make this step change in preventive dentistry,” said Sarah Hardy, Archangels’ chief investment officer. “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 U.S. to better preserve their patients’ teeth.”