Edinburgh-based Calcivis said the pre-market approval (PMA) from the US regulator for the imaging system, which “aims to revolutionise the dental sector by enabling the move to a more preventive treatment model”, would enable it to “tap into the multi-billion-dollar US dental market”.
Calcivis noted that pre-market approval “is only awarded after a statutory process of scientific review to ensure the efficacy and safety of medical devices”.
Explaining its technology, the company added: “The Calcivis imaging system allows dentists to visualise decay ‘live’ as it happens on patients’ teeth, providing crucial insight as to whether a caries lesion is likely to progress and requires treatment.
“The imaging system applies a patented photoprotein which, in the presence of free calcium ions released from an actively decaying tooth surface, produces a very short, low-level light flash. An integrated intra-oral sensor within the Calcivis imaging device immediately detects the luminescence (light flash) and presents clinicians with a chair-side demineralisation map.”
Adam Christie, chief executive of Calcivis, said: “It’s been a long process with delays caused by Covid restrictions, so we’re very pleased to have achieved PMA status. We have an ambitious growth plan for the highly developed US dental market which, with our FDA accreditation, we can now capitalise on.”
He added: “We are building a team in America to take Calcivis to market…Our technology can help shift the paradigm in dental healthcare from ‘drill and fill’ restorative dentistry to a more preventive approach.”
Since it was founded in 2012, Calcivis has raised £16 million of investment.
Investors include business angel syndicate Archangels, which has been involved with the company from the outset, and Scottish Enterprise, Scotland’s national economic development agency.
Kerry Sharp, director of entrepreneurship and investment at Scottish Enetrprise, said: “We’ve worked with Calcivis for many years so its great to see the company achieve this important approval, enabling the next big step in its growth journey. The company’s innovative, preventative approach has helped it go from strength-to-strength, while addressing a significant public health need.
“The US dental market offers fantastic expansion opportunities and our colleagues in Scottish Development International have also been working with the company to build those all-important overseas connections.”