Dental-focused Calcivis set to sink teeth into key US market after regulatory approval milestone

Edinburgh-based, dental-focused Calcivis is bracing itself for its long-held ambition of US growth after securing a key regulatory green light that it says is the first of its kind for Scotland.

The company has locked down pre-market approval (PMA) from the US Food and Drug Administration (FDA) for its Calcivis Imaging System, saying it is the first Scottish medical device to secure the coveted accreditation, which will allow it to bite into the multi-billion-dollar US dental market. It in 2020 noted that it had received an approvable letter from the FDA.

The dental imaging technology specialist also explains that its offering enables dentists to visualise decay “live” as it happens on patients’ teeth, providing key insight as to whether a caries lesion is likely to progress and require treatment.

Chief executive Adam Christie said: “It’s been a long process with delays caused by Covid restrictions, so we’re very pleased to have achieved PMA status. We are building a team in America to take Calcivis to market, and we’re ready to revolutionise patient care. Our technology can help shift the paradigm in dental healthcare from ‘drill and fill’ restorative dentisty to a more preventive approach.”

From left: Calcivis CEO Adam Christie and chair John Stark. Picture: Peter Devlin.

Calcivis also pointed out that since it was founded in 2012, it has raised £16 million, with backers including Archangels, which has been involved from the outset, and Scottish Enterprise.

Dr Sarah Hardy, director and head of new investments at Archangels, said: “Securing FDA approval is the culmination of more than ten years’ work for Adam, Bruce and the Calcivis team, and the commercial opportunities it opens up are potentially huge.” She added that the firm getting this official go-ahead “is testament to strength not only of the company, but of the broader technology and life science sectors in Scotland”, also stating: “Archangels continues to support Calcivis on the next exciting chapter of its growth.”

Kerry Sharp, director of entrepreneurship and investment at Scottish Enterprise, said: “We’ve worked with Calcivis for many years, so it’s great to see the company achieve this important approval, enabling the next big step in its growth journey. 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.”