Calcivis targets US expansion after securing FDA PMA approval

Dental imaging technology company Calcivis is setting its sights on US growth having secured pre-market approval (PMA) from the US Food and Drug Administration (FDA).

As the first Scottish medical device to secure the coveted accreditation, the Calcivis Imaging System aims to revolutionise the dental sector by enabling the move to a more preventive treatment model.

PMA approval is only awarded after a statutory process of scientific review to ensure the efficacy and safety of medical devices. PMA accreditation will allow Edinburgh-based Calcivis to tap into the multi-billion dollar US dental market.

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, CEO at 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.

“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.”

Since it was founded in 2012, Calcivis has raised £16 million investment. Investors include Archangels, the world’s longest-running business angel investment syndicate, which has been involved with the company from the outset, and Scottish Enterprise, Scotland’s national economic development agency.

Dr Sarah Hardy, Director and Head of New Investments at Archangels, said: “Securing FDA approval is the culmination of more than 10 years’ work for Adam, Bruce and the Calcivis team, and the commercial opportunities it opens up are potentially huge.

“Calcivis being one of, if not the first, Scottish medical device company to have FDA PMA approval is an achievement in itself and is testament to strength not only of the company, but of the broader technology and life science sectors in Scotland.

“Archangels continues to support Calcivis on the next exciting chapter of its growth.”

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.”