FDA approval

Rare US regulator backing for dental tech firm

Adam Christie, left, with chairman John Brown

Dental imaging technology company Calcivis is setting its sights on US growth after its medical device became among the first from Scotland to secure a coveted accreditation.

The Edinburgh Bioquarter-based business has received pre-market approval from the US Food and Drug Administration (FDA) and is establishing a US commercial capability in Boston.

Calcivis’s major shareholders are Archangels, Scottish Enterprise and Julz who are backing it to revolutionise the dental sector by switching to a more preventive treatment model.

The Calcivis Imaging System allows dentists to visualise decay ‘live’ as it happens on patients’ teeth.

Co-founder Adam Christie, CEO at Calcivis, said: “It’s been a long process with delays caused by Covid restrictions.

“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 from investors.

Dr Sarah Hardy, director and head of new investments at Archangels, said: “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 the 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 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.”

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