Dental imaging technology company Calcivis is setting its sights on US growth after having secured pre-market approval 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.
The approval is only awarded after a statutory process of scientific review to ensure the efficacy and safety of medical devices and it should now allow the Edinburgh-based business to tap into the multi-billion dollar US dental market.
The system allows dentists to visualise decay ‘live’ as it happens on patients’ teeth, providing insight as to whether a caries lesion is likely to progress and require 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 imaging device detects the luminescence and presents clinicians with a chair-side demineralisation map.
Adam Christie, chief executive at Calcivis, said: “It’s been a long process with delays caused by Covid restrictions, so we’re very pleased to have achieved approval.
“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.“
Since it was founded in 2012, Calcivis has raised £16m from investors including Archangels and Scottish Enterprise.
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 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.”
Kerry Sharp, director of entrepreneurship and investment at Scottish Enterprise, added: “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.”
Calcivis is based at the Edinburgh Bioquarter and is establishing a US commercial capability in Boston.
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