The FDA accreditation was awarded after Calcivis’ medical device was subject to scientific review to ensure its efficacy and safety.

The device claims to be a first-of-its-kind biotechnology-based imaging system which applies photoprotein that interacts with cavities to produce a low level light flash. The oral sensor detects the luminescence so present clinicians with immediate demineralisation maps, and allow them to see if the cavity will need treatment. 

“Our technology can help shift the paradigm in dental healthcare from ‘drill and fill’ restorative dentistry to a more preventive approach,” said Adam Christie, CEO at Calcivis.

Calcivis has been a part of the portfolio of the Scottish business angel investment syndicate, Archangels, since 2012. In 2021, the company raised £1.52 million in equity financing led by the group, which it used to finalise its preparations for launch in the US. The total funding raised by Calcivis to date is £16 million. 

Following the PMA, Calcivis may now enter the US dental market, which has a market size of over $171 billion, according to a report. The Covid-19 pandemic caused many dental offices to close down. Due to this, there is now a large backlog of patients whose tooth decay may have worsened during that time. 

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In the United States, 90% of adults ages 20 and older have had at least one cavity, and one in four adults between the ages of 20 and 64 currently have at least one. “Calcivis is in a strong position to help dentists in the world’s biggest market to identify dental decay before it’s too late to save the tooth,” said Dr. John Brown, executive chairman of Calcivis. 

“We have an ambitious growth plan for the highly developed US dental market which, with our FDA accreditation, we can now capitalise on,” said Christie.