An Edinburgh medical devices firm has raised £4.5 million to bring its “game-changing” dental system to the lucrative US market.
Calcivis has closed the final part of its multi-million-pound equity fundraise as it gears up to launch its system for assessing and treating tooth decay in the world’s largest dentistry market.
The company plans to access the US market next year, subject to receiving pre-market approval (PMA) from the government-run Food and Drug Administration (FDA).
Calcivis is “confident” of securing PMA following positive results from a pivotal clinical study to assess the product’s efficacy. The company claims its device is “revolutionising” the management of tooth decay and enabling preventive dentistry methods, leading to better preservation of patients’ original teeth and improved oral hygiene.
The latest funding round was led by Edinburgh business angel syndicate Archangels and supported by the Scottish Investment Bank, the investment arm of Scottish Enterprise, both of which are longstanding supporters of the business.
The BioQuarter-based firm also has the backing of US-based healthcare fund Julz and has raised equity and grant funding totalling more than £14m since its inception.
Its technology, which uses a glowing protein to show where teeth are beginning to be damaged, was developed by Chris Longbottom and Nigel Pitts at Dundee University.
Chief executive Adam Christie said: “This new investment allows us to continue to execute our strategy as we anticipate PMA approval for our Calcivis Imaging System later this year from FDA.
“We remain very confident in the potential of this new approach to preventive dentistry in the US, when it is launched in the world’s largest dentistry market in 2020.
“This optimism has been reinforced by our experience in the UK, where the Calcivis Imaging System has been shown to provide reliable, visualisation of demineralisation enabling bespoke, evidence-based preventive treatment for dental caries patients.”
Sarah Hardy, chief investment officer at Archangels, said the system “will prove to be a catalyst for the wide-spread adoption of preventive dentistry, bringing significant benefits both to patients and dental practitioners”.
She added: “We are confident that PMA approval of this system will add shareholder value and we look forward to Adam and the Calcivis team achieving this major breakthrough, which would not only be game-changing for dentistry but an amazing achievement for the company.”
Kerry Sharp, director of Scottish Investment Bank, said: “We have been an enthusiastic supporter of Calcivis for many years and we remain excited about its potential to transform dental practice globally, resulting in improved dental health for individuals, families and communities.”