The firm’s patented system enables early detection of tooth decay – which in turn can enable timely preventive treatment – by deploying a biologic diagnostic agent in combination with an imaging device.

The technology uses bioluminescence to highlight quickly and clearly where preventive measures are required before decay becomes irreversible.

The company’s latest investment round was led by £4m in funding from the Scottish National Investment Bank, along with £1m from IFS Maven Equity Finance, which is managed by Maven Capital Partners and is part of the Investment Fund for Scotland (IFS), delivered by the British Business Bank.

Calcivis will use the funds to bring its flagship product to market in the US after the Food and Drug Administration (FDA) granted premarket approval, which is the most stringent regulatory review of the safety and effectiveness of medical devices. The system is the first Scottish medical device to secure the prestigious certification from the FDA.

The US market is the largest for medical technology and Calcivis anticipates a subsequent launch in the UK and other European markets. Through this investment, Scotland will benefit from the potential returns of the multi-market launch, and the product will contribute to delivering the nation’s health and wellbeing aims.

Adam Christie, CEO of Calcivis, said: “Early diagnosis and treatment of tooth decay is essential, allowing patients to reverse the damage to their teeth before it is too late.

“This investment will enable us to launch our innovative product to global markets – first in the US and eventually in the UK – leading to faster diagnoses and early intervention treatments.

“This technology has the potential to revolutionise prevention in oral health care, with cavities impacting more than two billion people globally, according to the World Health Organisation.

“We look forward to seeing where this product can go with the support of both the Scottish National Investment Bank, and the Investment Fund for Scotland, through Maven.”

Paul Callaghan, investment director from the Scottish Bational Investment Bank, said: “Calcivis is a shining example of how Scotland is leading the way in developing cutting-edge technology that improves our health and wellbeing.

“We are proud to help the company scale-up and enable its flagship product to reach international markets, creating jobs in Scotland.

“As a development investment bank, we see Calcivis’ technology as fully aligned with our Innovation mission, and the product’s launch in the UK has the potential to deliver substantial health benefits to people in Scotland.”

David Milroy, partner at Maven, said: “Tooth decay is the most common nontransmissible disease globally and is believed to cost western economies over $300 billion annually, much of which is spent treating, rather than preventing damage to our teeth.

“Maven is therefore delighted to be supporting Calcivis’ revolutionary technology. We look forward to working with the Calcivis team as they launch this exciting new product.”

Ken Cooper, managing director of Venture Solutions, at the British Business Bank, said: “Health tech and life sciences are key areas of opportunity for the Scottish economy and, through the Investment Fund for Scotland, we’re committed to supporting businesses with high-growth potential, such as Calcivis.”

Calcivis is based at Edinburgh’s BioQuarter, where it continues to expand its research and development operations and explore innovative, lower carbon manufacturing processes.

Since it was founded in 2012, Calcivis has raised more than £18m in funding. Investors include Scottish Enterprise and Archangels, which has been involved with the company from the outset.

Sarah Hardy, head of new investments and director at Archangels, said: “We are delighted to welcome the Bank and the Investment Fund for Scotland through Maven, alongside our strong syndicate of investors at this exciting juncture as we roll out a new level of preventive dentistry with the revolutionary Calcivis product.”