Edinburgh-based preventive dentistry firm Calcivis said on Friday it closed a £3.15 million equity funding round from existing investors Archangel Investors, Julz and the Scottish Investment Bank.
“The proceeds will be used to support the completion of the FDA’s pre-market approval (PMA) review process for the Calcivis Imaging System in the United States, the world’s largest dentistry market,” said Calcivis, which is based at the Edinburgh BioQuarter near Edinburgh Royal Infirmary at Little France.
“The filing of the PMA application to the FDA was made in October 2017.
“The company plans the launch of the Calcivis imaging system in the US in 2019, subject to the PMA being approved …
“The proceeds will also be used to drive the commercialisation of the imaging system in the UK.”
Calcivis CEO Adam Christie said: “We are delighted by the continuing commitment of our existing investors in this financing round.
“This new investment positions us to gain PMA approval for our Calcivis Imaging System in the US ahead of a launch planned for the second half of 2019.
“We also plan to use the funds to drive sales and optimize the commercial model for the system in the UK where it has received a positive reception from both dentists and patients since its first launch earlier this year.”
Sarah Hardy, chief investment officer at Archangels, said: “This funding round will enable Calcivis to generate significant shareholder value by gaining FDA approval for its unique Calcivis Imaging System paving the way for the product US launch in 2019.
“We believe the system will bring significant benefits both to patients and dental practitioners by catalysing the adoption of preventive dentistry.
“We are proud to contribute to the growth of such an innovative company.”
Kerry Sharp, head of Scottish Investment Bank, said: “We’re pleased to be co-investing with Archangels and Julz Co to help Calcivis gain FDA approval and launch the product in the US.
“We’ve assisted the company on its growth journey and it’s now showing promising commercial development with the launch of its imaging system in the UK earlier this year a significant event for preventive dentistry.
“We look forward to working alongside Calcivis to help it continue to achieve its potential, both in Scotland and internationally.”