CALCIVIS Completes £4.5 Million Fund Raising Ahead of Anticipated PMA Approval of the CALCIVIS® Imaging System in the US

EDINBURGH, Scotland, Sept. 4, 2019 /PRNewswire/ -- CALCIVIS, a medical devices company focused on revolutionising the management of tooth decay and enabling preventive dentistry, announces it has closed the final part of a £4.5 million equity funding round led by Edinburgh based business angel investment syndicate, Archangels, and supported by the Scottish Investment Bank.

The proceeds will be used to support the Company's development as it anticipates Pre-Market Approval (PMA) of the CALCIVIS® Imaging System from FDA in the US, providing access to the world's largest dentistry market. The Company plans the launch of the CALCIVIS imaging system in the US in 2020, subject to the PMA being approved.

The PMA submission is based around positive data from the pivotal clinical study, which evaluated the CALCIVIS Imaging system in the assessment of active dental demineralisation. Results showed a highly significant level of agreement between the clinical assessment of the original dentist and the independent dentist's assessment using the CALCIVIS imaging system for teeth with active lesions (90.7%; p<0.0001) and sound (healthy) teeth (97.8%; p<0.0001).

In addition, the results of the User and Patient Questionnaires from the study showed high levels of usability and acceptance of the CALCIVIS system, with patients reporting the procedure to be "quick and painless".

The CALCIVIS imaging system is a sophisticated medical device and consumable combination that helps dental practitioners offer bespoke, evidence-based preventive treatment for dental caries patients. This new approach will dramatically change care planning and intervention for patients, leading to better preservation of their original teeth and improved oral hygiene.

The CALCIVIS imaging system provides reliable, visual evidence of demineralisation at an earlier stage than was previously possible. It means dentists can differentiate between active and non-active lesions on tooth surfaces, allowing them to monitor the condition of tooth enamel accurately and effectively over time. This is a significant improvement on the visual inspection and X-ray images that dentists have relied on for decades as the main detection and diagnostic aids for caries.

Adam Christie, CEO of CALCIVIS, said: "We are delighted by the continuing commitment of our existing investors in this financing. 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."

Dr Sarah Hardy, Chief Investment Officer at Archangels, said: "Our investment in CALCIVIS is driven by our belief that the CALCIVIS Imaging System will prove to be a catalyst for the wide-spread adoption of preventive dentistry, bringing significant benefits both to patients and dental practitioners. 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, Scottish Enterprise said: "We are pleased to provide further support to CALCIVIS as it progresses towards PMA approval for the CALCIVIS Imaging System, in advance of the US launch of this novel product in 2020. 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."                                                                                                                                              

About CALCIVIS

CALCIVIS is an innovative medical devices company focused on revolutionising the management of dental caries or 'tooth decay'. CALCIVIS brings together novel biotechnology approaches and world-class device development expertise and is at the forefront of applying biotechnology to dentistry.

The CALCIVIS imaging system will, for the first time, allow the real-time detection and visualisation of calcium ions released by demineralising caries lesions in routine dental practice.

CALCIVIS began operations in 2012 and is based in Edinburgh, Scotland. The Company has been funded by Archangel Investors Limited and the Scottish Investment Bank, the investment arm of Scottish Enterprise and Julz, a US-based healthcare fund. The Company has raised equity and grant funding totalling over £14m since its inception.

CALCIVIS has received funding from the European Union's Horizon 2020 research and innovation programme under grant agreement No 666440 and Innovate UK's Biomedical Catalyst.

www.calcivis.com

About Archangels                                               

Archangels is a prominent business angel syndicate which has been at the forefront of early stage investing in Scotland for more than two decades. Its members invest in, and mentor, promising start-up and early stage companies from Scotland's vibrant technology and life sciences sectors. Originally formed in 1992 and based in Edinburgh, the syndicate now comprises over 130 investor members and leads investment of around £15m per year in early stage Scottish companies, including leverage from partners, the largest being the Scottish Investment Bank. Archangels is interested in Scottish technology companies, which are looking for initial funding of £50,000 to £2m. In addition, Archangels is keen to welcome new investors to its syndicate.

www.archangelsonline.com

About Scottish Investment Bank

The Scottish Investment Bank (SIB) is the investment arm of Scotland's main economic development agency, Scottish Enterprise, operating Scotland-wide in partnership with Highlands and Islands Enterprise. It manages a suite of co- investment funds including the Scottish Co-investment Fund and the Scottish Venture Fund, which are partly funded by the European Regional Development Fund (ERDF), and the Renewable Energy Investment Fund. SIB is also an investor in Epidarex Capital's life sciences fund and is a participant in the Scottish European Growth Co-Investment Programme alongside the European Investment Fund. SIB's investment funds support Scotland's SME funding market to ensure businesses with growth and export potential have adequate access to growth capital. SIB also provides a team of Financial Readiness specialists to help companies prepare for new investment and access appropriate finance.

Contacts:

CALCIVIS

Adam Christie, CEO
Tel: +44-(0)-7795-600571
E-mail: [email protected]

Media Enquiries

Citigate Dewe Rogerson
David Dible, Shabnam Bashir
Tel: +44-(0)-207-638-9571
E-mail: [email protected]

SOURCE CALCIVIS