CALCIVIS, a medical devices company focused on modernising the management of tooth decay and enabling preventive dentistry, announces receipt of an Approvable Letter for the Premarket Approval (PMA) of its CALCIVIS® Imaging System from the US Food and Drug Administration (FDA).
CALCIVIS intends to introduce this novel product in the US in 2021 with the aim of creating a new preventive dentistry market segment in the US, projected to be worth up to $0.5 billion per year. The CALCIVIS Imaging System PMA approval by FDA is subject to customary preapproval facilities inspections.
The CALCIVIS Imaging System is a sophisticated medical device and biologic combination that highlights the presence of free calcium ions released during tooth demineralisation. Its use enables dentists, for the first time, to differentiate in real-time between active and inactive lesions on tooth surfaces. The CALCIVIS Imaging System provides visual evidence of active decay at an early stage.
This new approach is expected to change care planning and intervention for patients, leading to better preservation of their original teeth and improved oral health. The CALCIVIS Imaging System achieves this by enabling dentists to establish the need for preventive treatments such as remineralisation agents and sealants by differentiating active caries lesions from both sound enamel and inactive caries lesions.
The Approvable Letter is based around positive data from the pivotal clinical study, which evaluated the CALCIVIS Imaging System in the assessment of active dental demineralisation compared with the current best standard of care. 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).
CALCIVIS is working towards a US test launch of the CALCIVIS Imaging System in 2021 through its own commercial organisation in Massachusetts, based out of its US HQ in Boston. A full US national rollout of the System is planned to begin in 2022.
Adam Christie, CEO of CALCIVIS, said: “The receipt of an Approvable Letter from FDA is a very important step as we prepare to launch the Calcivis Imaging System in the world’s largest dentistry market. We are confident that CALCIVIS can help to establish a new standard of preventive care in US dentistry. The System enables clinicians to implement preventive strategies for caries management early in the caries process when it is still reversible, before cavities form. We also know that CALCIVIS images help patients to understand their condition and to value preventive interventions by their dentist. Our technology helps dentists and patients to collaborate in promoting better oral health.”
Dr Sarah Hardy, Chief Investment Officer at Archangels, said: “From the very beginning we have believed in the potential of CALCIVIS to make this step change in preventive dentistry. Today’s announcement is a major corporate milestone in achieving this goal, which will ultimately allow the CALCIVIS Imaging System to help dentists in the US to better preserve their patients’ teeth. CALCIVIS is now planning the US launch of this novel system via its own commercial organisation in the world’s largest dentistry market and we are confident of success that will bring significant return to shareholders.”
Kerry Sharp, Director, Scottish Investment Bank, said: “The Approvable Letter from FDA for the CALCIVIS Imaging System is a massive achievement for CALCIVIS and rewards the faith in Adam and his team over many years. Given the clear benefits the System delivers to both dentists and patients, I am confident that the CALCIVIS commercial team will drive significant uptake of this novel technology once launched, heralding a new era in preventive dentistry in the US.”