Medical device company Calcivis is launching its new preventive dental technology in the US after securing final stage FDA Pre-Market Approval (PMA). Calcivis filed a PMA supplement with the FDA for enhancements to its bioluminescent dental imaging system in 2023 and the new ergonomic, wireless, handheld imaging device is now approved for commercialisation.
The Calcivis imaging system applies a patented photoprotein which, in the presence of free calcium ions released from an actively decaying tooth surface, produces a very short, low level light flash. An integrated intra-oral sensor within the Calcivis imaging device immediately detects the luminescence, light-flash, and presents clinicians with a chairside demineralisation map.
The imaging system aims to impact caries management through early detection which allows for a more preventive treatment model. The ability to visualise active demineralisation, an early indicator of decay, live as it happens on patients’ teeth, is said to provide crucial insight as to whether a caries lesion is likely to progress and requires treatment. The Calcivis Imaging System is safe and effective for use in adults and children six years of age or older and can be used on all accessible coronal tooth surfaces.
As part of the business’ projected growth in the American market, the Scottish-based company has established its US headquarters in Milton, MA, and has strengthened its commercial team with the hire of Ronald Frezel as vice-president of sales and marketing, and Jill McGregor as chief financial officer.
“We are excited to bring the Calcivis Imaging System to market and are planning for our launch at the Yankee Dental Meeting, to be held in Boston, 25-27 Jan 2024. For the first time dental professionals and their patients will be able to visualise active demineralisation due to carious lesions in real time, chairside,” said Frezel.
The two executives have extensive experience in the dental and medical device space. Frezel has been responsible for bringing dental products to market in the US and Europe for more than 20 years and McGregor has led financial management for multiple early-stage companies in the UK and in the US. The US roll out will begin with a limited release launch in the greater Boston area in early 2024.
“With our US commercial team in place and a very user-friendly, ready for market device, we are confident that the Calcivis Imaging System will significantly improve patient care and enable restorative dentistry to move to a more preventive approach,” said Adam Christie, CEO at Calcivis.
Since it was founded in 2012, Calcivis has raised over US$19.6mil (£18mil) in funding. Investors include Archangels, which has been involved with the company from the outset, and Scottish Enterprise, Scotland’s national economic development agency.
Related: Calcivis Showcased its Calcivis Caries Activity Imaging System for the First Time at the Chicago Dental Society Meeting
