CALCIVIS® to Launch Revolutionary New Bioluminescent Dental Imaging System in the US After Securing Final Stage Food and Drug Administration Pre-Market Approval (PMA)

EDINBURGH, Scotland–(BUSINESS WIRE)–Calcivis is launching its groundbreaking new preventive dental technology in the United States. The business filed a PMA supplement with the FDA for enhancements to its imaging system last year and the new ergonomic, wireless, handheld imaging device is now approved for commercialization.

“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.”

Adam Christie, CEO at Calcivis

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.

The two executives have extensive experience in the dental and medical device space. Mr. Frezel has been responsible for bringing dental products to market in the United States and Europe for more than 20 years and Ms. McGregor has led financial management for multiple early-stage companies in the United Kingdom and in the United States. The US roll out will begin with a limited release launch in the greater Boston area in early 2024.

Adam Christie, CEO at Calcivis, said: “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.”

Ronald Frezel, VP of Sales and Marketing added: “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 January 25-27, 2024. For the first time dental professionals and their patients will be able to visualize active demineralization due to carious lesions in real time, chairside.”

The Calcivis Imaging System will revolutionize caries management through early detection which allows for a more preventive treatment model. The ability to visualize active demineralization (an early indicator of decay) ‘live’ as it happens on patients’ teeth, provides crucial insight as to whether a caries lesion is likely to progress and requires treatment.

The 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 demineralization map. The Calcivis Imaging System is safe and effective for use in adults and children 6 years of age or older and can be used on all accessible coronal tooth surfaces.

Since it was founded in 2012, Calcivis has raised over £18 million in funding. Investors include Archangels, the world’s longest-running business angel investment syndicate, which has been involved with the company from the outset, and Scottish Enterprise, Scotland’s national economic development agency.