USA: Medical device company Calcivis is preparing to launch its groundbreaking preventive bioluminescent dental imaging system in the United States. The company has successfully obtained final-stage approval from the US Food and Drug Administration (FDA) for its innovative ergonomic, wireless, handheld imaging device, marking a significant milestone for commercialization.
Quoting Calcivis CEO Adam Christie, he expresses confidence in the potential impact of the Calcivis Imaging System on patient care, stating, “We are confident that the Calcivis Imaging System will significantly improve patient care and enable restorative dentistry to move to a more preventive approach.”
Unique Technology and Real-Time Demineralization Mapping
The Calcivis Imaging System employs a patented photoprotein that emits a brief, low-level light flash when exposed to free calcium ions from decaying tooth surfaces. Integrated with an intra-oral sensor, this luminescence is detected in real-time, providing dentists with a live demineralization map at the chairside. The system is deemed safe and effective for use in adults and children aged six years or older, offering a comprehensive approach to preventive dental care.
To support the US rollout, Calcivis has expanded its commercial team, welcoming Ronald Frezel as Vice-President of Sales and Marketing and Jill McGregor as Chief Financial Officer. Speaking about the upcoming launch, Frezel expresses excitement, stating, “For the first time dental professionals and their patients will be able to visualize active demineralization due to carious lesions in real-time, chairside.”
Limited Release in Greater Boston Area
The US release of the Calcivis Imaging System is scheduled to commence with a limited release in the greater Boston area early this year. This strategic approach allows for targeted introduction and implementation of the innovative technology.
The official launch is anticipated to take place at the Yankee Dental Meeting in Boston from January 25–27, 2024.
With the new technology poised to provide real-time insights into dental demineralization, Calcivis aims to revolutionize restorative dentistry and advance towards a more proactive and preventive approach in patient care.
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